In regards to Missouri House Bill 1169

And why science-based policy making should be required from both sides.

The following is a look at some aspects of the proposed Missouri Bill on “gene therapy products”. Note that this perspective is coming from a science one and not necessarily one based on law or politics. However, because the bill itself is a merging of science into law I thought it was worth looking at some aspects of it. I should reiterate that the intent here is not to scrutinize per se, but to raise some arguably healthy concerns over proposed bills that are supposedly rooted in science.

Image: Missouri State Capitol

These 3 additions are intended to serve as a method of labeling products as being “gene therapy products”.

I didn’t give much thought to this bill, but upon looking at it further there’s a few things that I found strange, or at least not “scientific”.

So I decided to dive a little into some of the discourse surrounding this bill and seeing what I can find, and in doing so I’m curious how much of this bill is based in science or a product of reactionary politics.

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In reviewing the bill

The entire bill, which is only two pages, can be found at this website.

Upon first glance what stood out was the term “gene therapy product”, which is defined in the bill as follows:

(3) "Gene therapy product", any product with any capacity to alter, interfere with, or otherwise act in any manner similar or equivalent to genes;

In my own writings I have stayed away from using the term “gene therapy” because it runs into the issue of a term of art being used colloquially to reflect something different.

Note here that the term gene therapy product is intended as a term of art- it’s a rather broad definition that infers an ability directly influence genes or to act in the same way as genes. This includes mRNA/DNA vaccines which carry genes that are intended to induce an immunogenic response and provide some form of protection, or even something such as microRNAs which halt the translation of proteins by binding to mRNA and “silencing” the expression of proteins found in cancer and other diseases.

But when used colloquially the term generally infers the first aspect- an alteration of genes. Thus, when describing a “gene therapy” the intention is to infer that these products, such as the mRNA vaccines, are changing people’s genes.

And this is how the general discourse has directed the use of these terms- to infer that genetic alterations are occurring in those who have received the vaccines.

But there’s several problems with this argument. For one, the data on the mRNA vaccines actually altering genomes is rather limited with one of the only studies out coming from Aldén, et al.¹, which comes with issues in methodology and results.²

There’s also the problem that this use of “gene therapy” is counter to what a therapy is, as the intended use of the phrase gene therapy is more in line with…gene modification (well, genome modification if a gene is argued to be inserted).

So here the terms are being used both synonymously and interchangeably, muddying what the term “gene therapy product” actually refers to.

Semantics, yes, but when these terms are being introduced into policy some arguments should be raised over the use of certain terms if they are to be codified into law.

The use of the term “gene therapy product” is described in the following paragraph of the bill:

Any product that has been created to act as, or exposed to processes that could result in the product potentially acting as, a gene therapy or that could otherwise possibly impact, alter, or introduce genetic material or a genetic change into the user of the product, individuals exposed to the product, or individuals exposed to others who have used the product shall be conspicuously labeled with the words "Potential Gene Therapy Product" unless the product is known to be a gene therapy product. Reasonable steps shall be taken to ensure the potential purchaser or user of the product is made aware of the presence of this label.

Note that product here encapsulates food as well as drugs and vaccines.

What I find rather concerning about the above paragraph is the inclusion of “individuals exposed to others who have used this product…”, as it appears to allude to the idea of “shedding”.

I have raised criticisms of this idea of shedding, mainly because it’s a hypothesis that never appears to have been validated aside from anecdotes. No one has proposed a model to describe the dispersion of spike from a vaccinated individual, usually following this mode of thought:

1. Vaccinated person makes spike

2. Spike may get packaged into exosomes and moved throughout the body

3. ???? (Spike gets out of body…somehow?)

4. Spike gets “shed”

The problem with this model is not just that it doesn’t provide an explanation for the release of shed spike, but it also doesn’t explain how this shed induces the adverse reactions seen in spike. Sure, spike is cytotoxic, but how does spike in the air induce myocarditis or other adverse reactions?

Here, again, the model lacks critical steps:

1. Someone inhales shed spike.

2. ??? (movement of spike in the body?)

3. ??? (cytotoxic effect of spike at translocated region?)

4. Adverse reaction occurs

When arguing about the inclusion of language into a policy, shouldn’t there be substantial evidence to support such an inclusion?

And if anyone was curious, I have provided remarks with respect to the mRNA shedding hypothesis proposed by Banoun, H.³ I find the references, interesting, albeit lacking in actually explaining this method of dispersion and transfection.

However, this hypothesis, which again is a hypothesis, has been cited by many to argue that the phenomenon of spike shedding is indeed occurring.⁴ It’s one thing to have a hypothesis; it’s another if a hypothesis warrants inclusion into law.

What I find interesting, although given my lack of legalese, was the inclusion of this section which defines the term “genetically modified”:

"Genetically modified", the alteration of genetic material through modern biotechnology, directed evolution, or any other mechanism in a way that does not occur naturally or that does not occur at its natural rate.

Which is used in the following section:

2. Upon the written request of any resident of this state, any entity that produces, sells, or distributes a product in this state with the capacity to infect an individual with a disease or to expose an individual to genetically modified material, including, but not limited to, vaccines, gene therapies, drugs, and medical interventions, shall provide any and all information related to the ways in which individuals who did not directly obtain or use such product may be exposed to the product or a component of the product. Any product manufacturer, government agency, or organization of any type that has an interest in the production, sale, or distribution of such product shall be subject to the disclosure requirement of this section and shall provide all relevant reports, research, and knowledge upon request under this section.

I’m curious whether this description may fall in-line with the synonymous use of gene therapy and genetic modification.

The term “genetically modified” is itself so broad that it would really capture many foods that may not have intentional genetic modifications but may be bred to have specific flavor or texture profiles (the directed evolution remark above).

Many fruits and vegetables in the market, even if not genetically manipulated, are bred to be more sweet and fuller (such as berries) than their wild counterparts, and so would these foods also be considered in this labeling amendment?

And so this raises a question of both redundancy and futility; would laws on genetically modified foods already encapsulate “gene therapy product”, or would the term become watered down and indistinguishable from GMO's in marketing?

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Is there science in this policy?

The intent of looking at this amendment was to make an argument that has been around the entire COVID discourse- if policies are made around science is there scientific evidence for these policies.

In that regard, I’m curious what evidence is being used for some of the language in this bill, in particular about the intent of using “gene therapy product”, or what evidence is being used to argue “individuals exposed to others” language included in the bill.

In a post from The Vigilant Fox both Tom Renz and Naomi Wolf talk about this bill, but here they both describe genetic modifications occurring.

I’m not sure what evidence they are using to make this claim, but it follows with the question of whether gene therapy is being used as a term of art or colloquially to mean something different here (it appears to be the latter in this case).

They also describe vaccines getting into the food supply, which has itself been the crux of this bill as it suggests there’s an intent to include vaccines into foods.

There is evidence that such research is being conducted⁵, however I’m unsure of the applications of these processes in the general population.

When it comes to mRNA vaccines there’s an argument to be made about concerns of livestock being vaccinated, although the longevity of mRNA and the stability of the expressed proteins after processing, cooking, and consumption are all things that would be worth considering and likely reduces the bioavailability of these products immensely (the review from Saxena, J., & Rawat, S. suggests that potatoes genetically modified to express toxins from E. coli lost up to 50% of the immunogenic proteins due to cooking).

One thing that does worry me, and fortunately I have not really seen it so far, is the term “mRNA vaccine” used in conjunction with fruits and vegetables, as these words used together would indicate an inherent failure in understanding foundational biology.

Remember that protein expression follows the following process:

Genomic (DNA/RNA) → mRNA → Protein

It makes sense that livestock may be vaccinated with mRNA technology and that may enter into our food supply as a workable model. However, this model completely fails when referring to plants because how exactly would you have plants express mRNA in particular, let alone mRNA vaccines?

The only method of doing so is to insert such a gene, such as the spike protein, into a plant and hope that it expresses it without causing issues in plant development (the review notes that a limitation in antigen expression is that inducing a large degree of expression limits the viability of the plant). However, at that point the plant is no longer a “gene therapy product” but would be inherently genetically modified, and would not be producing “mRNA vaccines” but would be producing the immunogenic antigen.

In another interview with Paul Harrel of Stew Peters Network Renz makes remarks in regards to foods and mRNA vaccines. I’m more critical of this interview as GMO’s here are being used rather broadly.

Harrel cites a study from The Institute of Responsible Technology about mice and organ damage in mice fed GMO’s, but when looking for this study I only came across an article from IRT which links to the supposed study⁶.

This study looked at a particular endotoxin from the bacterial species Bacillus thuringiensis, and it wanted to see if mice given these toxins would show signs of hematotoxicity (destroyed red blood cells).

Note that the mice in this study was never given plants modified to produce these toxins, but were given the toxins directly so it doesn’t infer anything related to plants modified to have these toxins (this doesn’t mean that these toxins are not harmful but the model in the study doesn’t match the argument being proposed).

This is more to point out that in this discussion of the bill GMO’s is being used extremely broadly to argue their harms. It’s possible that GMO’s that produce bacterial toxins will be a serious concern; GMO’s intended to make fruit bigger is a different story (maybe…).

Overall, the intent of this post is not to be contrarian or attack anyone (I would consider these good-faith criticisms. I also don’t know much about Renz and many people are likely to attest to the work he is doing involving the vaccines), but to argue that a policy that appears to be rooted in science should inherently have evidence to back up codification into law.

I’m curious what evidence is being used to produce the language in the bill or if any scientists had a hand in constructing the bill, but I’m also growing more concerned that many people may be acting in a reactionary manner rather than a rational one.

More importantly, I’m concerned that all of the work to inform people about topics of science may not be bearing the fruit that I originally thought.

Consider the egg yolk IgY issue that came up several months ago and the production of anti-spike antibodies in egg-yolks.

A foundational understanding of immunology would suggest that production of antibodies would first be met with antigenic exposure. It’s at that point that people should have raised some doubts about this anti-spike IgY issue as it would require that the chickens be exposed (i.e. vaccinated) in order to produce the antibodies to target spike.

Of course, a pro-IgY anti-spike position would also go against concerns over vaccines the food supply anyways, so these ideas would also be diametrically opposed to one another.

More and more, it’s important that evidence remain in the realm of science, eve with all of the flaws that science has (and boy are there a ton!).

But I’m also curious what other people think. What are your thoughts on the current discourse, what do you think of the bill (will it do much or will it have the issue of redundancy/futility), and have you read the bill? Again, the bill is very short and isn’t inundated with legalese that other bills have.

But also important, and something that isn’t asked often, do you feel like you have actually learned stuff over the past few years and are able to retain some of the information? This doesn’t apply to just my Substack, but any other information you’ve come across.

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1. Aldén M, Olofsson Falla F, Yang D, Barghouth M, Luan C, Rasmussen M, De Marinis Y. Intracellular Reverse Transcription of Pfizer BioNTech COVID-19 mRNA Vaccine BNT162b2 In Vitro in Human Liver Cell Line. Current Issues in Molecular Biology. 2022; 44(3):1115-1126. https://doi.org/10.3390/cimb44030073

2. Brian Mowrey of Unglossed has covered this study previously, but the remarks made by TJ Lees in the comments are insightful and add additional context to the issues with the study. The conclusions drawn are that the study may show reverse transcription, but done rather poorly and requiring additional studies in order to validate the hypothesis (the latter argument being a requirement of all studies released).

Shaky DNA integration study

3. Banoun, Helene. (2022). Current state of knowledge on the excretion of mRNA and spike produced by anti-COVID-19 mRNA vaccines; possibility of contamination of the entourage of those vaccinated by these products. Infectious Diseases Research. 2022;3(4):22. 10.53388/IDR20221125022.

4. As an aside, there was something I should have mentioned in my comments on Banoun’s hypothesis with respect to BioNTech’s document detailing exposure to the vaccine.

There’s a rightful criticism in arguing that these pharmaceutical manufacturers have not done enough to capture the full scope of pharmacology data when designing and testing these vaccines.

However, the release of these documents essentially place BioNTech and these manufacturers into a Catch-22 scenario.

Again, no sympathy for these vaccine manufacturers, but if let’s suppose that in the clinical trials BioNTech did not list any adverse reactions or exposure concerns because they didn’t think it would be a serious idea.

Then they would be blamed for not doing enough work to check for these adverse reactions (which they already didn’t even as they list hypothetical adverse reactions in their clinical trials, which is a rather more egregious issue).

But what happens if they list an entire list of hypothetical adverse reactions? Well, then BioNTech will be blamed for somehow knowing that these adverse reactions would occur instead of citing all adverse reactions that may or may not become present during clinical trials (thus, a Catch-22).

Essentially, no matter what gets included in these clinical trials BioNTech (or the other manufacturers) would be implicated in something nefarious. There’s already plenty of evidence that not enough studies were conducted, but I would argue that the inclusion of a list of adverse reactions or safety precautions aren’t indicative of actual adverse reactions.

5. Saxena, J., & Rawat, S. (2013). Edible Vaccines. Advances in Biotechnology, 207–226. https://doi.org/10.1007/978-81-322-1554-7_12

6. Mezzomo, B. & Miranda-Vilela, Ana Luisa & Freire, Ingrid & Barbosa, L. & Portilho, F. & Lacava, Zulmira. (2013). Hematotoxicity of Bacillus thuringiensis as spore-crystal Strains Cry1Aa, Cry1Ab, Cry1Ac or Cry2Aa in Swiss Albino Mice. J Hematol Thromb Dis. 1.