The Sudden Alarm Bell

When former FDA Commissioner Scott Gottlieb recently warned of a potential forthcoming HHS report that might point to aluminum in vaccines as a cause of autism might lead to litigation against vaccine manufacturers, the subtext was unmistakable. It wasn’t a scientific refutation. It wasn’t a call for more research. It was a warning to corporatists. What this tells us is stark: it was never about the science. It was always about protecting an industry model built atop silenced dissent and regulatory capture.

The timing is not a coincidence. For decades, scientists, toxicologists, physicians, and parent advocates have raised valid concerns about aluminum adjuvants in vaccines. We were mocked, blacklisted, defunded, and censored. Now, as the threat of legal accountability creeps closer, the very institutions that dismissed our work as fringe are blinking. The narrative is collapsing under its own weight. And Gottlieb is heralding the collapse too late.

Historical Context: Warnings Ignored

In spite of the fact that a National Vaccine Injury Compensation Program Special Master first tried to bribe me to change my testimony about aluminum, and then resorted to character assassination from the “bench” to destroy my credibility as an expert witness, the role of aluminum in vaccine injury has been documented in the scientific literature for over three decades. Early warnings came in the 1990s and 2000s from researchers like Gherardi and Kawahara. They were among the first to link aluminum adjuvants to persistent macrophagic myofasciitis, encephalopathy, and neuroinflammatory sequelae.

In 2004, Drs. Lucija Tomljenovic and Chris Shaw began a prolific run of publications analyzing aluminum’s neurotoxic potential. Their studies, later corroborated by Crepeaux et al. (2017, PMID: 27908630) and others, showed that aluminum adjuvants injected intramuscularly are taken up by phagocytes, transported to the brain, and cause microglial activation, oxidative stress, and behavioral abnormalities in animal models.

Over the years, the U.S. Vaccine Court (NVICP) quietly ruled against families whose children suffered developmental regression after receiving aluminum-adjuvanted vaccines, neverthless awarding damages for encephalopathy in cases in which autism is not mentioned. These cases were settled without public acknowledgment that the adjuvants were the likely trigger.

In what I consider to be one of the most important papers published in the history of vaccine injury,

• The authors conducted a legal database review of U.S. Vaccine Injury Compensation Program cases and identified 83 compensated instances where “vaccine-induced brain injury” (primarily encephalopathy) occurred, some of which included subsequent autistic-like symptoms

Theses awards were based on encephalopathy or neurologic injury, without explicit attribution to autism. Many of the 83 cases involved potentially causative adjuvants—like aluminum—were never publicly acknowledged in those decisions.

Federal regulations list encephalopathy as a table injury for pertussis- and related vaccines repository. Since encephalopathy cases form the bulk of the NVICP awards in that category—and pertussis, Hib, and HepB vaccines carry aluminum—it is highly plausible that most of the 83 brain injury cases involved aluminum-adjuvanted vaccines.

FOIA requests for safety data on aluminum adjuvants have also revealed internal knowledge of gaps in toxicity data. Nonetheless, no corrective action was taken.

The IPAK Studies That Dismantled the FDA’s Mitkus Model

The FDA’s principal defense of aluminum safety in pediatric vaccines—Mitkus et al. (2011)—relies on a flawed model that assumes infant renal clearance of aluminum is similar to adult excretion of dietary aluminum. It uses a single-compartment model and fails to account for cumulative, body-weight-adjusted burden or retention in neural tissue. The Institute for Pure and Applied Knowledge (IPAK) responded with a rigorous series of peer-reviewed studies that dismantled this model on empirical, physiological, and pharmacokinetic grounds.

Pediatric Dose Limits Based on Real Physiology

In Lyons-Weiler & Ricketson (2018), IPAK presented the first scientifically grounded Pediatric Dose Limit (PDL) for aluminum. Their method applied Clark’s Rule for weight-adjusted dosing and corrected regulatory MRL assumptions to reflect pediatric physiology. They showed that infants receiving aluminum-adjuvanted vaccines per the CDC schedule experience aluminum exposure vastly exceeding FDA safety limits of 4–5 μg/kg/day (21 CFR §201.323), with body weight-adjusted doses at 2 months reaching 254 μg/kg—over 5,000% higher than the safety limit for premature neonates.

The authors identified critical errors in how JECFA and ATSDR derived “safe levels,” including misapplication of adult dietary exposures to injected doses, and the complete absence of safety testing for injected aluminum adjuvants in neonates.

Aluminum Retention Models and the %AlumTox Metric

In McFarland et al. (2020), IPAK developed dynamic models of aluminum clearance and accumulation using updated physiology, including:

• Body weight progression from 0–2 years

• Immature renal function (20% GFR at birth)

• Dose stacking effects

• Chronic retention modeled using the Priest equation with parameter variation

They introduced %AlumTox, the percentage of days infants spend above the modeled safe threshold of aluminum body burden. Under the CDC schedule, the %AlumTox reached:

• 70% of days in the first 7 months

• 24% of all days in the first two years

Alternative schedules such as the “Vaccine Friendly Plan” reduced this burden dramatically (to 2% of days).

Crucially, the study showed that chronic retention from multiple doses results in compounding aluminum accumulation—contradicting FDA’s implicit “reset” assumption that each dose begins with a clean baseline.

Catch-Up Vaccination and Cumulative Burden

In a third study (Lyons-Weiler et al., 2020), IPAK extended its models to post-pandemic “Catch-Up” schedules. The findings were stark: infants re-entering the CDC schedule at 6 months after missed doses could experience 100% aluminum toxicity (by %AlumTox) in the first year of life. This risk was shown to be highest in children with immature renal systems and lowest body weights, with no published data validating this scenario as safe.

They modeled not only genetic variability in aluminum detoxification but also aluminum-induced impairment of detoxification itself—a form of recursive toxicity unaccounted for by any FDA model.

The Verdict: Mitkus Was Found Obsolete in 2018

The IPAK models prove beyond reasonable doubt:

• Aluminum pharmacokinetics must be modeled as a function of age, body weight, renal function, and dose accumulation.

• Injected aluminum is not equivalent to dietary aluminum.

• FDA’s fixed per-dose limits are incompatible with pediatric safety thresholds.

No regulator has rebutted IPAK’s findings. Mitkus remains the FDA’s “official” model—not because it is defensible, but because to abandon it would be to admit that millions of children were overexposed to a neurotoxin due to regulatory inertia.

Institutional Denial and Gatekeeping

Despite the growing empirical literature, U.S. agencies like the CDC and FDA have never re-evaluated the pharmacokinetics of aluminum as used in pediatric vaccines. The GRADE framework used by ACIP, while ostensibly evidence-based, never once reviewed aluminum’s cumulative neurotoxicity in neonates.

Vaccine safety studies funded by NIH overwhelmingly emphasize short-term immunogenicity, not long-term systemic toxicity. Independent scientists attempting to publish studies critical of aluminum are often subject to targeted retraction campaigns. One infamous example was the withdrawal of valid aluminum biodistribution data by journals following pressure from undisclosed parties.

Aluminum adjuvants are grandfathered into vaccine approval pipelines, often without new GLP-compliant toxicology testing. This reliance on historical assumptions creates a blind spot that Gottlieb now admits could explode legally. His messaging therefor has the effect of warning the vaccine manufacturers to brace for loss of liability protection.

Scientific Reality Check: Aluminum’s Biological Profile

Aluminum is a well-established neurotoxin with the following properties:

• It activates the NLRP3 inflammasome, a key driver of neuroinflammation.

• It persists in macrophages for months to years post-injection.

• It accumulates in the brain through translocation by immune cells (Crepeaux et al.).

• It causes glutamate excitotoxicity, damaging neural synapses.

• It is linked to mitochondrial dysfunction and oxidative stress.

The EPA’s intravenous aluminum safety limit is exceeded multiple times by the CDC’s recommended schedule for infants in the first 6 months of life. Yet CDC risk models still assume oral exposure kinetics, a basic category error, based on the wrong type of aluminum exposure in adult, not infant, animals.

Synergistic toxicity with other agents (e.g., mercury, glyphosate, formaldehyde) is barely explored but heavily implicated.

The Cost of “Settled Science”

To call the question of vaccines and aluminum “settled science” is to redefine the word. Aluminum safety has never undergone GRADE review, nor is it the subject of prospective cohort studies with unexposed controls. It remains “settled” only by edict, not by empiricism.

CDC’s VSD database has been structurally closed to truly independent researchers. Post-licensure safety surveillance does not require manufacturers to study adjuvant toxicology. When studies were conducted showing adverse neurological impacts, journals were pressured into retraction under questionable circumstances.

The 2004 and 2011 IOM reports both identified significant gaps in adjuvant research, yet no policy change followed. Instead, health authorities doubled down, increasing the aluminum burden across the schedule placing an unwitting and trusting public at unknown risk without a safety net.

They expected the public to eat the cost of encephalopathy, autoimmunity and who knows what else forever. That expectation may not be met if HHS calls their card.

Gottlieb’s Warning as a Turning Point

When Gottlieb warns of potential litigation, he is not invoking new data. He is reacting to the mounting weight of ignored data that now threatens to resurface in court. He fears Daubert standards being met by mechanistic and epidemiological studies that regulators failed to act on.

The so-called liability shield of the NCVIA can be pierced if plaintiffs can show willful ignorance or if claims are brought in state courts outside of the federal vaccine court framework.

Gottlieb’s concern is not about misinformation. It’s about the end of information control.

It Gets Worse: Aluminum Is Used to Reliably and Routinely Induce Autoimmunity in Animal Models

Far from being a benign component of vaccines, aluminum salts—particularly aluminum hydroxide and aluminum phosphate—are routinely used in experimental biology to reliably induce autoimmune conditions in animal models. This is not a theoretical concern: it is foundational methodology in immunotoxicology, autoimmunity research, and pharmaceutical development.

Aluminum Adjuvants as Experimental Triggers of Autoimmunity

Across multiple studies, aluminum compounds have been employed to elicit a controlled autoimmune response in order to study pathogenesis, therapeutic interventions, or immunosuppressive strategies. Examples include:

• Systemic Lupus Erythematosus (SLE) models: Aluminum hydroxide has been shown to exacerbate lupus-like autoimmunity in mice, increasing anti-dsDNA autoantibodies and glomerulonephritis severity.

• Autoimmune/inflammatory syndrome induced by adjuvants (ASIA): Chronic exposure to aluminum adjuvants has been shown to replicate ASIA-like phenotypes in mice and rats, including behavioral changes, memory impairment, and neuroinflammation (Tomljenovic & Shaw, 2011; PMID: 21745510).

• Rheumatoid Arthritis and multiple sclerosis-like models in animals have also incorporated aluminum adjuvants to potentiate immune dysregulation, enhance Th17 profiles, and accelerate progression of joint or neural inflammation.

These outcomes are not incidental—they are the result of aluminum’s capacity to activate innate immunity, stimulate pro-inflammatory cytokines (e.g., IL-1β, IL-6, TNF-α), and skew T-cell polarization toward Th2 and Th17 profiles implicated in autoimmunity. (See the citations in this presentation).

Dose and Route Relevance

The doses used in these experiments are typically equivalent to, or lower than, the cumulative aluminum doses infants receive under the CDC vaccination schedule by 6 months of age. Furthermore, the intramuscular route used in both animal studies and pediatric vaccination ensures depot formation and prolonged systemic exposure, which promotes macrophage uptake and transport to distal tissues, including the brain.

Chronic Effects and Delayed Onset

Animal models show that aluminum-induced autoimmunity can present after a latent period, consistent with real-world patterns of autoimmune disease in humans following immunization. This includes:

• CNS demyelination,

• motor dysfunction,

• antibody-mediated organ damage,

• and persistent neuroinflammation.

Long-term studies in animals confirm that low-dose, repeated exposure can result in cumulative retention, especially in tissues with limited lymphatic clearance such as the brain, spleen, and liver (Crepeaux et al., 2017).

Regulatory Blind Spots

Despite this extensive experimental literature, the capacity of aluminum to induce autoimmunity has never triggered formal reevaluation of its safety profile in human pediatric vaccine schedules. There have been no long-term human studies designed to detect autoimmunity following vaccination, nor any modeling to identify susceptible genotypes—despite clear evidence from animal studies that genetic background heavily modulates autoimmune risk following aluminum exposure.

Aluminum is not merely capable of triggering autoimmune responses—it is used precisely for that purpose in laboratory research. It is both biologically active and immunologically disruptive by design. To continue claiming that such effects are impossible or irrelevant in humans is no longer scientifically defensible.

The disconnect between experimental use and regulatory assumption is no longer tenable. If aluminum reliably induces autoimmunity in animals, then its use in humans—especially neonates with immature immune and renal systems—demands a renewed and rigorous scientific reckoning.

You Can’t Have It Both Ways

For decades, critics of aluminum in vaccines were branded anti-science, anti-vaccine, or worse. But now that litigation risk looms, the very same concerns are being framed as credible threats.

Aluminum is used to reliably and routinely induce autoimmunity in animals. It causes encephalopathy. You can’t say aluminum is unquestionably safe and also worry that proof of harm will upend vaccine manufacturing. You can’t suppress the data, then fear its release. You can’t scoff at concerns, then claim you were blindsided.

If aluminum isn’t essential, and if it isn’t safe, why was it defended so vigorously?

Conclusion: The Reckoning Was Always Coming

This was never about conspiracy. It was about integrity.

Gottlieb’s warning is decades late. The questions are old. The science has been there. What was missing was accountability. Now, the organizations that silenced those who asked these questions must answer them.

The reckoning is not retribution. It’s a return to first principles. Vaccines must be safe, not just claimed safe. And safety cannot be declared in the absence of inquiry.

We tried to warn you. We are glad you are finally listening.

References

Mary Holland, Louis Conte, Robert Krakow & Lisa Colin, Unanswered Questions from the Vaccine Injury Compensation Program: A Review of Compensated Cases of Vaccine‑Induced Brain Injury, 28 Pace Envtl. L. Rev. 480 (Winter 2011), DOI: 10.58948/0738‑6206.1681

Lyons-Weiler, J., & Ricketson, R. (2018). Reconsideration of the immunotherapeutic pediatric safe dose levels of aluminum. J Trace Elem Med Biol, 48, 67–73. https://doi.org/10.1016/j.jtemb.2018.02.025

McFarland, G., La Joie, E., Thomas, P., & Lyons-Weiler, J. (2020). Acute exposure and chronic retention of aluminum in three vaccine schedules and effects of genetic and environmental variation. J Trace Elem Med Biol, 58, 126444. https://doi.org/10.1016/j.jtemb.2019.126444

Lyons-Weiler, J., McFarland, G., & La Joie, E. (2020). Impact of catch-up vaccination on aluminum exposure due to new laws and post social distancing. J Trace Elem Med Biol, 62, 126649. https://doi.org/10.1016/j.jtemb.2020.126649

 

IPAK-EDU is grateful to Popular Rationalism as this piece was originally published there and is included in this news feed with mutual agreement. Read More