Vaccine Safety and the Precautionary Principle
Vaccine safety expert, Dr. Judy Wilyman publishes a compelling analysis today in Science, Public Health Policy & the Law. The article establishes that the burden of proof of vaccine injury has been misplaced by what she calls a “Misapplication of the Precautionary Principle“.
Dr Wilyman’s analysis, which went through rigorous and repeated rounds of peer review, is a sharp reminder of the unintended consequence of misguided policy decisions and should help inform a broader discussion in society.
Abstract
Vaccination is a medical intervention that comes with a risk for some people. In the expression of infectious diseases, it is known that the pathogen alone does not cause disease: it is a combination of the pathogen, environment, and genetic factors that determines expression and severity of the disease in individuals.
In 1960 Macfarlane Burnet, Nobel Prize laureate for immunology, stated that genetics, nutrition, psychological and environmental factors may play a more important role in resistance to disease than the assumed benefits of artificial immunity induced by vaccination. He considered that genetic deterioration of the population may be a consequence of universal mass vaccination and he postulated that in the long-term vaccination may be against the best interests of the state.
The current belief that much of the burden of infectious diseases can be alleviated if every child, in every geographical location, has access to multiple vaccines, does not consider the influence of genetics and environment on the health of populations. The historical record shows that deaths and illnesses to infectious diseases
fell due to public health reforms – and prior to the introduction of most vaccines.
Since 1990 there has been a 5-fold increase in chronic illness in children in developed countries and an exponential increase in autism that correlates directly with the expansion of government vaccination programs. Many individuals are genetically predisposed to the chronic illnesses that are increasing in the population and since 1995 governments have not used mortality or morbidity to assess outcomes of vaccination programs.
Human health can be protected in government policies if the precautionary principle is used in the correct format that puts the onus of proof of harmlessness on the government and pharmaceutical industry, and not the general public. This has not been done in current vaccination programs and we cannot rule out the possibility that the increased use of vaccines is destroying the genetic fabric of society as MacFarlane Burnet postulated.
- Introduction
The focus of this paper is to examine the historical evidence for the control of infectious diseases and to describe the changes in health outcomes that have occurred in all populations concurrent with the increased use of vaccines. The decline in health that is being observed is discussed with respect to governments’ use of the precautionary principle to show that its use in the correct format is critical to protecting public health.
- Causality Inference Unsupported
When the World Health Organisation (WHO) and governments claim that vaccines are ‘safe and ef- fective’ this claim is based on a lack of scientific evidence because they have never performed the empirical causal study that would prove or disprove the direct link that we are observing, in all countries, between the significant increase in chronic illness in children and the expanding vaccination program [1][2][3].
This causal study would use an inert placebo in the unvaccinated group to provide empirical evidence of the effects of the vaccine /combination of vaccines on the human infant, but such a study has never been conducted [4]. This evidence could also be collected from active surveillance systems that monitor adverse health events of all vaccinated individuals for 5-10 years. But these monitoring systems have also never been implemented [4].
Further, the WHO and national governments have never tested vaccines, even the vaccines with a long history of use, in formal controlled clinical trials to demonstrate with empirical evidence that the vaccine can prevent the vaccine-targeted disease
Instead of studying the effects of vaccines on detectable infection rates, studies use the surrogate of seroconversion (antibody titre) to claim that vaccines can prevent infectious diseases. Titres are known to not be a reliable indicator of protection from the disease [5][6][7]. This does not suggest that vaccines do not have any benefit in reducing the transmission of the disease in the community, only that it is not accurate to describe these diseases as “vaccine-preventable diseases” when this criteria has not been proven by governments.
Stanley Plotkin described as the ‘father of world vaccinology’, states that it is not possible to rely on the antibody titre that is considered suitable to con- fer immunity for measles because it is not known [8]. He also states that antibody titre is not a reliable indicator because we do not know precisely how antibodies work. In other words, without the empirical clinical evidence from controlled clinical trials to demonstrate that vaccine-induced (artificial) antibody titre is protective against each infection, we cannot claim that vaccines are effective in preventing them.
It is known that antibody sero-conversion is achieved by natural exposure to the infectious agent, with or without clinical symptoms. Cases with- out symptoms are referred to as asymptomatic infections (sub-clinical infections) and they result in long-term immunity in contrast to the short-term immunity obtained after a vaccine [6][8][9].
Plotkin also admits that some vaccinated individuals are still being diagnosed with vaccine-targeted diseases after they are vaccinated and they can spread these diseases even if asymptomatic – ‘The possibility that a subclinical infection or paucisymptomatic infection (a few symptoms) with measles virus occurs in vaccines must be considered’ [8].
- Precautionary Principle Misapplied and Burden of Proof
Government vaccination programs are now recommending up to 16 vaccines for children (>52 doses from 0-14 years old). Yet the claims made by the WHO and governments about the safety and efficacy of the program are not evidence-based due to a lack of sufficient empirical evidence.
It is incumbent on the proponent of this medical procedure, the WHO and governments, to provide the evidence that this program is safe and effective, not the general public upon whom the policies are enforced. This is because governments have a duty of care to promote healthy outcomes in government health policies and this can only be done if a medical procedure is proven not to cause significant harm in the population before it is implemented [10] .
This is implied in the precautionary principle (pp) when it is used in the correct format in decisions for government health policies. The risk to human health that current vaccination programs represent has arisen because the precautionary principle has not been applied in a manner that would protect human health in the design of government vaccination policies.
In order to protect human health, the PP should be used in the format that states that the onus of proof of harmlessness of any medical intervention is on vaccine proponents, and not the general public [10]. When used in this format the PP will protect human health in government policy.
This is because the government is required to provide sufficient evidence to make causal inference on the question of whether the combined schedule of 16+ vaccines is, or is not causing the chronic illness that we are seeing escalate in children be- fore they recommend or mandate this program for children. Instead, safety is presumed, out of concern for instilling doubt in the publics’ mind about vaccines, and retrospective studies are used to assess safety after the vaccines are unleashed upon the public.
The reversal of the PP in the design of these programs places the burden of proof of harm, in individual instances, on the general public. This is logically equivalent to placing the burden of proof of harmlessness on the public. In this format it allows public health authorities and doctors to ignore the empirical evidence of chronic illness that is increasing in children in direct correlation to the increased use of vaccines.
Governments and doctors today claim this association is a ‘coincidence’ and that vaccines are ‘safe and effective’ by ignoring evidence supportive of plausibility of a causal relationship between vaccination and chronic illness in children and by not investigating this relationship in controlled clinical trials.
When the precautionary principle is reversed to put the burden of proof of harmlessness on the general public, instead of the pharmaceutical companies and governments, then it can be used to protect the vested interests of industry in government vaccination policies and not the health of the general public.
The current alignment in misuse of the precautionary principle can be expected to lead to the perceived need for enforced policy due to the reliance on uninformed or misinformed regulation of vaccines (Figure 1). An appropriate application of the precautionary principle could be expected to reduce resistance to vaccination due to transparency, in- formed regulation and respect for informed consent (Figure 1).
Vaccination is a medical intervention that comes with a risk for some people. When adopting a strategy to prevent infectious diseases it is important to choose the preventative measure that best addresses the causal mechanisms for the disease. In the expression of infectious diseases in humans it is a combination of the agent, environment, lifestyle and genetic factors that determines the severity of the disease. There is a wealth of data showing that environmental factors are the primary determinants of health and infectious disease [7][9][11][12].
Wilyman, J. Misapplication of the Precautionary Principle has Misplaced the Burden of Proof of Vaccine Safety. Science, Public Health Policy & the Law Nov 2020 2:23-34.
Access the full PDF of the paper at www.publichealthpolicyjournal.com
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Alan
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This raises important questions that should be investigated. Although entirely subjective I feel that people are not as healthy as the used to be. The majority of my grandparents life was before the NHS was formed and they could not afford to see a doctor, but they both survived to 78. I lived in the same house and when they became ill and obviously dying children were not allowed to see them. I remember doctors came to the house but there was no hospitalisation. When they died the coffin was brought to the house and they were laid out at home. This seems to be a far better death compared to today when we are filled with pills, extending our life but with poor quality for many, ending up in care homes and the final indignity of a post mortem slab. Just like many areas of our life the state has taken over control from families. The state does this to collect statistics but I can see little value from this de-humanising activity. This must be reversed in my view.
Also of interest is that one of my uncles died long before I was born in the 1918 flu epidemic. He was 10 at the time and was living in a two up, two down house with his two parents and six other children. Unfortunately, I don’t know if any others got the flu but he was the only one who died. This surely proves that genetics play a big part in disease, which this article points out.
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Tom O
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When it comes to changes in humans, evolution is considered to take a very long time. In truth, it starts with a change in one generation. The introduction of multiple vaccinations at a time when children are actively building their own immune systems seems to be a poor idea to start with since it would seem to most logically affect the way their immune systems develop. This could potentially become a re-coding of their genetics which then is passed on to the next generation. I am not sure there is “wisdom” in vaccines during this active time of immune development, and certainly not so in infants, before they even have the opportunity to start developing the robustness of their own immune systems.
Being an antique to start with – 76 – and not having children of my own, I can’t honestly see the changes in the rate of sickness of children through the ages. I recall that as a child myself, it was unusual to miss two days of school in a row for sickness, and in my own personal case, often a day missed because of being sick too often was a day I just didn’t feel like going to school. Yet I know people that do have children and they are out for several days, usually, when they are sick, and those don’t appear to be “acts” as they were in my case. It does almost “suggest” that the human immune system is less robust than it was, but that could also be that as children, humans aren’t exposed as much to disease as we were in my childhood.
Because of a lifestyle change towards higher sanitation practices, such as the usage of anti-bacterial cleaners and the cleaning habits used, we have moved towards lifestyles that more closely represent the environment of “the boy in a bubble” than we were before we started freaking out over “germs.” And the freaking out over “germs” was all part of the push to “vaccinate all disease out of existence.” If people were afraid of it, you could push that program forward.
One thing we have learned but not learned, is that when you have moved your civilization to a state where they are immune only to certain things that cause no significant problems, you end up with an immune system, such as was in North American native populations, that were unable to adjust to new pathogens brought by immigrants from Europe, though even theirs rapidly developed over a few generations to be more tolerant. It would appear, then, that exposure to disease is the best way to develop a population that will not be decimated by it later. That and a better state of health in general due to proper nuitition. Every major pandemic in history has followed that pattern – until this so called pandemic, that is.
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Brian James
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Dec 1, 2020 Bill Gates’ COVID vaccine goal: Dosing seniors, kids and pregnant women
https://youtu.be/6y2I0xAPSQk
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Isaiah
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“Governments and doctors today claim this association is a ‘coincidence’ and that vaccines are ‘safe and effective’ by ignoring evidence supportive of plausibility of a causal relationship between vaccination and chronic illness in children and by not investigating this relationship in controlled clinical trials.”
I can think of nothing more supportive of this statement than the following
Library of Congress, 49 Fed. Reg. (June 1, 1984). https://www.loc.gov/item/fr049107/
Additional Standards for
Poliovirus Vaccine, Live,
Viral Vaccines;
Oral; Final Rule. Rules and Regulations 23007 Pg 255 “any possible doubts, whether
or not well founded, about the safety of
the vaccine cannot be allowed to exist
in view of the need to assure that the
vaccine will continue to be used to the
maximum extent consistent with the
nation’s public health objectives.
Accordingly, because of the importance
of the vaccine and of maintaining public
confidence in the immunization program
that depends on it,”
https://tile.loc.gov/storage-services/service/ll/fedreg/fr049/fr049107/fr049107.pdf
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