When performing scientific studies of the effectiveness and safety of medical treatments, the gold-standard study design is widely considered to be the so-called “prospective, randomized, double-blinded, placebo-controlled clinical trial.”
While this claim is not universally true for all types of medical investigation, when examining the effectiveness and safety of new – or existing – medical treatments, this rule applies very well indeed. For the purposes of this essay, we will focus on the placebo-controlled aspect of clinical trials.
There are two excellent reasons for a clinical trial to be placebo-controlled.
- First, one does not want to perform a treatment on patients unless the treatment is more effective than leaving them alone.
- Second, one does not want to perform a treatment on patients if the treatment is more harmful to them than leaving them alone.
Unless you are in the vaccine business, that is. The vaccine industry has a long, disgraceful history of shielding the ineffectiveness and toxicity of their products by using false placebos in the clinical trials of their products.
What Is a Placebo, and Why Are Placebo-Controlled Studies Important?
According to the Merriam-Webster Dictionary a placebo is defined as:
1a: a usually pharmacologically inert preparation prescribed more for the mental relief of the patient than for its actual effect on a disorder
b: an inert or innocuous substance used especially in controlled experiments testing the efficacy of another substance (such as a drug)
The first definition touches on the famous ‘placebo effect,’ which is the observed tendency for even inert or ‘sham’ treatments to produce positive effects in some patients.
The second definition is relevant to the clinical trial process. Here, a ‘placebo’ is the inert treatment that is used in the ‘control group’ of a clinical trial – that is, the group that doesn’t get the active treatment. The control group provides a valid baseline for comparison with the ‘treatment group’ of the study – that is, the group of subjects that get the actual treatment in question. Note that the placebo must be both inert (inactive) and innocuous (harmless).
The reasons for using a true placebo comparison group in a clinical trial are straightforward. By comparing the active therapy under investigation to a true placebo, several vital determinations can be made about the therapy.
First, since a true placebo is harmless, one can identify, by comparing harmful effects seen in the group that got the treatment with harmful effects seen in the group that got the placebo, any and all harms caused by the treatment.
For example, if a harmful effect is seen equally in both the treatment group and the placebo group of the study, that harmful effect is not attributed to the treatment, but rather to other factors. However, if a harmful effect appears only in the treatment arm of the study (or appears with significantly higher frequency or intensity), it is attributed to the treatment.
Second, since a true placebo is inactive, one can determine, by comparing the intended or beneficial effects seen in the treatment group with beneficial effects seen in the placebo, any and all benefits caused by the treatment.
For example, if a beneficial effect is seen equally in both the treatment group and the placebo group of the study, that beneficial effect is not attributed to the treatment, but rather to other factors. (In such cases, the beneficial effect seen in the treatment group is often described as ‘no better than placebo.’) However, if a beneficial effect – especially if it was intended – appears only in the treatment arm (or appears with significantly higher frequency or intensity), it is attributed to the treatment.
It should be obvious how the proper use of true placebo control is essential to arriving at the truth in clinical studies of medical treatments. However, one can also see why a dishonest researcher would not want to employ a true placebo-controlled clinical study, if they did not want the truth about either the safety or effectiveness of a medical treatment to be exposed.
The Curious Case of the Cleveland Clinic, or, Why Use Fake Placebos in Vaccine Studies?
If the goal of a clinical study is to truthfully determine whether or not a medical treatment is, to quote the infamous slogan, “safe and effective,” then proper use of true placebo-controlled studies is essential.
However, if the goal of a clinical study is to get a vaccine past FDA regulators, onto the market, widely accepted by patients, and perhaps even onto the CDC vaccine schedules, then a properly run, true placebo-controlled trial can be a death sentence to that medical treatment. In fact, simply comparing a vaccine’s effects against nothing at all – not even a placebo – can expose the problems with such a product.
During the winter of 2024-2025, researchers at the prestigious and very mainstream Cleveland Clinic performed a large, well-designed study comparing the incidence of influenza in its vaccinated employees versus its unvaccinated employees. Their findings:
This study found a significantly higher risk of influenza among the vaccinated compared to the unvaccinated state in northern Ohio during the high influenza activity period of the 2024-2025 influenza season.
In fact, the vaccinated group showed a whopping 27% increased risk of contracting influenza in the months after vaccination, compared with the unvaccinated group. The researchers hypothesized possible reasons for this apparent dismal failure of the flu shots, including the following:
…there is biological plausibility for why this could possibly happen. Antigenic imprinting refers to a phenomenon where the first exposure of the immune system to influenza by infection or vaccination shapes the breadth of immune responses to subsequent influenza infections or vaccinations, preferentially recalling memory B cells targeting epitopes of the originally encountered strain rather than generating new responses to current strains.
The findings of the Cleveland Clinic study demonstrate a phenomenon that, in the vaccine literature, is often referred to as “negative efficacy.” To ordinary people, the phrase is “harm.” A vaccine that increases the risk of your getting the disease it is supposed to protect you from is causing harm.
Comparing vaccines against no treatment – or placebos – exposes their harms. Vaccinologists have found a way around this through the use of fake placebos.
How Does the Vaccine Industry Use Fake Placebos?
It is simple and easy, not to mention scientifically rigorous and ethically sound, for any clinical study of vaccines to include a true placebo group. For example, the treatment group could receive the vaccine, while the placebo control group could receive an identical-appearing injection of sterile saline.
However, in vaccinology, true placebos are almost never used. Why not?
It is not because of legitimate ethical concerns. Healthy subjects are almost always used in vaccine trials. Nobody is being denied a potentially lifesaving treatment in favor of a placebo, as may sometimes be the case in other areas of medical research, such as in oncology or surgery.
The only logical explanation is the intent to conceal undesired findings.
For example, in its recent, controversial Phase 3 clinical trial for its new mRNA influenza shot (which in fact is a gene therapy posing as a vaccine), Pfizer did not compare their new product to a true placebo. Instead, they did this:
…we randomly assigned healthy adults between the ages of 18 and 64 years to receive either a quadrivalent modRNA influenza vaccine (modRNA group) or a licensed inactivated quadrivalent influenza vaccine (control group) during the 2022–2023 influenza season in the United States, South Africa, and the Philippines.
Let’s step back and think about this for just a second. Instead of using a simple, cheap, true placebo such as a sterile saline injection, Pfizer – which designed and conducted their own study – used something they called a “control vaccine,” consisting of whatever standard licensed traditional flu vaccine was being used at the time in South Africa and the Philippines.
Really?
Sure, one can argue, they wanted to show their new shot was better than the old-fashioned one. Still, this in no way excuses not adding a third group as well – a true placebo group.
The results of the study give a strong clue why Pfizer designed their trial with a fake placebo.
With regard to safety, in almost every category the clinical trial measured for adverse events, the Pfizer mRNA shot showed higher incidence than seen with the traditional vaccine. In fact, the adverse effects were so much worse in the most important age group – 65 and older – that Pfizer simply omitted all the data from that demographic in their report in the New England Journal of Medicine.
Imagine how those safety data would have looked compared to a true placebo group. No wonder Pfizer chose a fake placebo – apparently, this was whatever flu shots the Filipino and South African public health officials had on hand at the time.
But the New England Journal article declared victory, claiming “adverse event profiles were similar in the two groups” while adding:
The relative efficacy of the modRNA vaccine as compared with the control vaccine against influenza-like illness was 34.5% (95% confidence interval [CI], 7.4 to 53.9) on the basis of 57 cases in the modRNA group and 87 cases in the control group, a finding that met the criteria for both noninferiority and superiority.
Pfizer states their shot’s “relative efficacy” was 34.5%. Doesn’t sound too impressive. But here’s the kicker – it’s not even an absolute reduction. It’s 34.5% less than the traditional vaccine. How does the Pfizer jab compare to just leaving people alone? We have no idea.
Behold the cesspool of doubletalk and patent dishonesty in which we are now mired. Harm is now “negative efficacy.” Worse findings are called “similar.” True placebo controls have been dumped in favor of something called a “control vaccine.”
(And in case you’re wondering, “noninferiority” is just vaccine-clinical-trial-speak for ‘this one doesn’t suck any worse than the other one.’)
No medical product should ever be allowed to be brought to market and administered to patients on the basis of “relative efficacy.”
After all, these products aren’t marketed to consumers as “relatively safe and effective,” are they?
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