The monthly drop of Pfizer files from the FDA should be providing us all with additional information on the safety and effectiveness of the Pfizer Covid vaccine. Unfortunately, this has not been the case as the information being prioritized for release by the FDA is not the information that the World needs to see.
The publication schedule that The FDA must follow requires the release of thousands of pages of information every month. However, the court judgement does not stipulate which documents must be released as a priority. This has allowed the FDA to meet their legal obligations whilst keeping the most sensitive information unpublished, for now at least.
In my last blog I summarized the most significant information that the FDA had released thus far. This included very concerning new safety information that should have resulted in the withdrawal of the Pfizer vaccine. Of course, this information did not reach the mainstream and the Pfizer vaccine continues to be used across the world. The FDA’s latest release of 10,000 pages of Pfizer documents has not revealed any new significant information but has revealed the methods being used by the system to keep the truth hidden from clinical professionals and patients.
The infamous 5.3.6 post-marketing experience document did receive a small update in the latest release. Previously redacted information has now been supplied, confirming that Pfizer anticipated a very large increase in adverse event reports and recruited over 1800 additional full-time employees to process these reports. It is highly significant that no safety and effectiveness information for the period after February 2021 has yet been published. Why is this information being withheld?
One significant new document is the Pfizer application for the priority review¹ of the vaccine by the FDA. The document confirms that Pfizer stated there was a significant clinical need which required the emergency use authorization of the vaccine. The document merely states that no other vaccine has been authorized and completely fails to address the issue of the many drugs that could be used to treat Covid. As we all know the use of these drugs to treat Covid was being actively suppressed by the system to allow the emergency use authorization of vaccines.
The priority review request document summarizes the safety information provided by Pfizer that I summarized in my last blog. Pfizer’s safety summary in the priority review document does a very good job of hiding the true information. Time and time again, alarming safety information was summarized as “not showing any new safety signals or concerns”. The same deception and misrepresentation continued with the effectiveness information by using relative risk reductions rather than absolute risk reductions as the basis for the effectiveness conclusions. This all constitutes a fraudulent deception of clinicians and their patients.
A recent British Medical Journal article titled “The Illusion of Evidence Based Medicine”² or EBM, lays bare the cozy corporate reality of the pharmaceutical industry and its regulators. The fiduciary duty of every corporation is to make money for its shareholders. This duty trumps safety and effectiveness, resulting in a choreographed dance between the regulators and the regulated. Higher drug sales mean more profits for the regulated and plenty of employment and status for the regulators. The BMJ article opens with this description of how the illusion is maintained:
“The advent of evidence-based medicine was a paradigm shift intended to provide a solid scientific foundation for medicine. The validity of this new paradigm, however, depends on reliable data from clinical trials, most of which are conducted by the pharmaceutical industry and reported in the names of senior academics. The release into the public domain of previously confidential pharmaceutical industry documents has given the medical community valuable insight into the degree to which industry sponsored clinical trials are misrepresented. Until this problem is corrected, evidence-based medicine will remain an illusion.”
*¹ https://phmpt.org/wp-content/uploads/2022/03/125742_S1_M1_priority-review-request.pdf
*² https://www.bmj.com/content/376/bmj.o702
Clinicians across the World have been educated to trust the regulators and the authorities producing the guidance that they follow every day. This trust and their overworked clinics mean very few clinicians have the interest or time needed to study the original source evidence for the drugs they are recommending. Clinicians have put their faith in evidence-based medicine as a brand and have allowed themselves to be brainwashed into believing what they are told. Clinicians are members of a cult, worshiping at the altar of EBM. The BMJ article is very clear how the ‘evidence’ to be used for worship is obtained:
“The pharmaceutical industry’s responsibility to its shareholders means that priority must be given to their hierarchical power structures, product loyalty, and public relations propaganda over scientific integrity. Although universities have always been elite institutions prone to influence through endowments, they have long laid claim to being guardians of truth and the moral conscience of society. But in the face of inadequate government funding, they have adopted a neo-liberal market approach, actively seeking pharmaceutical funding on commercial terms. As a result, university departments become instruments of industry: through company control of the research agenda and ghostwriting of medical journal articles and continuing medical education, academics become agents for the promotion of commercial products.”
The final obstacle for EBM to clear is the requirements of the regulators. But the drug companies need not worry too much, as the regulators are safely in the pocket of the pharmaceutical industry, as described in the BMJ:
Regulators receive funding from industry and use industry funded and performed trials to approve drugs, without in most cases seeing the raw data. What confidence do we have in a system in which drug companies are permitted to “mark their own homework” rather than having their products tested by independent experts as part of a public regulatory system? Unconcerned governments and captured regulators are unlikely to initiate necessary change to remove research from industry altogether and clean up publishing models that depend on reprint revenue, advertising, and sponsorship revenue.
So, we have a very well-designed system that promotes the continuous supply of pharmaceutical products neatly packaged with the illusion of safety and effectiveness; the detailed evidence having been checked and verified by the regulators. Clinicians and patients believe they are participating in a healthcare system where safe and effective drugs ensure the health of the population. The reality is that they are actually willing victims in a system designed to make money through the deception of clinicians and patients with the illusion of promoting health.
The outputs of the system are the documents provided for patients and clinicians. No ordinary clinician or patient has the time or inclination to read the source data within clinical trials or the documents produced by regulators. Fortunately, I do have the time and inclination and have followed the Pfizer story along every twist and turn, deception and lie, in order to present you with the facts about the illusion produced by the system for the brainwashed. I will conclude with some of the information contained in the Pfizer Summary of Product Characteristics¹ and the Patient Information Leaflet² approved for use in the UK.
Both of these documents were recently updated, and it is the information that is removed or changed that is most revealing about the nature of the deception we are all being exposed to. If you read my last blog, you will appreciate that the true representation of the safety and effectiveness of the Pfizer (Comirnaty®) vaccine was hidden and misrepresented in the both the clinical trial summary and the application documents to the FDA. This level of deception and translation is taken a step further in the documents provided to clinicians and patients.
Here are some quotes and translations:
“The interchangeability of Comirnaty with COVID-19 vaccines from other manufacturers to complete the primary vaccination course has not been established.”
TRANSLATION: We don’t know what will happen if you have our vaccine after a different vaccine.
“There is an increased risk of myocarditis and pericarditis following vaccination with Comirnaty. These conditions can develop within just a few days after vaccination and have primarily occurred within 14 days. They have been observed more often after the second vaccination, and more often in younger males (see section 4.8). Available data suggest that the course of myocarditis and pericarditis following vaccination is not different from myocarditis or pericarditis in general. The risk of myocarditis after a third dose of Comirnaty has not yet been characterized.”
TRANSLATION: Your heart may be damaged and we have no evidence that you will recover.
“Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress‐related reactions (e.g. dizziness, palpitations, increases in heart rate, alterations in blood pressure, paraesthesia, hypoaesthesia and sweating) may occur in association with the vaccination process itself. Stress-related reactions are temporary and resolve on their own.”
TRANSLATION: These symptoms are not evidence of drug harm, you are just scared of needles.
“The duration of protection afforded by the vaccine is unknown as it is still being determined by ongoing clinical trials.”
TRANSLATION: We don’t know if our vaccine works.
“Limitations of vaccine effectiveness. As with any vaccine, vaccination with Comirnaty may not protect all vaccine recipients. Individuals may not be fully protected until 7 days after their second dose of vaccine.”
TRANSLATION: We know that our vaccine doesn’t work for everyone.
“Excipients. This vaccine contains less than 1 mmol potassium (39 mg) per dose, that is to say essentially ‘potassium-free’. This vaccine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium- free’.”
TRANSLATION: There’s no other ingredients in our vaccine, unless you can be bothered to read through another 10 pages to section 6.1 where all the other 11 ingredients are listed.
“Comirnaty can be used during pregnancy. A large amount of information from pregnant women vaccinated with Comirnaty during the second and third trimester have not shown negative effects on the pregnancy or the newborn baby. While information on effects on pregnancy or the newborn baby after vaccination during the first trimester is limited, no change to the risk for miscarriage has been seen.”
TRANSLATION: We have hidden the facts about the harms observed in pregnant women.
During my career in the health system, I have always known about the inbuilt conflicts of interest amongst drug companies and their regulators. For a long time, my experience was that there were enough good local administrators and clinicians working in the system to follow true EBM in order to promote patient safety. What I have witnessed in the last two years has changed my view. I know consider that the cozy relationship between drug companies and their regulators has been exploited by Governments who have also removed or sidelined the local administrators. Clinicians and patients now effectively get their information about drugs directly from Governments.
Do you have faith that your Government is benevolent and truly prioritizes your health?
Do you have faith that your clinicians are following EBM?
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