Proving Safety and Efficacy
Studies follow a hierarchy in terms of the quality of evidence that they can provide. Randomized double blind placebo control (RDBPC) studies are considered the “gold standard” of epidemiologic studies. As rigorous as this study method is, it has failed many times in the past. Drugs like Vioxx killed tens of thousands of people despite having undergone this form of study. Lets break down what this means in simple terms.
Approved study participants are chosen at random to be placed in either the treatment group or the placebo group.
In the context of a clinical trial, double-blind means that neither the patients nor the researchers know who is getting a placebo and who is getting the treatment. Because patients don’t know what they’re getting, their belief about what will happen doesn’t taint the results. Because the researchers don’t know either, they can’t hint to patients about what they’re getting, and they also won’t taint results through their own biased expectations about what the results will be.
Definition of Placebo, noun, Merriam Webster1a: a usually pharmacologically inert preparation prescribed more for the mental relief of the patient than for its actual effect on a disorderb: an inert or innocuous substance used especially in controlled experiments testing the efficacy of another substance (such as a drug)
In drug trials, a control group is given a placebo while another group is given the drug (or other treatment) being studied. That way, researchers can compare the drug’s effectiveness against the placebo’s effectiveness.
Randomized Double-Blind Placebo Controlled Study
Not a single vaccine licensed for use has ever undergone RDBPC study. More over, not a single licensed vaccine has ever undergone inert placebo controlled study, much less randomized and double-blinded. It is this break from established scientific protocol that has parents across the world concerned about the safety of what we inject into our children soon after they are born. We would expect that as our most precious assets, whom are the most vulnerable, that medical interventions would need to be thoroughly tested using rigorous scientific studies that have been proven to yield the highest quality of evidence.
Excerpt from the Infrarix-Hexa Monograph (DTaP-HB-IPV-Hib):
A double-blind, randomized, placebo (DT)-controlled trial conducted in Italy, sponsored by the U.S. National Institutes of Health (NIH), assessed the absolute protective efficacy of INFANRIX when administered at 2, 4 and 6 months of age. A total of 15,601 infants were immunized with 1 of 2 tri-component acellular DTP vaccines (containing inactivated PT, FHA and pertactin), or with a whole-cell DTP vaccine manufactured by Sanofi Pasteur, or with DT vaccine alone.
When reading the first sentence, there’s an assumption that true scientific protocol has been followed. But then the next sentence reveals the “placebo controlled” groups merely received other vaccines. This scientific sleight of hand dupes people into believing a high level of scientific rigor has been employed.
Some vaccine trials claim to be “placebo controlled” on the surface, but reviewing the study one discovers that instead of using a true inert placebo (like a saline solution), instead they use “active” placebos. Sometimes this active placebo is another vaccine, and other times its all the ingredients of the vaccine (such as mercury, aluminum, aborted fetal tissue, protein particles, DNA, RNA, polysorbate 80, squalene, viral or bacterial particle contaminants etc) except the antigen itself. This completely negates the purpose of what a placebo is designed to control for.
When we compare the effects of an intervention versus a true inert placebo, we can conclude that increases in adverse events or beneficial effects in the treatment group are a result of the treatment.
Using active placebos we could prove that being struck in the head with a baseball bat does not increase headaches if our active placebo group is being struck with a golf club. 90% of participants in both groups reported headaches, and thus being struck with a baseball bat did not increase reports of headaches versus placebo. This is the level of scientific fraud that is being called “settled science.”
Aluminium adjuvant has been administered to both experimental and control group in the vast majority of randomised clinical trials on HPV vaccines, thus masking its potentially harmful effects. Clinical trials designed to administer vaccine adjuvants to the experimental group as well as the placebo group do, de facto, not compare an intervention against a true placebo, and therefore, do not adequately assess safety. Indeed, aluminium adjuvants, new or old, should be evaluated for benefits and harms on their own merits. – Exley 2011
Most doctors do not know that unlike virtually every drug that is approved (with few exceptions) vaccines do not undergo true placebo controlled study. When vaccination proponents are confronted with what should be a startling realization, the answer for why this fundamental type of study has not been conducted is that it would be “immoral” to withhold a vaccine from someone.
What is truly immoral is injecting newborns and infants with drugs that have never undergone comprehensive study to prove safety prior to being licensed. Nazi’s were hung at Nuremburg for exerimentation on people without informed consent, today this immorality is praised for the Greater Good.