Written by Saeed A Qureshi PhD (edited by John O’Sullivan) via https://principia-scientific.com/
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Regulatory authorities, such as the CDC/FDA all insist that their handling of the current Coronavirus pandemic (SARS-CoV2/COVID-19) is based on science and associated data or facts. This is especially the case in the United States.
We are told that an identified virus causes the infection which in turn causes, or may cause, deaths – potentially in the millions.
Furthermore, authorities also claim that the viral disease (COVID-19) can only be treated with a vaccine – which at present does not exist – and must be developed urgently and then made available to the public worldwide.
Let us evaluate these claims on a proper scientific basis. First of all, let us see if the virus has been proven to exist in humans. Then more importantly, determine to what extent, if any, it can be measured as the disease which causes all these alleged deaths.
The presence or absence of COVID-19 in humans has not been determined effectively and efficiently because of the known current technical (scientific) limitations, as explained below.
In most cases (in fact, in almost all cases) the presence/absence of the virus is established by indirect testing. These indirect tests are commonly known as PCR and antibody tests. Without going into technical details, one may consider that these tests monitor specific types of proteins or related chemicals which are produced by the presence of viruses, not only by SARS-CoV2 or COVID-19, but by all pathogenic viruses as a defence mechanism to get rid of the viruses and/or to protect our bodies from their ill effects.
It is important to note here that when someone refers to testing for a virus, one does not determine the actual virus itself but a marker (such as a protein).
The Irony Is That These Markers Are Not Specific To COVID-19, But Are Generic To All Viruses To Which We Are Exposed.
Saying it differently, these tests are never sufficiently specific – and scientifically speaking should not be relied upon for declaring the presence of a specific virus – including COVID-19. Obviously, if a virus cannot be monitored reliably, then by implication the associated disease or deaths cannot be established reliably and accurately – at least scientifically.
Hence, we see confusion and the inaccuracies over the predicted death rate which turns out to be no higher than a normal to severe influenza and concurrent attrition rate. In a simpler and daily life example, one may explain the situation as akin to establishing car safety by monitoring the air pressure levels of the tires (the marker) because someone decided that deviation in car tire pressure is to be the determinant of safety.
It is quite possible (by chance) that a deviation in tire pressure could compromise vehicle performance/safety. However, it is neither accurate or logical using tire pressure alone as your safety criteria and to then label “unsafe” any and all cars with one or more tires with somewhat irregular pressure. One or more tires alone may be the problem – not the car.
Unfortunately, in the extreme, the authorities end up deciding that all car safety will be monitored only on the basis of tire pressure level. Now this would become a “Regulatory Compliance Requirement” or the law for car safety assessment.
On top of this comes the irony that these authorities provide their own version of tire pressure gauges to test all our tires, which happens to show tire failure routinely in otherwise perfectly acceptable cars.
This is exactly the situation we have with the pandemic and COVID-19 monitoring i.e. a regulatory compliance requirement that COVID-19 infection will be established based on PCR/antibody tests (let’s call that the “Official Test”) which, as noted above, is not specific at all to COVID-19. Worst yet, the authorities are specifying the use of a testing protocol instituted and “approved/authorized” by them alone.
It is important to understand that the “Official Test” is solely on a regulatory compliance requirement basis. It is NOT a scientific validation of having COVID-19. Yet it is promoted as scientific.
While it may be true that believers and promoters of this requirement of testing are experts from the areas of pharmacy, epidemiology, virology, genetics, microbiology, immunology, medicines, and biochemistry to name a few. They are not experts in testing.
Where the real capability lies in determining a valid test falls in the category of analytical chemistry. The multiple aforementioned disciplines named are the users of the tests. They should not claim to being the developers and/or validators of the test – they lack the required expertise. I say this as an expert in this field of testing.
To better illustrate the subtlety of this point let us consider the analogy of a baker who uses agricultural products (e.g. flour) and cooking equipment (e.g. oven) to make bread but then believes he is somehow also qualified and holds authority over the developing and manufacturing of the items used to make the bread. If one sees the issue from an analytical chemistry perspective, it should become immediately obvious that such inexpert testing is scientifically invalid and so, too, are all the associated claims based upon it.
The reason that current COVID-19 testing should be considered bogus is that these tests do not meet the basic and fundamental requirements of science (analytical chemistry) which is the procedure of validation of the tests.
This validation step is commonly based on establishing four parameters: (1) accuracy; (2) precision; (3) specificity; (4) references used to validate the test.
No analytical test is accepted without meeting these validation requirements – the most essential scientific requirements.
However, at present no COVID-19 test is used (or is even available) which has such validation. As such, the current practice is ordinarily considered as a cardinal sin in the scientific community.
Pro-PCR/antibody test scientists often argue that seeking a specific test for COVID-19 (or its associated disease) is like seeking “absolute truth” which would hinder the current and (to them) “acceptable” testing/science. This unfortunately is the most deceptive, even fraudulent position possible and yet it is often supported (and promoted) by the regulatory authorities.
Therefore, at present, regulatory authorities are not implementing the true scientific principles applicable to this pharmaceutical issue. Instead, their methodology is self-created and an arbitrary science of “regulatory compliance requirements” with various flashy and catchy marketing phrases.
Now, if the COVID-19 virus cannot be determined (isolated), and by extension the real nature of the pandemic, for what purpose is a vaccine being developed?
Again, this is all just a regulatory requirement because regulatory authorities are asking for it, and as such, it needs to be developed. On the other hand, it is impossible to develop a true vaccine for COVID-19 because – if we are incapable of actually monitoring the virus or disease – how can the effectiveness of a vaccine be established?
In short, it cannot!
Therefore, most likely a fake vaccine will be developed to satisfy the regulators’ wishes (as well as to calm down the created public hysteria and fear). Unfortunately, such vaccines, if developed and administered, will certainly create potentially dangerous side effects, without any presumed benefits, by interfering with the body’s own immune system, as well as other related physiological processes.
The ill-thought out regulatory compliance requirement is not new or just associated with COVID-19, it is pervasive in other pharmaceutical areas as well. For example, it reigns for the approval process of traditional pharmaceutical products such as a tablet or capsule – and it has been standard procedure for at least three decades, which certainly has ruined the science, as well as pharmaceutical product development and manufacturing.
All kinds of enforceable regulatory requirements have been spawned and implemented in the name of quality control of the manufactured products. The irony here is that authorities have never defined what they mean by a “quality product” with some (scientifically) measurable parameter/criteria.
However, there now exists a huge battery of compliance requirements (such as regulatory guidance documents) available from authorities, in particular the FDA. The requirements and guidance, are enforced with or without numerous unrelated testing requirements. They have never been validated to see if they meet their intended purpose or claim. But industry must comply if it wants to survive and the public goes on assuming it is receiving “quality” pharmaceutical products.
In summary, at present there is a serious and fatal flaw in the practice of regulating pharmaceutical products, development and assessment. This can only be addressed by critically evaluating and implementing appropriate scientific principles from relevant scientific disciplines and expertise.