"FDA study reinforces no safety concerns from residual formaldehyde in some infant vaccines"
http://www.fda.gov/biologicsbloodvaccines/scienceresearch/ucm349473.htmRipping this thing apart!! My comments in red :)
The amount of formaldehyde present in some infant vaccines is so small compared to the concentration that occurs naturally in the body that it does not pose a safety concern, according to a study using a mathematical model developed by scientists at the U.S. Food and Drug Administration (FDA). (NOTE: using a mathematical model, not using any real tests! They are presuming! I hate this aspect of "science")
Formaldehyde has a long history of safe use in the manufacture of certain viral and bacterial vaccines. (Interestingly, I just learned, from Paul Offit's course even, that "safe" in medical terms means "the benefits outweigh the risks. Not that there is no risk. In this case, the risk to benefits are the risk of using formaldehyde versus not using it in a vaccine. Well not using it means the virus isn't attenuated or that the vaccine isn't antibacterial. So ya the risk to benefit ratio of formaldehyde use in a vaccine versus not is pretty obvious! But that doesn't mean that formaldehyde is actually safe. It is safer to use it in a vaccine then to not use it. Tricky wording huh?)
It is used to inactivate viruses so that they don't cause disease (e.g., polio virus used to make polio vaccine) and to detoxify bacterial toxins (e.g., the toxin used to make diphtheria vaccine). Formaldehyde is diluted during the vaccine manufacturing process, but residual quantities of formaldehyde may be found in some current vaccines.
Formaldehyde is also produced naturally in the human body. It is essential for the production of some basic biological materials, such as certain amino acids. Amino acids are necessary for important life processes as they are the building blocks of proteins in the body. (Guess what is also produced in the body - viruses! In fact they cannot survive without a body. But they are "bad", so why are ingredients like formaldehyde automatically ok when they are produced in the body?)
Formaldehyde is also found in the environment. For example, it is used in the manufacture of building materials, as a preservative for specimens in labs and to make many household products. (Oh well that must make it ok then, right?)
The latest research has shown that the highest risk of harmful effects from formaldehyde is from breathing it, and this occurs more frequently in people who routinely use formaldehyde in their jobs. (Oh so breathing it is bad, but injecting it is totally ok? Seems to me like they really just don't know. http://www.inchem.org/documents/iarc/vol62/formal.html "Studies in which formaldehyde was applied to the skin or injected subcutaneously were inadequate for evaluation.")
Exposure to formaldehyde from vaccines differs from environmental exposure because the small amount of formaldehyde via injection with a vaccine occurs briefly and only occasionally. (Except they haven't looked much at injecting formaldehyde versus other modes of exposure. So how can they say this conclusively????)
When the body breaks down formaldehyde it does not distinguish between formaldehyde from vaccines and that which is naturally produced or environmental. (This is true. What it DOES distinguish is in the route of administration. http://jem.rupress.org/content/6/4-6/487.abstract "8. The injection of formalin into the muscles produces myositis. 13. Pneumonia and bronchitis are found in all animals after the injection of formalin. 15. Formalin is, directly or indirectly, chemiotactic (it tells the cells which direction to move) for leucocytes (white blood cells).
The tissues which are not infiltrated with leucocytes after the injection of formalin are those which have been so injured by the chemical that an inflammatory reaction is impossible. (In other words, formaldehyde damages the tissue so much that leucocytes can't even go in to repair the damage).
Using modeling, the FDA scientists assessed the concentrations of formaldehyde in the blood and total body water of a hypothetical 2-month-old infant following injection of formaldehyde containing vaccines into the muscle at a single medical visit. They compared this estimate with the natural levels of formaldehyde that occur in the body. The model considered the natural reactions in the body that process formaldehyde and how long it would take for these processes to occur. (They assume that injected formaldehyde is processed the same as naturally occuring formaldehyde. But injecting isn't natural is it?)
To ensure that the model did not underestimate the amount of formaldehyde the infant was exposed to, the FDA scientists assumed that the hypothetical 2-month old infant was in the 10th percentile for age-weight relationship for the United States. Such an infant would receive the highest maximum exposure to vaccine formaldehyde relative to its weight.(Again the words assume and hypothetical. This is a friggin guess!! How is allowed to be accepted as conclusive??)
Based on a maximal level of 200 micrograms of formaldehyde exposure from vaccination,the FDA model showed that the majority of the formaldehyde is essentially (?) completely removed from the injection site within 30 minutes. (Essentially? in a fundamental or basic way. http://www.thefreedictionary.com/essentially basically, primarily, at heart, intrinsically, at bottom virtually, fundamentally, in effect, substantially) So not totally! But my question is how do they know this when it is a computer model making the assumption? They are using the natural levels of formaldehyde in the body as a base line for how it breaks down from the injection site, but as we KNOW this is not one in the same!!! Gosh this frustrates me!!)
The majority of the formaldehyde is broken down (metabolized) in the muscle and any remaining formaldehyde enters the bloodstream and body water. The model showed that at its highest concentration this remaining formaldehyde is less than 1% of the existing, naturally occurring level of formaldehyde in the body. (Ya because it gets converted to formic acid in the body. But formic acid is also casrcinogenic!! http://en.wikipedia.org/wiki/Formic_acid Not to mention that formadelhyde enters the body via the bloodstream, so concentrations are NOT the same, therefore matabolization cannot be the same.)
The FDA scientists note that the natural level of formaldehyde in the body is more than 100 times higher than that found in vaccines. Moreover, there are no known adverse health affects from this naturally occurring formaldehyde. They concluded that the temporary presence of a very small amount of additional formaldehyde contributed by vaccination would pose no safety concerns. (Concluded based on presumptions that naturally occuring formaldehyde is the same as injected formaldehyde. Whatever the case may be, injected formaldehyde is 100%. So say 200ug/kg of ingested formaldehyde is harmless, it is going to be a fraction of that for injectable. I'm going to make an educated guess of at least 5 times the "strength" when injected, so 200ug would be 1000ug injected! According to this table, for intramuscular administration, only 0.5ml of a substance is required versus 5ml when gavaged (ie forcefed/ingested) so that is 10 times the amount! Which translates to 2000ug/kg of formaldehyde when injected. "Intramuscular administration of substances is a common parenteral route in large animals and humans but often is avoided in smaller species because of the reduced muscle mass. Generally, intramuscular injections result in uniform and rapid absorption of substances, because of the rich vascular supply (Figure 3). Smaller volumes are administered intramuscularly than for subcutaneous delivery (Table 1). http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3189662/
This study is part of a rigorous and ongoing evaluation of the safety of biological products for which FDA has oversight." Ya, right. Rigorous. If it were rigorous, we could EASILY find info on injecting formaldehyde. Not just computer models...
And just to add one final thing, check out this paper that says "formaldehyde may act as a cofactor in carcinogenesis." http://www.nj.gov/dep/watersupply/pdf/append-b-section-i.pdf In otherwords, its not JUST the formaldehyde that is carcinogenic, but that it is a co-factor. IE: injecting someone with formaldehyde ALONG with other carcinogenic substances (like SV-40 perhaps?) are more likely to produce carcinoma. So is it just me, or are these HUGE holes in the science?
~ Dayna B.
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