Offit and The Casual Cruelty of Pseudo-Placebo Vaccine Trials, Which Resulted in 44 Dead Babies.
Offit made verifiably wrong claims about inert placebos/adjuvants, and used the same dishonest vaccine safety trial methods with pseudo-placebos to obscure vaccine harm and subsequent infant deaths.
To show how absurdly wrong Paul Offit is in his interview with MicrobeTV, we are going to look at one of his own studies with the RotaTeq vaccine that he did in partnership with Merck, with the clinical study documentation that was acquired through a FOIA request submitted by Siri & Glimstad LLP.
This study is what got them pre-approval for another study on the oral RotaTeq vaccine in infants, which resulted in 44 deaths. Obviously none were attributed to the vaccine because the “blinded investigators” said so, but I think we can all make our own determinations on the causality after reviewing the evidence on the toxicities of these substances in the pseudo-placebos used.
So first let’s set the field with the synopsis of his study and make sure we have the objectives in mind so we have proper context for why a completely inert placebo is required to properly discern the safety profile. Then we will review what he said in his interview and detail exactly why he is wrong and being disingenuous, before we show the end result of such bad science.
Primary Objective: To determine if the vaccine is safe in healthy immune adults.
Secondary Objective: To investigate immune responses after a single dose of quadrivalent vaccine when administered orally to healthy adults.
As you can see, Paul A. Offit is the investigator and the study center in his his practice in Philly, PA, and the study design in claimed to be Double-Blind, Randomized and PLACEBO-controlled - key word placebo - and the principle objective of this study to figure out how safe the oral RotaTeq vaccine is in adults.
So what was in the placebo they used in the RotaTeq vaccine study?
It contained the following ingredients, some of which are undeniably not inert if you take 10 minutes to review the literature on their effects.
Vincent: So we talked about this last time, but the the placebo definition, this is a big part of this point that they're making, and that's something that RFK Jr talked about you know with “placebo-controlled trials are never done”, and and in your article you talk about them using a CDC definition of placebo so explain why that isn't correct.
Paul: Right, so first of all the CDC doesn't regulate vaccines, that's the FDA. The CDC is a recommending body, but what they do is just sort of make up a series of things which then supports their point of view. So the CDC definition according to them is that a placebo is something that has no effect on any living organism. I can't think of anything that would be, but they argue therefore if you use that definition of only water or salt water could be considered to be true placebos. Well first of all water and and salt water which are both chemicals, can have a negative effect on living organisms. You can have water intoxication. Drink three to four liters of water and you could exceed your body's capacity to hold on to sodium and you'll have the seizure, which could be fatal and has been. Um, salt also, there's such a thing as salt intoxication, so I think that the FDA definition of placebo is something that is inert, which I think to them is defined as immunologically inert and harmless, and that's what is usually done. So typically it'll be what's in the vaccine, and then the placebo is those buffering agents or stabilizing agents or emulsifying agents, but no actual vaccine virus or bacterial protein. So you can basically control for the vaccine itself by isolating that as a variable.
Vincent: So a let's say an adjuvanted vaccine. Would the placebo have adjuvant or not?
Paul: It could have an adjuvant, but again it's not adjuvanting anything right? I mean if it's an aluminum salt or if it's a so-called CPG Motif, you know it's not adjuvanting anything, so because again the other substances are immunologically inert, so therefore it's harmless.
1. Both the CDC and FDA definitions of placebo are relevant to their claims about safety testing, and nor are they contradictory like Paul is trying to dishonestly imply. Having no effect on humans and inert mean the same thing, so why would he respond to the question in such a way? Could it be projection? I think so, considering he’s the one trying to contrive some separation between the CDC and FDA definitions to paint RFK, Bigtree, and Siri as wrong, cherry picking, or lying to fit their narrative. They’re being truthful and objective in the true definition of placebo and the meaning of inert, and Paul is the one being a weasel and trying to spin it into justifying the addition of substances and adjuvants that are objectively not inert and will severely skew the data by making the real vaccine seem comparatively safe, when it’s not.
CDC Definition of Placebo: A substance or treatment that has no effect on living beings, usually used as a comparison to vaccine or medicine in clinical trials.
FDA Definition of Placebo: Placebos, defined as inert substances with no pharmacologic activity, are commonly used in double-blind, randomized controlled clinical trials
2. He then proceeds to argue that salt and water are both chemicals, saying that they are not inert because if you drink enough water or eat enough salt, you will die. This is so absurdly disingenuous and I’m dumbfounded that he would even take this approach to the question, especially being he’s a supposed scientist - one of the worlds most eminent leading vaccine scientists at that. This is contrary to all of the most basic medical and scientific research standards that have been accepted for over a century, and by his stupid logic, would invalidate basically every single drug trial that has ever discerned it’s safety profile when compared to a saline placebo. The only acceptable placebos that are as close to totally inert as possible, are sugar pills or saline. It’s inarguable, undeniable, and has been the gold standard for decades. Arguing otherwise means nothing on earth can be an acceptable inert placebo, and is therefore a “no true Scotsman fallacy”, or an appeal to an unattainable purity as a reason for why we should be fine with using Aluminum adjuvants, polysorbate, or sodium phosphate, or tissue culture mediums in a “placebo”. It’s so laughable.
3. This is where Paul truly buries himself in excrement and shows how he’s knowingly being dishonest. Paul says: “So typically it'll be what's in the vaccine, and then the placebo is those buffering agents or stabilizing agents or emulsifying agents, but no actual vaccine virus or bacterial protein. So you can basically control for the vaccine itself by isolating that as a variable”.
Why are you trying to control for the safety of the viral vector or bacterial agent, and not the vaccine as a whole? That’s not what the objectives say in your own RotaTeq study, yet your placebo was impure with numerous non-inert agents.
The only way to effectively discern the true safety profile of a vaccine or any drug or medical product for that matter, is to use a control that is as close to nothing as possible, which would be pure saline with no buffering, stabilizing, or emulsifying agents.
This begs the question… Why are all the vaccine studies so eager to convolute and contaminate the “placebo” control with various non-inert and immunologically substances or even using another vaccine approved with the same reified methods as the control? It’s because it allows them to compare toxins vs toxins, and skew the data where both the control and trial groups both have the same number of adverse events, which they can then use to infer that it’s a “background rate” and unrelated, having nothing to do with either the pseudo-placebo or the real vaccine, therefore manufacturing the claim that the vaccine is safe. This is just fraud and extremely misleading, by design.
4. Vincent then asks Paul if placebos have “adjuvants” in them and he confirms yes and says “it's not adjuvanting anything, so because again the other substances are immunologically inert, so therefore it's harmless.”.
How can he say objective and obvious lies like this and not immediately burst into flames? In the context of injected vaccines, he cannot possibly argue that aluminum is immunologically inert, when it’s entire purpose in a vaccine is to generate an immune response to the viral vector. Without the viral vector, IT’S STILL GOING TO GENERATE AN IMMUNE RESPONSE. With the most simple logic imaginable, Aluminum cannot be both an adjuvant that is in vaccines to stimulate the immune system, and also immunologically inert and acceptably used in a placebo to discern safety. This is totally contradictory and Paul Offit knows that, so he’s just outright lying to your face.
Here are some papers to show why aluminum should never be considered inert or acceptable in a vaccine safety trial placebo.
Although aluminum adjuvants have been used for over 70 years in human vaccines, the mechanism by which they enhance the immune response remains not fully understood. This probably reflects the fact that several mechanisms are operating simultaneously, rather than a lack of awareness of an individual mechanism.
Injection of aluminum-adjuvanted vaccines induces a limited amount of necrosis of tissue cells at the site of injection, which may lead to the limited release of some “danger-associated” molecular patterns, including DNA,99,100 uric acid,101 ATP,102 heat shock protein-70,103 IL-1α104,105 and IL-33,106,107 which are molecules that recruit and activate inflammatory cells. The multitude of released factors suggest significant redundancy and explains why inhibition or deletion of one of these molecules typically has limited or no effect on immune enhancement.
Adjuvants are indispensable components of vaccines. Despite being widely used in vaccines, their action mechanisms are not yet clear. With a greater understanding of the mechanisms by which the innate immune response controls the antigen-specific response, the adjuvants’ action mechanisms are beginning to be elucidated. Adjuvants can be categorized as immunostimulants and delivery systems. Immunostimulants are danger signal molecules that lead to the maturation and activation of antigen-presenting cells (APCs) by targeting Toll-like receptors (TLRs) and other pattern recognition receptors (PRRs) to promote the production of antigen signals and co-stimulatory signals, which in turn enhance the adaptive immune responses.
Aluminum is an experimentally demonstrated neurotoxin and the most commonly used vaccine adjuvant. Despite almost 90 years of widespread use of aluminum adjuvants, medical sciences understanding about their mechanisms of action is still remarkably poor. There is also a concerning scarcity of data on toxicology and pharmacokinetics of these compounds. In spite of this, the notion that aluminum in vaccines is safe appears to be widely accepted. Experimental research, however, clearly shows that aluminum adjuvants have a potential to induce serious immunological disorders in humans. In particular, aluminum in adjuvant form carries a risk for autoimmunity, long-term brain inflammation and associated neurological complications and may thus have profound and widespread adverse health consequences. In our opinion, the possibility that vaccine benefits may have been overrated and the risk of potential adverse effects underestimated, has not been rigorously evaluated in the medical and scientific community. We hope that the present paper will provide a framework for a much needed and long overdue assessment of this highly contentious medical issue.
According to Offit. Injected aluminum is immunologically inert because it’s not with the viral vector, yet every bit of experimental research evaluating the effects of just injected aluminum says the complete and total opposite, and that it’s extremely immunological active, neurotoxic, and has a profound impact on human health.
Paul is willfully and knowingly ignoring all the science contradicting his nonsense.
“It is difficult to get a man to understand something, when his salary depends on his not understanding it.”
― Upton Sinclair
This means every single vaccine study that used adjuvant cocktails with no viral vector or another vaccine as the placebo control, is not a proper safety study of vaccines, like RFK, Aaron Siri, Del Bigtree, and others have been saying for years. This means they are all knowingly committing fraud with the intent of muddying the data to make vaccines appear comparatively safe, when in reality they are unavoidably unsafe due to the foundational nature of injecting objective toxins directly into peoples bodies.
It’s unbelievable, but the unfortunate reality of modern science.
Now onto the RotaTeq study in adult humans and the non-inert ingredients in his pseudo-placebo.
Oral sodium phosphate cannot be considered immunologically inert, given it's primarily used as a laxative for bowel cleansing before surgeries or colonoscopies. Anything that causes a gut disruption cannot be considered inert, especially given what we know now about the guts connection with the immune system. There are also well know side effects of oral SP, like electrolyte imbalances lowering potassium, calcium, magnesium, etc. Reducing these minerals can cause adverse events in the cardiovascular and nervous systems, which will lead to a litany of possible symptoms that would obscure and delegitimize the data in discerning the safety of an oral vaccine.
”Sodium phosphate can cause serious kidney damage and possibly death. In some cases, this damage was permanent, and some people whose kidneys were damaged had to be treated with dialysis (treatment to remove waste from the blood when the kidneys are not working well). Some people developed kidney damage within a few days after their treatment, and others developed kidney damage up to several months after their treatment.”
Tissue culture medium should not be ingested in the first place, and you cannot find any studies on it's safety. I asked ChatGPT out of curiosity if consuming tissue culture mediums was safe, and this was the response.
No, oral consumption of tissue culture medium is not safe and should be avoided. Consuming tissue culture medium can be harmful and may lead to various adverse effects, including gastrointestinal distress, nutrient imbalances, and potential health risks. It is essential to remember that laboratory chemicals and reagents are intended for scientific research purposes and not for ingestion by humans. If you accidentally ingest tissue culture medium or any other laboratory reagent, seek immediate medical attention."
Finally, to the most egregious of all the adjuvants to add to a placebo in a vaccine safety trial, Polysorbate-80. There are many papers on it’s effects both orally or via injection, but one of the better summaries with good references is from a paper called “Safety of Polysorbate 80 in the Oncology Setting”
Polysorbate 80, also known as Tween 80, is a synthetic nonionic surfactant commonly used in food, cosmetics, and drug formulations as a solubilizer, stabilizer, or emulsifier. Polysorbate 20 and 60 (Tween 20 and 60) are also included in this family of surfactants. It has also been used to prevent protein adsorption and/or aggregation. A wide range of pharmaceutical agents are available in formulations that contain polysorbate 80, including amiodarone, vitamin K, etoposide, docetaxel, various vaccines, protein biotherapeutics, erythropoietin-stimulating agents [9, 10], and fosaprepitant. Recent data have indicated that polysorbate 80 is a biologically and possibly pharmacologically active compound and consequently may alter the pharmacologic properties of the drug it is formulated with or may itself directly mediate adverse events. Consequently, polysorbate 80 has been implicated in some of the adverse reactions associated with drugs formulated with this vehicle.
Polysorbate 80 has demonstrated several pharmacodynamic properties, including altering membrane fluidity and increasing membrane permeability [26]. An in vitro study indicated that polysorbate 80 potentiated the effect of antibiotics in resistant cell lines, which was thought to be due to the effect of polysorbate 80 on cell membrane permeability [27]. In vitro, polysorbate 80 increases the susceptibility of cells to oxidative stress [28]. In animal tumor models, it appears to have cytotoxic effects [3]. Cytotoxicity and antitumor activity associated with polysorbate 80 may be linked to the release of oleic acid, known to interfere with cell proliferation through the formation of peroxides [29–32]. In animal studies, polysorbate 80 has been associated with a profound and sustained decrease in blood pressure, which may be attributable to the negative inotropic properties of polysorbate 80.
Polysorbate 80 has been associated with a number of adverse events. In food, small concentrations of undigested polysorbate 80 may enhance bacterial translocation across intestinal epithelia, a potential explanation for an observed increase in the incidence of Crohn’s disease [34]. In drug formulations, polysorbate 80 has been implicated in a number of systemic reactions (e.g., hypersensitivity, nonallergic anaphylaxis, rash) and injection- and infusion-site adverse events (ISAEs; e.g., pain, erythema, thrombophlebitis) [3, 35–37]. Polysorbate 80 has also been implicated in cases of renal and liver toxicity
Immediate hypersensitivity to PEG 3350 with cross-reactive polysorbate 80 hypersensitivity may be under recognized in clinical practice and can be detected with clinical skin testing. Our studies raise the possibility of an IgE mediated Type I hypersensitivity mechanism in some cases.
The latest class of food additives to receive poor press are emulsifiers, due to the association of their ingestion with inflammatory bowel disease, specifically Crohn's disease, as well as cardiovascular and metabolic disease, as shown in epidemiological, animal and laboratory studies. For example, polysorbates affect permeability of cell lines in culture,1 promote translocation of Escherichia coli across ileal epithelium and M cells in vitro,2 and induce intestinal inflammation and metabolic syndrome in susceptible mice.
How can Paul call this cocktail of toxins an adequate placebo in a safety study? It’s indefensible, and considering he is one of the worlds leading vaccine scientists, he should be well aware of the research on the substances used in the placebo and how they could skew the results because they’re so far from being inert. It’s not possible to view this as negligence or ignorance in the face of such undeniable evidence. Offit is not stupid and knows exactly what he is doing here.
With all that absurdity and inversions of reality in mind, let’s end with a review of the study on the RotaTeq vaccine in infants that went forward because of the results of the adult human study referenced above.
Before I do that, I want to make one thing very very clear, so we all fully understand the gravity of the situation and how this bad and corrupt science impacts all our lives, and especially the lives of babies receiving these vaccines.
THIS STUDY WAS ON INFANTS FROM AGES 6 TO 12 WEEKS OLD, WITH THE MOST COMMON CAUSE OF DEATH BEING SUDDEN INFANT DEATH SYNDROME. 7 IN THE VACCINE TRIAL GROUP, AND 8 IN THE PLACEBO DIED FROM SIDS.
This study got RotaTeq approved to be on the current vaccine schedule as a 3 dose series for babies at 2 months, 4 months, and 6 months old.
Looking at figure 2 with the percentage of subjects and their adverse events…. How can a pure saline placebo given orally in a very small amount, cause fever, vomiting, diarrhea, and hematochezia? It shouldn’t right? That’s because again, the placebo contained “Sucrose, sodium citrate, sodium phosphate, tissue culture medium, and polysorbate 80”, and those substances will most definitely cause those symptoms, especially in infants with an under developed microbiome and gut lining.
It gets worse. Intussusception is when the intestine folds into the section immediately ahead of it. I’ll repeat one more time… Saline placebo wouldn’t do this, but their cocktail of gut disrupting toxic surfactants and laxatives in the fake placebo most definitely would do this to an infant.
Last and most important, is the adverse event data and how many babies died in the study.
Serious adverse events were reported in 803 of 34,035 vaccine recipients (2.4 percent) and 859 of 34,003 placebo recipients (2.5 percent). Overall, 44 deaths occurred during the study, 24 among vaccine recipients (<0.1 percent) and 20 among placebo recipients (<0.1 percent). The most common cause of death in both groups was sudden infant death syndrome, which occurred in seven vaccine recipients and eight placebo recipients. No deaths were attributed to vaccination by investigators blinded to treatment assignment.
The most common cause of death in both groups was sudden infant death syndrome, which occurred in seven vaccine recipients and eight placebo recipients No deaths were attributed to vaccination by investigators blinded to treatment assignment.
Conclusion
This isn’t science. This is criminal and fraudulent barbarism masquerading as science to allow pharmaceutical companies to keep manufacturing bad research to continually add more toxic vaccines to the schedule and set people up for a life of health issues, which they will then happily profit off of. It’s a circular feedback loop of death and misery, and it’s foundation is bad science like this that too few people understand.
I hope I’ve helped you understand how they manipulate research that leads to a vaccine being added to the schedule, and how authorities and scientists like Offit invert and obfuscate the truth to defend his pharma handlers and ultimately keep his career and credibility.
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