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I told the CDC that the formula they use to trigger safety signals was seriously flawed in Aug 2021. They ignored me. But even using their own flawed formula, "death" should have triggered a signal.
Executive Summary: If you want objective proof of total ineptitude by the CDC and the medical community in monitoring the safety of the COVID vaccines, this is the article you’ve been waiting for.
We use their numbers and their own algorithm and show that it should have triggered a safety signal for “death.” There is no way they can argue their way out of this one. There is no rock that is large enough for them to hide under.
We need look no further than the vaccine safety signal monitoring formula used by the CDC to prove our point.
Problems include:
The formula the CDC uses for generating safety signals is fundamentally flawed; a “bad” vaccine with lots of adverse events will “mask” large numbers of important safety signals.
The CDC refused to correct their algorithm when officially notified of the error in August 2021.
Death is such a huge signal in the COVID vaccines that even the CDC’s flawed formula still shows a safety signal
The CDC failed to notify the public that the death signal was triggered. That is unconscionable.
The mainstream medical community didn’t notice anything was wrong and remained silent while hundreds of thousands of Americans were killed by the COVID vaccines. See this article or Dr. Naomi Wolf’s independent validation of my numbers.
CDC management still isn’t aware of any of these problems (or if they are aware, they aren’t acknowledging or doing anything about them).
It is doubtful that the mainstream media will ever hold the CDC accountable.
Introduction
Very early on in my new professional career as a misinformation superspreader (which began on May 25, 2021 when I authored a 285-page article “Should you get vaccinated?” for Trial Site News), I discovered a document entitled Vaccine Adverse Event Reporting System (VAERS) Standard Operating Procedures for COVID-19 (Jan 29, 2021).
Note that FOUO stamped on each page means “For official use only” so please do not use this for other than official use or you could get in trouble. I clearly violated that warning and look at what happened to me.
It was immediately clear to me when I first read this document in early July 2021, that the formulas they used to trigger safety signals were flawed.
I tried to bring this to the attention of the CDC and the outside committee of the CDC. The CDC ignored me and the outside committee members refused to consider my emails and the two that replied said to submit it as a public comment which I did months later when they opened the window for public comments. See Comment tracking number: ksy-ckr3-73lv.
I also pointed the error out to Mathew Crawford. I didn’t have a substack at the time, but Mathew did.
Mathew memorialized it in a Substack article dated July 26, 2021 aptly titled Defining Away Vaccine Safety Signals. That was the first article in a three part series. Here are Part 2 and Part 3.
So there is a clear public record that we pointed this out in Mathew’s Substack article.
The medical community doesn’t seem to mind. No complaints from any of them. Even Vinay Prasad said nothing.
The flaws in the CDC safety signal detection algorithm
Let me summarize the key points for you in a nutshell:
PRR is defined on page 16 in the CDC document as follows (and note they should have capitalized all the letters in the formula):
A “safety signal” is defined on page 16 in the CDC document as a PRR of at least 2, chi-squared statistic of at least 4, and 3 or more cases of the AE following receipt of the specific vaccine of interest. This is the famous “and clause.” Here it is from the document
Only someone who is incompetent or is deliberately trying to make the vaccines look safe would use the word “and” in the definition of a safety signal. Using “and” means that if any one of the conditions isn’t satisfied, no safety signal will be generated. As noted below, the PRR will rarely trigger which virtually guarantees that most events generated by an unsafe vaccine will never get flagged.
The PRR value for the COVID vaccines will rarely exceed 1 because there are so many adverse events from the COVID vaccine because it is so dangerous (i.e., B in the formula is a huge number) so the numerator is always near zero. Hence, the “safety signal” is rarely triggered because the vaccine is so dangerous.
Chronology of events
The CDC publishes: Vaccine Adverse Event Reporting System (VAERS) Standard Operating Procedures for COVID-19 (Jan 29, 2021).
I first learned of this paper in July after I couldn’t figure out why the CDC wasn’t warning anyone of the safety signals in plain sight.
I read the paper. It was clear on my initial reading that the formula the CDC uses to trigger safety signals is seriously flawed: it will rarely fire if the vaccine under test is very dangerous because it relies on using PRR in an “and” clause (more about that below).
On July 25, I notified Mathew Crawford and others of the error. Here’s the email I sent:
Crawford cranks out an article (first in a series of 3 articles) just one day later on July 26, 2021: Defining Away Vaccine Safety Signals.
On August 29, 2021, I notified the CDC using their official notification channels of the flaw: see Comment tracking number: ksy-ckr3-73lv which was submitted prior to the August 30, 2021 ACIP meeting. See Attachment 1, page 1 and page 6 which documents the error as well as my attempts to bring the error to the attention of the ACIP committee (that part continues on to page 7). The other two attachments are also useful reading and proves that the CDC was notified and they chose to entirely ignore all the input that the vaccines are unsafe.
The safety signal for death (and likely many more adverse events) is so extreme that even using their own flawed formula for detecting safety signals, the “death” safety signal should have triggered as I show below. Yet we heard nothing, not even in the FOIA requests. How is it possible that they missed the single most important safety signal for a vaccine? The deaths are off the charts; even their flawed safety signal was finally triggered, but they said absolutely nothing to the American people.
The medical community has chosen to look the other way and ignore all of this: (a) the flawed formula, and (b) the failure of the CDC to use their own erroneous formula with the data in plain sight to notify the public of a potential problem.
The mainstream media has refused to report on this.
The only member of Congress that will talk to me about vaccine safety is Senator Ron Johnson. The others hang up or refer me to staffers who then ignore me.
An example using a fictitious dangerous vaccine
If you don’t see why dangerous vaccines will rarely generate a PRR signal, here’s an example.
Suppose we have the world’s most dangerous vaccine that causes adverse events in everyone who gets it and generates 25,000 different adverse events, and each adverse event has 1,000 instances. That means that the numerator is 1,000/25,000,000 which is just 40 events per million reported events.
Now let’s look at actuals for something like deaths.
For all other vaccines, there are 6,200 deaths and 1M adverse events total.
Since 40 per million is less than 6,200 deaths per million, we are not even close to generating a safety signal for deaths from our hypothetical vaccine which killed 1,000 people in a year (the MMR vaccine by comparison reports around 5 deaths per year in VAERS for 10M doses).
The point is that a dangerous vaccine can look very “safe” using the PRR formula.
PRR calculation for death for the COVID vaccine
Let’s do the PRR for death for the COVID vaccine.
For all other vaccines, there are 6,200 deaths and 1M adverse events total.
For the COVID vaccines, there were 31,214 deaths and 1.4M adverse events total.
PRR = (31214/1.4e6) / (6200/1e6) = 3.59 which exceeds the threshold.
In other words, the COVID vaccine is so deadly, that even with all the adverse events generated by the vaccine, the death signal did not get drowned out!!!
So the symptom “death” generated a PRR of 3.59 which exceeds the threshold of 2
But there is still the chi-square test.
Chi-square test results were 18,549 for “death” which exceeds the threshold of 4
The CDC chi-square test is clearly satisfied for the COVID vaccine.
I did a very rough calculation making simplifying assumptions since it was obvious that the value would be quite high. I assumed the number of vaccinations was the same in every year (which is approximately true) and that in 2021, the number of vaccinations went up by a factor of 5X normal.
The estimated chi-square statistic of 18,549 exceeded the threshold of 4 using the symptom of death.
Death should have triggered a safety signal. Why didn’t it?
Because the death signal is so huge, it even survived the PRR test.
This means that even using the CDCs own erroneous “safety signal” formula, all three criteria were satisfied:
PRR>2: It was 3.59
Chi-square>2: It was 18,549
3 or more reports: There were over 31,214 death reports received by VAERS so far.
A safety signal should have been generated but wasn’t. Why not?
Why does the CDC ignore me?
Does anyone care? Hundreds of thousands of American lives have been lost due to the inability of the CDC to deploy their own flawed safety signal analysis.
Could there be a Simpson’s paradox here where the overall numbers trigger the signal, but each age range does not?
No. You can't have a Simpson's paradox with fractions, only correlations. Here’s a partial analysis by Mike Deskevich.
As Mathew Crawford notes:
Essentially, if a safety signal is present in the aggregate, it must be present in at least one demographic group. This can be proved using Jensen's Inequality and viewing the aggregate as an average (which doesn't change PRR numbers).
Due to convexity of the function, the PRR on the aggregate is between the maximum and minimum of the PRRs of the subgroups for any given AE.
In plain English, the fact that the overall aggregate PRR number is bad (as calculated above) is sufficient to trigger the safety signal since it guarantees that at least one of the age cohorts would trigger the signal.
Furthermore, even if there was a Simpson’s paradox (which there isn’t), any cohort definition that shows a signal should be investigated.
The larger point still remains: the CDC didn't give a crap whether there was anything wrong with the vaccines. That’s the big problem.
Why am I bringing this up again now, more than a year later?
Because the Epoch Times just published an article today about newly disclosed emails about the CDC safety monitoring debacle where first they were doing it and then they weren’t and then they were and then they weren’t. It’s so confusing.
So I thought this would be a good time to bring to light the huge problem that they have a flawed definition and even with their flawed definition, the safety signals still trigger the signal, and the CDC remains silent. This is the big story that has not been reported.
There are at least 7 articles in The Epoch Times recently about the CDC safety monitoring disaster:
The most recent article reveals that the two people who appear to be most responsible for this failure are John Su and Tom Shimabukuro.
Also special mention goes to Martha Sharan who makes sure that people like me cannot talk to the principal players. Martha is nice enough to ignore all attempts at communication so that John and Tom are never held accountable for their mistakes.
None of them will respond to any emails I’ve sent them.
Maybe you will have better luck than I have had getting their attention.
Here are their emails:
John Su, the CDC VAERS expert. I’ve written many articles about John. My very first Substack article was about John and I didn’t mince words: It's time for John Su to go (Oct 30, 2021).
Tom Shimabukuro, a prominent member of the Vaccine Safety Team of the CDC COVID-19 Vaccine Task Force. Tom is also the first author of the NEJM paper on pregnancy and the vaccines, but there was never a follow-up paper showing what happened to women who got the shot early in their pregnancy. Why weren’t the final results ever published? He’s avoided answering this question and the press apparently doesn’t want to know the answer for some reason. How can the CDC promote the vaccine as safe and effective for pregnant women without publishing the result of the study? I don’t understand that.
Martha Sharan, the press gatekeeper who makes sure nobody gets to John and Tom. Martha and I have never talked, not even by email. She’s ignored every form of communication from me. Nice lady.
Reporting odds ratio
It’s been known since at least 2004 that using reporting odds ratio (ROR) is a better estimate of relative risk than PRR. I don’t know why the CDC doesn’t use it.
They don’t seem very receptive to input from the public, do they?
Comment from the CDC?
I’ve reached to Martha Sharan of the CDC for comment. I’ll update the story if I hear back. Don’t hold your breath.
Comment from David Gorski?
I’ve also reached out to David Gorski for comment. David long ago realized he can’t beat me on the science, so he requested I never contact him again. I don’t expect to hear from him, but I emailed him to leave no stone unturned.
Summary
The Proportional Reporting Ratio (PRR) is a measure used to assess safety signals in spontaneous reporting databases such as VAERS where people voluntarily report adverse events.
Using PRR alone is a very unreliable way to identify safety signals for a vaccine, especially vaccines which are extremely dangerous.
For the COVID vaccines, the PRR signal will rarely fire because there are so many adverse events so the numerator is always small so that the threshold (PRR>1) is only met for extremely serious events.
By making PRR a required element to detect a safety signal (the “and” clause described in the text above), the very dangerous COVID vaccines appear to be safe.
I was the very first person in the world to point out this error to the CDC in August 2021.
Nobody in the world except me and my misinformation spreader colleagues have questioned the clearly flawed safety signal formula used by the CDC.
The medical community looks the other way. Not a single member of the medical community has ever pointed out this error in the CDC formula.
The fact that no mainstream media, like the NY Times, Washington Post, CNN, and 60 Minutes will report on this even today shows you how captured the media is as well.
This is objective, unassailable proof of how deeply flawed and corrupt the medical system is. We pointed out the error publicly and everyone ignored it.
So important adverse events like death go unreported.
It simply doesn’t get any more clear than this that the people responsible for safety monitoring at the CDC are either incompetent, corrupt, or both.
