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

Last Updated on May 7, 2022 by Shaun Snapp

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 all to get the vaccines 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

If you want 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?

FDA Lie #2: No Answer On The Unblinded Study?

On some topics, FDA officials shared committee members’ concerns. On the issue of emergency use authorizations causing people to drop out of clinical trials, one official said, “I don’t have any specific remedies to offer at this time.” – POGO

Right, but that does not change the fact that the study can no longer track adverse reactions to the vaccines. This is not so much a lie as a quick exit from this conversational topic. This vaccine was to be rolled out to billions of people, and the FDA does not want to see adverse events known?

FDA Lie #3: There Is No Time to Consider Input From the Committee?

In her summary at the end of the meeting, Gruber, director of the FDA’s Office of Vaccines Research and Review, did not attempt to summarize the public comments. She made no mention of them.

She acknowledged committee members’ points about minority populations and, more obliquely, children.

“I hear there were some concerns and suggestions made for some of the details, the importance of making sure that minorities are included in clinical studies. We had some discussions on endpoints,” Gruber said. She indicated it might be too late for the FDA to act on the advice for vaccines already in advanced or “Phase III” clinical trials.

Naturally, there is “no time” to do a correct study. And it is now more than a year after this study was done, and there is still “no time” because it might show the adverse effects that the FDA does not want to be known. As is covered in the article The FDA, CDC, and NIH Do Not Want Adverse Drug Reactions Counted this is a constant feature of the FDA and other medical authorities, that they do not want the public to be aware of the adverse events from drugs.

FDA Lie (or Batch of Lies) #4: Misrepresenting What The Committee Said?

This is not just one lie, but multiple lies. The FDA took the concerns communicated by the committee and rephrased them to entirely change their meaning to effectively lie to the public that the FDA’s decisions were somehow addressed the concerns of the committee. In most cases, this involved making the meaning the exact opposite of what the committee stated to the FDA.

“What I want to know from you, the two months, the median two months follow-up that we said on the EUA [emergency use authorization], I’ve heard people expressing some concerns with that being maybe not short enough, but you know if it then cannot be longer by no means should it be shorter than two months of median follow up,” she said. “That’s what I heard.”

That seemed to distort committee members’ comments. (In her statement to POGO recapping Gruber’s remarks, the FDA spokesperson did not repeat Gruber’s observation that some people thought a median of two months of follow-up might not be short enough.) – POGO

No committee member stated that two months is “not short enough.”

Here the FDA makes it appear as if two months was some type of negotiated duration based upon opposing views. There were no opposing views that the study should have been shorter, and that is lunacy in any case. The committee members stated that 2 months was not long enough.

On Unblinding The Study

Addressing the threat that an emergency use authorization (EUA) would disrupt a clinical trial by unblinding it, Gruber seemed to assume committee members accepted that as inevitable. She falsely implied that committee members all bought into the idea of issuing emergency use authorizations.

“And in terms of the blind … even though you have an EUA, you said, even though we all would like for this to continue, but we have to realize that at some point we can’t really maintain the blind. But do I hear you saying and do I hear the committee saying that the blind should be maintained for as long as feasible and it should not necessarily be an automatic crossover of the placebo recipients … getting the vaccine?”

Again, the committee members disagreed with unblinding the study. The argument by the pharmaceutical companies on “ethical obligation” is clearly a fake argument.

The following slide from the Canadian Covid Care Alliance explains how the covid studies were unblinded.

In the article prior to the vaccines arriving I published an article titled Why the Public Expects a Coronavirus Vaccine Too Quickly, in which I showed the average length of time it takes to bring out a new vaccine. The establishment media stated repeatedly that the vaccines were brought out because of the new mRNA technology. What they did not communicate is that years were cut off the development time because the testing for the vaccines was skipped. This mentality is explained in the following graphic from the Canadian Covid Care Alliance. 

The FDA is now moving to skipping testing, and to determining effectiveness and safety from the overall rollout of the vaccine.

However, the problem is even worse than this. The FDA basically stops worrying about a drug after it has been rolled out, as is covered in the article How The FDA Did Nothing to Verify the Long Term Safety Of The Covid Vaccines.

And it is not just the adverse effects and safety of the covid vaccines. Observe the FDA’s behavior on opioids in the article How FDA Did Nothing to Stop And Turned a Blind Eye to The Opioid Epidemic, and the FDA’s behavior on proton pump inhibitors in the article Why The FDA Did Nothing to Moderate Nexium Prilosec And PPI Prescriptions.

Over a series of decades, the FDA has transitioned from an agency that helped stop dangerous drugs from getting to the public, to an agency that helps pharmaceutical companies cover up adverse effects.

Ethical Obligation, Or A Drug With Dangerous Side Effects That Need To Be Hidden?

The term “ethical obligation” has been used many times in the past by pharmaceutical companies as an excuse to end studies early. This is covered in the article Ethical Obligation Or A Drug With Dangerous Adverse Effects That Need To Be Hidden?

The Disaster That Was The Studies

When a study is presented to the FDA, the FDA does not participate in the study and is not able to verify anything published in the study. This means they assume that what the pharmaceutical company writes in the study document is accurate. However, it was later learned that the covid studies for Pfizer were a disaster of falsified information. This is explained in the following slide from the Canadian Covid Care Alliance.

Naturally, Pfizer is not going to investigate this, as they ordered Ventavia to falsify the results to get the vaccines given Emergency Use Authorization. However, what should set off alarm bells is that the FDA did not investigate these accusations of study falsification either. It should be recognized that there is usually no incentive for a whistleblower to come forward to make false claims, and they are putting their career at risk by coming forward.

Furthermore, the response from the FDA regarding this information coming out was that they “were aware” of these issues before the information became public. This means that the FDA knew the study was falsified or had a high potential to be falsified but then gave the Emergency Use Authorization for the Pfizer covid vaccine anyway. And there is no public statement that they ever investigated the claims of the whistleblower from Ventavia.

One final observation on this slide is that unblinding the study participants is something that apparently was done before the official unblinding, which was done after two months. This means that even during the two month period of the study, either the researchers themselves or the test subjects knew which was being given the vaccine and which was given a placebo.

How the Covid Vaccine Studies Were Rigged

The drug companies have rigged the studies to make the vaccines appear more effective than they are. Here are some critical factors related to research corruption that billions of people relied upon to decide to get vaccinated.

  • The Studies Had Enormous Financial Bias: The drug companies had a massive financial bias in doing these studies. As with all FDA-reported studies, they only reported the studies they wanted to and would have been able to hide those that were less impressive. Recall that Pfizer has already made roughly $35 billion from their vaccine, and much more money is coming.
  • Pfizer Controlled The Duration Of the Study: Pfizer selected the duration of the studies they wanted and never had any oversight from the FDA on study length.
  • Pfizer Recategorize Adverse Events: They misreported adverse events and faced no consequences they were caught. They then minimized the trial length so that adverse events could not be compared between the control and the placebo groups.
  • Operation Warp Speed: The FDA was under extreme pressure from the Trump Administration to approve the vaccines, and the interference and pressure brought by the Trump Administration are well documented. This was all so that Trump could increase his chances of getting re-elected.
  • Not Using Those At Risk For the Study: The drug companies misleadingly chose primarily young and healthy test subjects.

Conclusion

The covid vaccine studies had no validity because the pharmaceutical companies rigged them. The only watchdog checking to ensure that the studies were done with integrity (the FDA) was remotely controlled by the drug companies.

  • The FDA ignored the extremely valid concerns from their committee in order to get the vaccines the Emergency Use Authorization and to help the vaccine manufacturers hide the adverse events from the public.
  • This means that the covid committee which the FDA points to as increasing public accountability is an illusion. In verifying the record of the covid committee versus how the FDA spokesman described the concerns of the covid committee, it is clear that the FDA lied about what the committee members said.
  • In reviewing both the Pfizer and Moderna studies, I would have rejected both of them. Any person who understood how to read research would have done the same.
  • Once the FDA became aware of probable study falsification by Pfizer, the FDA refused to investigate. Once a whistleblower came out and declared the falsification, which meant that nothing in the Pfizer study documentation was reliable, the FDA still did nothing.

All of this might explain why the FDA has petitioned a US court to keep the entirety of their documentation on the Emergency Use Authorization of Pfizer’s covid vaccines to be postponed until close to the year 2100.

How About Europe

For those living in Europe, or that live in countries that rely on the European approval of the covid vaccines the European Medicine Agency is no better than the FDA, which you can see in the article How Pharmaceutical Companies Control both The FDA And The European Medicine Agency.