Aluminum Toxicity and Aluminum in VaccinesPosted on September 24, 2014 by Paul Thomas, M.D.

I wrote the following letter as a response to the Director of Quality measures at Providence in response to his request for more information and as rebuttal to the Q & A Aluminum in Vaccines: What you should know” vol 5, winter 2014 from CHOP (Children’s Hospital of Philadelphia) www.vaccine.chop.edu

Here it is in it’s entirety:

Aluminum Toxicity and Aluminum in Vaccines. By Paul Thomas MD FAAP ABIHM August 2014

In response to a document Q&A, “Aluminum in Vaccines: What you should Know”, published in Volume 5, Winter 2014 by The Children’s Hospital of Philadelphia (CHOP: vaccine.chop.edu) I give the following:

This 2 page document provides 7 references, in an attempt to support their claim, “Is the amount of aluminum in vaccines safe? Yes”.

There are hundreds of peer reviewed journal articles and three entire books[1] to the contrary. How can this Vaccine Education Center claiming to be “an educational resource for parents and healthcare professionals” present such a biased view while claiming “The center does not receive support from pharmaceutical companies”? One can only wonder.

The article points out that aluminum is the most common metal found in nature, and that it is present in water, air, and food. This is misleading because while aluminum is common in the earths

crust (rock and soil) it does not have a biological function and our bodies are extremely efficient at eliminating the aluminum that enters through food and water. While an adult may be exposed to 10 mg a day in the diet, very little is absorbed and the little that is absorbed is excreted in the kidneys such that a typical adult has about 5 micrograms/ L in the plasma.

The CHOP article points out that aluminum is in vaccines as an adjuvant to improve the immune response and that they have been used in this way for over 70 years. This is true, but sadly aluminum was grandfathered in as “safe” without any testing to prove that it was safe to be injected as an adjuvant. To this day it has not been tested for safety in vaccines, it is just assumed to be safe. Many studies suggest otherwise as I will point out soon.

The article discussed the issue of “how much aluminum is in vaccines” making the grave error that assumes ingested aluminum (that from the diet) is the same as that injected. Nothing could be further from the truth. They talk about an infant getting 4 milligrams during the first 6 months of life in vaccines and that during the same period infants get 10 milligrams from breast milk and about 40 milligrams in infant formula or 120 mg in soy-based formula. In addition to the ability of the gut to prevent absorption of the aluminum, the aluminum from the diet is spaced out over time and eliminated by the kidneys. In the case of vaccines, over a gram may be injected in a single moment of one day. A gram is 1000 micrograms– the units used when discussing toxicity of aluminum in the body. We have known since the 1980’s that aluminum in IV solutions resulted in elevated blood levels and bone deposition in infants receiving 14–18 micrograms/ Kg/ Day [2].

Aluminum in IV solutions was then shown to impair neurological development, with infants who received 45 micrograms/Kg/day compared to 5 micrograms/Kg/day having a reduced Bayley Mental Development Index of 1 point per day of exposure! [3]

We know that infants have reduced renal function and thus reduced excretion of aluminum. It was widely accepted in the 1980’s that aluminum was toxic when reports were published of neurotoxicity and bone toxicity (anemia) from aluminum in children who were not on dialysis.[4] It was due to the growing body of evidence of toxicity from parenteral aluminum (IV/IM), that the FDA made the recommendation that aluminum not exceed 5 micrograms/ Kg/ day for preterm infants.[5]

The exact quote in the 2001 FDA Ruling titled, “Aluminum in Large and Small Volume Parenteral Used in Total Parenteral Nutrition; Delay of Effective Date A rule by the Food and Drug Administration on 01/26/2001”, said “Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4–5 micrograms/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration”.

It appears the FDA never followed through with these recommendations, and indeed may have removed these publications. In 1991, the ASCN/ASPEN working group on Standards of Aluminum Content of Parenteral Nutrition Solutions, Parenteral drug products containing aluminum as an ingredient or a contaminant: Response to FDA notice of intent and request for information was issued. [6]

Gordon L Klein, Department of Pediatrics University of Texas published a summary of guidelines on parenteral aluminum as follows:

                                    Safe                 Unsafe              Toxic            microg/kg/d      <2                    15-30               >60

            Umol ig/d         <0.074             0.56-1.11         >2.24 [7]

 

From this knowledge, is there any doubt that injecting 250 micrograms of aluminum into a newborn should raise concern? Even a 10 pound baby, would be getting 50 micrograms/ Kg. Aluminum injected as part of a vaccine, would only be safe by these standards if the individual weighed over 200 pounds (100 Kg).

It is clearly time we work to reduce all exposures to aluminum for pregnant moms, newborns and infants, from maternal intake, reducing formula (especially soy formula), use lower aluminum TPN solutions when that is needed, and avoiding the injected aluminum with the Hepatitis B vaccine if the infant is not at risk for Hepatitis B, and the Tdap during pregnancy. [8]

An article of vital importance, warns that the combination of the adjuvant aluminum and the sheer number of antigens being injected with the current vaccine schedule, is triggering auto-immune disorders and brain dysfunction in children subjected to the current immunization schedule. [9]

The article from CHOP on aluminum in vaccines makes a concerning statement about what happens to aluminum after it enters the body saying: “about half of the aluminum in the blood stream is eliminated in less than 24 hours and more than three quarters is eliminated within two weeks”. In the case of injecting over a gram of aluminum, this would mean that 200 – 250 micrograms would be circulating in the body for over two weeks!  

If ½ the aluminum “is eliminated in less than 24 hours” as the CHOP article points out, then by half lives of excretion the rest should be gone in a few days, which clearly is not the case. They point out about ¼ is present at two weeks. We know that aluminum accumulates in bone and brain.[10] It would be more accurate to say that in less than 24 hours, most of the aluminum has been taken up by the body in bone and brain tissue where it

exerts it’s toxicity. The half-life of retained aluminum (that present after 13 days) was found to be 7 years.[11]

Given the above data, the CHOP article grossly underestimates the amount of aluminum that is accumulated in the body. They claim that by the time children are adults, they will have accumulated between 50 and 100 mg of aluminum, most coming from food.

It is important, when it comes to aluminum, that infants not be treated as older children and adults. Even term infants with normal renal function have rapidly growing and immature skeletons and brain, and a less well-formed blood-brain barrier making it much more likely that injected aluminum will accumulate in bone and brain. We know that until age 1 or 2 years, children have a reduced glomerular filtration rate.[12]

In the CHOP paragraph “Q. Is the amount of aluminum in vaccines safe?” they respond “yes” but then their own final paragraph says “For aluminum to be harmful, two criteria must be met: People must have kidneys that don’t work well or don’t work at all, and they must receive large quantities of aluminum for months or years. In these situations, a lot of aluminum enters the body and not enough leaves the body.”

The aluminum data from parenteral nutrition (IV aluminum which is just like injected aluminum) resulted in the FDA recommendation for a maximum of 5 micrograms/Kg/day. Most newborns weigh about 3 Kg so the maximum dose of aluminum should not exceed 15 micrograms. The Hepatitis B vaccine, now given to most newborns in America has 250 micrograms of aluminum. This is an embarrassing fact that most pediatricians either don’t realize, or choose to ignore.

It is absolutely possible that the aluminum in vaccines is causing harm. Plasma aluminum concentrations have been shown to increase several-fold, after parenteral nutrition, in term neonates

with normal renal function.[13]

So exactly how does aluminum cause it’s toxicity? It is known that aluminum can interfere with cellular metabolism.[14] Aluminum interferes with information transfer in DNA.[15] Aluminum has been found to interfere with enzymes such as the inhibition of hexokinase.[16] Aluminum is known to be neurotoxic through increased lipid peroxidation, making cells more vulnerable to free radical attack.[17] All of these factors are more significant in infants during periods of rapid brain development.

What about aluminum toxicity when the exposure occurs in the womb? Developmental delays were seen after an accidental aluminum exposure during pregnancy.[18] Numerous studies on animals (rats and rabbits) have shown behavioral, learning, developmental, and performance abnormalities in the offspring.[19] It is absolutely bewildering that the vaccine advisory boards would recommend that every pregnant woman in America get the Tdap with its 170 or more micrograms of aluminum at a time when the developing baby has no protection and a developing brain. It is equally baffling that the Hepatitis B vaccine is still being recommended to newborns, 2 month olds, and 6 month olds when their mothers do not have the disease.

So where are the long-term studies in humans looking at this issue of intrauterine or infant exposures to aluminum? The US population is the study. When it comes to neurodevelopmental disorders, it is not going well. Autism is now at a rate of 1/50 or 1/100 children.[20] Compare this to the rate in Norway where it is 1/1000 for moms who take folate with their prenatal vitamins.[21] Norway does not give the Hepatitis B vaccine with it’s 250 micrograms of aluminum, to newborns who are not at risk for the disease.

In a study published in 2010 in the Journal of Environmental Health, boys given the Hepatitis B vaccine in the first month of life had a three fold (300%) increased chance of developing

autism.[22]

Tomljenovic and Shaw in their article “Do aluminum vaccine adjuvants contribute to rising prevalence of autism?” point out that by applying Hill’s criteria for establishing causality between exposure and outcome, they investigated whether exposure to aluminum from vaccines could be contributing to the rise in ASD (Autism Spectrum Disorders) in the western world. They found those countries with the highest aluminum exposure had the highest rates of ASD, and that the increase prevalence in the USA and 7 western countries correlates with the increased exposure to aluminum.[23]

A recent study demonstrated conclusively that injected aluminum causes neurotoxicity.[24] In another study the aluminum in the vaccines is shown to have triggered autoimmunity, macrophagic myofasciitis, and chronic fatigue.[25]

We need more data and more studies that look at the differences in the experience from different approaches to vaccination. The Norway experience is one such study although it was not done comparing autism rates between Norway and the USA – that was my own interpretation. If returning the Hepatitis B vaccine back to preteen, early teen years as it was before 1991, could lower the autism rate from 1/100 to 1/1000, in the USA alone with our 4,000,000 births, this would result in 36,000 fewer cases of autism, every year! Since aluminum is toxic to neurodevelopment, this could affect things like ADD and ADHD, anxiety and depression, learning issues, language issues, etc.

Another review (not independent research) article reviews the substantial evidence that supports the link between aluminum, acetaminophen, and autism, with mention of the possible link with the MMR.[26]

Vaccines are vital and since the adjuvant aluminum is toxic, then we need to push for new technology, and find a safer adjuvant.

The dangers of aluminum in vaccines, has been known since early studies on its use in the 1950’s and early 1960’s with pertussis and polio vaccines. Studies were showing death of rats when aluminum vaccines were used ranging from 1.29% to 5.85 % by 14 days after the injection.[27] This was at a time that fevers were being seen in children receiving these vaccines, and occasional deaths, though causality was always in dispute. I am still baffled by the absence of control tests where just aluminum was injected, thus proving the safety of using aluminum as an adjuvant.

In the meantime, while we wait for safer technology, it makes perfect common sense that newborns whose mothers do not have hepatitis B, defer that vaccine and get it closer to school age or the preteen age when exposures might occur. We now have data showing that the Hepatitis B vaccine, when given to infants, is not providing lasting immunity.[28]

 

[1] J. A. T. Pennington and J. W. Jones, Aluminum and Health: A Critical Review, ed H. J. Gitelman (Marcel Dekker, NY, 1989).

P.F. Zatta and A.C Alfrey, Aluminium Toxicity in Infants’ Health and Disease (World Scientific Publishing Co. 1997)

Research Issues in Aluminum Toxicity ed R. A Yokel and M. S. Golub (Taylor and Francis 1996, 1997)

[2] Koo WWK, Kaplan LA, Bendon R, et. al. Response to aluminum in parenteral nutrition during infancy. J. Pediatr 1986;109:877-883.

Koo WWK, Kaplan LA. Et. al. Response of preterm infants to aluminum in parenteral nutrition. JPEN J Parenter Enteral Nutr. 1989; 13: 516-519

[3] Bishop NJ, Morley R, Day JP, Lucas A aluminum neurotoxicity in preterm infants receiving intravenous-feeding solutions. N. Eng. J Med 1997;336:1557-1561.

[4] Nathan, E and Pedersen, S 1980 Dialysis encephalopathy in non-dialysed uremic boytteated with aluminum hydroxide orally. Acta Paediatr. Scand. 69:793-796.

Andresoli, S P., Bergstein, J M. and Sherrard, D. J. 1984. Aluminum intoxication from aluminum-containing phosphate binders in children with azotemia not undergoing idalysis. N. Engl. J. Med. 310:1079-1084.

[5] Food and Drug Administration. Aluminum in large and small volume parenterals used in total parenteral nutrition; amendment; delay in effective date. Fed Regist. 2002;67:70691-70692.

[6] ASCN/ASPEN working group on Standards for Aluminum Content of Parenteral Nutrition Solutions, Parenteral drug products containing aluminum as an ingredient or a contaminant. Am. J. Clin. Nutri. 1991. 53:309-402

[7] Klein, G. Aluminum Congtent of Parenteral Nutrition Products in book Zatta, P.F. and Alfrey, A. C. Aluminum Toxicity in Infants’ Health and Disease. 1997 157-167.

[8] Fanni, D. et. al. 2014. Aluminum exposure and toxicity in neonates: a practical guide to halt aluminum overload in the prenatal and perinatal periods. World J Pediatr. May: 10(2):101-7

[9] Tomljenovic, L. and Shaw, C.A. 2012 Lupus 21(2):223-230.

 

[10] Andress, D. L. , Kopp, J. B. et. al. Early deposition of aluminum in bone in diabetic patients on hemodialysis. N. Engl. J. Med. 316:292-296

Bishop N. J. et. al. 1989. Increased concentration of aluminum in the brain of a parenterally fed preterm infant. Arch. Dis. Child. 64:1316-1317

[11] Priest. N. D. et. al. Hum. Exp. Toxicol. 1995 (14):287.

[12] Eagle, W. D. 1986 Evaluation of renal function and acute renal failure in the neonate. Pediatrt Clinic N, America 33:129-151.

[13] Moreno, A Domingues, C. and Ballabriga, A. 1994 Aluminum in the neonate related to parenteral nutrition. Acta. Paediatr. 83:25-29.

[14] Birchall, J. D. and Chappell, J. S. Aluminum, chemical physiology and Alzheimer’s disease. Lancet 2 (1988) 1008.

[15] Karlik, S. J. et. al. 1980, Interaction of aluminum species with DNA. Biochemistry 19, 5991.

Troncoso, J. C. et. al. 1986. Immunocytochemical studies on neurofilament antigens in the neurofibrillary pathology induced by aluminum. Brain Res. 364:295

[16] Trapp, G. A. 1980. Studies of Aluminum interactions with enzymes and proteins. Neurotoxicology 1:89

[17] Dominguez, M. C. et. al. 1994. Effect of aluminum and lead salts on lipid peroxidation and cell survival in human skin fibroblasts. Biol. Trace Elem Res. 57.

[18] Tariq, M. 1993 A review of reproductive toxicity of aluminum. In Reproductive toxicology, Ed M. Richardson, pp 245-261.

[19] Cherroret, G et. al. 1992. Long-term effects of postnatal aluminum exposure on choline acetyl transferase activity and learning abilities in the rat. Neurotoxicol. Teratol. 14:259-264

Golub, M. S. et. al. 1987 Maternal and developmental toxicity of chronic aluminum exposure in mice. Fund. Appl. Toxicol. 8:346-357

Golub, M. S. et. al. 1995 Behavioral performance of Swiss Webster mice exposed to excess dietary aluminum during development or during development and as adults. Toxicol. Appl. Pharmacol. 133:64-72

Muller, G. et. al. 1990. Developmental alterations in offspring of female rats orally intoxicated by aluminum lactate at different gestation periods. Teratology 42:253-261.

Reuhl, K. R. 1991. Delayed expression of neurotoxicity: The problem of silent damage. Neurotoxicity 12:341-346.

Santucci, D et. al. 1994. Early exposure to aluminum affects eight-arm maze performance and hippocampal nerve growth factor in adult mice.

Yorkel, R. A. 1985 Toxicity of gestational aluminum exposure to the maternal rabbit offspring. Toxicol. Appl. Pharmacol. 79:121-133.

[20] National Health Statistics Reports Number 65, March 2013. Changes in Prevalence of Parent-reported Autism Spectrum Disorder in school age children 2007 – 2012.

[21] Suren, P. et. al. 2013 Association between maternal use of folic acid supplements and risk of autism spectrum disorders in children. 309(6):570-7

[22] Gallagher, C. M. and Goodman, M. S. 2010 Hepatitis B vaccination of male neonates and autism diagnosis, NHIS 1997-2002. J. Toxicol. Environ. Health A 73(24):1665-77

[23] Tomljenovic, L. and Shaw, C.A. Do aluminum vaccine adjuvants contribute to the rising prevalence of autism? J. Inorg. Biochem. 2011 105(11):1489-99.

[24] Shaw, C.A. and Petrik, M.S. 2009. Aluminum hydroxide injections lead to motor deficits and motor neuron degeneration. 103(11): 1555-62/

[25] Exley, C. et. al. 2009. A role for the body burden of aluminum in vaccine-associated macrophagic myofasciitis and chronic fatigue. Med. Hypoptheses. 72(2):135-9

 

 

[26] Seneff, S., Davidson, R.M. and Liu, J. 2012 Empirical Data Confirm Autism Symptoms Related to Aluminum and Acetaminophen Exposure. Entropy 2012, 14, 2227-2253.

[27] Pittman, M. and Cox, C. B. 1965. Pertussis Vaccine Testing for Freedom-from-toxicity. Appl. Microbiol. 13(3):447-456.

[28] Wu, T. W., Lin, H.H., Wang, L.Y. 2013. Chronic hepatitis B infection in adolescents who received primary infantile vaccination. Hepatology 57:37-45

Keck, J.W. et. al. 2014 Hepatitis B Antibody Levels seven to nine years following Booster Vaccination in Alaska Native persons. Clin. Vaccine Immunol. July 23 pii: CVI.00263-14.