Chapter 2: Article 3 (Listen to the article Here)
Leading up to 1984, there had been a number of American lawsuits filed against vaccine manufacturers, for the injuries that vaccines caused to Americans. Recognizing how USA public vaccine support could be affected by those vaccine lawsuits, the USA Health and Human Services department (HHS) began paying very close attention to those legal proceedings. Based upon the evidence presented throughout the court proceedings, HHS realized that they had a serious problem, and as a result they took action, changing some FDA legislation.
HHS is the highest level of Government for all things health related. Therefore HHS oversees the FDA, they oversee the Center for Disease Control and Prevention (CDC), they oversee the National Institute of Health (NIH), and other American health agencies. That means that when HHS provides direction, all those subordinate agencies must follow through, and act accordingly to that HHS' instruction.
To quote FDA plainly, from their meeting minutes regarding proposed changes to FDA regulations, the minutes say:
"questions have been raised in litigation about whether the vaccine...met all of the technical requirements" [legislated by FDA law]...it is in the interest of the public health to make the amendment effective as soon as possible, to make certain, [litigation] questions... do not cast doubt on the safety of the vaccine and... immunization program."
Though subtly stated that is an incredible admission! What they are admitting to there, is the vaccine maker failed to strictly follow US law during the polio vaccine's clinical testing in the 1960s. Additionally, the FDA didn't catch the error and require the manufacturer to correct their testing process to comply with the regulation requirement. When this was pointed out during the 1984 court proceedings, the US government concluded that they needed to change the law, to save face and make “the issue” no longer an issue that could be pursued in court. That said, I believe the regulation in question and the changes made to it are less important than the why behind the change – the why being their underlying motivation. We learn their underlying motivation near the end of the minutes where they state:
…any possible doubts, whether or not well founded, about the safety of the vaccine cannot be allowed to exist in view of the need to assure that the vaccine will continue to be used to the maximum extent consistent with the nation’s public health objectives.
Accordingly, because of the importance of the vaccine and of maintaining public confidence in the immunization program that depends on it, good cause exists to issue these amendments as a final rule effective immediately.
That statement, that “any possible doubts, whether or not well founded...cannot be allowed to exist” in my opinion, very revealing.
Recently, a friend shared with me that they interpreted that statement to mean that the FDA was simply saying that they wouldn’t allow a safety problem to exist, meaning that they would do whatever necessary to fix such problem so the problem ceased existing. But I’m not convinced that that’s what’s being alluded to here.
I say that because of what they describe their goal to be. If safety was their goal, they would have said something like, “Any possible doubts about safety cannot exist. We need to assure safety to the maximum extent.” But they didn’t say that. Instead, they stated that vaccines need to be “used to the maximum extent,” which suggests maximum use is their highest goal and priority over safety.
So which is it? Which is their highest priority?
If safety was their highest priority goal, I believe they would seek out hearing any and all concerns, allowing the concern to exist whether well founded or not, so that they could test and challenge the claim, all in an effort to reveal, address and correct any problems. How else does a person, or regulatory body, assure maximum safety? Furthermore, their use of the phrase “whether or not well founded” is very odd to me.
By saying “whether or not well founded,” I think HHS and the FDA are subtly acknowledging that they recognize “concerns” – whether a mythical concern, a minor concern, a major concern, a concern that was exposed, addressed and corrected – any and all of those concerns would have a impact, maybe a serious impact, on ensuring a vaccine’s maximum use.
So, what is the highest priority goal, safety or maximum use? Is this quote saying safety problems need to be corrected and cease existing, or are they saying discussion about safety problems needs to cease even if a safety problem exists?
I believe we can lean towards answering that, if we we evaluate their actions, which were:
they changed the FDA regulation to stop the litigation questioning
they did not ask the court proceedings to pause, allowing them time to test a consecutive series of existing vaccine, to confirm consistency in production (and consistency of anti-body production across all recipients), as the regulation required. It’s true completing the testing would have had a cost, maybe a substantial cost. But, should there not be a cost and consequence when a business does not follow the laws properly, even if unintentionally? And it wasn't just the manufacturer alone at fault, the FDA was equally at fault, so they could have shared in the cost of completing the testing again. Testing the vaccine again, could have proven compliance (albeit after licensing not pre-licensing) with the standard expected. And if after completion of the testing, the FDA and HHS felt that testing a consecutive series was unnecessary, they could have changed the regulation eliminating that requirement. Such action would have demonstrated the government's utmost priority to safety, which would have enhanced public confidence.
Let's explore their statements further.
Looking at another part of that quote, where they say, “Accordingly, because of the importance of the vaccine and of maintaining public confidence in the immunization program that depends on it, good cause exists to issue these amendments as a final rule effective immediately, good cause exists to issue these amendments as a final rule effective immediately.” They explained two things of importance, which were:
the vaccine
maintaining public confidence in the immunization program that depends on it [the vaccine]
Over the years, I’ve reviewed numerous publications produced by the CDC, HHS, or Institute of Medicine (IOM) (an non-governmental agency that is often commissioned by the CDC or HHS to conduct reviews on vaccine safety). More times than not, the opening words of the review begins by expressing vaccines are the greatest achievement of the 21st century. To quote the opening sentence of the IOM review completed in 1991 titled, Avderse Effects of Pertussis and Rubella Vaccines, it says:
Next to clean water, no single intervention has had so profound an effect on reducing mortality from childhood diseases as has the widespread introduction of vaccines.
The opening sentence of the 2001 IOM review, titled Immunization Safety Review Thimerosal-Containing Vaccines and Neurodevelopmental Disorders says:
Vaccines are amongh the greatest public health accomplishments of the past century.
And the opening sentence of a 2013 IOM review titled The Childhood Immunization Schedule and Safety says:
Vaccines are among the most effective and safe public health interventions available to prevent serious disease and death.
These are safety reviews, and such was the opening sentence of each review.
Let’s reflect on that a bit further. Today the word “vaccine” often receives equal parity with “miracle.” Bill Gates, doctors and scientists around the world have described vaccines as biological miracles, as the greatest achievement of the 21st century, as the saviour of all mankind.
Can a person objectively evaluate the benefits verses risks of vaccines and the safety of vaccines, if their starting point belief is that vaccines are the greatest solution and achievement. Futhermore, in the 1984 FDA minutes, the goal identified above all else, was that vaccination needs to be utilized to the maximum extent? When this is the starting point belief, objectivity is lost, as strong bias is at the helm of decision making.
Recognizing how strong the government and medical establishment bias is, I feel it's important to counter that information with an equally strong bias, rejecting their starting point assertion - that vaccines are the greatest achievement and need to be used to the maximum extent. Though at the end of this book, such a conclusion might be reached, but we're not going to start there. I will provide an equally strong bias, in opposition, in an effort to reveal to you that maybe, the belief that vaccines are the greatest achievement needing to be used to the maximum extent, has unintentionally corrupted the scientific method. Sometimes, the path to hell is paved with good intentions. As this book progresses, I will provide you with numerous examples from government documents, which reveal how use to the maximum extent, has been prioritized over testing for safety.
I'll conclude with a final investigation. The FDA minutes were taken in 1984. If we look at the vaccination schedule, from 1984 until now, do you have any guesses as to what happened during the time in between?
Well I’ll tell you. In 1986, new legislation was brought forth, also as a result of the lawsuits occurring during this period of time. The new legislation inadvertently affected the vaccination schedule, resulting in a dramatic increase. Prior to 1986, American children were given 24 doses of 7 vaccines from birth to 18 years of age. Today, American infants receive more than that, receiving 25 doses of 9 vaccines in their first 6 months of life. Think about that. What was once received over a span of 18 years is now received within the first 6 months of life. That’s an incredible increase. Looking at the vaccination schedule today, from birth to 18 years of age, American children now receive 70 doses of 16 vaccines, a near tripling of what was received before 1986.
There is often confusion regarding how those “vaccine dosage” numbers are derived. To explain, vaccine preventable illnesses each have their own individual and unique vaccine, and sometimes those vaccines are later combined into combination vials. For example, the measles vaccine, mumps vaccine, and rubella vaccines are each made individually and specifically for those three separate illnesses. As the vaccine schedule grew, vaccines were combined into different combo shots, in this example producing the combined MMR vaccine, which reduced the number of injections that a child has to receive. The pro-choice often refer to MMR as either three separate vaccines, or three separate vaccine doses within one injection.
To frame this a different way, if you took one pill of each, Tylenol, Advil, and Aspirin should that be considered 3 separate drugs? Would it be fair to say 3 doses of pain killer? Or should we insist that such a combo be classified as a single dose of a single painkiller? I think most people would agree that such a combination could be referred to fairly as three separate drugs administered at the same time, or three doses of pain killer administered together.
Though Canada did not face the same legislative changes in 1986, Canadians were equally affected by this American legislation. As the American vaccine schedule grew drastically after 1986, the Canadian vaccine schedule grew comparably, changing nearly identically with only minor differences. Before 1986, over their entire childhood, from birth to 18 years of age, Canadian children received 24 doses of 7 vaccines. Today, Canadian infants receive more than that in their first 6 months, receiving 25 doses of 10 vaccines. Looking at the present Canadian schedule from birth to 18 years of age, Canadian children today receive 70 doses of 16 vaccines, again, a near tripling. And that does not include the Covid vaccine.
In the FDA meeting minutes from 1984, I think it’s reasonable to look at their statements and conclude that strong bias likely influenced government action and decision making. How and in what ways? I’m not completely sure of all those nuances, but based upon the statements made in these meeting minutes and the near tripling of the childhood vaccination schedule since then, I think all such action is quite revealing.
And remember, these are FDA meeting minutes, the FDA did not go rogue here, acting randomly, making up their own directives and initiatives. The FDA regulates vaccine testing, but they don’t approve the childhood vaccination schedule, that falls under the jurisdiction of the CDC. Both departments are subordinate to HHS. Remember, when lawsuits scrutinize government actions, the affected government department and their supervising department all meet together to discuss those developments, with the supervising department (HHS) providing leadership, oversight and direction. The quote, that “any possible doubts, whether or not well founded, about the safety of the vaccine cannot be allowed to exist in view of the need to assure that the vaccine will continue to be used to the maximum extent”... was likely not a siloed FDA opinion. I think it’s likely this statement came from HHS, and was directed to all the subordinate departments.
CONTINUE to the next article here: Ch3: Article 1
Article Sources
HHS Organizational Chart Here (pdf)
Must Read: HHS / Federal Register / Vol. 49 No. 107 / Friday June 1, 1984 / Rules and Regulations Amendments to 21 CFR Part 630, Food and Drug Administration, Final Rule - (pdf - with my highlights)
This small pdf file was extracted from the full document, so it loads more quickly. You can view the original Federal Register document Here (It's large and takes a while to load). If you download the file, you will need to scroll to page 252. If you don't download the document, then scroll to the page numbered 23004 and read until page numbered 23007.
NYU Professor speaking about vaccine propaganda and censorship Here
FDA Regulating Policy Part 630 - Additional Standards for Viral Vaccines Here
IOM review in 1991 - Adverse Effects of Pertussis and Rubella Vaccines Here
IOM review in 2001 - Immunization Safety Review Thimerosal-Containing Vaccines and Neurodevelopmental Disorders Here
IOM review in 2013 - The Childhood Immunization Schedule and Safety Here
Past US vaccination schedule Here
Current US vaccination schedule Here
Current Alberta, Canada vaccination schedule Here