In Safety & Efficacy Part 2, I explained that David Graham, an FDA employee and whistleblower, stated that the FDA is good at ensuring drug makers prove efficacy (effectiveness) of the drug. In an interview he gave, he is quoted as saying: (emphasis mine)
In terms of confidence in what the FDA does, there are two things that the FDA determines when it looks at a drug: it determines whether or not a drug is safe and it determines whether or not it's effective. Regarding the determination of drug effectiveness, I think the FDA does a pretty good job. If the FDA says that the drug will have a particular effect, probably for many of the patients who take the drug it will actually have that effect. If the FDA says a given drug will lower blood pressure and you're somebody who has high blood pressure, there's a good chance that the drug will have an effect that lowers your blood pressure. That has to do with the rigor with which they force the drug companies to establish that the drug actually has an effect.
So lets talk about that.
Defining Vaccine "Effectiveness"
What does vaccine "effectiveness" actually mean? To answer that, one needs to look at the pre-licensing tests that each vaccine goes through. If you look at that testing, you will discover that the “drug effect” that is tested and scientifically measured, for most vaccines, is the effect on antibody production. Did the clinical trial participants generate an adequate antibody response?
To test and measure vaccine effectiveness, all the clinical trial participants have their antibody levels measured (against a specific illness). Usually only participants who have low or no antibodies against that illness are enrolled in the clinical trial. From there, the researchers divide the participants into two different groups (often neither the doctors nor patients know which group the participants are assigned into). At that point, one group receives the experimental vaccine, and the other group receives a "placebo," which in the case of vaccine trials the placebo is almost never a solution of saline, and rather, is either a selection of vaccine ingredients without the viral or bacterial antigen, or the placebo is a different existing vaccine that is already licensed and on the market (more will be explained on this later). These types of placebo are often referred to as an "active control." After each injection of vaccine or active control (usually 1-3 doses), the trial participants' antibody levels are measured again. In studying the measurement of antibodies, 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 licensed vaccine against the same illness, and the experimental vaccine produced equivalent antibody levels as the control, 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.
When a different vaccine is used as the control, most times researchers are evaluating whether or not the new test vaccine produces an antibody response in the body which is the same or better than that produced by the existing vaccine. In the interview with David Graham, he stated that testing a new drug against a comparable existing drug is something that is very important to do. He said that this process is currently lacking in pharmaceutical drug trials. But as stated here, it often does happen in vaccine trials. Vaccines are classified a little differently than pharmaceutical drugs, and as a result their testing is different in some ways.
As I said, the drug effect that is accurately tested and measured, for vaccines, is antibody production. What is important to note about that is in vaccine effectiveness trials they NEVER EXPOSE all the trial participants to the illness after vaccination, to observe and measure what happens within that vaccinated immune system. Because they don't do that, they 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. They also don't follow the vaccinated group over their entire lifetime to see if that vaccine antibody generation fades or disappears completely in time. Related to that, they also don't monitor how "time past" since vaccination affects susceptibility to the illness. And as a final point, they also don't monitor vaccinated individuals for by-chance exposure to a pathogen, to test and measure whether or not the vaccinated person is actually immune to illness, or whether or not the vaccinated person still became infected and subsequently is contagious, while presenting with the standard illness symptoms, different or mild symptoms, or no symptoms at all.
Correlation vs Causation
Because researchers don't ever conduct that type of study and measurement, they can’t compare that data to an 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. However, because it would be exceptionally difficult to control for all the potential variables in a lifetime trial, and more importantly, because it would be unethical to purposefully expose all participants to the illness, that is why that type of study has never been conducted. So causation has never been established for the endpoints of illness protection, illness prevention, creation of immunity, lives saved, reduced mortality, etc.
With that explained, it's important to point out that in some clinical trials researchers have followed all clinical trial participants (though a never vaccinated control group has never been included in studies conducted in recent decades) 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). 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' admission in their various vaccine package inserts, as quoted there, show that the science isn't conclusive and solid. So, if you combine their messages, they're saying, "We don't really understand how it's working, 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 40s 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 understanding" 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):
It is generally accepted that an anti-HBs titre greater than 10 IU/L correlates with protection against hepatitis B virus infection.
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.
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.
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...
High and sustained antibodies against HPV are associated with protection against HPV- related infection and/or disease. Animal studies suggest that the efficacy of L1 VLP vaccines is predominantly mediated by the development of neutralizing antibody (humoral) immune responses. Vaccination with HPV L1 capsid proteins predominately induces serum neutralizing IgG antibodies; however, transudation of anti-HPV IgG neutralizing antibodies from the serum to the cervical mucosa is thought to provide a mechanism to prevent HPV entry into cervical epithelial cells which might otherwise lead to infection and cervical cancer. 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. While the minimum level of antibodies required to prevent HPV infection are not yet known, anti-papillomavirus antibodies have been shown to be sufficient to prevent infection and/or disease. These data suggest that the mechanism of action of L1 VLP vaccines is primarily mediated through a vaccine- induced antibody-mediated immune response.
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.
Further to that, it needs to be explained how testing would need to be conducted, to establish causation for an adverse effect following vaccination. That testing would have to go through a three step process. Researchers would have to give a drug to a patient or a group of patients and record the serious side effect occurring. Then they would have to withdraw the drug, and record the serious side effect going away. And then they would have to give the drug again – and record the exact same reaction occurring again.
In the book Death by Prescription, written by Canadian MP Terrence Young, it states:
[Such a study] would be foolish and unethical. No researcher would complete step three – [harming] a patient ... a second time – because it’s too dangerous. Step three simply can’t be completed for serious adverse reactions. So instead, the drug companies just put the drugs on the market.
When researchers study adverse effects following after-the-fact exposure, rather than testing something pro-actively before a population has been exposed, causation cannot ever be completely established, because purposefully subjecting humans to a suspected harmful exposure is deemed unethical (more on this below).
The CDC elaborates on causation studies further, when explaining their Vaccine Adverse Event Reporting System (VAERS). The CDC explains that to be able to determine a causal relationship between a vaccine and an adverse event (after a vaccine is being used en-masse in a population), health outcomes in a vaccinated group would have to be compared to an unvaccinated control group. What the CDC doesn't explain in this description is that a vaccinated vs unvaccinated study has never been conducted because the CDC refuses to do this research. Their website states (underline emphasis mine):
Inability to determine causation. VAERS reports are usually not helpful in assessing whether a vaccine actually caused the reported [adverse events] AEs because they lack either unique laboratory findings or the information necessary to draw such conclusions. Often multiple vaccines are administered at the same visit, making attribution of causation to a single vaccine or antigen difficult. Additionally, there is lack of an unvaccinated group for comparison in VAERS. Therefore, reports to VAERS are useful for generating hypotheses, but studies with vaccinated and unvaccinated subjects are necessary to confirm any hypotheses generated by VAERS observations.
Because vaccine makers (and the government) have never compared vaccinated and never vaccinated populations, to prove causation for anything - for what a vaccine does in the body, how a vaccine "causes" immunity, or for how a vaccine "causes" harm (despite the US government acknowledging that there are specific recognized injuries occurring from vaccines) - then that means they are relying entirely on correlations.
Today, because of current vaccine policy (that well founded concerns about vaccine safety cannot be allowed to exist), the health authority essentially has made it a national requirement to showcase only the vaccine positive correlations, correlations which suggest vaccines cause immunity and illness prevention. And this same policy requires national showcase of the correlations that support that vaccines are perfectly safe and DON'T cause harm. The truth though is that researchers and immunologists have no idea the full extent of what a vaccine causes within the immune system and body.
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. I say this, because the statement "Correlation does not equal causation" is used all the time against the group speaking out about vaccine risks. 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 on correlations, and in fact they have causation on their side. That is not the case. The pro-vaccine stance relies almost completely on correlative evidence, to defend that position.
I'll say that again, the pro-vaccine stance relies almost entirely on correlative evidence, to defend that position.
Think about 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, improved health, or reduced mortality, 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 on correlative evidence.
Correlation - An Example from History
To provide a different important historical example. Causation on it's own has never been established for tobacco and lung disease. That may shock you, but it's true. Remember, to prove causation - that tobacco causes disease - the testing would have to go through a three step process. First the test group would have to be exposed to tobacco and researchers would have to observe the development of disease. Then they'd have to stop exposing the group (or not expose a control group) and watch the disease rates reduce or go away. And then they'd have to repeat the exposure and observe the disease occurring again. So with tobacco, causation has never been established. Instead, biological evidence paired with correlative data led to a final consensus that tobacco must in fact cause disease. But to get there took a long time because the scientific consensus originally rejected any relationship. A BMJ article states (emphasis mine):
Lung cancer was once a very rare disease, so rare that doctors took special notice when confronted with a case, thinking it a once-in-a-lifetime oddity. Mechanisation and mass marketing towards the end of the 19th century popularised the cigarette habit, however, causing a global lung cancer epidemic. Cigarettes were recognised as the cause of the epidemic in the 1940s and 1950s, with the confluence of studies from epidemiology, animal experiments, cellular pathology and chemical analytics. Cigarette manufacturers disputed this evidence, as part of an orchestrated conspiracy to salvage cigarette sales. Propagandising the public proved successful, judging from secret tobacco industry measurements of the impact of denialist propaganda. As late as 1960 only one-third of all US doctors believed that the case against cigarettes had been established.
From first hypothesis that tobacco could cause disease, to medical consensus that it does, took 66 years years. The paper explains (date emphasis mine):
Tobacco was apparently not even suspected as a cause of lung tumours until the final decade of the 19th century. In 1898, a medical student by the name of Hermann Rottmann in Würzburg proposed that tobacco dust—not smoke—might be causing the elevated incidence of lung tumours among German tobacco workers. Rottmann's mistake was not corrected until 1912, when Adler proposed that smoking might be to blame for the growing incidence of pulmonary tumours.
...The 1964 Surgeon General's report, which recognised smoking as a cause of lung cancer in men, is often regarded as a turning point in the recognition of health harms from smoking. But the Surgeon General's report was actually a kind of scientific anticlimax: from an evidentiary point of view the case against smoking had been closed by the end of the 1950s, and it was only the truculence and obstinacy of cigarette manufacturers that forced a blue-ribbon review by the federal government.
In the first half of the the 1900s, when those well versed in the concerning tobacco data pointed at the evidence and correlations which implicated smoking as being the reason for the increased rates of disease, the argument that industry used against them, to cast doubt on any such a connection was none other than, "Correlation does not equal causation."
Unfortunately today, we just might be faced with a repeat of history. With the tobacco situation, that history saw the emergence of a tobacco/disease hypothesis, then it saw a consensus that rejected the possibility that tobacco could cause disease, and then that consensus flipped entirely on its head, with the final conclusion admitting that smoking must in fact cause disease. It took 66 years for that to play out. Much of the tobacco history parallels what we're witnessing today, but for me, one parallel was most unexpected, that being that in 1898 a medical student first theorized that tobacco caused cancer. If you're well versed on vaccine history, you know it was exactly 100 years later, in 1998, that Dr. Andrew Wakefield published a paper in the Lancet, a paper which today is extensively misrepresented and mis-quoted, and which is blamed for the entire "anti-vaccine" movement. So on the vaccine front, the publication date of that 1998 paper might be marked as day one in a projected 66 year timeline.
Knowing the tobacco history, that timeline and the tactics used by the tobacco industry throughout that debate, can serve as a metaphorical GPS for us, to help us pinpoint where exactly we are (21 years in) in bringing about awareness on this topic. One marked difference though between the tobacco and vaccine situation, is that tobacco was a habit started by choice, in adolescence or adulthood. In contrast, vaccination is a required medication forced onto every healthy infant and child. Hopefully because of the force with which vaccination is being pushed, hopefully that force will cause people to begin paying close attention sooner than happened with tobacco.
MUST WATCH: TEDx Talks Ionica Smeets - The danger of mixing up causality and correlation Here
Book - Death by Prescription Here
Explanation: HHS Policy that Vaccine Concerns Must Not be Allowed to Exist Here
CDC website - Inability to Determine Causation Here
BMJ article about the Tobacco History 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
MMR Vaccine package insert (starting at pg 20) Here
Priorix-Tetra vaccine package insert (starting at pg 16) Here
Meningitec Vaccine package insert (starting at pg 3) Here
Prevnar 13 vaccine package insert (starting at pg 24) Here
CONTINUE to the next post here: Safety & Efficacy - Part 5
Last updated February 23, 2019