Bishop et. al. is absolutely bullshit and I will die on this hill. Do I think people lie about when they make statistical decisions when the alternative is not meeting p=0.05? Yes, of course. I see it all the time. Note that there are no replications or even anything close. What do you call a study with non-adjusted p-size of 0.03 and no replications? False. This IS absolutely the crux here. Bishop is the main reason to suspect AL being dangerous to infants. If you remove it, why are we even considering the hypothesis in the first place?
The FDA changing IV regulations based on very weak evidence is in-character, but also means that replication studies are harder, which may explain why we don’t see them. But someone should still be able to analyze past data and come up with something if Bishop is right. We don’t have that. And it only takes 6-12 months to go from deciding to write a data reanalysis paper to having it published, so they’ve had enough time.
The really important thing is: how much do AL injections affect infant blood AL levels? Note that infants have AL in their blood without injections. Since AL can only reach the brain through the blood, the total amount of AL passing into the brain is just blood_AL_levels * time. Let’s call that TAL. So our research question is: do AL injections raise blood AL levels high enough such that TAL is significantly elevated? Remember that the brain has lower AL levels than other tissues, so there’s no selective uptake by the brain. Instead, it seems to mostly go to the kidneys and bones, where it’s harmless.
This is why the radio-labeled study is so important. It shows AL levels normalizing very quickly as it enters the body, even before it can be moved into urine by the kidneys. This is why I bring up the 50% in 1 hour and 99.5% in 24 hours statistics. This means that the AL from injections doesn’t have much time to sit in the blood and wait to enter the brain.
Therefore, in order for AL from injections to cause brain AL levels to rise significantly over the baseline, it has to raise AL levels long after injection. I found a rabbit study showing that a 0.85mg AL injection to ~2kg 21-day-old rabbits only resulted in their blood AL levels spiking to a peak of ~10 micrograms/kg of blood (for sanity, I’ll refer to this as 10 ug/L. I won’t quibble about whole blood vs. serum) before going back to <1 ug/L after <48 hours. This then increased somewhat back to 1 ug/L for some over the following days, but we don’t see a massive chronic increase. 1 ug/L is much lower than human infant levels, which weirds me out and makes me a bit suspicious. I assume the rabbits were eating very low aluminum diets, so the effects would be even lower in a human. I’m unsure about this study since the rabbits started with such a low AL level, but their estimate for vaccination raising the TAL of a human infant by 1% sounds about right.
Remember exposure in the womb. This Indian study found similar AL levels in cord blood and maternal blood, around 10-20 ug/L. By the time an infant gets their first vaccines, they’ve already been exposed to maternal blood AL for 10 months! So vaccines have to result in greater TAL than maternal exposure in order to have significant effects. Based on the data, I find this unlikely.
We just don’t see major changes in blood AL levels in children based on age. I’m using the data from this blood/hair study. If AL injections do chronically increase blood AL levels, we would see a sharp increase after each vaccination, which we don’t. These are 9-13 month infants, who are getting a lot of vaccines, and they only have 15 ug/L average blood AL. There was no significant correlation between age and blood AL levels! Older kids with more vaccinations don’t have a significantly higher AL level than younger kids. There are plenty of other studies showing similar (lower, in general) blood AL levels. If vaccination was chronically increasing blood AL, why can’t we see that?
The big question these days is about ASIA syndrome—autoimmune disorder triggered by adjuvants. Here is a review from this year, which also links to a 2019 review of Al-induced chronic fatigue syndrome. “Once the aluminum-containing vaccine is injected, instead of rapidly solubilizing in the extracellular space, it accumulates at the injection site, forming aluminum conglomerates. This delay in solubilization allows the injected aluminum particles to be quickly captured by cells of the immune system and transported to different organs, including the brain, where aluminum stimulates the inflammatory response and causes chronic neurotoxicity.”
They also talk about a 2020 sheep study that showed ” Animals in the vaccine and adjuvant-only groups exhibited individual and social behavioral changes. Affiliative interactions were significantly reduced and aggressive interactions and stereotypies were significantly increased. Some of these alterations observed in this experimental model are similar to those observed in the ASIA syndrome.”
Some symptoms used to diagnose ASIA include “myalgia, myositis, arthralgia, arthritis, chronic fatigue, sleep disturbances, demyelination, memory loss, pyrexia, and dry mouth.”
One paper points out that the immune system plays a role in mediating brain development via intercellular cross-talk. It also points out that in children, renal function and the blood-brain barrier are incomplete, and so in conjunction with the small size of children and elevated levels of Al exposure relative to adults, there’s mechanistic reason to think they may be vulnerable to Al-induced ASIA-mediated neurological disorders. There is some evidence (which they cite, i.e. Gallagher and Goodman) that vaccines are linked to autism in neonates. There is also apparently substantial evidence linking ASIA to neurological disorders in adults.
Based on what I see, there are two plausible mechanistic routes by which aluminum adjuvants could directly or indirectly impair childrens’ neurological development, and some modest animal experimental and human epidemiological evidence to support that this might actually be going on. It’s not enough for me to be convinced that this is a widespread common issue, or that the risks posed by vaccines outbalance the risks posed by infection, but I am intrigued.
1,2. [this point edited] I do think the neurotoxicity has been shown in animal studies; not sure how to assess comparability of scales to humans though—see this comment. I agree lack of follow up / re-analysis is kinda sketch, but the study area seems to be generally neglected? I think FDA regulations hit soon after the study, which would limit options for replications, but maybe some retrospective analysis would have been possible in the period where manufacturers were struggling to remove Al from IV fluids.
345. I think the hypothesis is, yes, the aluminum sits in muscle at first and doesn’t rush directly into the blood. I can’t judge it myself, but this paper has lots of thoughts about the rabbit study and ways it could be misleading, and perhaps-too-complicated-but-heck-if-I-know theories about the chemistry.
6. very interesting, this looks like a strong argument I hadn’t considered. thanks for bringing this up! I’m glad they don’t find a correlation in this study. Blood / cord aluminum may be a relatively variable/fleeting thing, though; if this were averaged over gestation time I’d find it quite convincing. Not sure how much it would change in these women day-to-day, and whether we should think a reasonable signal is findable?
7. The child is growing about linearly and getting more vaccines / aluminum load about linearly. blood vol is proportional to body mass. net result, everything looks kinda constant per blood unit, if we didn’t add more then Al per blood unit should drop over time.
Neurotoxicity where blood levels reach 500ug/L and cause clear problems with brain function has been shown. But we don’t see any effects on animals at 10-20ug/L. The window for studies, however, isn’t closed! We can go back and use past records. Data like which IV nutritional formula is used and infant/adult brain function are easy to collect, even decades after. This is why I am so suspicious about the lack of replications.
I understand that aluminum may be released into the blood over time. However, the only way this can cause brain problems is by raising blood aluminum levels. We do not see an increase in blood aluminum levels. We don’t even see significant differences between vaccinated and unvaccinated children in the US from the hair/blood analysis paper! That’s enough for me to call it case closed until new information comes out.
It’s entirely possible that 10-20 ug/L is bad for children, before and after birth. But removing AL from vaccines would barely move the needle.
I am not sure it’s accurate to say that chronically increased blood levels of aluminum is the only way to cause brain problems. The reviews I linked in my other comment suggest that aluminum can affect brain function by:
Being carried to the brain by immune cell endocytosis.
Disrupting immune cell cross-talk with the CNS.
Rapidly crossing the incompletely developed neonate blood brain barrier before being cleared more slowly by incompletely developed neonate kidneys. Remember that the aluminum clearance data is from healthy adult males.
”there are numerous reports of neurotoxic effects in mice and rats, confirmed by coherent neurobiological alterations, for oral doses of Al much < 26 mg/kg/d: 6 mg/kg/d reported in 1993 [86], 5.6 mg/kg/ d reported in 2008 and 2009 [87,88], 10 mg/kg/d reported in 2016 [89], 3.4 mg/kg/d reported in 2016 and 2017 [90,91], and even 1.5 mg/kg/d reported in 2017 [92].”
What blood levels would you think this maps to? Or do you think these studies are bunk?
The study they were citing was a typically underpowered mouse study with p-hacked groups. Why did they choose to run 2 groups, each with their own controls, on the same tests? The only significant behavioral difference between the groups was that controls performed better on the memory test.
But 1.5 mg/kg and 8.3 mg/kg are normal human-level AL intakes! And look at those error bars! Also, they ran their analysis completely wrong. This null hypothesis you’re supposed to be testing against is “there is no difference in exploration time (c-a) between each groups”. Instead, they were testing against “there is no difference in exploration time between a and c”. That is, their null hypothesis was that their mice had no memory, they found that their control group definitely did have memory, and concluded that AL had an effect… But then they used the wrong control group? Everything in this study is wrong and the authors and reviewers should feel bad.
Let me reiterate that. THEIR ONLY STATISTICALLY SIGNIFICANT RESULT WAS THAT CONTROL MICE HAD FUNCTIONAL MEMORY. THE ERROR BARS ON TEST GROUP MICE WERE SO HIGH YOU CAN’T TELL EITHER WAY. THEY DID THEIR ANALYSIS WRONG AND THEIR CONCLUSIONS SHOULD BE DISCARDED. So yeah, it’s completely bunk.
Just noting that in the hair/blood analysis paper there were no unvaccinated children, so no useful comparison could be made from that paper alone—I complained about this in the main post body.
Also, most of these kids were probably arriving at the lowest point in their Al cycle, when they’re right about to get more shots? It says “We obtained data for this cross-sectional study from a cohort of healthy infants presenting to an urban, primary care center for well child care.”
They had aluminum levels median ~15 ug / L and a much higher mean with some large positive outlier samples, which the study then excluded. I don’t see this study as evidence against vaccines causing increase in blood aluminum levels
Remember exposure in the womb. This Indian study found similar AL levels in cord blood and maternal blood, around 10-20 ug/L. By the time an infant gets their first vaccines, they’ve already been exposed to maternal blood AL for 10 months! So vaccines have to result in greater TAL than maternal exposure in order to have significant effects. Based on the data, I find this unlikely.
But mikes above said:
We give the hepatitis B vaccine, >200micrograms aluminum, at birth
And that looks a heck of a lot higher. So I’m confused by the “Based on the data, I find this unlikely” statement. Edit: I see, it’s because it’s absorbed by the muscle and doesn’t go to the blood, or if it goes to the blood it then goes to the bone?
Like, the maternal blood is being circulated so I’d expect it to lead to some equilibrium Al level (unless it’s absorbed somewhere and not coming free again). Whereas, the vaccine is adding a whole lot that isn’t being circulated out by the vaccine itself (though I assume there must be other mechanisms to dump it out of the body if it isn’t increasing a lot after vaccines).
OK, thanks. On the other hand, if Aluminum is excreted that fast, doesn’t that suggest that the blood level is pretty heavily increased for a short time (since I assume it must be in the blood to get excreted and I also assume that the timescale of such excretion, given that it’s in the blood, should probably be at least a day or so?)
You’re right—it’s what we would expect. And yet the actual blood aluminum levels we measure aren’t that high! So where is all the aluminum? Well, biopsies show that kidneys have something like 10x the AL levels of other soft tissues in rabbits, so I suspect that’s where a lot of the aluminum goes during the first hour. This is then excreted in urine, explaining why urine AL levels are sometimes higher than blood AL levels. After that, tissues slowly release their aluminum into the bloodstream, where they get absorbed by the kidneys before blood AL levels can rise too much. Sounds nice in theory, but probably more complicated/downright wrong in practice.
Bishop et. al. is absolutely bullshit and I will die on this hill. Do I think people lie about when they make statistical decisions when the alternative is not meeting p=0.05? Yes, of course. I see it all the time. Note that there are no replications or even anything close. What do you call a study with non-adjusted p-size of 0.03 and no replications? False. This IS absolutely the crux here. Bishop is the main reason to suspect AL being dangerous to infants. If you remove it, why are we even considering the hypothesis in the first place?
The FDA changing IV regulations based on very weak evidence is in-character, but also means that replication studies are harder, which may explain why we don’t see them. But someone should still be able to analyze past data and come up with something if Bishop is right. We don’t have that. And it only takes 6-12 months to go from deciding to write a data reanalysis paper to having it published, so they’ve had enough time.
The really important thing is: how much do AL injections affect infant blood AL levels? Note that infants have AL in their blood without injections. Since AL can only reach the brain through the blood, the total amount of AL passing into the brain is just blood_AL_levels * time. Let’s call that TAL. So our research question is: do AL injections raise blood AL levels high enough such that TAL is significantly elevated? Remember that the brain has lower AL levels than other tissues, so there’s no selective uptake by the brain. Instead, it seems to mostly go to the kidneys and bones, where it’s harmless.
This is why the radio-labeled study is so important. It shows AL levels normalizing very quickly as it enters the body, even before it can be moved into urine by the kidneys. This is why I bring up the 50% in 1 hour and 99.5% in 24 hours statistics. This means that the AL from injections doesn’t have much time to sit in the blood and wait to enter the brain.
Therefore, in order for AL from injections to cause brain AL levels to rise significantly over the baseline, it has to raise AL levels long after injection. I found a rabbit study showing that a 0.85mg AL injection to ~2kg 21-day-old rabbits only resulted in their blood AL levels spiking to a peak of ~10 micrograms/kg of blood (for sanity, I’ll refer to this as 10 ug/L. I won’t quibble about whole blood vs. serum) before going back to <1 ug/L after <48 hours. This then increased somewhat back to 1 ug/L for some over the following days, but we don’t see a massive chronic increase. 1 ug/L is much lower than human infant levels, which weirds me out and makes me a bit suspicious. I assume the rabbits were eating very low aluminum diets, so the effects would be even lower in a human. I’m unsure about this study since the rabbits started with such a low AL level, but their estimate for vaccination raising the TAL of a human infant by 1% sounds about right.
Remember exposure in the womb. This Indian study found similar AL levels in cord blood and maternal blood, around 10-20 ug/L. By the time an infant gets their first vaccines, they’ve already been exposed to maternal blood AL for 10 months! So vaccines have to result in greater TAL than maternal exposure in order to have significant effects. Based on the data, I find this unlikely.
We just don’t see major changes in blood AL levels in children based on age. I’m using the data from this blood/hair study. If AL injections do chronically increase blood AL levels, we would see a sharp increase after each vaccination, which we don’t. These are 9-13 month infants, who are getting a lot of vaccines, and they only have 15 ug/L average blood AL. There was no significant correlation between age and blood AL levels! Older kids with more vaccinations don’t have a significantly higher AL level than younger kids. There are plenty of other studies showing similar (lower, in general) blood AL levels. If vaccination was chronically increasing blood AL, why can’t we see that?
The big question these days is about ASIA syndrome—autoimmune disorder triggered by adjuvants. Here is a review from this year, which also links to a 2019 review of Al-induced chronic fatigue syndrome. “Once the aluminum-containing vaccine is injected, instead of rapidly solubilizing in the extracellular space, it accumulates at the injection site, forming aluminum conglomerates. This delay in solubilization allows the injected aluminum particles to be quickly captured by cells of the immune system and transported to different organs, including the brain, where aluminum stimulates the inflammatory response and causes chronic neurotoxicity.”
They also talk about a 2020 sheep study that showed ” Animals in the vaccine and adjuvant-only groups exhibited individual and social behavioral changes. Affiliative interactions were significantly reduced and aggressive interactions and stereotypies were significantly increased. Some of these alterations observed in this experimental model are similar to those observed in the ASIA syndrome.”
Some symptoms used to diagnose ASIA include “myalgia, myositis, arthralgia, arthritis, chronic fatigue, sleep disturbances, demyelination, memory loss, pyrexia, and dry mouth.”
One paper points out that the immune system plays a role in mediating brain development via intercellular cross-talk. It also points out that in children, renal function and the blood-brain barrier are incomplete, and so in conjunction with the small size of children and elevated levels of Al exposure relative to adults, there’s mechanistic reason to think they may be vulnerable to Al-induced ASIA-mediated neurological disorders. There is some evidence (which they cite, i.e. Gallagher and Goodman) that vaccines are linked to autism in neonates. There is also apparently substantial evidence linking ASIA to neurological disorders in adults.
Based on what I see, there are two plausible mechanistic routes by which aluminum adjuvants could directly or indirectly impair childrens’ neurological development, and some modest animal experimental and human epidemiological evidence to support that this might actually be going on. It’s not enough for me to be convinced that this is a widespread common issue, or that the risks posed by vaccines outbalance the risks posed by infection, but I am intrigued.
1,2. [this point edited] I do think the neurotoxicity has been shown in animal studies; not sure how to assess comparability of scales to humans though—see this comment. I agree lack of follow up / re-analysis is kinda sketch, but the study area seems to be generally neglected? I think FDA regulations hit soon after the study, which would limit options for replications, but maybe some retrospective analysis would have been possible in the period where manufacturers were struggling to remove Al from IV fluids.
345. I think the hypothesis is, yes, the aluminum sits in muscle at first and doesn’t rush directly into the blood. I can’t judge it myself, but this paper has lots of thoughts about the rabbit study and ways it could be misleading, and perhaps-too-complicated-but-heck-if-I-know theories about the chemistry.
6. very interesting, this looks like a strong argument I hadn’t considered. thanks for bringing this up! I’m glad they don’t find a correlation in this study. Blood / cord aluminum may be a relatively variable/fleeting thing, though; if this were averaged over gestation time I’d find it quite convincing. Not sure how much it would change in these women day-to-day, and whether we should think a reasonable signal is findable?
7. The child is growing about linearly and getting more vaccines / aluminum load about linearly. blood vol is proportional to body mass. net result, everything looks kinda constant per blood unit, if we didn’t add more then Al per blood unit should drop over time.
Neurotoxicity where blood levels reach 500ug/L and cause clear problems with brain function has been shown. But we don’t see any effects on animals at 10-20ug/L. The window for studies, however, isn’t closed! We can go back and use past records. Data like which IV nutritional formula is used and infant/adult brain function are easy to collect, even decades after. This is why I am so suspicious about the lack of replications.
I understand that aluminum may be released into the blood over time. However, the only way this can cause brain problems is by raising blood aluminum levels. We do not see an increase in blood aluminum levels. We don’t even see significant differences between vaccinated and unvaccinated children in the US from the hair/blood analysis paper! That’s enough for me to call it case closed until new information comes out.
It’s entirely possible that 10-20 ug/L is bad for children, before and after birth. But removing AL from vaccines would barely move the needle.
I am not sure it’s accurate to say that chronically increased blood levels of aluminum is the only way to cause brain problems. The reviews I linked in my other comment suggest that aluminum can affect brain function by:
Being carried to the brain by immune cell endocytosis.
Disrupting immune cell cross-talk with the CNS.
Rapidly crossing the incompletely developed neonate blood brain barrier before being cleared more slowly by incompletely developed neonate kidneys. Remember that the aluminum clearance data is from healthy adult males.
If 10-20 ug/L would mean a loss of 1-2 points of IQ it’s unlikely that the animal studies were strong enough powered to pick up such an effect.
If the aluminium goes into the brain that would mean you wouldn’t see it in the blood or hair.
If you want to make a statement about it not going to the brain you either have to account where it went or look in the brain.
For animal studies at lower ranges of Al exposure:
This source says:
”there are numerous reports of neurotoxic effects in mice and rats, confirmed by coherent neurobiological alterations, for oral doses of Al much < 26 mg/kg/d: 6 mg/kg/d reported in 1993 [86], 5.6 mg/kg/ d reported in 2008 and 2009 [87,88], 10 mg/kg/d reported in 2016 [89], 3.4 mg/kg/d reported in 2016 and 2017 [90,91], and even 1.5 mg/kg/d reported in 2017 [92].”
What blood levels would you think this maps to?
Or do you think these studies are bunk?
https://sci-hub.ru/10.1007/s12640-016-9656-y
The study they were citing was a typically underpowered mouse study with p-hacked groups. Why did they choose to run 2 groups, each with their own controls, on the same tests? The only significant behavioral difference between the groups was that controls performed better on the memory test.
But 1.5 mg/kg and 8.3 mg/kg are normal human-level AL intakes! And look at those error bars! Also, they ran their analysis completely wrong. This null hypothesis you’re supposed to be testing against is “there is no difference in exploration time (c-a) between each groups”. Instead, they were testing against “there is no difference in exploration time between a and c”. That is, their null hypothesis was that their mice had no memory, they found that their control group definitely did have memory, and concluded that AL had an effect… But then they used the wrong control group? Everything in this study is wrong and the authors and reviewers should feel bad.
Let me reiterate that. THEIR ONLY STATISTICALLY SIGNIFICANT RESULT WAS THAT CONTROL MICE HAD FUNCTIONAL MEMORY. THE ERROR BARS ON TEST GROUP MICE WERE SO HIGH YOU CAN’T TELL EITHER WAY. THEY DID THEIR ANALYSIS WRONG AND THEIR CONCLUSIONS SHOULD BE DISCARDED. So yeah, it’s completely bunk.
Just noting that in the hair/blood analysis paper there were no unvaccinated children, so no useful comparison could be made from that paper alone—I complained about this in the main post body.
Also, most of these kids were probably arriving at the lowest point in their Al cycle, when they’re right about to get more shots? It says “We obtained data for this cross-sectional study from a cohort of healthy infants presenting to an urban, primary care center for well child care.”
They had aluminum levels median ~15 ug / L and a much higher mean with some large positive outlier samples, which the study then excluded. I don’t see this study as evidence against vaccines causing increase in blood aluminum levels
But mikes above said:
And that looks a heck of a lot higher. So I’m confused by the “Based on the data, I find this unlikely” statement.Edit: I see, it’s because it’s absorbed by the muscle and doesn’t go to the blood, or if it goes to the blood it then goes to the bone?Like, the maternal blood is being circulated so I’d expect it to lead to some equilibrium Al level (unless it’s absorbed somewhere and not coming free again). Whereas, the vaccine is adding a whole lot that isn’t being circulated out by the vaccine itself (though I assume there must be other mechanisms to dump it out of the body if it isn’t increasing a lot after vaccines).It gets excreted over time but also accumulates in the bone, where it is slowly released into the blood over time.
OK, thanks. On the other hand, if Aluminum is excreted that fast, doesn’t that suggest that the blood level is pretty heavily increased for a short time (since I assume it must be in the blood to get excreted and I also assume that the timescale of such excretion, given that it’s in the blood, should probably be at least a day or so?)
You’re right—it’s what we would expect. And yet the actual blood aluminum levels we measure aren’t that high! So where is all the aluminum? Well, biopsies show that kidneys have something like 10x the AL levels of other soft tissues in rabbits, so I suspect that’s where a lot of the aluminum goes during the first hour. This is then excreted in urine, explaining why urine AL levels are sometimes higher than blood AL levels. After that, tissues slowly release their aluminum into the bloodstream, where they get absorbed by the kidneys before blood AL levels can rise too much. Sounds nice in theory, but probably more complicated/downright wrong in practice.
Will do more research tomorrow.