A Lone FDA Scientist Could End the Autism Epidemic
In a brand new published study, the only science vouching for the “safety” of injected aluminum adjuvant has come under extreme criticism by heavyweight scientists. Dr. Robert J. Mitkus — author of the misleading aluminum safety study from 2011 — could change the autism debate forever by telling the truth.
While you were (hopefully) enjoying the winter holidays, a study was published in the Journal of Inorganic Biochemistry (it went online on December 27th) that could change the autism debate permanently. In fact, this new study placed the burden of proof for the safety of aluminum adjuvants used in vaccines so squarely on the shoulders of a lone FDA scientist — Dr. Robert J. Mitkus — that he alone could permanently change the outcome of the autism debate. Forever.
Aluminum science is moving at light speed
Science moves at a glacial pace. By scientific standards, what has been learned about the aluminum adjuvant from vaccines in just the past few years has been genuinely revolutionary, and should scare the daylights out of every parent on the planet. Mystifyingly, the first time ANYONE decided to test the impact, biologically, of aluminum adjuvant was 2007, where it was pioneered by Dr. Christopher Shaw at the University of British Columbia. I’ll let him explain:
It’s hard to put Dr. Shaw’s work in proper context. Our public health officials, signing off on a massive growth in the number of vaccines given to children, and therefore massive growth in the amount of injected aluminum, had never conducted biological studies to assess the safety of aluminum, which allowed Dr. Shaw to do something groundbreaking in 2007.
It also raises an obvious question: what have our regulatory agencies been relying upon to assess the safety of injected aluminum?
The answer: a single study published in 2011 by Dr. Robert J. Mitkus in the journal Vaccine.
About Dr. Mitkus
Dr. Robert J. Mitkus is a Computational Toxicologist in the Center for Biologics Evaluation and Research at the FDA. He’s held that position since 2010. He’s also an adjunct professor in the School of Public Health at the University of Maryland. Previously, Dr. Mitkus was a “Mammalian Toxicologist” for the EPA, he received a Ph.D. in Toxicology from the University of Maryland in 2004.
Dr. Mitkus’ published study, “Updated aluminum pharmacokinetics following infant exposures through diet and vaccination” from 2011 is the Gold standard and the primary document the FDA relies upon to declare injected aluminum safe for use in infants. It is, quite literally, the SOLE defense the FDA and CDC cite for any concerns raised about injected aluminum. In fact, Dr. Mitkus’ study was in part a response to safety concerns about aluminum, as he writes in the Abstract of his study:
“Because concerns have been expressed by the public that aluminum in vaccines may pose a risk to infants, we developed an up-to-date analysis of the safety of aluminum adjuvants.”
As you can guess, Dr. Mitkus’ paper gave aluminum the “all clear” sign.
“…for infants, our study demonstrates that there is little risk for aluminum toxicity following immunizations administered according to ACIP recommendations even with maximal exposures to aluminum adjuvant. For the general population of infants, who receive less than the maximal dose, the risk is even lower.”
To the layperson, this study would probably be reassuring. To scientists who are closely studying the issue of injected aluminum adjuvant, and particularly to scientists who are doing their own biological studies of aluminum adjuvant, Dr. Mitkus’ study is somewhere between a professional disgrace and a fraudulent disaster, but I’ll let them explain.
Aluminum: A Primer
Recent science, completed all over the world, is pointing the finger at aluminum adjuvant injected into newborns as the probable cause of autism. Here’s a simple graphic to explain what has been learned:
Source: Vaccine Papers
In a nutshell, scientists all over the world have learned the following about aluminum adjuvant, most of it since 2010 (not a single one of these new discoveries or published studies was considered in Dr. Mitkus’ paper).
- From Canada, 2012: “Aluminum (Al) is highly neurotoxic and has been shown to impair both prenatal and postnatal brain development in humans and experimental animals.”
- From France, 2013: “However, continuously escalating doses of this poorly biodegradable adjuvant in the population may become insidiously unsafe, especially in the case of overimmunization or immature/altered blood brain barrier…”
- From France, 2015: “Thus alum and other poorly biodegradable materials taken up at the periphery by phagocytes circulate in the lymphatic and blood circulation and can enter the brain using a Trojan horse mechanism similar to that used by infectious particles. Previous experiments have shown that alum administration can cause CNS dysfunction and damage, casting doubts on the exact level of alum safety.”
- From France, 2016: “We conclude that Alhydrogel [aluminum adjuvant] injected at low dose in mouse muscle may selectively induce long-term Al cerebral accumulation and neurotoxic effects.”
- From England, 2017: “The amount of aluminum in the brain tissue was, I would say, extraordinarily high. Very high. My group has measured the aluminum content of probably more than one hundred human brains, and these brain tissues taken from the individuals with a diagnosis of autism were some of the highest we’ve measured bar none. The only ones we’ve seen that are similar were a recent study of familial Alzheimer’s. This in itself is a very important finding.”
So, versus ten years ago, scientists now know that aluminum adjuvant, when injected, can 1) impair brain development, 2) remain in the brain much longer than thought, 3) is brought into the brain by macrophages that grab the aluminum from the vaccine injection site and recirculate it, 4) may actually be worse when injected in small doses repeatedly (like it’s done during vaccination), and 4) there’s remarkably high levels of aluminum in the brains of people diagnosed with autism.Dr. Chris Exley, the author of this most recent study (#5, and the subject of my recent article) was so moved by the results of his study he said the following:
“I did not see a role for aluminum in autism. And I didn’t see a role for aluminum in vaccines in autism. I have to change my mind now on both of these. I have to change my mind that aluminum has a role in autism, I believe it now does. Now, because I have seen the same cells that we will see at an injection site carrying a cargo of aluminum into the brain tissue of individuals who died with autism I would now say that we have to think very carefully about who receives a vaccine that includes an aluminum adjuvant. We need to think carefully, is this vaccine a life-saving vaccine or not? If it isn’t, don’t have it with an aluminum adjuvant.”
That’s Dr. Chris Exley. He’s arguably the world’s leading expert on aluminum neurotoxicology. He just said he’d shy away from any vaccines containing aluminum. He now also believes “aluminum has a role in autism.” These are revolutionary things for scientists to be saying, and they’re being said by the leading scientists in their field.
Dr. Chris Exley discusses his study
I wanted you to get a feel for Drs. Gherardi and Exley, and to hear from them directly. I want you to understand that these are two of the leading aluminum scientists in the world. I need you to appreciate the “weight” of their words, because then my comment makes more sense:
If science were pro wrestling, then Drs. Gherardi and Exley just body-slammed Dr. Robert Mitkus and his 2011 study so badly, he may never get up off the canvas.
Dr. Mitkus’ Paper — scientists are “empty handed”
What would be lost on the average layperson trying to make some sense of Dr. Mitkus’ work is the reality that the only biological science Dr. Mitkus considered in making his safety assessment was a single study that infused (rather than injected) aluminum citrate (rather than aluminum hydroxide) into adults (rather than babies). At least Mitkus acknowledges this difference in the paper, noting “The determinations of the kinetics of aluminum retention by Priest were based on experiments where human volunteers were given an intravenous injection of aluminum citrate. For vaccines, the injection is intramuscular, the aluminum is in an insoluble form (e.g., as the phosphate or hydroxide of aluminum), and muscle at the site of injection is considered to be a storage depot for aluminum.” It’s hard to put this seemingly minor detail in proper context:
In no other drug on the planet (except for vaccines) would safety standards ever be determined without using the actual product (aluminum hydroxide) administered in the proper way (intramuscular injection), into the proper patient population (infants). Of course, we now know that doing so has triggered devastating results (just ask Dr. Shaw, above).
Vaccine Papers, an excellent resource on this topic, provides some additional perspective on Dr. Mitkus’ study, citing one of its “fatal flaws”:
“The MRL [minimal risk level for aluminum] is derived from feeding experiments with aluminum salts, not experiments with injected aluminum adjuvant. The safety of injected aluminum adjuvant must be determined from experiments with injected aluminum adjuvant (insoluble and persistent), not ingested, water-soluble aluminum. Scientific studies have established that injected aluminum adjuvant has unique toxic properties and ways of moving around the body (“kinetics”) that are not the same as ingested water-soluble aluminum.”
And, Vaccine Papers provides a final refutation:
“Mitkus 2011 is the best scientific evidence vaccine promoters have for defending Al adjuvant safety. It is fatally flawed and incredibly bad. It is not based on any toxicity experiments with actual Al adjuvant. It ignores key studies that contradict the assumptions it is based on. And yet, government agencies (FDA, CDC) and vaccine promoters cite it as powerful and conclusive evidence of safety. Aluminum adjuvant nanoparticles are very different from dissolved aluminum ions. Consequently, the only scientifically-valid way to establish the safety of injected aluminum adjuvant, is by experiments with injected aluminum adjuvant. Studies of ingested, soluble aluminum salts cannot establish the safety of Al adjuvant. Models of only dissolved aluminum cannot be used to determine the toxicity of the particles. Ignoring the toxicity of Al adjuvant particles is scientifically indefensible. Why do the vaccine promoters rely on oral-ingestion studies to defend Al adjuvant safety? It is because they have no experimental research showing that injecting Al adjuvant is safe! They are empty-handed.”
In 2016, Neil Miller published a study in the Journal of American Physicians and Surgeons called “Aluminum in childhood vaccines is unsafe” where he too disassembled Dr. Mitkus’ study, stating it had “major flaws” including the fact that Dr. Mitkus studied “dietary aluminum fed to mice” and reiterated that, “to determine the safety of injected aluminum, scientists must conduct experiments with injected — not ingested — aluminum.” Miller concluded:
“Aluminum adjuvants are added to several vaccines to elicit a more robust immune response and increase vaccine efficacy. Infants and young children throughout the world receive high quantities of aluminum from multiple inoculations. Incremental changes to the vaccination schedule during the past several years significantly increased the quantity of aluminum in childhood shots. Numerous studies provide compelling evidence that injected aluminum can be detrimental to health. Aluminum is capable of remaining in cells long after vaccination and may cause neurologic and autoimmune disorders. During early development, the child’s brain is more susceptible to toxins and the kidneys are less able to eliminate them. Thus, children have a greater risk than adults of adverse reactions to aluminum in vaccines.”
The Body-Slam: “Critical analysis of reference studies on the toxicokinetics of aluminum-based adjuvants”
Just one week ago, this highly critical study of the safety standards used for vaccine aluminum adjuvant was published in the Journal of Inorganic Biochemistry. The study, “Critical analysis of reference studies on the toxicokinetics of aluminum-based adjuvants” addressed the limitations of studies relied upon, in particular Dr. Mitkus’ study, by both the FDA and the CDC, to declare vaccine aluminum “safe” to be injected into children. The study authors included the aforementioned Dr. Romain Gherardi, and Dr. Chris Exley. They explained:
“To date, aluminum adjuvants per se have, perhaps surprisingly, not been the subject of any official experimental investigation, and this being in spite of the well-established neurotoxicity of aluminum.”
The study authors also mention a laundry list of countries who have produced studies implicating aluminum-containing vaccines in chronic illness:
“The occurrence of myalgia and arthralgia, chronic fatigue and neurological disorders following multiple injections of aluminum-containing vaccines against hepatitis B, tetanus and human papilloma virus (HPV) has been reported in many countries: Australia, Canada, Denmark, France, United Kingdom, Italy, Israel, Japan, Mexico, Portugal, and USA.”
The study authors made many of the same criticisms of Dr. Mitkus’ work that I have shared with you above from Vaccine Papers and Neil Miller. But, they did so in a prestigious journal, and they did so with the weight of their collective backgrounds. It would be a bit like Warren Buffet telling you that your business is a poor investment. The gist of their paper? None of the studies done to date on aluminum safety would properly answer if aluminum is in fact safe. (Remember, in all cases, the study authors of this paper have done their own biological studies of aluminum adjuvant, and found it to be highly neurotoxic.) Their conclusion:
“Both paucity and serious weaknesses of reference studies strongly suggest that novel experimental studies of Al adjuvants toxicokinetics should be performed on the long-term, including both neonatal and adult exposures, to ensure their safety and restore population confidence in Al-containing vaccines.”
Words like “paucity” and “serious weaknesses” are not words you want to hear when you are the CDC or the FDA, certifying that something is safe when it appears that’s not remotely true. Dr. Mitkus, are you listening?
The “Big 6” of aluminum science have stepped forward, changing everything
At great potential cost to their careers, it appears that six scientists — none American — have stepped forward to sound the alarm loudly about the extreme danger of aluminum, and perhaps initiate a reckoning of the true cause of the autism epidemic once and for all. Dr. Chris Exley of Keele University; Drs. Romain Gherardi and Guillemette Crepea of Université Paris Est Créteil; Drs. Christopher Shaw and Lucija Tomljenovic of the University of British Columbia; and Dr. Yehuda Shoenfeld of Tel Aviv University have all contributed to the understanding we now have of aluminum, and the way it appears uniquely able to trigger immune activation events in the brains of certain children, leading to autism. Looking at some of their quotes collectively will help you appreciate how bold their statements really are. This new scientific understanding of aluminum changes everything. For me personally, I feel like I finally have a plausible explanation for what happened to my son.
“Now, because I have seen the same cells that we will see at an injection site carrying a cargo of aluminum into the brain tissue of individuals who died with autism I would now say that we have to think very carefully about who receives a vaccine that includes an aluminum adjuvant. We need to think carefully, is this vaccine a life-saving vaccine or not? If it isn’t, don’t have it with an aluminum adjuvant.” — Dr. Chris Exley, Keele University (England), 2017
“Concerns about its [alum’s] safety emerged following recognition of its unexpectedly long-lasting biopersistence within immune cells in some individuals, and reports of chronic fatigue syndrome, cognitive dysfunction, myalgia, dysautonomia and autoimmune/inflammatory features temporally linked to multiple Al-containing vaccine administrations…In the context of massive development of vaccine-based strategies worldwide, the present study may suggest that aluminium adjuvant toxicokinetics and safety require reevaluation.” — Dr. Guillemette Crépeaux, Ecole Nationale Vétérinaire d’Alfort (France), 2016
“Thus alum and other poorly biodegradable materials taken up at the periphery by phagocytes circulate in the lymphatic and blood circulation and can enter the brain using a Trojan horse mechanism similar to that used by infectious particles. Previous experiments have shown that alum administration can cause CNS [central nervous system] dysfunction and damage, casting doubts on the exact level of alum safety.” — Dr. Romain K. Gherardi, Université Paris-Est Créteil (France), 2015
“… it is somewhat surprising to find that in spite of over 80 years of use, the safety of Al adjuvants continues to rest on assumptions rather than scientific evidence. For example, nothing is known about the toxicology and pharmacokinetics of Al adjuvants in infants and children…Yet, in spite of these observations children continue regularly to be exposed to much higher levels of Al adjuvants than adults, via routine childhood vaccination programmes.” — Dr. Chris Shaw, University of British Columbia (Canada), 2012
“continuously escalating doses of this poorly biodegradable adjuvant in the population may become insidiously unsafe, especially in the case of overimmunization or immature/altered blood brain barrier.” — Dr. Romain Gherardi, Université Paris-Est Créteil (France), 2013
“Experimental research has showed that alum adjuvants have a potential to induce serious immunological disorders in humans. Thus, efforts should be put in clarifying the potential threat of alum-containing vaccines.” — Dr. Yehuda Shoefeld, Tel-Aviv University (Israel), 2013
“The problem with vaccine- derived aluminum is really twofold: It drives the immune response even in the absence of a viral or bacterial threat and it can make its way into the central nervous system. It is not really a matter of much debate that aluminum in various forms can be neurotoxic.” — Dr. Lucija Tomljenovic, University of British Columbia (Canada), 2013
What can Dr. Robert J. Mitkus do?
I firmly believe that Dr. Robert J. Mitkus, a federal employee of the FDA, can help unravel the autism mess. All he needs to do is tell the truth. He needs to admit that these scientists are right, that the paper being relied upon to vouch for the safety of injected aluminum that he wrote in 2011 is inadequate, in light of much more recent science about aluminum adjuvant, and that the regulatory agencies need to heed the warnings of these scientists, as they explained so eloquently in their recently published paper. It’s time for honest scientists to step up and do the right thing.
Here are two slides developed by the website Vaccine Papers that help explain the aluminum-autism connection, you can get your own copy.
J.B. Handley is the father of a child with Autism. He and his wife co-founded Generation Rescue, a national autism charity. He spent his career in the private equity industry and received his undergraduate degree with honors from Stanford University. He is also the author of “The Only Vaccine Guide a New Parent Will Ever Need,” “An Angry Father’s Guide to Vaccine-Autism Science” and “7 reasons CDC employees should be ‘crying in the hallways.’”
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