ON placebos: either way, it's evidence of negligent harm

To placebo or not to placebo, does it even matter anymore?

Welcome back! My brilliant friend (let’s call her Lizard Brain because I love lizards and her name is Liz) sent me an article today that you can read here. It got her thinking got me thinking as well. I have never been comfortable with the use of the word “placebo” (as most of you are aware) in the context of the COVID-19 injectable products and have postulated that the “placebo” groups were in fact being administered empty LNPs and not saline, due to the rates of severe adverse events in the context of “placebo”.

https://static2.srcdn.com/wordpress/wp-content/uploads/2020/02/austin-powers-dr-evil-featured-Cropped.jpg

The reason I postulated this was because of the rates of (severe) adverse events occurrences in the context of the Pfizer and Moderna clinical trials that I have been studying for the past year or so. Some of these adverse events were severe including death. In fact, if you go back to this Substack, you’ll see that 15 people died in the placebo arm (along with 16 in the mRNA drug arm) during the ‘Blinded Part (A)’ trial according to the peer-reviewed analysis of the Moderna product efficiency and safety. Now, this was following the ‘2nd injection’. Following the 1st injection, only 3 died in the placebo arm. Hmm. That is very strange. If this was saline, why would there be a 400% increase in death following the 2nd injection? Why would anyone die at all? Is that ‘normal’? I don’t know the answers to these questions. Yet.

https://www.nejm.org/doi/suppl/10.1056/NEJMoa2113017/suppl_file/nejmoa2113017_appendix.pdf. Page 22.

There are countless examples of placebo inducing reported severe adverse events in both Pfizer and Moderna’s safety documents. This particular Moderna trial included individuals 18 years and older. But what about infants and younger children?

You may already be aware of the documents produced by Pfizer and Moderna in preparation for the VRBPAC meeting that happened last week on June 15, 2022.

Here is some data on fevers of varying degrees that arose in the respective trials.

Please go to page 89 in the Moderna document and page 44 in the Pfizer document for Figure 26 and Table 24 - converted into a like-wise Figure for your viewing pleasure! (You’re welcome Pfizer).

https://www.fda.gov/media/159157/download (Figure 26) https://www.fda.gov/media/159195/download (Table 24)

It is clear that the infants/toddlers reported fevers of 38-38.4 within 7 days in the context of the placebo in both the Moderna and the Pfizer trials. That’s strange. The fevers were reported at similar rates as reported for the ‘drugs’ in both cases as well. The only notable difference is in the PD2 Moderna data (top plot; first square) where they report 2.1 times as many fever occurrences in the drug arm, but still, 3.6% of the participants experienced low grade fever in the context of the placebo. So the big question is: why? I see three options:

1. The placebo is not saline - rather empty LNPs

2. The placebo is saline and the reactions (including fevers) are due to the immune responses induced from OTHER VACCINES

3. A combination of 1 and 2.

Now, we all know in the United States that infants (from birth!) and toddlers are ‘expected’ to be injected with a plethora of different types of vaccines throughout their very young lives - 50 times injected with 10 different vaccines against 14 different diseases - to be exact (unless I miscounted - you get the drift) by the time they are just 6 years old, according to the guidelines below. These are endorsed and promoted by the CDC, the American Academy of Family Physicians (AAFP), the American Academy of Pediatrics (AAP) and HHS.

https://www.cdc.gov/vaccines/parents/downloads/parent-ver-sch-0-6yrs.pdf

Now, since these infants from 6 months -4/5 years old enrolled as participants in the Pfizer and Moderna trials, would presumably be of parents who are prone to compliance with CDC (etc.) recommendations, I think it is safe to assume that each of these participants were all on the ‘schedule’ and had been administered each of the above ‘Recommended Immunizations’. ‘Other vaccines’ are not included in the exclusion criteria list for these trials. Which is, in and of itself, insane, if you ask me. The only exclusion criteria for counter-indication with regard to vaccines was point 11: “Previous vaccination with any coronavirus vaccine”¹ in the context of the Pfizer trial.

So why is it that my brilliant friend and now me are the only people publicly asking the question:

Could the adverse events in the placebo groups in both trials be due to the effects (adverse reactions) to other vaccines?

Let’s create a framework and ask a question. 6 month old infants, by the time they reach 6 months, have already been injected with 4X Hepatitis B (don’t even get me started on the lunacy of this), 3X Rotavirus, 3X DTaP, 3X HiB, 3X PCV13, 3X IPV and 1X Influenza. Now, combine this with being injected, as part of a clinical trial, with an experimental product that contains mRNA + LNPs. Is there anyone on the planet who can answer the questions:

Are there any counter-indicated vaccines in this mix?

Is it possible that the adverse events observed are due to the other vaccines?

No. There isn’t anyone on the planet who can answer this question because no one is doing this required work to ensure the actual safety of your babies.

This is the question for the ages. Because, if we are to believe that both Pfizer and Moderna are using saline placebo, then SOMETHING must be CAUSING these reactions. I used fever as an example here, which may be considered to be a mild adverse event. It is a common immune reaction to many things including the injection of a foreign agent or pathogen (see what I wrote there?) to the body. But it is documented in both trials that the saline placebo induced severe adverse events (SAE or ‘severe’) in 6-23 month olds (2.3% placebo vs 1.4% BNT162b2!! [Page 41-42, Table 21] in the case of Pfizer and 0.5% placebo versus 0.7% mRNA-1273 (‘related to vaccination’) [Page 92, Table 38] in the case of Moderna), so these adverse events described as severe would be unlikely to be caused by saline.

The problem I have with this (beyond the obvious ones), is that if one was to report only on the Moderna data in Table 38, for example, it would not be incorrect to report that the drugs did not induce statistically-significantly more SAEs than the placebo. If you glance back at the bar plots above for fever, you’ll clearly see my point. So, you don’t have to be lying, per se! (That’s not a suggestion for an out, by the way.)

But here’s the thing, and this is how BAD SCIENCE is happening all around all of the time. No one had prefaced, in this imaginary report of the Moderna data in Table 38 to VRBPAC (ahem), that it might be possible that these SAE occurrences might have occurred due to confounding factors such as OTHER VACCINE REACTIONS.

Can you think of a reason why one with financial conflicts with pharmaceutical companies would not want to report such a thing? I can. It would require an admittance of the possibility, the mere possibility, that one or all of these multiple vaccines/injections may be inducing/causing harm/SAEs.

So here’s the catch 22:

Both Pfizer and Moderna have to explain the SAE data from placebo in their trials. I would be content with explanations pertaining only to the recent studies².

They have the following options:

1. The placebo was not saline and induced SAEs - I want to know what that placebo is in this case (FOIA)

2. The placebo was saline as indicated and something else induced the SAEs - a reasonable explanation would be SAEs induced by other vaccines given as per the schedule.

In the former case, you are in quite a bit of trouble.

The the latter case, you have to do an investigative study which would necessarily mean a temporary halt to the current experimental trial and all subsequent EUA allowances withdrawn until the answers are provided.

1. https://clinicaltrials.gov/ct2/show/NCT04816643

2. Extension of C4591007 to 6 month olds - 4 year olds, EUA amendment request for Pfizer-BioNTech COVID-19 Vaccine for use in children 6 months through 4 years of age; mRNA-1273 PRIMARY SERIES 6 MONTHS TO 17 YEARS.