One of the items that has concerned me since vaccinations have become widespread has been the lack of attention given to clear signals that there are significant problems with side effects from the COVID “vaccines.” Mathew Crawford, a statistics and math guy, has an interesting take on this issue. Essentially he states that the CDC potential circuit breakers (safety signals) for the various therapeutics being called COVID “vaccines” are ill defined. And that is not good.
Any statistician will tell you that you can manipulate the same set of stats to achieve a lot of different goals and outcomes. As Crawford notes, axioms and definitions are the bedrock for understanding a particular outcome. When new equations are defined, they must be carefully attuned to the field that one is working in. As Crawford noted:
What we don’t do,… is lackadaisically establish definitions entirely ill-suited to a purpose.
And yet this appears to be what has happened with equations used to identify potential problems with the various mRNA gene therapies being used as vaccines.
Some background on this includes knowledge that the US government has a reporting system for adverse events. It is known as the Vaccine Adverse Event Reporting System (VAERS) where health care workers and patients can submit adverse events (AEs) suffered post-vaccination. It is a voluntary reporting system and is decidedly not user friendly. Some doctors have noted that it can take 30 minutes to enter a single event.
As Crawford states:
While the VAERS database is understood to record an often small subset of the AEs, the information can still be used for purposes of establishing safety signals. A new influenza vaccine can be compared to other influenza vaccines, for instance. If the old ones were safe enough, and the reported AEs of a new one are in line or better than for past vaccines, then the risk-benefit analysis for the new vaccine (assuming sufficient efficacy) either remains the same or improves.
Sufficient efficacy is an important point here. Regardless of how safe a vaccine may be, if it does not confer an effective shield to the infection being targeted, it should not be used.
On January 29, 2021, the CDC published a document entitled Vaccine Adverse Event Reporting System (VAERS) Standard Operating Procedures for COVID-19.
Please note the date. Since this is a government document, it undoubtedly was under development for some time. Who had input into the development of the safety signals portion of the document? As you will see, this is an important question.
Section 2.3 of the document is where signals for assessing the safety/danger of the vaccines are defined. As you will see, definitions in the form of equations are very important and they are screwed up.
Crawford identifies Section 2.3.1 as an important definition area. From the doc:
Chi-squared statistic is a bit wonkish and is not necessary to understand what has been done with the safety signal. So, I will ignore that in further discussions here. PRR is the key.
What is PRR? PRR is the proportional reporting ratio, and the PRR numbers are the outputs of a function defined by the CDC based on four variables. Again, the function definition is crucially important.
This equation is absurd for use as a safety signal. Here’s why.
“a” represents the number of occurrences of a specific adverse event (say a stroke) for a specific vaccine (think Pfizer, Moderna or Johnson & Johnson). “b’ represents the number of all other adverse events for that specific vaccine.
There is no differentiation between a safe vaccine and an extremely dangerous one that has multiple numbers of AE’s of all types. Crawford illustrates this with the equation below.
As Crawford notes this remains true for use of 50 in place of 20 or 1000 in place of 20. And what we are seeing in the real world is just what Crawford has illustrated. Many different AE’s have scaled up. This means that “b” is scaling up as “a” scales up.
It appears that the spike protein used in the mRNA gene therapy is responsible for many of the adverse events seen. And we are seeing large multiples of AE’s over what a safe vaccine might have experienced. By large, I mean several hundreds of MULTIPLES of such events for specific categories of AE’s.
The defined PRR might work if there is ONE particular class/type of Adverse Event (AE) that is much worse than other observed AE’s. That is not the case with the mRNA therapies.
Crawford notes:
Just during the COVID-19 vaccination campaign, important safety signals have come and gone without notice, such as the MedDRA term “death” showed up as a signal in dispersion analysis in February, but no longer does due to the rising quantity of so many other AE’s.
And it is not necessary for the number of all AE’s to scale up to hide a safety signal. Crawford provided this example.
Please note the relatively minor changes in the values on the right. The potential for a safety signal to emerge is very low. Crawford goes on to address another problem which is with the lower portion of the equation.
If ratios among AEs change little between vaccines (like for an AE that is the result of the presence of the spike protein) due to correlation, the denominators will change in a manner that is very similar to the changes in the numerators!
What Crawford is saying is that if a particular feature of the therapy is responsible for many of the AE’s seen (say the spike protein), this will manifest itself across all the vaccines being compared. Safety signals will be even harder to detect.
Is the PRR function designed to hide safety signals?
Never underestimate the potential incompetence of a government bureaucrat. I am reminded of a problem I had with one a bunch of years ago. I owed a fee to an agency in Canada. I paid the fee via my credit card. The credit card company charged me in US dollars the amount that needed to be sent in Canadian dollars using the appropriate exchange rate. Two years later I receive a letter from the Canadian agency claiming I had underpaid the fee by $4 Canadian. They wanted to charge me a late fee as well. It took THREE letters to get them to understand that the exchange rate two years after the bill was paid was not the same exchange rate at the time the bill was paid.
Crawford stated that mathematicians and statisticians worthy of the title do not miss the kind of nonsense embedded in the PRR—particularly not when working in a dedicated group on a serious problem. There is a pride among geeks in identifying subtle mathematical or logical flaws in a system and this is not subtle at all. Having been part of such groups at different times during my working career in technology, I can attest to this being true.
Crawford noted that calling this a safety system is decidedly unsafe. Even worse—given that numerous academics, including statisticians, reviewed this document, it is hard to believe that the problems embedded in the definition of PRR went unnoticed.
Was the intent of the CDC to establish an illusion of safety or was this just sheer incompetence? You be the judge.