RTE Roundtable Talk #19: Pseudovaccine Quality Inconsistency
With Maria Gutschi
Though I wasn't aware where this week's Roundtable discussion was going (this was Liam's schedule, not mine), it was one of the most educational for me personally. That and I love Maria—she is the kind of good energy intellect that gives hope for community regulation.
Understand that I am a believe that overly centralized regulation simply cannot ever retain high fidelity necessary to govern an industry so important as medicine. The honey pot just gets too large, and the people involved don't have to look most of those affected by their decisions (or even their community leaders) in the eyes, ever. And the whole industry being regulated is too closely tied to other power centers, including the military-banking complex. But I do strongly believe in the value of community, and the reason individuals support a healthy, functioning community, is that their members, including leaders and role players, all contribute to the health and safety of the community. Maria is exactly that person I'd be proud to have guarding my tribe.
And if you don't learn from her presentation, it could only be because you're already inside either her discussion circles or one of the few other circles that has taken great pains to tease apart all of the available information.
Originally this discussion was going to be called something like "All of this is fake (except the adverse events", but we wanted to be able to stream to YouTube to maximize the audience reach.
A few topics discussed:
How negotiation theory (similar to the game theory of auctions math) may be a jedi mind trick that results in regulatory capture.
How tolerances involved in the approval process do not necessarily have any meaning known to the regulators (though there may be asymmetric understanding on the part of the pharmaceutical manufacturers), hence use of the jedi mind trick above.
How LNP size may be changing over the course of the pandemic, and why that matters.
How we do not even know if there is a "goldilocks zone" in which these products are net beneficial.
And many others. Like I said, this was one of the more educational discussions for me during the pandemic. I am still learning about the regulatory processes, and being shocked by new twists and turns. It's as if the drug distributors always had a thousand tricks at their disposal, and decided to use them all at once for the shock and awe many of us intuitively felt even if we could not decipher all of the many details.
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Awesome coverage by Gutschi.
I believe the Australian Nonclinical Eval has cryoEM of the Pfizer mRNA-encoded spike on page 37 https://www.tga.gov.au/sites/default/files/foi-2389-06.pdf
This was at the stage where they were still considering four builds. The text doesn't actually make it clear that what we are looking at is from any of them, let alone BNT162b2.
The 30% benchmark for flow cytometry might not correspond to transfection rate since that's essentially a semi-quantitative assay, and might not catch all cells that are producing spike - it could be that the real-world rate is higher at least when all the other stars align and the gods of stainless steel shavings grant their blessing.
Thank you for bringing Maria Gutschi’s work to attention. Such an important piece, along with Latypova, and JJ Couey.
Just one quibble: ‘National Security’ is a highly problematic phrase. I would caution against its use here. It has been popularized for very specific messaging from the MIIC and has, and continues to be, used as a justification for all manner of illegality, secrecy, and fraud. I understand the intent of the concern raised here, but this phrase should be thoroughly parsed and must be considered a highly loaded label.