Ethical Guidelines for Clinical Trials Prevent Many Vaccines From Being Adequately Tested For Safety

The CDC (Centers for Disease Control), the WHO (World Health Organization), the National Institutes of Health (NIH), and the FDA (Food and Drug Administration) are considered by most Americans to be the most credible, trusted sources of “unbiased” information regarding disease, medical treatment, and the safety of pharmaceuticals. Your doctor and the entire medical community base their decisions about your care on recommendations from these organizations, which are theoretically based on the studies brilliant, highly-qualified scientists perform for these organizations. These organizations publicly publish this information so that anyone who wishes to educate themselves can do so.

That is precisely what millions of Americans, including myself, are now doing when it comes to the subject of vaccine safety. Unfortunately we are finding that these “trusted” recommendations are not adding up with the information provided by their own sources and many times are blatantly at odds with this publicly published information. I’m going to clearly demonstrate that to you today.

The focus of this article is the following claim publicly stated by the CDC:

“Before vaccines are approved by the Food and Drug Administration (FDA), they are tested extensively by scientists to ensure they are effective and safe.”

How do scientists test vaccine safety?

There are 3 phases in prelicensure vaccine safety testing as described by the FDA. According to the FDA, “Clinical trials are conducted according to plans that FDA reviews to ensure the highest scientific and ethical standards. The results of the clinical trials are a part of FDA’s evaluation to assess the safety and effectiveness of each vaccine.” Herein lies the rub.

What are the highest scientific standards when it comes to determining safety?

According to the NIH, randomized double blind placebo control studies are the “gold standard.” The NIH goes on to state that, “RDBPC studies remain the most convincing research design in which randomly assigning the intervention can eliminate the influence of unknown or immeasurable confounding variables that may otherwise lead to biased and incorrect estimate of treatment effect.”

The problem is, most vaccine studies are not RDBPC due to the ethical standards that must be maintained.

The fact is most vaccine safety clinical trials do not and cannot use a placebo in the truest sense of the word. According to the CDC’s own glossary of terms, a placebo is, “a substance or treatment that has no effect on human beings.” In the case of vaccine testing, a true placebo would have to be an injectable substance that is completely inert, such as saline solution for example. However, that is NOT what is predominantly used in vaccine trials.

If they aren’t using true placebos, what are they using?

According to the 2013 WHO Expert Consultation on the Use of Placebos in Vaccine Trials, the following replacements are used in lieu of a true placebo:

    • “In place of a placebo, a vaccine against a disease that is not the focus of the trial is given to participants who do not receive the trial vaccine.”

Or, an “add-on” vaccine can be used:

    • “In this design, the trial vaccine or placebo product is mixed with an existing vaccine not studied in the trial, and the subjects are given either (a) the trial vaccine mixed with the existing unrelated vaccine or (b) the combination of a placebo and the existing unrelated vaccine.”

Yes, you read those correctly! These vaccines are not being tested for safety against substances that are known to be safe. They are tested against other vaccines which contain the same or similar toxic ingredients common to all vaccines. Some trials are performed using “add-on” vaccines as a placebo. In these cases, potentially everyone in the trial is injected with the actual vaccine being tested! It doesn’t take a rocket scientist to deduce that these methods are unacceptable when the goal is to ascertain safety.

The WHO freely admits this:

“A methodological disadvantage, however, is that trials using these types of placebos provide a less perfect control. It may be difficult or impossible to assess fully the safety and reactogenicity of the trial vaccine, although its efficacy can usually be assessed satisfactorily.” (emphasis mine)

(Reactogenicity is the ability of the vaccine to cause adverse reactions.)

“Methodological disadvantage!?” That’s the understatement of the century!

Let’s look at some very disturbing clinical trial data for a few of the vaccines the CDC recommends. Each vaccine is linked to its package insert so that you can read this information for yourselves:

Engerix B Hepatitis B vaccine (Recombinant) GlaxoSmithKline

“Ten double-blind studies involving 2,252 subjects showed no significant difference in the frequency or severity of adverse experiences between ENGERIX-B and plasma-derived vaccines…All subjects were monitored for 4 days post-administration.”

This study doesn’t prove that this vaccine is safe. Plasma derived vaccines were used in the control group instead of a placebo. It demonstrates that this vaccine doesn’t cause any more or any worse adverse effects than other vaccines cause- at least within the 4 day time frame the subjects were monitored.

This vaccine is given to babies on their very first day of life whether they are at risk for Hep B or not. Only babies born to Hep B positive mothers are at risk for Hep B. For millions of babies this vaccine is a completely unnecessary risk that provides them with absolutely zero benefit.

Infanrix (DTaP) GlaxoSmithKline

Table 4, on page 18 shows that Infanrix was not compared to a placebo, it was compared to the whole cell DTP vaccine.

According to WHO, acellular vaccines (like Infanrix) were introduced “to address the adverse reactions observed with whole cell vaccines…” This WHO report also notes that acellular vaccines have replaced whole cell vaccines in industrialized countries. However, due to the increased cost of acellular vaccines, the whole cell is still used in many developing countries. This vaccine is being tested against a control vaccine that we already know to be more dangerous than the type of vaccine being studied!

**Note figure 8.1 on page 18: “Pregnancy Category C Animal reproduction studies have not been conducted with INFANRIX. It is not known whether INFANRIX can cause fetal harm when administered to pregnant women or can affect reproduction capacity.

Despite this information listed in the product packaging, the CDC routinely recommends the DTaP vaccine to pregnant women. You can read about that on the CDC’s website in their article, Pregnant? Get Tdap in your 3rd trimester.

The CDC recommends either the BOOSTRIX vaccine or the Adacel vaccine (both DTaP) to pregnant women. While BOOSTRIX is rated one category safer than Adacel (Category B),the packaging still notes, “A developmental toxicity study has been performed in female rats at a dose approximately 40 times the human dose (on a mL/kg basis) and revealed no evidence of harm to the fetus due to BOOSTRIX. Animal fertility studies have not been conducted with BOOSTRIX. There are no adequate and well controlled studies in pregnant women. Because animal production studies are not always predictive of human response, BOOSTRIX should be given to a pregnant woman only if clearly needed.”

Still feeling safe? Still feeling like the CDC has your back?

GARDASIL- Merck

In 7 clinical trials (5 Amorphous Aluminum Hydroxyphosphate Sulfate [AAHS]- controlled, and 1 uncontrolled), 18,083 individuals were administered GARDASIL or AAHS control or saline placebo on the day of enrollment, and approximately 2 and 6 months thereafter, and safety was evaluated using vaccine report cards (VRC)- aided surveillance for 14 days after each injection of GARDASIL or AAHS control or saline placebo in these individuals.”

In these Gardasil trials, there actually WAS a control group which was given a true saline placebo. However there was another (much larger) control group given AAHS, which is the adjuvant in the Gardasil vaccine (the toxic portion that triggers immune response.) According to the insert, 15,706 subjects received Gardasil, 13,023 received AAHS and 594 received the placebo. However, they did not compare the three groups separately; they combined the AAHS and placebo group together and compared them to the Gardasil group. This means that the whole Gardasil vaccine was tested primarily against an injection containing its own toxic ingredients and determined to be “safe.”

Furthermore, 40 deaths occurred in the entire study which were broken down by cause. When you subtract the number of deaths that were due to car wrecks, overdoses/suicides and gunshot wounds, and compare the number of subjects who died: 18 subjects who were given either Gardasil or AAHS died and only 1 who had been given the placebo died.  Think about that! Subjects who received Gardasil or AAHS instead of placebo, died at a rate of 18 to 1!

Why Don’t Scientists Use Appropriate Placebos in Trials?

The “gold standard” in clinical trials cannot be implemented because the use of a placebo in many cases is unethical. The purpose of the 2013 WHO Expert Consultation on the Use of Placebos in Vaccine Trials was to detail the guidelines placed on the ethical use of placebos in vaccine trials. If using a traditional, inert placebo in the control group doesn’t “add any risk of serious or irreversible harm,” then clearly there is nothing unethical about using it. But what about when it does?

For example, according to WHO reports, in 2008 rotavirus was responsible for about 5% of all child deaths globally, with 90% of these deaths occurring in Africa and Asia. In a 2011-12 clinical trial in India for a new rotavirus vaccine, 2/3 of the infants received the test vaccine while 1/3 got a saline placebo injection. At the time, two approved oral rotavirus vaccines were already available. Not giving 1/3 of the Indian children in the trial a vaccine already known to be effective against rotavirus, constituted a human research violation that would not have been allowed in the US. Allowing preventable harm to occur in the name of research is unethical.

This means, for very legitimate ethical reasons, using true placebos according to the “gold standard” of clinical testing is not feasible. However, this in no way negates the fact that due to ethical constraints, it is impossible to accurately assess vaccine safety in many cases. It is also unethical to fail to provide this information to parents when discussing vaccine safety.

It crosses the line of unethical and meanders into the territory of illegal, when this information is intentionally censored from vaccine education sheets given to parents in the pediatrician’s office (as well as from conversations with your pediatrician) assuring that vaccines are “extensively tested for safety” knowing full well that safety and reactogenicity are “difficult or impossible to assess” by their own publicly published standards.

The next time someone tells you that vaccines have been proven safe in numerous extensive studies you can tell them that information is blatantly false, and the CDC, WHO, NIH, and FDA know it. Vaccines cannot be both adequately and ethically tested for safety.

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