AS A WORKING SCIENTIST, highly trained and skilled in both the art and in the importance of bona fide scientific discourse, it bothers me when I see sorry excuses for scientific engagement such as the articles published, sans peer review, at the obscure Vaccine Risk and Injury Denialist website “Skeptical Raptor”. These articles use an immature style of attacking objective Science under the pretext of defending Science, composed of a mixture of ad-hominem attacks combined with a Gish-Gallop of throwing anything and everything they think might stick at bona fide Scientific inquiry, with a swirl of argument from authority while hiding behind the pretext of fear of being attacked by
anti-vaccine, I mean, vaccine risk aware advocates. Science? I don’t think so.
The over-the-top high-horsed tone of the articles published at Skeptical Raptor may be amusing to those who enjoy a good street fight. However, Scientific discourse requires that we take a different tack than Romper Room tantrums in our response. I will indulge a bit in this about the website, however, by stating that in my experience, the anonymous Ghost authors of the (non peer-reviewed) articles at Skeptical Raptor have never met a vaccine-induced injury or death they did not like.
I am only responding to this blog because my colleagues thought I should. I hate to amplify SR; it’s a hate-filled place. I would have expected more from people who call themselves Scientists. Surely the vaccine risk and injury denialista could have found someone willing to take our peer-reviewed study on old-school style, in the pages of the Journal of Trace Elements in Medicine and Biology, where our study was published following blinded peer review (3 reviewers). Frankly, I’m disappointed by the lost opportunity for bona fide rational discourse. In contrast, their online attack is not peer reviewed; the author, or author(s), hid behind the above-mentioned pretext of fear of attack. Perhaps there is a conflict of interest or two they would prefer to not reveal. In contrast, my resume and biography are on the web and I make no income from the sale, manufacture and distribution of vaccines.
Ironically, in their online attack on Science, the ghost author, or authors, whom I will refer to as the anonymous aluminum apologist bloggers (AAAB), unwittingly attacked and destroyed FDA’s “Apology Study” research on aluminum in their attempt to attack our study. I’m referring to the Mitkus study, which was FDA’s attempt to dispense with empirical research such as age-appropriate dose escalation studies of aluminum hydroxide in mice to determine the actual per body weight dose limits for humans. The AAAB’s unwitting attack on the FDA’s Apology Aluminum study (Mitkus et al.) starts with four entire paragraphs of futile and pointless ad-hominem attacks. They cite measles, however, the live virus measles, mumps and rubella (MMR) vaccine does not contain aluminum, and thus their “anti-vaxxers are going to destroy us all” trope proves equally futile.
Because such attacks are irrelevant in Objective Science, we’ll move right along to see how they slayed the FDA’s Mitkus study.
The first error in reasoning that I point out might actually save the Mitkus study, for now. The aluminum apologist blogger claim that because none of the authors of McFarland et al. are toxicologists, we did not know that we should be focused on plasma clearance rates.
Right there, we are done.
Whoever wrote this critique clearly knows or cares nothing about aluminum toxicodynamics. It’s all spelled out in the peer-reviewed literature: aluminum injected into the human body, either by intramuscular injection (IM injection) or IV, has a strong affinity for solid human tissue, explaning thus precisely why its “bioavailability” as measured by plasma clearance is very low. It is not low because it is cleared from the body in urine, feces, sweat, etc. This is why we changed, in our first study, the language from “absorption” to “metabolic availability”: all of the aluminum injected in each vaccine (100%), and all aluminum that is absorbed by the intestine (0.3%) must be dealt with by the body, and in those systems, the toxic effects also manifest. The mechanisms of aluminum toxicity described in the literature ignored by AAAB are intracellular, and include mitotoxicty, disruption of the cytoskeleton, and endoplasmic reticulum stress. A full collection of references on the cellular mechanisms of aluminum toxicity is available here. AAAB cites none of this literature.
Measuring aluminum in the the plasma (or serum, or blood) clearance does not reflect whole-body content and actual aluminum toxicdynamics: aluminum exerts its toxic effects while adhered to tissues, and inside cells. The body clearance, therefore is the concern. Whilst in cellular tissues, aluminum can be expected to act as an adjuvant on proteins from other viruses and bacteria, and oddly shaped human proteins expelled during cellular death following aluminum induced endoplasmic reticulum stress. The longer the whole-body retention, the more likely the aluminum is to induce harm during “detox-retox”, which we refer to in our study.
The long-term duration of aluminum in the human body is a cause for concern over chronic re-exposure via aluminum cellular release and recirculation. Take, for example, a recent study that focused on plasma concentrations and relative amounts to brain, bone and other tissues (Weissner et al., 2019). The authors report:
“Crude linear extrapolation from 100% on day 0 through the mean dose fraction of V1 remaining at the injection site on day 80 (77.7%) predicts that complete absorption of Al from AH-adjuvanted vaccines will take at least 350 days (1 year).
In contrast, linear extrapolation through the remaining dose fraction for V3 (14.5%) suggests that Al from AP-adjuvanted vaccines might be completed much earlier after ca. 120 days.”
Source: Weissner et al., 2019. https://link.springer.com/article/10.1007/s00204-019-02561-z
That’s a long time for the body to learn and reinforce autoimmunity – and that’s just absorption. That’s not whole body clearance.
Similarly, Flarend et al.’s rabbit study found that only 6% of aluminum hydroxide injected into rabbits had passed from the body after 28 days.
That means that the aluminum resides in human tissue, including bone, brain, and other organs, actively impairing cellular function, inducing cell death. Aluminum in all of these tissues is not static. The aluminum apologist bloggers ignore that while the amount of aluminum that makes it into the brain is relatively small compared to bone, its retention is much longer in the brain, and aluminum salt molecules remain toxic, killing cell after cell. This would explain why 90% of aluminum measured in the brain is found in the extracellular matrix, as reported by Priest. If it was not cytotoxic, it would be found in the cells.
In attacking our lack of focus on plasma clearance, AAAB showed the soft underbelly of why the Mitkus et al. study is all but flotsum in the scientific literature on aluminum because it focused on plasma clearance. Plenty of peer-reviewed critiques are available and see citations in McFarland et al. 2020.
Mitkus is, in my professional opinion, dead. That is part of the reason WHY we used Clark’s rule.
As for AAAB’s criticism of cherry picking, AAAB is/are guilty of this very offense, otherwise they would never claim (incorrectly) that we should all be concerned only about plasma concentration. Vaccine risk and injury apologists used the same tactic to try to convince the medical community and the public that Ethyl mercury was not a problem because it cleared from the serum more quickly than Methyl mercury. But hundreds of thousand of Americans are not complaining about symptoms of their plasma. “Doctor, my plasma hurts”. No. They are complaining about symptoms of whole-body toxicity. Our study made it perfectly clear that we are addressing whole-body toxicokinetics. It’s a pretty straightforward analysis, and the difference between plasma and cellular organs is readily apparent.
Unlike the AAAB, we are concerned about the effects of aluminum on the circulatory system, the digestive and excretory sytem, the endocrine system, the integumentary system, the immune sytem, the muscular system, the nervous system, the renal and urinary system, the reproductive system, the respiratory sytem and the skeletal system. Why? Because these are the systems about which the public is reporting symptoms. The previous literature seems to consider the relative amount destined for bone to be “reassuring”, and refers to it as a storage depot, ignoring the constant exposure of cells circulating through bone as source of constant flux, recirculation, and exposure. The long-term whole-body burden is relevant when such diverse conditions as neurodevelopmental and immunological disorders are attributable to aluminum.
Plasma clearance rates are irrelevant to our study, other than the transient period of time that aluminum moves from tissue to tissue as it induces apoptotic and necrotic cell death. Priest largely focused on rates determined with co-administered citrates, which enhance the absorption, or adsorption, to tissue, and would expedite the plasma-based “bioavailability”. Importantly, Mitkus assumed that 90% of aluminum in whole blood was found in plasma (not 90% of whole body), with the rest adhered to erthrocytes, where it causes eryptosis (red blood cell death), and therefore likely causes anemia, so says Science. [ https://lupusnewstoday.com/2017/01/04/red-blood-cells-suicide-cause-anemia-sle-study-finds/ ] Note that animal studies of Lupus use aluminum hydroxide to induce SLE-like symptoms.
The diseases of the blood to which aluminum may also contribute are significant sources of morbidity and mortality in the US population, and in the population around the world. Having read all of the studies that use aluminum hydroxide to induce autoimmune conditions in mice, I’ve determined that the per-body-weight doses approach those in humans if the study use an animal that is a genetic mouse or rat model that predisposes the animal to the autoimmune condition. Conditions like asthma, allergic rhinitis, lupus, Sjogren’s syndrome, and so on are routinely and reliably induced by injections of aluminum hydroxide. But that’s just Science.
Similarly, animal studies reliably and reproducibly induce asthma and other autoimmune symptoms in mice using aluminum hydroxide. These are serious diseases with serious mortality burden; about 45 people in the US die from asthma every day. Readers can search Pubmed for studies that induce autoimmunity in mice and rats here:
The doses in these studies were systematically analyzed to compare them per body weight to a single dose in a single vaccine that a two-year old human receives on the CDC schedule, resulting in the following table:
This table and the paper in which it can be found, along with all of citations, is available here. (That paper survived peer review, but the publisher found a link to it on the IPAK website and claimed that we already published it. So much for the ‘open science’ and ‘open review’ experiment!)
Mitkus, based on Priest, used data from single or a handful of clearance rates of isotope-labeled aluminum. Our study took a different approach to a pediatric dose limit that introduces the question: since plasma-based bioavailability does not inform on whole-body toxicity corrected for body, weight, if 850 mcgs are “safe” for an adult, how does that scale to infants, newborns and toddlers? We also explored the effects of successive doses on accumulation and clearance, and introduce the problem that not everyone might be able to clear aluminum at the same rate as others, including those with genetic impairment of any number of biological pathways involved in detoxification, and newborns, which only have 20% glomular filtration rate of adults. None of the available studies on aluminum toxicology have considered aluminum toxicogenetics. Yet there is a patch for testing for aluminum allergy – clearly some people could be screened for aluminum allergy, yet pediatric practice ignores this reality.
The aluminum apologist bloggers also incorrectly interpret our results: They claim that we conclude that all of the aluminum injected simply accumulates:
“As it reads, the authors are trying to claim that under no circumstances aluminum is eliminated from the body and that the aluminum injected will accumulate in the body during the first 18 months of life.” – AAAB
None of our assumptions or conclusions even remotely resembles this straw man, and, as a straw man, it deserves no further attention than to say they must not have read, or understood, the full study.
We estimated a pediatric dose limit (PDL) based on a presumed per-dose safe level used clinically by FDA regulations, and compare the Priest equation results. By considering both body weight and cumulative retention, scaling their enforced per dose limit, we come to a very different conclusion than Mitkus. Notably, the McFarland et al. study did not derive the PDL estimate, it was already published in 2018, and we merely cited that previous estimated PDL. Why the FDA has not published and certainly does not enforce a per-body weight pediatric dose limit per day for aluminum hydroxide from vaccines is a mystery. On catch-up days, children can receive 5-9 vaccines in a single day.
Given their interest, I am surprised the aluminum apologist bloggers did not critique Mitkus and Priest for basing so much of their modeling on citrate-bound aluminum, which has a much higher absorption rate, thus clearing the plasma more quickly, making even our results (McFarland et al.) overly optimistic.
A salient question is why do AAAB not present their own whole-body PDL based on their own proposed methodology and submit it for peer review? The answer, I believe, is that they are afraid of (a) finding that their estimates would be similar to ours, and (b) they would be labeled “anti-vaccine” and lose their jobs, and perhaps (c) they may suffer from a cognitive blindness due to financial conflicts of interest (see (b)). (NB: Being in a School of Pharmacy as reported induces a COI).
Instead, they prefer childish Romper-Room Taliban-wanna be tactics.
If they do accept the challenge to actually engage in Scientific Discourse, I would expect them to start with the questions that began my research into aluminum pediatric dosing:
(1) How did the FDA come to determine that 850 mcg of aluminum is ‘safe’ for a single dose? (Answer: oral doses of oral forms of aluminum in adult mice levied via assumption after assumption into a per-injected dose amount of injected forms in humans. Then they abandoned all that, cherry-picked and misrepresented the Golub et al. study, and based it on the dose needed for a significant immune reaction).
(2) Why is aluminum dosing in vaccines expressed as “per dose” and why do the limits ignore both body weight, time and multiple doses?
(3) Why is there only one only published aluminum dose limit (4-5 mcg/kg/day) from parenteral sources (btw, anonymous aluminum apologist blogger, ‘parenteral’ means ‘non-dietary’, look it up, it arguably could include vaccines and not only IV sources.
(4) What IS the pediatric dose limit of aluminum hydroxide for humans, is it enforced, do pediatricians use it, does CDC consider it for catch-up days, or are we just arbitrarily injecting infants, newborns, and toddlers with toxic doses of aluminum and not realize it?
(5) AAAB represent themselves as stewards of Science. Why not join the increasing number of Scientists who are joining me in calling upon the FDA to do the dose increment studies in infant mice for all forms of aluminum used in humans so we know precisely which ill effects are likely to be expected by citizens who provide informed consent for vaccination with aluminum-containing vaccines?
Who’s afraid of a little Science?
PS If AAAB prefers anonymous bloggers, try Vaccine Paper’s execution of Mitkus and other “aluminum in vaccines is safe” apologist Science-Like Activities.