How The FDA Ignored Their Committee Recommendations On the Covid Vaccine Studies

Executive Summary

• The committee advising the FDA brought up multiple concerns about the covid vaccines.
• The FDA could not have cared less.

Introduction

The story of how the FDA ignored and ran roughshod over its committee on the covid vaccines to get them approved as quickly as possible is quite amazing. This story shows how non-existent the standards at the FDA are and the degree to which pharmaceutical companies control the FDA.

Our References for This Article

To see our references for this article and related Brightwork articles, visit this link.

POGO’s Investigative Journalism on the Internal Discussions

POGO, which stands for Project on Government Oversight, is the following.

The Project On Government Oversight (POGO) is a nonpartisan independent watchdog that investigates and exposes waste, corruption, abuse of power, and when the government fails to serve the public or silences those who report wrongdoing. – POGO

POGO performed an excellent job in documenting the internal discussions on the approval of the vaccines. We will cover these concerns that POGO highlighted in their reporting.

Concern #1: Concerns Voiced Around The Wrong Endpoint Being Used

The following quotation describes concerns by a committee that advised the FDA on the speed of vaccine development and how the vaccine trials were measuring endpoints.

Committee members also challenged the way vaccine trials are measuring success—where they are setting goal lines, which are known as “endpoints.” Most of the trials are designed to declare a coronavirus vaccine effective if it reduces the number of mild cases of COVID-19, whether or not it reduces severe or fatal cases.

Some committee members said it is more important to determine if a vaccine spares people from the worst effects of the virus. One criticized key endpoints in company-sponsored trials as flawed because they reflect patients’ subjective impressions of symptoms rather than items that are objectively measurable. Another member called for greater focus on whether vaccines prevent people from getting infected in the first place…

Dr. Luigi Notarangelo, a committee member who is a chief researcher at the National Institutes of Health, minced no words as he articulated several of the critiques.

Notarangelo said measures of vaccine effectiveness included in an FDA document the committee was asked to review have two problems.

“First of all, they really are biased—skewed towards mild disease,” he said. “Mild disease may not mean very much.” – POGO

Concern #2: Concerns Voiced Around How Success Was To Be Measured

Committee members also challenged the way vaccine trials are measuring success—where they are setting goal lines, which are known as “endpoints.” Most of the trials are designed to declare a coronavirus vaccine effective if it reduces the number of mild cases of COVID-19, whether or not it reduces severe or fatal cases.

Some committee members said it is more important to determine if a vaccine spares people from the worst effects of the virus. One criticized key endpoints in company-sponsored trials as flawed because they reflect patients’ subjective impressions of symptoms rather than items that are objectively measurable. – POGO

Concern #3: Concerns Voiced Around the Subjectivity Of The Efficacy Measures

(Again from Dr. Luigi Notarangelo,)

“The other problem with those efficacy measures is that most of them are really subjective,” he said. “And I think that’s a major concern. I mean, we’re relying basically upon reporting from the subjects without any objective validation of what they’re reporting.” – POGO

Concern #4: Concerns Voiced Over the Brevity of the Study

Toubman also challenged the FDA’s stated openness to granting an emergency use authorization based on two months of observations.

“There could be adverse effects we don’t know about, and so isn’t two months a little short?” he asked.

Toubman recommended that the FDA not grant emergency use authorizations for coronavirus vaccines. – POGO

Pharmaceutical companies love abbreviated studies. It allows them to hide the long-term adverse reactions from their drugs more effectively. Drug companies have a special department inside them where they come up with excuses as to why the study needs to be shortened.

The FDA Ignores the Concerns of the Committee And Then Lies About Their Concerns

The degree to which the FDA is a shill for Big Pharma is shown in their response to these concerns.

FDA Lie #1: Severe Cases Cannot Be Tested?

FDA officials rebutted some of the committee members’ concerns—saying, for example, that focusing on more severe cases would require enrolling an unrealistically large number of people in the clinical trials. – POGO

Why would that be true? People could have been paid to be infected with covid. Furthermore, why was it so difficult to find and test for severe cases if covid was so deadly?

Addressing the Damage

One of the best ways to address the damage caused by the covid vaccines is with Ivermectin. This is the reason I began taking Ivermectin -- before investigating all the other health benefits of the drug. Now, I take Ivermectin for many reasons.

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• We also cover the broader problems with dosage calculation in medicine at the article The Problem With Dosage Calculation in Medicine, as this is an issue much larger than for one drug. 

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