Excerpts below are taken from the first chapter of Turtles All The Way Down: Vaccine Science and Myth (pages 40-82).
In a “simple” vaccine clinical trial (one without a control group, as is the case for trials in Phases 1 and 2), researchers face an inherent difficulty in determining whether a specific condition reported during the trial period is actually caused by the experimental compound or not. If a trial subject experiences a severe and immediate phenomenon following the receipt of the test vaccine, such as fainting or cardiac arrest, it could be reasonably assumed that the recently consumed vaccine was the culprit. When the side effect is less pronounced, or appears days or weeks following vaccine administration, however, the researchers decision is less obvious.
One option is to have every participant who experiences a health related condition during the trial undergo a series of in depth medical examinations in order to uncover possible links to the experimental vaccine. This strategy is not feasible or economical…
A better option is to conduct an “enhanced” clinical trial – a controlled, randomized, and blinded trial (also known as a randomized controlled trial – RCT. In an RCT, subjects are divided into two groups: the trial group, receiving the test compound, and a control group, receiving a dummy or existing compound…
…RCTs are widely considered the industry’s “gold standard”.
…the use of a control group in a clinical trial allows researchers to examine the therapeutic effect of the compound (efficacy) and the rate of adverse events it causes (safety) by comparing outcomes…
…when deciding upon the type of compound given to the control group in an RCT, there are two options. For a trial of a completely new drug or vaccine, i.e. one which does not have an approved equivalent, the control group should receive an inert compound (placebo)…
…if a proven treatment [or current FDA approved drug] already exists, it may be unethical to prevent control group participants [e.g. cancer patients] from receiving it.
This practice [of giving a control group an active comparator or existing drug] is also the norm for vaccines even though vaccines are used preventatively (not treatment for an existing condition) and are given to healthy individuals.
When the control group’s subjects are given a placebo, an inert substance not known to cause high fever, it is assumed that the incidence of high fever recorded for the group represents the background rate (or baseline rate) of the phenomenon… the number of subjects who would experience high fever naturally…
…an RCT in which the control group receives an inert placebo is designed to answer the critical question of How many adverse events does the new vaccine cause?
In order to determine the true rate of adverse events of a new generation vaccine, a three-arm trial must be conducted, combining the two methods described above. In this kind of trial, subjects would be randomly allocated into three groups, one trial and two controls: The trial group would receive the new generation vaccine, the first control group would receive the current vaccine, and the second control group would receive an inert placebo.
From a public health perspective, the three-arm trial answers two important questions: (1) How many adverse events does the new vaccine cause when compared to not vaccinating? and (2) How many adverse events does the new vaccine cause when compared to the existing vaccine?
…in a clinical trial of an (entirely) new vaccine, the control group should receive a placebo so that the absolute rate of the vaccine’s adverse events can be determined. This design does not pose an ethical problem, since the vaccine has no existing alternative.
…examine a hypothetical scenario: A major pharmaceutical company has developed a new drug… [and] the drug is associated with a relatively high incidence of serious side effects that may negatively affect its chances to win FDA approval.
…since the company spent hundreds of millions of dollars developing the drug and the target market segment is worth billions of dollars in sales per year, the company decides to move forward with the licensing process and start a Phase 3 clinical trial.
…what are the company’s options… for ensuring that the trial demonstrates a positive safety profile, thus clearing the way for the drug’s approval?
…design a trial in which the reported rate of adverse events in the control group would likely be very similar to that of the trial group.
(1) It is 100% legal, (2) it is very effective, and, as it turns out, (3) it has the full approval of licensing authorities around the world. As we shall shortly see, this method is exactly the one vaccine manufacturers employ to deliberately obscure the real incidence of vaccine adverse events.
The entire vaccine program is founded upon this deception.
Vaccine trials in general, and childhood vaccine trials specifically, are purposely designed to obscure the true incidence of adverse events of the vaccine being tested.
…a new vaccine… is always tested in a Phase 3 RCT in which the control group receives another vaccine (or a compound very similar to the experimental vaccine… A new pediatric vaccine is never tested during its formal approval process against a neutral solution (placebo). Comparing a trial group to a control group that was given a compound that is likely to cause a similar rate of adverse events facilitates the formation of a false safety profile. The rate of adverse events of the tested vaccine is said to be similar to the “background rate”, hence it is considered safe.
…all parties involved ensure that the true rate of vaccine adverse events is never discovered… and that rate is never shared with the public, or even the medical world.
The practice of giving a different vaccine to the control group in an RCT of an entirely new vaccine and calling it “placebo” is a deliberate misrepresentation of the term.
If the rates of adverse events observed in the trial and control groups appear similar, is it because the experimental vaccine is safe or because the control compound is just as unsafe as the vaccine?
Giving the control group an active substance… would be a bad design decision… Yet this is exactly how new vaccine Phase 3 trials are performed…
This deliberate distortion of the placebo concept in clinical trials of new vaccines is so prevalent that researchers and vaccine package inserts frequently refer to the bioactive compound given to a control group as “placebo”, even when it’s clear it is another vaccine or a similar bioactive compound… Falsely using the term “placebo” allows researchers to conclude that the new compound “was proven safe”…
No logical explanation can be found for the ubiquitous practice of administering bioactive compounds to control groups in trials of new vaccines other than a desire to conceal the true rate of adverse events of the vaccine.
…there is no justification for conducting a chain of trials (turtle upon turtle upon turtle) that ultimately stands on nothing but air.
Would a safety trial for a new cigarette have any credibility at all if the “control” group consisted of subjects who smoked a different kind of cigarette?
The true rate of adverse events of routine childhood vaccines is virtually unknown; therefore, there is no scientific basis for claiming they’re safe.
…safety trials conducted for some childhood vaccines blatantly and seriously violate the medical code of ethics.
…rotavirus vaccine manufacturers did not have a ready-made vaccine available for use in the control group, and… there was no impediment to using a cheap, available and effective substance, such as sugar water.
A preliminary examination of the clinical trial record of the rotavirus vaccine shows that the control groups in the RotaTeq and Rotarix trials received… a placebo! Was this, then, the industry’s first breach of the sacred tradition that vaccines never be tested against a true placebo? Were the rotavirus vaccine trials the first to provide reliable and relevant information about the rate of adverse events of a childhood vaccine?
The answer to these questions is, unfortunately, “no and no”.
…the placebo received by the control group in the main Rotarix trial… is nothing but the tested vaccine without its antigenic component.
…a potentially potent compound whose side effects are likely to be quite similar to those of the vaccine being tested.
…what was the placebo in Merck’s RotaTeq vaccine trial?
Merck deleted its description from the licensing document submitted to the FDA… the trial’s placebo is a trade secret, which implies its contents were very similar to the vaccine’s.
In another RotaTeq clinical trial, the control group received the vaccine-sans-antigen, similar to the compound control group subjects received in the Rotarix trial.
The bioactivity of the compounds given to the control groups in rotavirus vaccine trials was seemingly apparent in the rate of adverse events reported in the trials. In the Rotarix trial, about 1 in 30 control group subjects experienced a “severe” medical event…
The rotavirus vaccine makers…gave their trials control groups compounds that were very similar to their vaccines, and… the resultant rates of adverse events were not significantly different…
…tens of thousands of infants were given an utterly useless compound whose safety was unknown and whose side effects could be… severe and permanent. Thus, the Phase 3 clinical trials of the rotavirus vaccine constitute blatant violations of the medical code of ethics.
…there was no scientific justification for giving the vaccine-sans-antigen to the control group other than a malicious intention to conceal the experimental vaccine’s true rate of adverse events. Using a real placebo that posed no health risk – a few drops of sugar or salt water – would have cost less and led to more scientifically valid conclusions by enabling straightforward calculations of the true adverse event rates as well as vaccine efficacy.
…it is the FDA that approved these trials.
The vaccine also received CDC approval and that of other health authorities around the world, even though the vaccine trials unnecessarily endangered tens of thousands of children and may have caused serious harm to hundreds, as well as dozens of needless deaths.
There is not a single vaccine in the US routine childhood vaccination program whose true rate of adverse events is known.
Current vaccine clinical trial methodology completely invalidates the claims that vaccines are safe and that they are thoroughly and rigorously tested.
…officials’ [FDA, CDC, WHO, etc.] assurances of vaccine safety rely primarily on deliberately flawed, industry-sponsored clinical trials.
The entire vaccine program is based on a deliberate cover-up of true vaccine adverse event rates.