The “Vaccines are Safe” Narrative: Scientific Proof? By Brian Simpson

One of the positions that circulated in the vaccine critique movement, like the idea that viruses do not exist, or if they do, don’t do what received biology says they do, is the idea that there is no scientific proof, by double-blind, gold standard tests, that vaccines actually are safe. As detailed below, Steve Kirsch follows this issue through with his request to have presented to him such studies. But, I suppose by default, there could not be any such study, as all medications for at least someone have possible adverse effects. One can see this with the nice printout that comes with medication, with a fine-print list of all that could go wrong. Thus, I would suggest that the real issue is the actual probability of specific harms, rather than finding some sort of total safety.

https://stevekirsch.substack.com/p/is-there-a-credible-us-based-study

“Executive summary

There is a huge flaw in the narrative that nobody really realized existed:

The whole “vaccines are safe” narrative for the past 200 years is actually based on an assumption that all the vaccines are safe. There is actually no credible large-scale post-marketing study for any vaccine used in the US today that actually backs up this claim. It’s all based on faith in seriously flawed studies.

There isn’t a credible post-marketing objective epidemiological study for any vaccine in the US. That’s right. Not a single one.

Why isn’t there a study?

It’s not because it isn’t possible. In fact, every state in the US has the ability to do such a study.

It is because the states have never done the necessary studies nor will they expose data needed to allow the public to do the studies.

Will keeping public health data private improve clinical outcomes? No, of course not! It’s all kept hidden from view because there is no upside for them in doing the study. It can only end badly, very badly.

As Dr. Ryan Cole has often said, “You will never find what you don’t look for.”

In short, it’s time to call a spade a spade: “the Emperor has no Clothes.” It’s turtles… turtles all the way down.

The whole “vaccines are safe” narrative is built on belief and seriously flawed studies, and not on proper objective epidemiological studies which could have been easily done but were not.

Since we cannot prove safety at the level of <1 death per 10M doses in children, we should not be vaccinating more kids until we have done the proper post-marketing safety study on the kids we’ve already vaccinated. The fact that no state is willing to do the study but is at the same time still recommending that kids get vaccinated should be deeply troubling to everyone. It is a symptom of a seriously out-of-control medical community that cares more about following directives from the CDC than patient safety. The rationale for vaccinating kids is nonsensical.

The most important point is that a single honest state epidemiologist who is willing to do the right thing could change the world by setting the data free. The others who do nothing should be ashamed of themselves for allowing the truth to remain locked behind closed doors.

This is a long but very important article. It took me a long time to research and write. I hope you will find it valuable.

Introduction

Dorit Reiss is a well-known “debunker” of anti-vax so-called misinformation spreaders like me.

When I posted my plans to increase data transparency in California, she wrote a hit piece attacking me and my article. I was surprised by her reaction because data transparency always leads to superior health outcomes. Only pharma companies or their paid shills should be attacking me for wanting to expose the truth. Nobody else.

Science is about finding truth, challenging assumptions, making hypotheses, gathering quality data, and figuring out which hypothesis best fits the observed data. No real scientist should be attacking me for asking for transparency of public health information; they should all be cheering me on. More data is always better. Anyone who attacks you for wanting to see the data is not a scientist.

So I decided to turn the tables on her in the comments section of her article by attacking her fundamental assumption of vaccine safety and showing it is all based on a belief or in believing deeply flawed studies rather than the proper studies (such as the UK has attempted to do).

I wanted to expose to the world that her belief in the safety of vaccines is not based on credible data, i.e., I wanted to show that the “vaccines are safe Emperor” has no clothes.

So I challenged her to show me any objective credible large-scale, post-marketing US study showing that any of the vaccines in the US are “safe” as defined by Paul Offit back in 2002 as fewer than 1 death per million doses.

She failed.

At first she directed me to a list of articles and none of them were responsive to my request. Next, she cited a deeply flawed study that she said was “just for fun.”

I repeated my request was serious and this was a serious issue, and she confirmed that her answers were serious.

She failed to respond with a document that met the objectives because the data simply isn’t there.

None of her readers could find a credible objective large epidemiological study done in the US showing that any US vaccine is safe either.

I just got off the phone with Dr. Peter McCullough who is a walking encyclopedia of studies and he wasn’t aware of any credible study either for large-scale vaccine safety.

So let’s see if any of my readers can find one!

My $1,000 challenge aka “The Kirsch Safety Study Challenge”

Here are the terms of the offer which expires at the end of May 2023 (so I don’t have to keep monitoring this article):

1. Show me the URL of any credible objective epidemiological post-marketing study done prior to May 10, 2023 (the contest launch date) that was done on people in the US which demonstrates that any of the vaccines currently in use in the US are “safe.”
2. “Safe” is defined by Paul Offit back in 2002 as causing fewer than 1 excess death per million dosesacross an age-standardized US population over a one year observation period post-vaccine. The population consists of those people who would normally consume that vaccine. So a vaccine which is normally given to kids would measure the excess mortality of the kids who got the vaccine over a 1 year period. A vaccine given to all ages would be a standardized distribution for the US population measured over a year. For the purposes of this challenge, the failure to detect any statistically significant safety signal in any of the analysis buckets (which must not be unreasonably broad so as to miss safety signals) shall be deemed adequate proof of safety.
3. “Objective” means that “experts” aren’t doing causality assessments on the cause of death. The numbers should do the talking. For example, the UK ONS data were used to prove the vaccines were safe and effective. The only problem was the data was flawed so the results were unusable.
4. Epidemiological means in this case that the analysis is based on analyzing the death-vax records (the join between the death table and the vaccination table) as well as vaccination statistics by age range, gender, week, and vaccine type (and possibly more but that’s the minimum).
5. “Credible post-marketing study” means, for the purpose of this offer, the study was done after the vaccine was approved by the FDA by at least one of (a) -(c) and the “obvious flaws” condition is true (i.e., no obvious flaws)
   1. Done by a state government and published in paper or electronically,
   2. Done by the CDC and published in paper or electronically, or
   3. Published in a peer-reviewed medical journal anywhere in the world.
      AND
      The study does not contain obvious flaws that would discredit its conclusions (for an example of what I mean by this, see the text below).
6. The study must study a minimum of at least 10M person-yearsover the standardized population of the vaccine.
7. To win, your entry in the comments must clearly identify the specific section(s) showing that the people who get the shots aren’t dying at a statistically significantly higher rate than those that don’t. This should be an easy bar since the “healthy-vaccine bias” works in your favor and you don’t have to adjust for that.
8. The first one to post a qualifying entry will win $1,000.There will only be one award.
9. Entry order is determined by timestamps of the comment. If you modify your entry, your timestamp will be the latest timestamp.
10. If you think this is not a legit offer, you have my permission to ignore it. You should see what happened to Mike Lindell on his $5M offer: Lindell lost in court. So maybe you should take it seriously since it costs nothing to enter and takes seconds if you know the material.
11. My paid subscribers as of the 5pm on May 10, 2023 will vote to judge the contest and will select the first entry to meet the conditions.
12. Anyone can enter in the comments in this article.
13. If you make a legit entry and I fail to recognize it, my readers and the general public will hold me accountable.
14. My readers will also help identify if an entry satisfies the challenge by upvoting it which will make it much easier for me to find it.

This is not a “trick contest” that is impossible to do

In fact, the UK ONS analysis satisfies every single one of these conditions except 1) it is in the UK and 2) the underlying data is deeply flawed (and they admitted it). I’m not thrilled with the bucket choice either, but I’ll take it.

An honest society would be able to produce these studies in every state in the US easily that meets all the conditions.

The sad fact is that, as far as I know, this doesn’t exist for any state in the US, for any vaccine, ever.

Here’s another challenge… this one is for $5K and has been out for 4 years with NO takers

He just gets personal attacks. The challenge has been out for 4 years. I’ll match his $5K so if there is a winner, I will double it for the first winner if you win before the end of June 2023.

How can I be so confident that the safety study doesn’t exist?

None of my colleagues I asked knew of such a study.

A big clue for me was the analysis done in the US for the COVID vaccines. It’s terrible.

It basically sucks because the CDC doesn’t have the vaccination data of each person.

So the CDC has never been able to do a proper analysis to prove safety using their own data. They could use VSD, but that would be seriously flawed as I’ll show below.

The states, who do have the information needed for a proper analysis, may be:

1. not sophisticated enough to do the epidemiological studies required.
2. not motivated enough to do the work because there is not enough public pressure on them to do this the right way and this is hard work to get it right.

What you need is analysis like that described in my “Is it safe?” article which goes into detail about how I think the data should be made public and analyzed (and I confirmed it with professional epidemiologists I work with). Nobody in the US has ever done it this way AFAIK. That’s pretty sad. The records are not available anywhere and the states won’t do the required analyses for reasons I just noted.

They do it in the UK to some extent. The UK ONS bucket analysis is decent, much better than anything in the US I’ve seen. At least in the UK they have the right methodology; this is exactly the style of report all countries and US states should be adopting. But they are deficient in the choice of buckets and the quality of the underlying data; they undercount the unvaccinated so that the vaccines look like they work. If you know what you are doing, you can take one look at their tables and realize the data makes no sense (e.g., all cause non-COVID age-standardized mortality suddenly instantly changes dramatically when people start to get vaccinated).

Martin Neil, Norman Fenton, and others caught them red-handed and they were honest enough to admit their data was crap and should not be used to determine whether the vaccines are safe. This was a major embarrassment, but there’s a lot to be said for such honesty especially during these times. I applaud the UK ONS people for their honesty.

Even though their data is flawed, I have enormous respect for what the UK did. They made a very credible attempt to do a proper epidemiological study and they made the full data summary public. So kudos to the UK. Still deficient (data quality and bucket choice), but scores highly (7 out of 10) for their approach which was very good. Bravo. To get a 10 out of 10, they need to release the underlying data. That is critical. That mistake caused lives. They are still not doing that. I told them how to do that and comply with the regulations and they stopped responding to me. That’s not commendable.

In the US, the best that researchers can do is use the VSD system but that is really flawed as well because it doesn’t capture all the events. It’s also hard to get access to… they keep it under lock and key. If you find anything bad, they yank your access to the system (Brian Hooker has stories he can tell you… once he got close, the CDC told him that the HMO’s didn’t like his results so they are cutting off his access).

The other problem with VSD is that there are reporting issues. For example, I remember sitting in on ACIP meetings where they showed event rates in VSD were sometimes lower than VAERS (they made the false assumption that VAERS is fully reported). There was the famous “fountain of youth” study that I’ve written about before that is unbelievably flawed (despite that it got accepted in a peer-reviewed journal). And there are only 9M people in the VSD system and not everyone gets vaccinated so it’s hard to get to the numbers you need. So I’m not impressed with VSD as a reliable source of data. Plus, because it is so controlled, only positive studies can emerge.

So basically, the US is set up for failure which means it is highly unlikely someone would get reliable data or the proper setup.

Then I checked with Harvard Professor Martin Kulldorff who I consider to be one of the world’s top epidemiologists, but also a super nice guy. Could Professor Kulldorff cite such a study which was sufficiently powered to be able to prove safety across a standardized age distribution in the US? Nope. He sure couldn’t.”