Divide and Conquer

Our drug safety monitoring systems are designed to identify an increase in the incidence of a rare condition. That is why they worked relatively well at identifying the Cerebral Venous Sinus Thrombosis and myocarditis cases. They are bad at identifying increases in more common conditions and terrible at identifying multi-system conditions. Conditions are compared to each other and where there underlying rates are high or where more than one label is given to a condition, reaching a high enough number to achieve statistical significance can prove impossible.

Dr David Graham, Associate Director for Science and Medicine and the FDA’s Office of Drug Safety in 2004, commented on the high threshold to declare drug side effects as genuine. He said, “That is an incredibly high, almost insurmountable barrier to overcome. It’s the equivalent of beyond a shadow of a doubt. And here’s an added kicker, in order to demonstrate a safety problem with 95% certainty, extremely large studies would be needed. And guess what? Those studies usually aren’t done, or they can’t be done.” 

Let’s say the covid vaccines caused heart issues then the analysis should include both analysis of specific heart issues, such as myocarditis, but also analysis of all heart issues together. If the latter analysis is not done then the problem can be hidden by labelling it with multiple terms such that the numbers are split and small and can’t reach statistical significance. 

This is what Pfizer has done in their latest safety analysis. The safety analysis was carried out on five databases and not all showed a signal. People in the European PHARMO dataset were healthier – they had a far lower incidence of death, for example. Therefore any signal would be most likely to show up in this database because they are less likely to be lost in the background noise. A separate European database, NHR, also showed a signal if, instead of splitting cardiac events, all of them are considered together.

The total number of cardiovascular events of any type works out at a risk of 1 in 264 for NHR and 1 in 362 for PHARMO. By contrast the claimed risk of severe covid was reduced by 1 in 2403 for NHR and 1 in 5181 for PHARMO.

Pfizer admit there is a signal in the PHARMO database but articulated a plan to make it disappear, saying, 

“it could be possible to model some constructive bias analysis to correct this in the final analysis.”

The rate of cardiac arrhythmias showed a statistically significant increase in all the databases. There is a mortality rate associated with arrhythmias of the heart. Pfizer claimed that the excess arrhythmias was because the vaccinated are healthier!

Figure 1: Cumulative incidence of cardiac arrhythmias by vaccination status for four of the databases. The red line shows the incidence in the vaccinated and blue the unvaccinated.

The same principle, that splitting can hide issues where grouping reveals them, is true for non-cardiac injury too. The pressures on hospitals in 2021, including in Australia where there was minimal covid, and the rise in long term sickness among the working aged population despite claims that injury was rare, are both illustrations of that.

Specific injuries end up being compared to overall illness and do not stand out because of the multi-system harm caused by these novel products. This is due to:

1. Cell death

The mechanism of action of all covid vaccines is to cause cells throughout the body to express a foreign protein and be killed by the immune system. The result can mean either an illness that mimics autoimmune disease or else a reduction in the cell reserve for a particular organ that exposes a disease that otherwise might have remained sub-clinical and undiagnosed for the life of the individual.

2. Auto-immune

Conventional auto-immune disease is also a high risk because the spike protein has marked overlap with the sequences of human proteins. The result is that the immune system is being trained to attack something which can be mistaken for healthy self tissue.

3. Vascular Injury

Only 2% of the mRNA products are taken up by cells according to Moderna. The rest circulates such that the endothelial cells have the highest risk of being affected and damaged. The end result is microclotting which could affect any organ.

4. Lipid Nanoparticles

Lipid nanoparticles are known to be toxic. In Moderna’s biodistribution study submitted to the FDA they admit that the toxicity problems “are driven primarily by the composition of the LNPs and, to a lesser extent, by the biologic activity of the antigen(s) encoded by the mRNA.” 

5. Endotoxin

Contamination with endotoxin derived from bacterial cell walls used in the processing can lead to hugely diverse adverse events. 
Our drug safety systems excel at spotting rare issues but fail to capture broader, multi-system harms. Pfizer’s data splitting hides significant overall cardiac risks. Without doing an analysis on overall harm to an organ system and even all cause illness, then the full story isn’t revealed.  Without a more thoughtful approach the real dangers will remain buried, and public trust will pay the price.