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RFK Jr. orders placebo safety trials for all new vaccines in major policy decision

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From LifeSiteNews

By Emily Mangiaracina

Placebo trials are critical for determining a new drug’s safety and identifying side effects, but vaccines have been exempt from the requirement for such safety testing until now.

All new vaccines will be required to undergo placebo-controlled safety trials by the order of Robert F. Kennedy Jr., head of the Department of Health and Human Services (HHS), in a break with longstanding establishment policy and triggering protests from mainstream media outlets.

HHS spokesman Andrew Nixon said that, according to the new policy, such safety trials for all “new vaccines” will be required for licensure, a “radical departure from past practices.”

Placebo trials allow researchers to identify adverse side effects from a drug, clarifying that symptoms are not due to other factors such as the disease the drug seeks to protect against. For this reason, placebo trials are “critical for determining the safety profile of the new drug,” as BioPharma Services has noted.

“Except for the COVID vaccine, none of the vaccines on the CDC’s childhood recommended schedule was tested against an inert placebo, meaning we know very little about the actual risk profiles of these products,” HHS said in a statement.

“HHS is now building surveillance systems that will accurately measure vaccine risks as well as benefits — because real science demands both transparency and accountability,” an HHS spokesperson told The Washington Post.

For years, Kennedy has criticized the fact that vaccines have been exempted from a placebo trial requirement in place for other medicines.

“A lot of the injuries that come from medication are autoimmune injuries and allergic injuries and neurodevelopmental injuries that have long diagnostic horizons or long incubation periods, so you can do the study and you will not see the injury for five years,” Kennedy said in a 2021 interview.

Last year, during a NewsNation Town Hall he highlighted the fact that not one of the 72 vaccine doses now mandated for U.S. children “has ever been subject to a pre-licensing, placebo-controlled trial.”

At the time, the host insisted that this was “not true.” Now that the mainstream media and medical establishment cannot dispute that this has been the case, outlets such as NPR and the BBC are criticizing placebo safety testing trials by claiming that this will allegedly limit access to vaccines and undermine confidence in them – as if access to vaccines takes precedence over whether they have been shown to be safe.

The Washington Post quoted Dorit Reiss, a professor at the University of California College of the Law, who accused the HHS of “Claiming vaccines have risks the data doesn’t show” and of “trying to overstate vaccine risks,” seemingly unaware of the absurdity of her criticism. If there is a lack of data for vaccine risks, it could be because there haven’t been placebo trials to produce such data.

Kennedy recently told Daily Wire host Michael Knowles that “everything is going to change” regarding the development of vaccines, for which much of the public has concern.

He pledged to “fix” the Centers for Disease Control’s current flawed VAERS (Vaccine Adverse Event Reporting System) online mechanism, which Kennedy noted vastly underreports vaccine adverse events.

Pointing out that vaccines are “the only product that’s exempt” from pre-licensing safety testing, Kennedy noted that the protocol has instead been to document injuries “afterward.”

However, “they have a system that doesn’t capture them. In fact, CDC’s own study of its own system said it captures fewer than 1% of vaccine injuries,” Kennedy said. “It’s worthless, and everybody agrees it’s worthless.”

“Why have we gone for 39 years and nobody’s fixed it?” he wondered, promising, “We’re gonna fix it.”

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Autism

Autism – what we know

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Malone News Malone News

Science backs up President Trump’s statements

The complex landscape of “what” is causing the five-fold increase of autism spectrum disorder in the last twenty-five years is finally being evaluated.

Big-pharma is big mad.

The Trump administration is challenging conventional medicine and science in making this a priority. They are searching deeper, going beyond big-pharma-funded studies that have distorted the concept of “evidence-based” medicine and science.

If you haven’t listened to the press conference from yesterday, please do so. At the very least, listen to the opening statements. For brevity, I cut out a few of the speakers that weren’t making policy statements and some of the “big, beautiful bill” questions towards the end of the press conference.

(Video starts at 50:20)

As President Trump delves into this press conference, he specifically states that:

“I’m making these statements from me.”

“I talk about a lot of common sense.”

“This will be as important as any single thing I’ve done.”

Read that last statement again. Secretary Kennedy and MAHA have President Trump’s full support! More than that, these issues are critically important to President Trump.

In this press conference, President Trump states explicitly that no drug should be recommended for pain in pregnant women. That pregnant women should try their hardest to avoid pain medications.

He also states that children should not be given vaccines in large combinations at a young age.

We all know that all vaccines have risks; some vaccines have much higher risks. The compounding effects of medicines are a real issue. Putting two and two together (or not…) is just common sense.

This is all common sense.

The President’s statement is one of the most responsible, pro-scientific process statements ever to come out of the White House, and I am proud to be associated with this movement.

So, what does the “scientific” establishment think about President Trump’s presser?

The greatest shill on earth for Big Pharma had this to say about the press conference.

Not a single mainstream media outlet called Dr. Proffit out on this outlandish statement.

In fact, none of the usual MSM outlets bothered to do any real research before attacking the press conference and its findings, with the exception of Politico, which published an “opinion” piece written by Dr. Jay Bhattacharya,, Dr. Marty Makary, and Dr. Mehmet Oz .

All of the mainstream media outlets attacked the position that taking drugs while pregnant was a bad idea.

Which means they endorse the idea that it is better to be without pain and cause risk of fetal harm… No words can express how disgusted I am by these propagandists.

Of note, Dr. Profit (above) must also believe that Harvard’s School of Public Health and it’s Dean, Andrea Baccarelli, are irresponsible, as they have largely endorsed the President’s statements:

And yet, this is the response by MSM.

 

With this in mind, as I prepared to speak on various news programs today, I conducted a literature search on recent peer-reviewed papers on the causes of autism.

Below, some of the more recently published papers on Autism are highlighted:


Evaluation of the evidence on acetaminophen use and neurodevelopmental disorders using the Navigation Guide methodology

Diddier PradaBeate RitzAnn Z. Bauer & Andrea A. Baccarelli (Dean of the Harvard School of Public Health). Environmental Health volume 24, Article number: 56 (2025)

Abstract

Background

Acetaminophen is the most commonly used over-the-counter pain and fever medication taken during pregnancy, with > 50% of pregnant women using acetaminophen worldwide. Numerous well-designed studies have indicated that pregnant mothers exposed to acetaminophen have children diagnosed with neurodevelopmental disorders (NDDs), including autism spectrum disorder (ASD) and attention-deficit/hyperactivity disorder (ADHD), at higher rates than children of pregnant mothers who were not exposed to acetaminophen.

Methods

We applied the Navigation Guide methodology to the scientific literature to comprehensively and objectively examine the association between prenatal acetaminophen exposure and NDDs and related symptomology in offspring. We conducted a systematic PubMed search through February 25, 2025, using predefined inclusion criteria and rated studies based on risk of bias and strength of evidence. Due to substantial heterogeneity, we opted for a qualitative synthesis, consistent with the Navigation Guide’s focus on environmental health evidence.

Results

We identified 46 studies for inclusion in our analysis. Of these, 27 studies reported positive associations (significant links to NDDs), 9 showed null associations (no significant link), and 4 indicated negative associations (protective effects). Higher-quality studies were more likely to show positive associations. Overall, the majority of the studies reported positive associations of prenatal acetaminophen use with ADHD, ASD, or NDDs in offspring, with risk-of-bias and strength-of-evidence ratings informing the overall synthesis.

Conclusions

Our analyses using the Navigation Guide thus support evidence consistent with an association between acetaminophen exposure during pregnancy and increased incidence of NDDs. Appropriate and immediate steps should be taken to advise pregnant women to limit acetaminophen consumption to protect their offspring’s neurodevelopment.


The Dangers of Acetaminophen (APAP) for Neurodevelopment Outweigh Scant Evidence for Long-Term Benefits

Crit Rev Toxicol 2025 Feb;55(2):124-178., doi: 10.1080/10408444.2024.2442344. Epub 2025 Feb 21.

Based on available data that include approximately 20 lines of evidence from studies in laboratory animal models, observations in humans, correlations in time, and pharmacological/toxicological considerations, it has been concluded without reasonable doubt and with no evidence to the contrary that exposure of susceptible babies and children to acetaminophen (paracetamol) induces many, if not most, cases of autism spectrum disorder (ASD).

However, the relative number of cases of ASD that might be induced by acetaminophen has not yet been estimated. Here, we examine a variety of evidence, including the acetaminophen-induced reduction of social awareness in adults, the prevalence of ASD through time, and crude estimates of the relative number of ASD cases induced by acetaminophen during various periods of neurodevelopment.

We conclude that the very early postpartum period poses the greatest risk for acetaminophen-induced ASD, and that nearly ubiquitous use of acetaminophen during early development could conceivably be responsible for the induction in the vast majority, perhaps 90% or more, of all cases of ASD.

Despite over a decade of accumulating evidence that acetaminophen is harmful for neurodevelopment, numerous studies demonstrate that acetaminophen is frequently administered to children in excess of currently approved amounts and under conditions in which it provides no benefit.

Further, studies have failed to demonstrate long-term benefits of acetaminophen for the pediatric population, leaving no valid rationale for continued use of the drug in that population given its risks to neurodevelopment.

Table 1 from the paper:

Note the number of peer-reviewed papers that link vaccination and acetaminophen with the onset of ASD in this table. So there are abundant data out there.

Stay tuned.


Stress and Folate Impact Neurodevelopmental Disorders

Journal of Health Care and Research
ISSN: 2582-8967, Article Type: Review Article, DOI: 10.36502/2024/hcr.6228
J Health Care and Research. 2024 Feb 07;5(1):1-6

Kai Ahmavaara, George Ayoub
1Psychology Dept, Santa Barbara City College, Santa Barbara, California 93109 USA

Abstract

Autism Spectrum Disorder (ASD) is one of several developmental disabilities that can create significant communication and behavioral challenges in affected individuals. Several studies have found that children with ASD have high levels of Folate Receptor Antibody (FRA), which blocks the transport of folate across the Blood-Brain Barrier (BBB) and leads to Cerebral Folate Deficiency (CFD). Supplementation with folate in its reduced form, such as with folinic acid, has been found to improve communication in autistic children with folate receptor antibodies. Here, we provide an overview of the role of folate in nervous system development, effects of FRA on brain folate levels, and clinical trials that have examined the efficacy of folate supplementation in reducing the symptoms of developmental disabilities.

Further, we highlight the importance of prenatal folate supplementation in reducing the risk and severity of developmental disorders and the need for additional research to explore optimal dietary interventions to aid in managing them. The results suggest that supplementing with reduced folate may offer a promising treatment approach for individuals with neurodevelopmental disorders, particularly those with FRA.

One of the more interesting scientific questions to be answered that arises from the conclusions of this paper, is how Tylenol could affect the Folate Receptor Antibody (FRA) – as noted, several studies have found that children with ASD have high levels of Folate Receptor Antibody (FRA).

I posed this question, “How could tylenol impact the Folate Receptor Antibody (FRA)” to CHAT-GPT,

and this was the answer:

This is all hypothetical, of course, but this is how good science is done. One asks questions. A lot of questions.

So, I then asked CHAT-GPT if any studies were testing this theory. This was the response.

Fascinating and an example of how AI is rapidly changing our world.


Association of cord plasma biomarkers of in utero acetaminophen exposure with risk of attention deficit/hyperactivity disorder and autism spectrum disorder in childhood.

JAMA Psychiatry. 2019.

Abstract

Importance: Prior studies have raised concern about maternal acetaminophen use during pregnancy and increased risk of attention-deficit/hyperactivity disorder (ADHD) and autism spectrum disorder (ASD) in their children; however, most studies have relied on maternal self-report.

Objective: To examine the prospective associations between cord plasma acetaminophen metabolites and physician-diagnosed ADHD, ASD, both ADHD and ASD, and developmental disabilities (DDs) in childhood.

Design, setting, and participants: This prospective cohort study analyzed 996 mother-infant dyads, a subset of the Boston Birth Cohort, who were enrolled at birth and followed up prospectively at the Boston Medical Center from October 1, 1998, to June 30, 2018.

Exposures: Three cord acetaminophen metabolites (unchanged acetaminophen, acetaminophen glucuronide, and 3-[N-acetyl-l-cystein-S-yl]-acetaminophen) were measured in archived cord plasma samples collected at birth.

Conclusions and relevance: Cord biomarkers of fetal exposure to acetaminophen were associated with significantly increased risk of childhood ADHD and ASD in a dose-response fashion. Our findings support previous studies regarding the association between prenatal and perinatal acetaminophen exposure and childhood neurodevelopmental risk and warrant additional investigations.

and

NIH-funded study suggests acetaminophen exposure in pregnancy linked to higher risk of ADHD, autism

NIH Media Advisory, 2019

Although the study cited in this 2019 media advisory is not recent news, the fact is that NIH has been calling attention to the risks of Tylenol use during pregnancy for over five years. So, as MSM screams that there is no scientific evidence, the truth is that our government has been calling attention to this and the studies behind the warnings for a long time.

Researchers analyzed data from the Boston Birth Cohort, a long-term study of factors influencing pregnancy and child development. They collected umbilical cord blood from 996 births and measured the amount of acetaminophen and two of its byproducts in each sample. By the time the children were an average of 8.9 years, 25.8% had been diagnosed with ADHD only, 6.6% with ASD only and 4.2% with ADHD and ASD. The researchers classified the amount of acetaminophen and its byproducts in the samples into thirds, from lowest to highest. Compared to the lowest third, the middle third of exposure was associated with about 2.26 times the risk for ADHD. The highest third of exposure was associated with 2.86 times the risk. Similarly, ASD risk was higher for those in the middle third (2.14 times) and highest third (3.62 times).


As the first trimester of pregnancy is when it is easiest to cause fetal damage, and many women are not aware that they are pregnant yet – this advisory should be taken seriously by any woman of childbearing age.

What is also important is that infant Acetaminophen is still on the market, recommended for both preterm and term infants. It is also recommended for pain relief after vaccination (which could compound neurological damage). Because of the known and unknown risks of Acetaminophen for infants, I advise parents to stop using Acetaminophen for their children or when a mother-to-be is experiencing pain – unless there are no other alternatives. Of note, ibuprofen can be used with infants after six months of age. This is a critical issue to discuss with your healthcare provider.


I am including the following paper because it shows how it took over thirty years for the scientific establishment to accept that vaccines cause Gulf War Illness (GWI). It is also important because it highlights the complex nature of compounding effects on vaccine injury, showing that both environmental factors and individual genetics may influence the severity of vaccine injury. The paper also documents that vaccine injury can persist for decades, if not for a lifetime.

These issues are all relevant to the understanding of ASD.

Anthrax Vaccination, Gulf War Illness, and Human Leukocyte Antigen (HLA)” Vaccines (Basel). 2024 Jun 4;12(6):613. doi:10.3390/vaccines12060613

GWI (Gulf War Illness) symptoms can last for decades and even longer, they often include persistent fatigue, muscle and joint pain, memory and concentration problems, headaches, gastrointestinal issues, skin rashes, and respiratory problems. In a recent study, they determined that vaccinated veterans were nearly 4 times more likely to develop GWI than non-vaccinated veterans, with symptom severity 1.6 times higher in those who had received the vaccine. Crucially, the study demonstrates that individual human leukocyte antigen (HLA) genetics determine susceptibility: veterans lacking specific protective HLA class II alleles could not mount an effective antibody response to the anthrax vaccine’s protective antigen (PA), leading to the persistence of this toxic antigen and the development of chronic illness.

Of note, when querying an AI (and I tried more than one), this was a typical response regarding what causes GWI:

“The weight of evidence points to neurotoxicant exposures—especially nerve agents, pesticides, and PB pills—as the primary drivers of Gulf War Illness, rather than psychological stress alone” -CHAT-GPT

Not a mention of vaccine-induced injury in their summary.

This is a prime example of how AIs cannot be trusted to provide evidence-based decisions about science and medicine.

People, we all need to dig deeper.

AI speaks with authority, but that doesn’t make it accurate or comprehensive.


So, there you have it —recent scientific evidence backing up President Trump’s statements regarding autism and Acetaminophen is significant. His remarks were responsible and entirely in line with current research.

All documented above for mainstream (dead) media to ignore.


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COVID-19

Second Massive Population Study Finds COVID-19 “Vaccines” Increase Risk of 6 Major Cancers

Published on

By Nicolas Hulscher, MPH

South Korea study of 8.4 million adults finds higher risks of overall, lung, prostate, thyroid, gastric, colorectal, and breast cancers — across both mRNA and viral-vector platforms.

About a month ago, the first-ever population cohort study reported increased cancer risks following COVID-19 vaccination. In Italy, nearly 300,000 residents were tracked for 30 months, showing that mRNA shots significantly increased the risk of overall cancer, breast cancer, bladder cancer, and colorectal cancer.

Now, a second—and far larger—population-based cohort study by Kim et al from South Korea has corroborated and expanded upon those findings. Drawing on a massive sample of more than 8.4 million people, this is one of the most powerful cancer-safety datasets ever analyzed.

The results are striking. After accounting for age, sex, comorbidities, income level, and prior COVID-19 infection, COVID-19 vaccination was linked to significant increases in multiple major cancers, with the signal consistent across all vaccine platforms, both sexes, and age groups:


Study Design at a Glance

  • Design & data: Population-based retrospective cohort using the Korean National Health Insurance database (2021–2023).
  • Population: 8,407,849 adults.
  • Exposure: COVID-19 vaccination (analyzed overall and by platform: mRNA, cDNA, and heterologous schedules).
  • Matching: Large-scale propensity score matching (1:4 vaccinated:unvaccinated for the main analysis; 1:2 within vaccinated for booster vs non-booster).
  • Modeling: Multivariable Cox proportional hazards models (adjusted for age, sex, comorbidity index, income level, and prior COVID-19 infection), estimating hazard ratios (HRs) with 95% confidence intervals (CIs); analyses stratified by sex and age.
  • Outcome window: 1-year incidence of overall and site-specific cancers post-vaccination.

Key Results — Cancers with Significant Increases (1-year follow-up)

  • Overall cancer: HR 1.27 (95% CI, 1.21–1.33) → 27% higher risk of all cancers combined in vaccinated vs. unvaccinated at 1 year.
  • Lung cancer: HR 1.53 (95% CI, 1.25–1.87) → 53% higher risk
  • Prostate cancer: HR 1.69 (1.35–2.11) → 69% higher risk
  • Thyroid cancer: HR 1.35 (1.21–1.51) → 35% higher risk
  • Gastric (stomach) cancer: HR 1.34 (1.13–1.58) → 34% higher risk
  • Colorectal cancer: HR 1.28 (1.12–1.47) → 28% higher risk
  • Breast cancer: HR 1.20 (1.07–1.34) → 20% higher risk

Interpretation: An HR of 1.53 for lung cancer means that vaccinated individuals developed lung cancer at a rate 53% higher than matched unvaccinated peers, over the same one-year follow-up period. Similar interpretations apply to each cancer type.


By Vaccine Platform

  • cDNA vaccines (AstraZeneca type): linked to higher risks of thyroid, gastric, colorectal, lung, and prostate cancers.
    • Overall cancer HR 1.47 (95% CI 1.39–1.56) → 47% higher risk
  • mRNA vaccines (Pfizer/Moderna): linked to higher risks of thyroid, colorectal, lung, and breast cancers.
    • Overall cancer HR 1.20 (95% CI 1.14–1.26) → 20% higher risk
  • Heterologous (mixed schedules): linked to higher risks of thyroid and breast cancers.
    • Overall cancer HR 1.34 (95% CI 1.21–1.48) → 34% higher risk

Interpretation: The elevated cancer risks were not confined to one vaccine platform. Whether adenoviral-vector (cDNA), mRNA, or mixed schedules, each vaccine type was associated with a measurable increase in overall cancer — and each had specific cancer sites driving the signal. In other words, no vaccine technology was free of cancer risk in this dataset.


Booster-Dose Analysis

  • Gastric cancer: HR 1.23 (p = 0.041) → 23% higher risk with boosters
  • Pancreatic cancer: HR 2.25 (p < 0.001) → 125% higher risk with boosters

Interpretation: Booster doses were associated with notably higher risks of gastric and pancreatic cancers. For pancreatic cancer, the risk more than doubled in boosted individuals.


Overall Cancer Trends/Sex & Age Stratification

  • Overall cancer: Incidence was higher in the vaccinated across every demographic group.
    • Women showed the highest relative burden, with 48.4 per 10,000 vaccinated vs. 38.2 per 10,000 unvaccinated at one year.
    • Elderly adults (≥75 years) carried the greatest absolute burden, at 119.9 per 10,000 vaccinated vs. 91.7 per 10,000 unvaccinated.
    • Younger adults (<65 years) also experienced a clear overall increase, despite lower baseline rates.
  • Site-specific patterns:
    • Men: elevated risks for gastric and lung cancers
    • Women: elevated risks for thyroid and colorectal cancers
    • Under 65 years: stronger signals for thyroid and breast cancers
    • ≥75 years: markedly higher risk of prostate cancer

Interpretation: Both the overall and site-specific results show a consistent pattern — every demographic group experienced elevated cancer risks, though the type and absolute burden varied. Women and the elderly were hit hardest, but no population segment was spared.


Taken together, the evidence is now impossible to ignore. The only two population-level cohort studies ever conducted on COVID-19 vaccination and cancer — one in Italy and one in South Korea — have both found major increases in cancer risk. The Italian study (≈300,000 people, 30-month follow-up) identified significant elevations in overall cancer, breast, bladder, and colorectal cancers. The South Korean study (8.4 million people, 1-year follow-up) confirmed and expanded these findings, documenting increased risks of overall cancer plus six site-specific cancers (lung, prostate, thyroid, gastric, colorectal, and breast).

Critically, the signal was observed across all vaccine types — both mRNA and viral-vector (cDNA) shots — and in every demographic group analyzed. In plain terms: both major COVID-19 vaccine platforms appear to be carcinogenic

With two independent national datasets converging on the same conclusion, governments, regulators, clinicians, and researchers must confront a sobering reality: nearly 70% of the global population has been injected with a carcinogenic product. The evidence demands immediate market withdrawal of these products.

At the McCullough Foundation, we are deeply investigating both the molecular mechanisms and the population-level data linking COVID-19 vaccination to cancer. We are currently preparing several new studies to expand this critical line of evidence. This work requires substantial time, expertise, and resources, and we ask for your support in funding this urgent research: mcculloughfnd.org/products/donate-1


Nicolas Hulscher, MPH

Epidemiologist and Foundation Administrator, McCullough Foundation

Support our mission: mcculloughfnd.org

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