How The Endpoint of the Covid Vaccine FDA Studies Was Rigged by Pharma Companies

Last Updated on May 7, 2022 by Shaun Snapp

Executive Summary

  • Pharmaceutical companies have tricks they use to make their drugs look more effective than they really are.
  • Pfizer and Moderna did this for the covid vaccines.

Introduction

One of the old tricks used by pharmaceutical companies is to set or change the endpoint to falsely appropriate the desired outcome. One of these tricks is called setting or changing the endpoint of the study, to falsely approximate the desired outcome. We cover how the vaccine manufacturers did this in the vaccine studies they submitted to the FDA.

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What is An Endpoint In a Study?

An endpoint is an outcome that is being measured. When the study is controlled by the pharmaceutical company, which is almost always is, there is an incentive for the company to find an endpoint that it can show an improvement upon, but that does not necessarily correlate to the desired outcome. The pharmaceutical company is not focused on improving the condition with a clinical trial or with overall drug development, but on getting the drug approved. As soon as the drug is approved, they can then say to customers that it will assist with their condition.

How the Chemotherapy Drug Companies Run Their Studies

For example, chemotherapy studies are famous for moving the endpoint to whatever may do short-term things (like shrinking a tumor) while severely damaging the test subjects due to the toxicity of the drugs. This is covered in the article How Dangerous Cancer Drugs Had Endpoints Changed by Pharmaceutical Companies for FDA Approval.

How Was the Number of Study Participants That Came Down with Covid Measured?

At first, I thought that the PCR tests were used to determine who came down with covid. That would have been a problem as the PCR tests were disavowed by the WHO in January of 2021 as an effective way for testing for covid. However, the studies used a different method.

In a September interview Medscape editor in chief Eric Topol pondered what counts as a recorded “event” in the vaccine trials. “We’re not talking about just a PCR [polymerase chain reaction test]-positive mild infection. It has to be moderate to severe illness to qualify as an event, correct?” he asked.

“That’s right,” concurred his guest, Paul Offit, a vaccinologist who sits on the FDA advisory committee that may ultimately recommend the vaccines for licence or emergency use authorisation.

But that’s not right. In all the ongoing phase III trials for which details have been released, laboratory confirmed infections even with only mild symptoms qualify as meeting the primary endpoint definition.

In Pfizer and Moderna’s trials, for example, people with only a cough and positive laboratory test would bring those trials one event closer to their completion.

Part of the reason may be numbers. Severe illness requiring hospital admission, which happens in only a small fraction of symptomatic covid-19 cases, would be unlikely to occur in significant numbers in trials.

Hospital admissions and deaths from covid-19 are simply too uncommon in the population being studied for an effective vaccine to demonstrate statistically significant differences in a trial of 30,000 people. – BMJ

Therefore, the those with a cough and positive lab test (was that the completely unreliable PCR test) is what supposedly their vaccines prevented study subjects from getting.

POGO’s Investigative Journalism on the Internal Discussions Between The FDA and Its Advisory Committee on Covid

POGO provided critical information on the internal discussions between the FDA and its covid advisory committee. In these discussions, one of many concerns raised was regarding the endpoints as is covered in the article How The FDA Ignored Their Committee Recommendations On the Covid Vaccine Studies.

How the Covid Vaccine Studies Were Rigged

The drug companies have rigged the studies to make the vaccines appear more effective than they are.

  • The drug companies had a massive financial bias in doing these studies, and 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.
  • The drug companies selected the duration of the studies that they wanted and never had any oversight from the FDA on study length.
  • They minimized the length of the trial so that adverse reactions would be minimized.
  • The FDA was under extreme pressure from the Trump Administration to approve the vaccines and the interference and pressure brought by the Trump Administration is well documented.
  • The drug companies misleadingly chose mostly young and healthy test subjects.
  • They also hid and downplayed the negative consequences of taking the vaccine.
  • Neither the drug companies nor the FDA addressed the fact that the protection offered by the vaccines, unlike previously developed vaccines, declines over time, necessitating the need for “booster shots” which are really just later doses of the vaccine to one again increase antibodies.

Because these drug companies are very powerful, and because the FDA’s standards were lowered due to Trump’s Operation Warp Speed, which had nothing to do with making sure the vaccines were safe and effective but was entirely focused on getting Trump elected. During this time Trump was repeatedly found to have been intimidating the FDA to get the vaccines approved.

By dropping standards they were able to get these highly profitable vaccines approved by the FDA with a single study each.

Conclusion

The endpoints were set by the pharmaceutical companies without any pushback from the FDA, and this allowed them to decide what they were going to control for, and then rig the study to make it look like the vaccines were effective.