The case for aluminum adjuvant safety is based on analyses by Mitkus (2011) and Keith (2002). Keith relies on the assumption that animals can ingest 62mg/kg/day aluminum without adverse effects. Mitkus relies on the assumption that animals can ingest 26mg/kg/day aluminum without adverse effects.
As the research on aluminum toxicity progressed, the accepted maximum safe dose went from 62 mg/kg/day in 1999 to 26 mg/kg/day in 2008. This is according to the Agency for Toxic Substances and Disease Registry (ATSDR).
For example, Keith states:
“The basis [for the MRL] was an intermediate-duration study (Golub et al.) in which mice were fed a diet containing aluminum lactate. They experienced spontaneous motor activity interference with a no-observed-adverse-effect level (NOAEL) of 62 mg/kg per day.”
“Intermediate duration”= 6 weeks
MRL=minimal risk level
Vaccine promoters understand that the 62 or 26 mg/kg/day-is-safe assumption is essential for their defense of vaccine aluminum adjuvant. They must defend it, and they defend it vigorously. For example, Dr Paul Offit wrote in 2003:
“For determining the quantity of aluminum below which safety is likely, data were generated in mice that were inoculated orally with various quantities of aluminum lactate. No adverse reactions were observed when mice were fed quantities of aluminum as high as 62 mg/kg/day (42). By applying uncertainty factors of 3 (for extrapolation to humans) and 10 (for human variability), the ATSDR concluded that the minimum risk level for exposure to aluminum was 2 mg/kg/day. The half-life of elimination of aluminum from the body is approximately 24 hours. Therefore, the burden of aluminum to which infants are exposed in food and vaccines is clearly less than the guideline established by the ATSDR and far less than that found to be safe in experimental animals.” (Emphasis added)
–Dr Paul Offit, “Addressing Parents’ Concerns: Do Vaccines Contain Harmful Preservatives, Adjuvants, Additives, or Residuals?” Pediatrics, Vol. 112, No. 6, 2003.
ATSDR=Agency for Toxic Substances and Disease Registry. Offit is referring to the 1999 version of the ATSDR report (i.e. not the 2008 version used by Mitkus).
Ref #42=Golub et al.
The 26mg/kg/day dosage relied upon by Mitkus comes from the 2008 ATSDR report. See pages 17-26, and page 24 in particular: ATSDR: Toxicological Profile for Aluminum, 2008
It is not rational or scientific to use studies of ingested, water-soluble aluminum salts (like AlCl3 or Al-lactate) to establish a safe dose of injected aluminum adjuvant (comprising poorly-water-soluble aluminum hydroxide/phosphate nanoparticles). The chemical forms and route of administration are different. It is well-established today that nanoparticles can have higher toxicity than bulk or soluble forms of the same material. But that is not the subject of this article.
It’s the vaccine promoters that created this inherently-invalid approach to aluminum adjuvant safety. Vaccine critics including us argue that the safety of injected aluminum adjuvant is best studied in experiments using injected aluminum adjuvant, not ingested soluble aluminum salts like AlCl3 or Al lactate. This should be common sense.
So, leaving aside the important issues of nanoparticle toxicity and administration route, I want to address the question: is it really true that animals (mice or rats) are not harmed by ingesting 62mg/kg/day or 26 mg/kg/day aluminum? After all, this is the fundamental basis for aluminum adjuvant safety. Vaccine promoters rely on Keith and Mitkus to make the case that aluminum adjuvant is safe, and Keith and Mitkus depend on the claim that these dosages are safe for animals to ingest. If the 62 or 26 mg/kg/day dosages are in fact harmful to animals, then the analyses by Keith and Mitkus are wrong and unsalvageable.
Several studies clearly demonstrate that dosages much lower than 62mg/kg/day and 26 mg/kg/day are neurotoxic, and they are presented below.
All dosages indicated below are for elemental aluminum. For example, AlCl3 = 20.2% elemental aluminum, so 100mg AlCl3 contains 20.2 mg aluminum. The Golub study and ATSDR analysis refer to elemental aluminum.
All the studies administered aluminum by ingestion, like the Golub et al study cited by vaccine promoters.
We start with Golub, because even the Golub study shows adverse effects from ingesting 62mg/kg/day aluminum.
Golub et al., 1989
Dosage: 62mg/kg/day Al (the “LO” group)
Dosing Duration: 6 weeks
Form: Al lactate
Full Paper: Effects of Aluminum Ingestion on Spontaneous Motor Activity in Mice
Golub reports two adverse effects from the 62mg/kg/day dosage: fur loss and cyclic food intake. Golub states:
“After the first week of Al exposure, mice began to show a localized loss of fur on the tip of the snout that was identified by veterinarians as a low level sign of poor condition in the colony. This condition was reported more frequently in the LO and HI Al groups than in the controls.”
“LO mice did not show as clear a cycling pattern but did have somewhat higher intake than controls on days 21-24, 33-36 and 36-39 and lower intake on days 24-27 (p=0.04-0.05 at these times).”
“Food intake…followed a cyclic pattern similar to that seen in rodents eating diets deficient in a specific nutrient (2) or adulterated with a poison (17). “
Golub clearly identifies the cyclic food intake as an adverse, toxic effect. The cyclic food intake was statistically significant, since p=0.04-0.05.
So, the Golub study, used by vaccine promoters, has been dishonestly represented. Golub reported that 62mg/kg/day caused adverse effects. Offit is contradicted by his own citation (Golub is citation #42 in paper above).
Dosage: 6mg/kg/day (30mg/kg/day AlCl3), and 20.2mg/kg/day (100mg/kg/day AlCl3)
Dosing Duration: 90 days
Forms: AlCl3 and Al(OH)3
Full paper: Neurotoxic effect of enteral aluminium
Bilkei-Gorzo reports adverse effects on learning and memory at 6mg/kg/day and 20.2 mg/kg/day.
Above: Animals ingesting 6mg/kg/day aluminum (30mg/kg/day AlCl3) required about 2.7 times as long to learn and remember a maze. This contradicts the claim by vaccine promoters that 62 or 26mg/kg/day produces no adverse effects. Adverse effect on learning was slightly worse at 20.2mg/kg/day aluminum (from 100mg/kg/day AlCl3). From Bilkei-Gorzo, 1993.
Bilkei-Gorzo also reported (at 20.2mg/kg/day) adverse changes in two brain enzymes known to be affected by aluminum toxicity: acetylcholinesterase and choline-acetyltransferase.
Bilkei-Gorzo concludes: “We found that the learning ability was diminished by the treatment with all of the aluminum compounds.”
Sethi et al., 2008, 2009
Dosage: 6.3mg/kg/day (50mg/kg/day AlCl3-6H2O)
Dosing duration: 6 months
Full paper (2009): Curcumin attenuates aluminium-induced functional neurotoxicity in rats
Full paper (2008): Aluminium-induced electrophysiological, biochemical and cognitive modifications in the hippocampus of aging rats
Sethi observed numerous toxic effects of ingested aluminum at 6.3mg/kg/day, in both young and old rats. Specifically, Sethi observed the following:
1) Adverse changes in electrophysiological function (“multiple unit activity”), indicating neuron hyperexcitation.
2) Adverse biochemical changes including increase in lipid peroxidation and decrease in Na-K ATPase activity. Both are known to play roles in causing brain diseases, and are indicators of neuron degeneration.
3) Behavior changes in open-field tests, including elevated anxiety in the aluminum-ingesting animals (neuronal hyperexcitation causes anxiety).
4) Neurodegeneration and changes in cellular structure.
5) Curcumin (an antioxidant from turmeric) prevented some of the damage caused by aluminum.
6) Impaired spatial memory ability (See charts below).
Above: Animals ingesting 6.3mg/kg/day aluminum (from 50mg/kg/day AlCl3-6H2O) displayed impaired spatial memory performance. Both young and old animals were affected. Many other adverse effects were also reported. From Sethi et al., 2008.
Above: Animals ingesting 6.3mg/kg/day aluminum (from 50mg/kg/day AlCl3-6H2O) displayed behavioral changes. Both young and old animals were affected. These outcomes are not necessarily pathological, but they are cause for concern because aluminum is a known neurotoxin. From Sethi et al. 2008
Cao et al., 2016
Dosage: 10, 30, and 90 mg/kg/day (from 50, 150 and 450 mg/kg/day AlCl3)
Dosing duration: 90 days
Full paper: Aluminum chloride induces neuroinflammation, loss of neuronal dendritic spine and cognition impairment in developing rat.pdf
Cao et al reported numerous adverse effects, including impaired learning/memory, neuroinflammation, and loss of dendritic spines.
Above: Ingested aluminum dosages of 30 and 90 mg/kg/day caused a significant loss of dendritic spines. Dendritic spine loss is an indicator of neurological damage. From Cao et al, 2016.
Cao et al. also reported that 30mg/kg/day aluminum caused significant increases in many indicators of neuroinflammation (cytokine gene expression).
Above: Gene expression of inflammatory cytokines (including interleukin-6) in the brain was significantly increased by 30 mg/kg/day ingested aluminum. Interleukin-6 (IL-6) causes autism. 10mg/kg/day was associated with non-significant, but consistently adverse changes (increases in inflammatory cytokines, and decreases in BNDF and CXCL1). From Cao et al, 2016.
Cao et al. conclude: “Our results suggest AlCl3 can induce neuroinflammation that may result in loss of [dendritic] spines, and thereby lead to learning and memory impairment.”
Alawdi et al., 2016
Dosage: 3.4 mg/kg/day Al (from 17mg/kg/day AlCl3)
Dosing duration: 6 weeks
Full paper: Neuroprotective Effect of Nanodiamond in Alzheimer’s Disease Rat Model: a Pivotal Role for Modulating NF-κB and STAT3 Signaling.
Alawdi et al performed many behavioral tests and measurements of neurodegeneration and brain inflammation. Alawdi also tested the effects of nanodiamond particles (ND) and memantine (MEM, a drug for alzheimers disease) on aluminum toxicity. The ND and MEM results are not relevant to the present discussion. However, the MEM results are interesting because they show that aluminum likely produces toxicity via an effect on NMDA receptors (since MEM interacts with NMDA receptors), such as excitotoxicity. Excitotoxicity occurs in autism.
Alawdi also showed that aluminum caused a 4X increase of IL-6 in the brain. This is an important finding because IL-6 causes autism.
Above: 3.4 mg/kg/day aluminum caused 3.8-fold and 4-fold increases in the cytokines tumor necrosis factor-alpha (TNF-a) and interleukin-6 (IL-6) in the brain. IL-6 causes autism. Elevated TNF-a is associated with autism. From Alawdi et al. 2016.
Alawdi also reported that 3.4 mg/kg/day ingested aluminum caused learning and memory impairment.
Above: 3.4 mg/kg/day aluminum caused learning and memory impairment in two different learning tests: the morris water maze and the Y-maze tests. From Alawdi et al., 2016.
Alawdi also reported that ingested aluminum caused increased indicators of inflammation and damage in the brain.
NF-kb: An indicator of inflammation and toxicity. Increased in many diseases. https://en.wikipedia.org/wiki/NF-%CE%BAB
Phosphorylated-STAT3 (p-STAT3): A protein involved in immune function and nervous system development. Decreased p-STAT3 is associated with some neurological diseases. https://en.wikipedia.org/wiki/STAT3
bcl-2: A protein that regulates programmed cell suicide (apoptosis). Abnormal levels of bcl-2 are associated with diseases such as cancer and schizophrenia. https://en.wikipedia.org/wiki/Bcl-2
Caspase-3: An indicator of apoptosis and therefore tissue damage. When cells are injured or diseased, apoptosis occurs. https://en.wikipedia.org/wiki/Caspase_3
Above: 3.4 mg/kg/day aluminum caused adverse changes in 4 different indicators of inflammation, disease and tissue damage in the brain. From Alawdi et al., 2016
Dosage and Detectability
26 mg/kg/day is a high dosage. For a 70kg person, 26 mg/kg is 1,820mg per day. Ingesting almost 2 grams per day of a toxic metal should be expected to have adverse effects. If a study cannot observe adverse effects from 26 mg/kg/day then its likely the study is using insensitive outcome measurements. This is the case with the Golub study, which used outcome measurements (e.g. fur loss, seizure activity) that are likely not particularly sensitive to aluminum toxicity. Thats why Golub was barely able to detect toxicity from 62mg/kg/day.
The scientific reasoning in the Keith and Mitkus papers is based on false assumptions. Animals are damaged by doses of aluminum far less than 62mg/kg/day or 26mg/kg/day. The scientific literature reports adverse effects from aluminum dosages of 3.4, 6, 6.3, 10, and 30 mg/kg/day.
The claim that aluminum adjuvant in vaccines is safe for infants is contradicted by the scientific evidence.
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