Vaccine Science and the Replication Crisis

The process of science could be visually conceptualized as pyramid. Hypotheses are posited in studies and tested, and are proven or disproven. Theories are developed from hypotheses and still more testing done to prove or disprove them. At the top of the pyramid are scientific laws (ie: like the Law of Gravity) that have been proven via **repeated** testing (Newton and others have dropped a lot of apples over the years!) – and even though it is a “Law” it continues to be further refined via the scientific method.

An important topic in science is the “reproducibility crisis”. This is about how many studies do not provide similar results when they are repeated by other scientists leading to doubts about the validity of the original study. The fact that this is being discussed in the scientific literature can only strengthen science.

I can think of at least two ways that this concept (reproducibility) is relevant to the subject of vaccines.

One – you cannot reproduce a study you do not do. Vaccine advocates rely almost exclusively on epidemiological studies to “support” their position that vaccines are “safe and effective”. Epidemiological studies may show correlation, but by design they cannot show causation – so they are not proof of safety. While doing this many will mock those who question vaccines (frequently enough after they have observed a loved one’s injury subsequent to vaccination) who they state cannot “prove” that vaccines are dangerous. Oddly enough, it is those who have experienced vaccine injury that want “gold standard” studies done so high-quality hard data on safety and efficacy will be available to all. It is strange that those who advocate for vaccination do not want “gold standard” science done. One would think that if they were that confident in the product’s safety and efficacy they would be calling for gold standard science (multiple randomized double blind placebo controlled studies on the individual vaccines as well as the schedule as a whole) because this would silence those who are critical of vaccination.

Yet they don’t. They hide behind the fig leaf of “it’s not ethical to deny vaccines” (ie: to the placebo and/or control group). Huh. But if providing solid proof would shut the “anti-vaxxers” down for once and for all, why not do it? Resorting to censorship is bad optics and absolutely implies there is something to hide. It’s a power play that historically has been used by bad men with evil agendas. Truth has nothing to fear from the lie – so what are they trying to hide? It is those who are vaccine risk aware who are calling for greater transparency! We WANT the truth to be told!

The phrase “safe and effective” is a talking point based on an assumption – it is an assumption because the types of studies that would explicitly reveal if this is true have not been done (ie: gold standard double blind placebo controlled trials comparing vaccinated against unvaccinated – where the placebo is not biologically active, and where the control group is truly unvaccinated). I can think of several other issues in one medical specialty that were based on assumptions but were finally tested – the routine use of episiotomy during vaginal birth (not only did we discover that women are able to birth without them but that their routine use was actually causing more damage and increased risk of worse tearing!) – so for decades it was assumed that episiotomy was “protective” and yet when it was actually studied it was found to be the exact opposite. Vaginal Birth After Cesarean was assumed to be too risky to do, but now that it has been studied it is clear that it is a reasonable option for most women who have had a cesarean (even if they have had multiple cesareans!), yet for decades the dictat “Once a cesarean always a cesarean” was virtually a law in obstetrics.

Part of the “reproducibility crisis” in vaccine science is the generation of endless epidemiological studies – the over reliance on one study type is a weakness. This is also seen in the refusal to use actual placebos in faux safety and efficacy studies (that are submitted to ACIP and the FDA as part of the approval process). It is standard practice to use another vaccine (or excipient that is biologically active just sans the antigen of interest) as a faux-cebo. This is not science.

Lastly, what apparently is reproducible is vaccine injury (including death) as reported by thousands of parents. It is not scientific to ignore their observations and dismiss them as “coincidence”. Anecdotal reports are a legitimate source of hypothesis generation. This is exactly what drove Andrew Wakefield to do his infamously (and I think wrongly) now retracted Lancet study (in which he *does not* conclude vaccines cause autism!) Multiple parents approached him with reports of their children having significant gut issues (and autism) subsequent to vaccination. He listened and investigated and reported (the retracted article is not actually a study, but a case series report). He listened. He investigated. He reported – and concluded there was a need for additional studies to obtain more data about the issue so hypothesis could be generated and proven or disproven.  Please also read this letter to The Lancet by Dr. Wakefield in which he schools the journal on the scientific process (I’m a bit surprised it was published).

The existence of and need for a vaccine court further supports the fact that vaccine injury is real (as is the fact that the manufacturers have total legal immunity for a product that is “safe and effective”). It seems to me that these three things (an abundance of reports of vaccine injury, vaccine court to compensate the injured, and a legal liability shield for the product) are plenty of reason to do “gold standard” research to obtain explicit data regarding both safety and effectiveness – to determine just how safe, and how effective, are vaccines? There can be no informed consent (or informed refusal) until this is done.

Policy makers should be demanding that this be done – they need complete and accurate data on which to base their policy. The data they have now is woefully inadequate for that. Parents and adults who are considering vaccine use also need complete and accurate data on which to base their decisions. Healthcare providers need complete and accurate data to provide informed consent (or refusal as the case may be).

Truthfully, what should be said of vaccines is not “safe and effective” but “incomplete and inaccurate” dataset. We deserve better. The data is available – it just needs to be analyzed and made public.

 

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