Reading Between The Lines - An Illustration of Corporate Deceit and Active Manipulation of "THE Science"
Words and Data Matter: A close look at Pfizer's CUMULATIVE ANALYSIS OF POST-AUTHORIZATION ADVERSE EVENT REPORTS OF PF-07302048 (BNT162B2) RECEIVED THROUGH 28-FEB-2021 dated 4/30/21.
In response to a lawsuit filed by Siri & Glimstad LLP on behalf of their client Public Health and Medical Professionals for Transparency, the FDA has released the first 91 pages of documents to them. Which they have made public. The following document was included in this first round and contains data and information submitted to the FDA by Pfizer for the approval of their covid vaccine. Below are the link and the pdf of the document which is the subject of this article.
I’ve been reading pharmaceutical documents, scientific studies and medical journal articles for a number of years and have learned to look beyond the conclusions and the summaries. I make sure to read each word and closely examine the data. Whenever a so-called expert mentions a study or a document that they are summarizing (in the name of convenience for the reader I suppose), I always go to the original source and read that so that I can draw my own conclusions and pull the most relevant data myself. When you dig into these documents it becomes easy to see where the manipulation occurs. This article is my interpretation of the words and the data contained in this report. Not to mention the omissions which contribute to the overall manipulation that occurs here in order to present the most favorable (financial) outcome for the company involved in this caper. Items copied directly from the Pfizer report are in italics. Please read the document yourself and if you see any additional manipulation that I’ve not already pointed out, please share it with us in the comments below.
Page 4 - The classifications of “adverse event (AE)” and “adverse event of special interest (AESI)” introduced on this page are better defined in Appendix 1; pages 1-9 or as re-numbered for inclusion in this document as pages 30-38. NINE PAGES OF MEDICAL DISORDERS/ILLNESSES/DISEASES/DIAGNOSES of possible injuries and in particular those of special interest to Pfizer. Nine pages of very fine print.
The terms “vaccine-associated enhanced disease (VAED) and “vaccine-associated enhanced respiratory disease” are shown in the glossary. Merriam-Webster’s thesaurus lists the following words as synonyms for the word “associated”: affiliated, conjoined, connected, interrelated, linked and related. Let’s insert a couple of these alternate words to see the differences in their meaning.
“Vaccine-linked enhanced disease” and “vaccine-related enhanced respiratory disease”. Sounds a little different than vaccine-associated, doesn’t it? By simply substituting these synonyms the meaning of the term changes. The deliberate choice of the word “associated” softens the true meaning.
Page 6 - “The spontaneous reporting system should be used for signal detection rather than hypothesis testing”. Yes, Pfizer, it SHOULD be used for signal detection. And according to the CDC’s own Vaccine Adverse Event Reporting System as summarized by the data consolidation software used at OpenVaers, there are MANY signals that are screaming to be detected by Pfizer and by the FDA and the CDC. When you consider that many scientists, doctors and laypersons detected these signals almost immediately after the covid vaccines were authorized and administered to humans. Where are the Pfizer, FDA and CDC employees in charge of spotting these signals?
Among adverse event reports received into the Pfizer safety database during the
cumulative period, only those having a complete workflow cycle in the safety database
(meaning they progressed to Distribution or Closed workflow status) are included in the monthly SMSR. This approach prevents the inclusion of cases that are not fully processed
hence not accurately reflecting final information. How many adverse event reports are not included in this report because they are still in progress? Furthermore, this statement alone discounts the validity of the entire report due to inaccurate or incomplete data.
“Due to the large numbers of spontaneous adverse event reports received for the product, the MAH has prioritised the processing of serious cases….non-serious cases are processed as soon as possible and no later than 90 days from receipt.” Large numbers of reports? For a safe vaccine? That’s weird. What constitutes a serious case? Non-serious cases might not be processed for up to 90 days? As an aside, 12 year old Maddie de Garay was a participant in the Pfizer clinical trial for this vaccine and suffered a severe multi-systemic adverse reaction leaving her virtually incapacitated with numerous injuries. It was recently discovered that Pfizer listed her injury simply as “functional abdominal pain” in their report to the FDA. Here’s that story:
Page 7 - Gender: Female 29914, Male 9182, No Data 2990. I’m just going to leave this here. NO DATA? On gender? Would this not be one of the most important questions asked of everyone reporting an adverse event? I mean, it’s the first piece of data in the entire report indicating that this is the most important item as related to the rest of this report. Looking further down the chart one cannot help but notice also that they failed to collect the ages of 6876 of those 42086 that reported adverse events following vaccination. Hmmm. Science?
Meanwhile we also glean from this report the fact that Pfizer and the FDA were aware of 42086 case reports containing 158,893 events in these first three months (December 1, 2020-February 28, 2021) that this vaccine was administered under an Emergency Use Authorization (EUA) from the FDA (EUA granted December 9, 2020). According to my calculations this reflects an average of 3.77 injuries per reporting individual. Given the data on the System Organ Classes (see the last paragraph on page 7 and Figure 1 on page 8) one would presume that some of these victims suffered injuries to multiple organ systems. Like Maddie de Garay did.
Also, earlier in this report (page 6) they redacted the number of shots distributed worldwide over the same period; so it is impossible for us to calculate an injury rate. But Pfizer and the FDA each have the original unredacted report so one would think that they might have calculated that percentage. As to whether or not anyone at Pfizer or the FDA actually put those numbers into a calculator, we may never know. Because, you can’t find what you’re not looking for.
Now this might be my favorite deceptive data in the entire report: Case outcome: Recovered/Recovering 19582. Excuse me? So now recovered and recovering are the same thing??!! OK Pfizer.
Page 8 - Look closely at the pink in the chart titled Figure 1. That’s for serious events. In relation to total events. Nothing to sneeze at. Looks pretty high proportionately to me. Lots of pink. In fact some of the smaller columns don’t look like they have much, if any, blue in them.
Page 10 - Table 4 tells us There were 1002 cases (54.0% of the potentially relevant cases retrieved) So after the Pfizer folks went through and excluded 46% of the cases they ended with 1002 likely cases. Now let’s skip down to the bottom of this section for these two nuggets: 1. Conclusion: Evaluation of BC cases Level 1 - 4 did not reveal any significant new safety information. Anaphylaxis is appropriately described in the product labeling as are non-anaphylactic hypersensitivity events. Surveillance will continue. 2. There were 4 individuals in the anaphylaxis evaluation who died on the same day they were vaccinated. WHAT?
Pages 12 & 13 - Table 6 indicates that there were 270 pregnant mother cases and 4 foetus/baby cases. Each of the 4 foetus cases seem to have been classified as serious. Of the 124 pregnant mother cases involving “clinical events”, 49 are classified as non-serious versus 75 that are listed as serious. And in paediatric individuals (12 and under) there were 34 cases reported of which 24 were classified as serious. Now remember, this time period was well before this vaccine was authorized for use in children and before it was advised for pregnant women, so these numbers are likely much lower than those we’ll see in subsequent reports. One can assume that some of these cases came from clinical trial participants. You’ll be happy to know that despite this data, Pfizer concluded that There were no safety signals that emerged from the review of these cases of use in pregnancy and while breast feeding and that No new significant safety information was identified based on a review of these cases compared with the non-paediatric population.
Pages 16-25 - Table 7 lists 17 Adverse Events of Special Interest (AESI) categories including Anaphylaxis which was previously addressed in Table 4 and Missing Information (pregnant and nursing mothers, foetus’ and paediatric individuals) in Table 6. Aside from those 2 categories, and despite many claims of injury within each of the remaining 15 categories; the following conclusion is reached in each. This cumulative case review does not raise new safety issues. Surveillance will continue. Only the AESI category titled Facial Paralysis further elaborates beyond these two sentences to discuss the future unblinding of clinical trial data and a making causality assessment. Interestingly it states that they need data on a sufficiently large vaccinated population to detect an increased risk of Bell’s palsy in vaccinated individuals.
This, my friends, is the sound of the broom sweeping data under the rug. While collecting billions of dollars from the sale of this product. It’s no wonder that the FDA asked the judge in this case for 55 years to release all of the documents that Pfizer submitted to them and upon which the FDA gave them full approval of this product. In 108 days. The FDA claims that they carefully reviewed 329,000 pages of documents in the 108 days it took them to approve this vaccine. But that they are unable to produce these documents to the plaintiffs in this case at a rate faster than 500 pages per month. For the next 55 years. Nothing to see here.