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Vaccine Safety Testing - Placebo Controls

Updated: Apr 29, 2021

Chapter 4: Article 5

When I reflect on my childhood, on getting sick, I recall my mom speaking incredibly highly of vaccines. I remember her describing how smart the scientists were, that they learned you could give a weakened version of an illness through a vaccine, and that the vaccine would make your body stronger than before. She described that the scientists worked for so long, testing the vaccines in different ways on different groups of people with some receiving a placebo - placebo in her words was a fake medicine that looked real but it didn't do anything so no one knew if they received the test medication or not. She explained that those studies showed that people who received a vaccine instead of a placebo ended up healthier, and that's why vaccines are given today. 

Mom was my world. If she said something was so, I knew it was true.

And then a few short years ago I learned that vaccines are NOT tested against a placebo. I thought to myself, "If that was wrong, what else have I mistakenly believed to be fact."

High school science class taught me that when you establish a hypothesis, you must challenge that hypothesis in different ways to prove that your bias hasn't influenced your observations. As a 16 year old high school student I understood the critical importance of a placebo control, yet today vaccine scientists think genuine saline placebos are unnecessary. This disconnect is baffling to me.

Let's take a moment to learn what the Centers for Disease Control and Prevention (CDC) and Health and Human Services (HHS) have to say about the actions of placebos and the importance of placebos.The CDC defines placebo as:

“A substance or treatment that has no effect on human beings.”

HHS states (emphasis mine):

In undertaking a clinical trial, researchers don’t want to leave anything to chance. They want to be as certain as possible that the results of the testing show whether or not a treatment is safe and effective. The “gold standard” for testing interventions in people is the “randomized, placebo-controlled” clinical trial....A placebo is an inactive substance that looks like the drug or treatment being tested.

From the FDA, their Code of Federal Regulations 21 CFR 201.57, we learn how drugs and vaccines are tested. The regulations state (emphasis mine):

Any statements comparing the safety or effectiveness of the drug with other agents for the same indication must, except for biological products [vaccines], be supported by substantial evidence derived from adequate and well-controlled studies ... For biological products, such statements must be supported by substantial evidence.

The omission in that regulation is revealing. Though pharmaceutical drugs need "substantial evidence" demonstrated through "adequate and well-controlled studies," vaccines aren't held to that same standard. Vaccine studies need not meet the standard of "adequate and well controlled."

And so, saline placebos are almost never used it vaccine trials.

But with that said, you will hear the media, the health authority, and your doctor make statements about the vaccine compared to placebo, or they will say a vaccinated group compared to an unvaccinated control group. Those statements need explanation. When you hear the term  “placebo” in a vaccine discussion, that "placebo" is one of three things:

  1. a different vaccine (for the same or a different illness)

  2. the vaccine solution without the antigen (antigen is the vaccine virus or vaccine bacteria)

  3. specific vaccine ingredient(s), like the aluminum adjuvant (the aluminum adjuvant in the vaccine boosts the immune response within the body so the adjuvant does have an effect on the body)

And when the Health Authority says an “unvaccinated” person, that does not usually mean a person who has NEVER been vaccinated. Instead, “unvaccinated” also means three different things:

  1. a person who has inadequate health records to prove which vaccines they've received or not received, and/or

  2. a person who is not fully up-to-date and vaccinated according to the most recent schedule (even if they are missing only one vaccine), or a person who has not received all the available vaccines recognizing that there are vaccines in use which are not mandated or recommended in a vaccination schedule, and In reference to a person participating in a clinical trial who is “unvaccinated” that participant is:

  3. a person who was given vaccine ingredients (less the antigen), or a control vaccine, either a competitor vaccine for the same illness, or a completely unrelated vaccine for a different illness. This group is compared against the group which receives the experimental vaccine which is being tested.

In about 2018 or 2019 (I cannot be certain on the date because YouTube has cancelled the organization's channel), Del Bigtree of the Highwire explained on video that his team did an investigation reviewing all the clinical trials completed, trials which granted licensing approval for the childhood vaccines used in the United States. Keep in mind Canada uses many of those same vaccines. Through the team's investigation, they discovered that none of the vaccine's were compared to a saline placebo. Of the 35 vaccines they displayed in a illustrative graphic, only two of those vaccines had been compared against placebo. But, for those two vaccines compared against placebo, the one, Gardasil, used placebo for 306 of the trial participants. Keep in mind, Gardasil was tested in trials that enrolled approximately 26,000 people, so 306 of them receiving a saline placebo is a bit of a joke. And at the conclusion of the trial, those 306 placebo recipients then received the Gardasil shot. So if their health outcomes had been any different than that of the vaccine recipients, that difference would have been erased because they were also given the vaccine shortly after.

In Del's investigation, one other vaccine did get compared to placebo, but along with the placebo the trial participants were injected with 2 licensed vaccines. That means one group of participants received 3 vaccines, while the other group received 2 vaccines + placebo. Such a comparison is not useful for determining whether or not health outcomes differ between the vaccinated and "unvaccinated" groups.

Below you will see the graphic that Del's team produced. At the top, you see vaccines with lines going down to other vaccines. Those lines indicate which vaccines were compared against each other. When you get to the vaccines at the bottom of the graphic, those vaccines received approval without having been compared to a saline placebo. I haven't looked to see what the bottom vaccines were compared against, but it's likely they were compared to vaccine ingredients, for example the make-up of the vaccine without the antigen (viral or bacterial component of the vaccine), or the vaccines were compared to the aluminum adjuvant present in many vaccines.

As a result of never using a genuine saline placebo control or a never vaccinated control group, the safety data that is available is very limited. The reality of current vaccine safety testing is that most clinical trials have never established a baseline, looking to see if the vaccinated populations experienced DIFFERENT reactions compared to a CONTROL group which wasn't vaccinated.

To support why this is dangerous, I provide you with an article written by the American College of Pediatricians. In this article, they are discussing a potential adverse affect of Gardasil (an HPV vaccine). The safety issue discussed is just being recognized now, over ten years after Gardasil was originally approved for use in 2006. The condition in question is called premature ovarian failure (POF), and is also known as premature menopause. If Gardasil causes premature ovarian failure, the writer admits that the reaction was not identified in the pre-licensing safety trials, because the “placebo” used during the testing was a solution of vaccine ingredients.

The article states:

Few other vaccines besides Gardasil® that are administered in adolescence contain polysorbate 80. Pre-licensure safety trials for Gardasil® used placebo that contained polysorbate 80 as well as aluminum adjuvant. Therefore, if such ingredients could cause ovarian dysfunction, an increase in amenorrhea [loss of menstruation] probably would not have been detected in the placebo controlled trials.

It’s important to point out that Gardasil is now being recommended for girls as young as 9 years old. And it also needs to be noted that aluminum and polysorbate 80 are ingredients in many of the vaccines administered during infancy and childhood. If these ingredients cause premature ovarian failure, it would be nearly impossible to connect the resulting damage back to the vaccine, because the evidence of the damage (lack of menstruation) would not reveal itself until years/decades after vaccination. Currently, vaccine clinical trials usually follow the health of the participants for only a few days, weeks or months, and in some cases, for a couple years.

If you recall back to Ch2: Article 2 where I pointed you to the interview with David Graham, you will remember that one of the concerns he identified was that drugs are only being compared to placebo and not to existing drugs that are already on the market. He explained that this comparison to placebo only, means that drugs that are being approved are often inferior to existing drugs. This is because new drugs are not required to be equivalent or better than what's already approved and licensed, and new drugs simply need to be better than a "sugar pill." Graham explained that once a new drug passes that test, the manufacturer then implements a massive marketing campaign, which often results in patients being denied the more effective medication, because the doctor was unaware the new medication is less effective than the long established drug.

The take-away message from Graham, was that it's more important to compare a new medication to an existing drug, than it is to compare it to placebo.

But THAT is happening in the world of vaccines, vaccines are only ever compared to each other, and the strategy is not working, because vaccines were never tested against placebo in the first place. As a result, adverse events are being dismissed as unrelated to vaccination, without any evidence or data to support such a conclusion, all because the figures of such adverse events are similar across the vaccinated groups.

A baseline of health and safety needs to first be established, and that can only be established initially, by comparing an experimental drug with placebo. To dismiss this step entirely is incredibly dangerous. Recognizing what Graham has identified, I think IN ADDITION to testing against a genuine placebo, the testing should ALSO incorporate a comparison against any comparable existing medication on the market, to ensure the new drug is at equivalent or better in effectiveness. Safety measurement, testing against a placebo must never be eliminated.

The varying degree and extent by which vaccination is affecting health is completely unknown. Until vaccine SAFETY trials use a genuine placebo, and until the health of trial participants is followed over the long term, we simply will remain ignorant to all the effects the practice of vaccination is having. 

Covid Vaccines Were Compared to Placebo

Now with that said, this article was written in 2017, and was later updated to show Del's placebo pyramid graphic created in 2018 or 2019. So I need to touch on more recent developments occurring with the Covid 19 vaccine clinical trials. In protocol documents submitted to the FDA in March 2020, those documents stated a saline placebo would be used. Then in April those documents were amended to show a meningococcal vaccine would be used as the control, instead of saline. In June, the non-profit organization Informed Consent Action Network petitioned the FDA, to request that a saline placebo in fact be used, NOT the meningococcal vaccine. In July, Del Bigtree explains through video that it appears his petition was successful, and so based upon that, I believe a genuine saline placebo control was used in the Covid 19 vaccine clinical testing.

CONTINUE to the next article: Ch4: Article 6

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