The Emperor's New Clothes - part 4
Ladies and gents - fasten your seat belts and hang on - we are jumping into the rabbit hole!
Let’s begin with a brief explanation that will illustrate how manufacturers of diagnostic tests for medical conditions, whether they are for diseases or normal biological conditions, can determine with certainty that their test is indeed accurate. Let's take a rapid pregnancy test kit as an example. The evaluation is based on the detection of the pregnancy hormone (HCG) in the urine. Note that the test kit does not directly measure the existence of the fetus but relies on a proxy factor related to the physiology of the pregnancy. Of course, in order to determine the degree of accuracy of this test, it must be validated against a "Gold Standard".
The gold standard will be a measure that is not subject to interpretation and is actually a direct measurement of the condition we are diagnosing. In the case of pregnancy, the gold standard can be an ultrasound examination in which the presence of a fetus in the uterus is directly identified. This is how you can measure the success rate of a given test kit in relation to the gold standard in which we know for sure that there is a pregnancy.
In the same way, a test kit for Covid-19, in our case - based on PCR, must be validated against a gold standard. Why? Because the PCR test is based on the detection of a short genetic material segment that is supposed to be specific to the virus - SARS-COV-2 - which is claimed to be the cause of the covid 19 disease, that is, there is no direct measurement of the virus, rather a measurement of a proxy parameter that could indicate of the existence of it.
How can a PCR test kit could be validated? In order to do so, the manufacturer of the test, or the scientist who develops one and claims it to be accurate, must successfully go through at least 3 stages -
He must isolate and purify the aforementioned virus, that is, separate it from any other material. Why? Because if we are dealing with identifying a short genetic sequence that is associated with a virus, we must be 100 percent sure that the sequence does not belong to another organism and only if we separate the virus from any other material can we characterize and sequence its genetic code and then we may find a sequence that is specific to the virus and the virus alone.
He must prove the four postulates of Koch (the scientist - Robert Koch) for a pathogen associated with a certain disease, or alternatively the postulates of Rivers - we will expand on this next chapter.
He must have for the entire process described above a set of control experiments, whereby the same set of procedures is taken only excluding the pathogen. This is critical in order to make sure that no artifact is involved.
After he succeeds in the three above-mentioned tasks - the same test manufacturer might be able to claim it had developed a PCR kit that will identify the genetic segment associated with the virus that causes the disease, and again, provided that he has successfully passed the Koch test. The Koch test actually constitutes in this case the gold standard against which the - PCR is to be validated.
After understanding these principles, let's ask the Ministry of Health for the information that proves that such a process has indeed taken place - that validates the PCR tests against a gold standard and that qualifies them to diagnose the new disease -
I assume most readers are not Hebrew readers and so I only posted here a part of the full request. In short, I asked for the MOH to supply a scientific evidence for the full isolation and purification of SARS-COV-2 with emphasis that this information should contain specific information about controlled experiments on/with human subjects or human cells as well as detailed documentation of the complete purification and isolation of the virus from humans. In addition, I asked for a published evidence that all six Rivers postulates or Koch’s postulates (More on that - next chapter) were tested and fulfilled so that it is established that the new virus is the causative agent for COVID-19 and if not - what was the gold standard against which the PCR tests were validated.
On 1/18 /2023 The following response was received by the Ministry of Health addressing my query-
Again - this is a short segment from the full reply. What did they reply?
The Ministry of Health replies at relative length and a superficial reading gives the reader the impression that all the requested information has been provided to our satisfaction. For example - the Ministry of Health claims that the virus was isolated and purified in a virology laboratory and that the virus was fully sequenced. It continues and provides as proof, a reference to a scientific article in which there is an explanation and documentation of the process carried out to obtain the isolated and purified virus. Although this sounds good, if we examine it in depth and understand exactly what was actually done, we will discover a completely different picture.
First, we will examine the article referred to in section 1 by the Ministry of Health's -
The authors of this article were very short on details and it is very difficult to understand the virus isolation procedure. Therefore, I contacted the main author of the article, who is a senior researcher in the main virus laboratory at Sheba Hospital (one of the major hospitals in Israel), and asked her for clarifications and details on how the virus was isolated and purified.
I was directed by her to another article she published which should(according to her) contain detailed documentation of the scientific process that was carried out. We will now examine the additional reference I received:
Also in this article, unfortunately, the description of the procedure for isolating the virus is very short and consists of only two sentences (highlighted in color). What is clear so far is that lab work was done on monkey kidney cell culture (VERO-6) and not on human cells. In order to make sure that I did understand what was the procedure in the laboratory that they performed, I wrote again to the author of the article above in which I described in my own words the procedure that was performed. In red - the corrections/additions of the author of the article:
Let us translate and clarify the above findings in simple language:
The procedure for isolating the virus (as is customary in the field of virology as we will see next chapter) is described as follows: taking a throat swab from people with a positive PCR result - that is, they found in them the presence of a short segment of genetic material that was determined to be specific to the virus. The throat sample is transferred to a monkey kidney cell culture (VERO-E6) for incubation and then, once they observe that the cells in the culture are dying, the same segment of genetic material is searched for and found again (by PCR) but in a larger quantity.
Now I would like you the reader to contemplate - In your opinion, is it possible to say with certainty that this is a procedure for isolating and purifying a virus?
We will expand on this in more depth later.
Allow me to share my view on this so-called “proof of virus isolation”. There is a circular "proof" mechanism here whereby they find something in a swab sample (a short sequence of genetic material identified through PCR) that they decided in advance - is a proof of the presence of the pathogen, and then that 'something' (the genetic sequence) is transferred to a solution (along with tens of countless other biological material present on the swab) and then it is poured on a culture of monkey cells (why monkey cells? - possible explanation later) and after a few days, they look again for the same sequence that they poured in the solution to find it again. And this is their proof that they found what they were looking for in first place... got it? circular process.
The question of the chicken and the egg is raised here - how did they know in the first place that the genetic sequence found by the PCR is the indisputable signature for the presence of the virus? Obviously, it was necessary in the first place to isolate, purify, identify and characterize the virus called SARS-COV-2 and only then to develop the PCR (remember the explanation at the beginning of the chapter?). You can't build the building from above, right?
In addition, pay attention to another nuance - what is their proof for the presence of a virus? The proof is the observation of cell death in the monkey cell culture with which the procedure was performed in the laboratory (what is called - CPE - cyto-pathic effect). At no point was it claimed that they saw or measured or did anything to purify the virus itself in its entirety as a whole functioning biological entity.
And beyond that - is this a proof that the virus (which was not measured directly) is the cause for the death of the monkey kidney cells?
Claiming ‘yes’ would be equivalent to giving someone a mystery cocktail consisting of alcohol, sugar, pineapple puree, coconut puree and mint. When that person will get drunk and feel bad we could claim that this is proof that peppermint caused the intoxication...
After reflecting on the matter, I remained troubled that I might be missing out something, so I asked Michal (the senior researcher) - what is their control for this -
Quote from the correspondence with her:
" How can you know that the genetic material you found does indeed belong to a real and functional virus and is not an artifact or accidental genetic material found in the liquid ? After all, there is a mixture of many things in the throat sample, isn't it?"
Her answer - quote:
" We know that the virus has grown because we check the amount of the virus, we see that we have more virus after the growth in the culture than in the original sample from which we started and when the culture grows we get virus values that are not normally seen in patient samples, so it is clear that the virus has multiplied... "
And again - pay attention to the nuance - she does not claim at any point that there is a direct measurement of the isolated and purified virus, but in fact it relies on several basic assumptions (that needs to be verified) -
That the PCR test with which the procedure was performed in the laboratory is indeed specific for the virus, meaning that someone else somewhere did everything necessary to validate the PCR kit. As we will see next chapter - this assumption is wrong.
If there is a quantitative increase in the genetic material after several days of incubation with the monkey cells - then the conclusion is that the virus is responsible for the observed increase in the amount of genetic material.
What does that actually mean? Is it possible to conclude from this - that there is no real control for this experiment ?!
As mentioned, it is not difficult to see that at no stage of the procedure that was carried out (and this is a fact - according to the researcher herself) - was there a real and direct measurement of the complete and fully functional virus. That is, all proof of the existence and isolation of the virus is based , according to the above information, on a quantitative change in a segment of genetic material that was decided to be the unique identification mark for the virus . The question arises then - on what basis did they determine the segment of the viral genetic material that is specific to this virus?
Again - they used PCR to detect the virus.
But how was the PCR designed in the first place?
So, we returned to the point that in order to have a valid PCR at all, the virus must be isolated and purified, sequenced, and then, and only then, a genetic segment (called -primer) could be designed that will be specific to the virus. You can't start straight from the end, can you?
In the next chapters we will further investigate this question, but for now - let's summarize this chapter.
In the request for information from the MOH I asked for proof of the isolation and purification of the virus in its entirety from humans and although superficially we received an answer with the requested information, when we delved into the details we discovered that according to the best information from the MOH -
There is no direct proof of the existence of a complete and functional virus.
There is no direct measurement of it in any scientific procedure carried out in the main virus laboratory in Israel .
There is no characterization of the virus except for sequencing of some genetic material.
And last but not least - there is no control process that will rule out an artifact or other variable found in the experimental system that was used in the laboratory.
Bare in mind - this is the official reply of the MOH regarding a scientific proof of validation for the existence of SARS-COV-2 and for the validity of PCR tests for COVID.
The emperor indeed seems to be quite naked.
But wait, there is more.
on future chapters we will explore the scientific literature and try to make sense of all of this.