April 12, 2020

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Introduction to Effectiveness Correlation vs Causation

When it comes to vaccines, the story about a vaccine's "effect" is very different from what media reports. Media tells us that the point of a vaccine is to create immunity, herd immunity, and protection from illness. 

 

But none of that has been carefully, scientifically tested

 

If you look at the clinical testing, at the “drug effect” that is measured and carefully tested, you'll discover it's antibody production. Did the clinical trial participants generate an adequate antibody response?

 

What's left out effectiveness testing is just as important as what is tested.

 

How Vaccine Effectiveness Is Measured

To measure vaccine effectiveness, the researchers divide trial participants into at least two different groups. Antibody levels are measured in everyone, then one group receives the experimental vaccine, and the other group receives an active control (more will be explained on this later). After each injection of vaccine or control (usually 1-3 doses), the trial participants' antibody levels are measured again. If the experimental vaccine recipients now have antibody levels against the illness, whereas the control recipients do not, then the vaccine is considered effective. Or, if the control was a different vaccine for the same illness, and all recipients have equivalent antibody levels, then again, the experimental vaccine is considered effective. When this type of trial is repeated again and again, with the same end result of antibody generation being observed, then a causal relationship is established - meaning the vaccine in fact causes the body to develop those specific antibodies.

 

For effectiveness trials, the researches NEVER EXPOSE all the trial participants to the illness after vaccination, to observe and measure what happens within that vaccinated immune system.

 

Does this pose a problem?

 

Because trial participants are never purposefully exposed to illness, researchers can't measure what percentage of the vaccinated/exposed group still gets sick despite being vaccinated, vs what percentage of the group became asymptomatic or mildly ill and still contagious, vs what percentage of the group became immune to the illness thanks to the vaccine. Remember, asymptomatic and immune mean very different things. 

 

A recent Canadian news article about the coronavirus touches on this lack of testing. The article states:

...thousands of healthy volunteers, including hundreds of Canadians, have offered to try a far riskier approach: getting injected with a potential vaccine and then purposely becoming infected with COVID-19 to test if the vaccine works.

 

The method is called a “human challenge trial,” and it’s been used before to develop treatments against smallpox, influenza and malaria. The World Health Organization says the approach can be “substantially faster” than standard vaccine field trials and, if designed properly, human challenge trials could lead to better vaccines.

But purposefully infecting healthy individuals with a potentially deadly virus has obvious ethical concerns, including the inherent risk of life-altering side-effects or death.

 

Infants, toddlers, children and teens are vaccinated against 16 different illnesses throughout their childhoods, of which one of the vaccines' they receive is the influenza vaccine. The other 15 vaccines they receive have never been tested with human challenge trials.

 

Researchers also don't follow the vaccinated group over their entire lifetime to see if that vaccine induced antibody generation fades or disappears completely in time. Related to that, they also don't monitor how "time past" since vaccination affects immunity and susceptibility to the illness. 

 

Correlation vs Causation

Because researchers have never conducted a human challenge trial, or followed the vaccinated group for the duration of their lives, they can’t compare that data to a never vaccinated control group, one that was followed and measured in the same or similar ways. Such a clinical trial, if well controlled, could show a causal relationship, if one exists, meaning that testing could show if vaccines cause illness protection, illness prevention, or the creation of immunity.

 

That means causation has NEVER been established for those endpoints.

 

With that explained, it's important to point out that in some clinical trials, researchers have followed all clinical trial participants for a few months to a few years after vaccination, to see who was naturally exposed to the illness by chance and who became sick (more on this later). In these studies a never vaccinated control group has never been included for comparison. Other studies have compared the rates of specific illnesses before a vaccine was licensed, and after a vaccine was utilized on a mass scale. Much of that data does show that the rate of specific illnesses in a population did drop, sometimes significantly after the vaccine was used widely. Those studies are epidemiological studies - often called population studies - and population studies cannot prove causation. Population studies show correlations, and the population studies that the manufacturers and health authority point to provide very strong correlative evidence to support that vaccines do alter rates of specific illnesses. 

 

Furthermore, for causation to be established, for the endpoints illness protection, illness prevention, immunity created, etc, scientists would have to understand exactly what happens within the body, following vaccination. In the vaccine package inserts, manufacturers clearly explain that they don't understand what a vaccine does. For example, in the Infanrix-Hexa vaccine package insert, the manufacturer states the following (emphasis mine):

Antigenic components of B. pertussis believed to contribute to protective immunity include: pertussis toxin (PT); filamentous hemagglutinin (FHA); and pertactin. Although the role of these antigens in providing protective immunity in humans is not well understood...

 

Media messaging makes it seem like vaccine science has been settled and definitive for decades now, that researchers know exactly what's happening. But the manufacturers' admissions in their vaccine package inserts, show that the science isn't conclusive and solid. So, if you combine their messages, they're saying, "We don't have a thorough understanding of what a vaccine does within the body, but we're certain that whatever it's doing, that action has to be only good." With the manufacturers quote above, they were talking about whooping cough. Keep in mind the whooping cough vaccine was licensed in the 1940s and we've been using it for nearly 80 years now, but we still don't understand how it works. So I ask, because we've been doing something for 80 years, without understanding the science of what's happening, does that make "length of time" OR "scientific evidence" the determinant behind the statement "Vaccine science is settled and indisputable."

 

I'll provide you a few more examples. These quotes below all come from the manufacturers package inserts, from the sections titled "Mechanism of Action" or "Action and Clinical Pharmacology": (emphasis mine):

 

Engerix-B (Manufactured by GSK)

It is generally accepted that an anti-HBs titre greater than 10 IU/L correlates with protection against hepatitis B virus infection. 

 

Rotarix (Manufactured by GSK)

The immunologic mechanism by which ROTARIX® protects against rotavirus gastro- enteritis is not completely understood. A relationship between antibody responses to rotavirus vaccination and protection against rotavirus gastroenteritis has not been established

 

Gardasil 9 (Manufactured by Merck)

HPV only infects human beings. Animal studies with analogous animal papillomaviruses suggest that the efficacy of L1 VLP vaccines may involve the development of humoral immune responses [antibodies]. Human beings develop a humoral immune response to the vaccine, although the exact mechanism of protection is unknown

 

FluAd Pediatric (Manufactured by Novartis)

Specific levels of hemagglutination inhibition (HI) antibody titers induced by vaccination with inactivated influenza virus vaccine have not been correlated with protection from influenza illness. Some studies of influenza infection, including human challenge studies following vaccination, have suggested that HI antibody titers ranging from 1:15 to 1:65 may be associated with protection...

 

Cervarix (Manufactured by GSK)

High and sustained antibodies against HPV are associated with protection against HPV- related infection and/or disease...CERVARIX® studies have demonstrated that there is a correlation between levels of anti-HPV antibodies in serum samples relative to anti-HPV antibodies in cervicovaginal secretion samples. 

 

Does any of that sound like absolute proof demonstrating that vaccines cause immunity for the recipient? The manufacturers admit here in their drug inserts that they are relying on correlations, predictions and theorized beliefs, NOT causation. 

 

Because the studies have never established causation for anything other than antibody generation, it's important to remind you that correlation doesn't equal causation. The pro-vaccine shout "correlation does not equal causation," because of the correlative evidence we point to. Their emphasis that "correlation does not equal causation," infers that they are NOT relying upon correlations, and in fact they have causation on their side. That is not the case! Pro-vaccine advocates rely almost completely on correlative evidence, to defend their position.

 

Think about that.

 

Paul Offit, one of the most well respected vaccine advocates, points at this when he was explaining vaccine testing and the expedited coronavirus vaccine testing. In an interview he stated:

...Then what you would do, you would do dose ranging trials, seeing what dose I can give to induce an immune response in animal models that correlated with protection...

 

...Then you do a phase three trial, the definitive FDA licensure trial, which typically is a prospective placebo controlled trial, for our vaccine that was a 70,000 child [trial] over 4 years. And that's typical. Rotarix was a 60,000 person trial. [Indiscernible] pneumococcal was a 30,000 person trial. The HPV vaccine was a 35,000 person trial.

 

Interviewer Says: You've talked about antibodies, and immunity, and we're correlating presence of antibodies and immunity - essentially to give protection.

 

Paul Offit: You don't really know what level of [antibodies] is protective, that's why you do prospective, placebo controlled efficacy trials, because then you may know that. I mean we never knew that, with the rotavirus vaccine, even in 70,000 people, we still never had an immunological correlative for protection.

 

Vaccine proponents rely completely upon correlative evidence, and sometimes they don't even have that. If correlation is a concrete standard of evidence to assert that vaccines have caused protection from and prevention of illness and the creation of immunity, as is stated by media and doctors every day, then correlative evidence must also be recognized as a good enough standard of proof, to ALLOW for discussion of evidence that argues that vaccination may be causing harm. This currently is not allowed. 

 

A very good video to watch, that explains the difference between correlation and causation, is a Ted Talk given by Ionica Smeets. She explains the danger of interpreting correlation as meaning something caused something else. And based on a statement she made at the end of her talk, it sounds like she is pro-vaccine. 

 

Ionica explained in her talk that a correlation, paired with evidence explaining how something happens, can suggest causation. With vaccines, biological evidence showing vaccines cause antibody generation, paired with correlative data from population studies showing reduced incidence of specific illness, has led to the assumption that vaccines cause immunity, improved health, and lives saved.

 

But to conclude from the biological evidence and related correlations that vaccines cause immunity, etc, requires the denial and silencing of opposing scientific evidence, both biological evidence and related correlations. The denial and suppression of that opposing data will be discussed in extensive detail throughout much of this online book. Today however, in this article, my focus was simply to explain correlation vs causation, AND the media and health authority's double standard when it comes to reporting correlative evidence.

 

 

CONTINUE to the next post here: Ch3: Part 2 

 

 

Article Sources

  • MUST READ: Participants are never purposefully exposed to illness, nor is their health monitored for the rest of their life Here

  • TEDx Talks Ionica Smeets - The danger of mixing up causality and correlation Here

  • MUST WATCH: Paul Offit Interview - reliance on correlative data Here

Clinical efficacy testing from a random selection of vaccine package inserts, showing either causal evidence for antibody generation, or correlative evidence for protection from illness, or the package insert shows both:

  • Infanrix-Hexa vaccine package insert (starting at pg 20) Here

  • Engerix-B vaccine package insert (on pg 13) Here

  • Rotarix vaccine package insert (on pg 14) Here

  • Gardasil 9 vaccine package insert (on pg 16) Here

  • Fluad Pediatric vaccine package insert (on pg 16) Here

  • Cervarix vaccine package insert (starting at pg 18) Here

 

Last updated April 12, 2020

 

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