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DailyClout Pfizer Documents Analysis Pfizer Reports

Report 26: Proof the TrialMax App Unequivocally Contributed to Pfizer’s Deception of Safety

June 23, 2022 • by Camille Villa, Esq., Team 1
Proof the TrialMax App Unequivocally Contributed to Pfizer’s Deception of Safety

clinical trials

In the latest batch of the court-ordered release of Pfizer documents, there is unbelievable evidence supporting THE BIG LIE – that Pfizer’s vaccine was safe. In a document titled, “Annotated Study Book for Study Design,” we discover Pfizer contracted with a company called Signant Health to create an app in which trial participants could enter all their side effects.

https://www.phmpt.org/wp-content/uploads/2022/04/125742_S1_M5_5351_c4591001-fa-interim-sample-crf.pdf

The app, called TrialMax, was used to collect patient data in phase one and phase two of Pfizer’s COVID vaccine clinical trials (the C4591001-Post-12-July-2020 study).  Pfizer required all participants to log their side effects daily; however, this app was intentionally created to exclude nearly all adverse events! 

According to Signant Health, the user-friendly healthcare app developer, the goal of this app was to collect and manage a high volume of data from Pfizer’s “reactogenicity and COVID-19 illness diaries” in an effort to gain approval of the emergency use authorization. https://www.signanthealth.com/wp-content/uploads/2021/09/Case-Study-Coronavirus-Vaccines.pdf
A considerable failure of the app, however, was that it purposefully limited a trial participant’s input to only specific pre-determined side effects. 

Pfizer’s deception of safety was further supported by the basic philosophy of the TrialMax app developer. In a 2019 Clinical Research News article, discussing the company’s focus on simplified solutions, Signant Health’s CEO states, “. . . the more difficult it is to participate—the more impactful it is on somebody’s life, the more complex the technology or the process is—the less likely somebody is going to stay in a trial.” https://www.clinicalresearchnewsonline.com/news/2019/06/10/crf-bracket-relaunches-as-signant-health

The article goes on to state that Signant Health’s objective is “to make it easier to participate in—and run—clinical trials.”  In a supposed effort to keep the participants engagement uncomplicated, we can deduce that Pfizer purposefully substituted simplicity for safety by directing Signant Health to create a platform that prevented trial participants from reporting ALL unique side effects. 

In order to purposefully limit a participant’s input, the TrialMax “Vaccination Diary” module asked specific questions regarding ONLY the following symptoms: fever, redness at the injection site, swelling at the injection site, pain at the injection site, fatigue, headache, vomiting, diarrhea, chills, muscle pain, and joint pain.  These are commonly known side effects of most vaccines.

The additional symptoms of cough, shortness of breath, loss of taste/smell, and sore throat could be recorded in a supplemental manner in the TrialMax “COVID-19 Illness Diary” module. The app, however, did not allow for any independent reporting of symptoms. Therefore, these two modules were the only places available to record any side effect. For example, if a trial participant opened the app to report experiencing possible symptoms of Guillain-Barre Syndrome (pins and needles sensation in the toes, weakness in the legs, or difficulty with eye muscles or vision, etc.) there would be absolutely no place to record this information.  And what if one experienced chest pain, facial droop, or any other unusual side effect? Pfizer did not allow the collection of ANY OTHER side effect data. They purposefully limited these participants to enter ONLY the specific side effects they asked about!

Although tracking inflammation side effects, also referred to as reactogenic side effects, is beneficial, Pfizer’s primary objective here was to collect only inflammation-related side effects, and nothing else. The CDC advertises “common side effects” but limits their list to inflammation-related effects only. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/expect/after.html

In any clinical trial, however, the safety profile should refer to ALL adverse events and not just those related to inflammation. https://www.nature.com/articles/s41541-019-0132-6#Sec1 Pfizer limiting the reporting of side effects to those of inflammation appears deceptive and intentional. 

In conclusion, Pfizer contracted Signant Health to intentionally collect only specific vaccine side effects through the TrialMax app. This app was the primary collection tool that allowed for quick organization of data and a significant factor in Pfizer attaining their EUA, period.  They only collected the side effects that they wanted to collect, and this was willfully unethical and misleading!

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#Pfizer analysis clinical trials data document analysis findings information limited misleading report side effects trialmax unethical
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