By Brenda Baletti, Ph.D., Children’s Health Defense<div data-rt-embed-type='true'>A National Institutes of Health (NIH) program that health officials claimed reduced the number of infants who died suddenly in their sleep fell victim late last month to <a href="https://www.statnews.com/2025/04/30/nih-ends-participation-in-safe-to-sleep-campaign-to-prevent-infant-deaths/">budget cuts</a>, triggering an outcry from some experts and mainstream media.
The 30-year-old “<a href="https://safetosleep.nichd.nih.gov/">Safe to Sleep</a>” campaign was overseen by the NIH communications office at the National Institute of Child Health and Human Development. The program cut was part of the ongoing reorganization and streamlining of the NIH.
The program, which includes TV advertisements, was created to provide guidance to parents about <a href="https://safetosleep.nichd.nih.gov/reduce-risk/reduce">safe sleeping practices</a> for infants. It advises parents to place babies on their back to sleep, use a flat firm sleeping surface, keep the sleeping area clear, use a pacifier, and breastfeed, among other lifestyle interventions. That information will remain available on the website.
<a href="https://www.northcountrypublicradio.org/news/npr/nx-s1-5383871/trump-cuts-baby-safe-to-sleep-team-here-s-what-parents-should-know">North Country Public Radio</a>, <a href="https://www.motherjones.com/politics/2025/05/the-trump-administration-canceled-a-program-that-reduced-sids-enter-the-anti-vaxxers/">Mother Jones</a> and other mainstream media decried <a href="https://www.thebump.com/news/safe-to-sleep-program-cut">the program’s cancellation</a>.
In an article published May 5, Mother Jones claimed “Safe to Sleep” was responsible for “years of progress in reducing the number of babies that succumb to Sudden Infant Death Syndrome (SIDS).”
The article smeared <a href="https://childrenshealthdefense.org/">Children’s Health Defense</a> (CHD) and others who suggest that the sudden and unexplained <a href="https://childrenshealthdefense.org/defender_category/health-conditions/">death</a> of thousands of infants each year, often within a few days of vaccination, may in some cases be linked to <a href="https://childrenshealthdefense.org/defender_category/vaccines-2/">vaccines</a> rather than to sleep hygiene.
However, the <a href="https://childrenshealthdefense.org/news/the-plausible-connection-between-vaccines-and-sids/">plausible association</a> between vaccines and SIDS has been reported in peer-reviewed literature for decades.
And research published in top journals has long shown that claims about the success of the “Safe to Sleep” campaign are mistaken. SIDS deaths didn’t go down after the campaign was launched in the 1990s. The deaths were simply categorized differently because of a change to the codes used by medical examiners.
A short history of SIDS in the U.S. 
A <a href="https://www.ncbi.nlm.nih.gov/books/NBK513399/">SIDS diagnosis</a> is given when an infant under age 1 dies suddenly, typically during sleep, and an investigation into the death fails to yield a cause. However, 95% of SIDS deaths occur in the first six months of life, peaking at ages 2-4 months.
Each year, the U.S. records<a href="https://blogs.cdc.gov/nchs/2023/11/01/7479/"> more than five infant deaths per 1,000 live births</a>, far exceeding the rates in other high-income countries.
After birth defects and prematurity, SIDS is the <a href="https://www.cdc.gov/maternal-infant-health/infant-mortality/index.html">third leading cause of death</a> among infants. Yet the medical industry claims to remain <a href="https://www.nytimes.com/2020/04/17/parenting/baby/what-causes-sids.html#:~:text=Before%20the%201960s%2C%20healthy%20infants,%2C%20however%2C%20was%20a%20mystery.">puzzled about the cause</a> — similar to how health officials say they don’t know what <a href="https://www.cdc.gov/autism/about/index.html">causes autism</a>.
The SIDS diagnosis didn’t exist until the late 1960s, when the <a href="https://jamanetwork.com/journals/jamapediatrics/fullarticle/481278#:~:text=The%201969%20definition,in%20Infants%20near%20Seattle%2C%20Wash.">category was created</a> in response to a rise in sudden unexplained infant deaths. In 1971, the World Health Organization’s <a href="https://www.who.int/standards/classifications/classification-of-diseases">International Classification of Diseases</a> (ICD) assigned a code to SIDS.
The ICD is the list of about 130 categories that coroners globally use to assign the cause of death when a baby dies.
In a 2021 article in the peer-reviewed journal <a href="https://www.sciencedirect.com/science/article/pii/S2214750021001268">Toxicology Reports</a>, vaccine researcher <a href="https://www.vacbook.com/">Neil Z. Miller</a> provides a history of the SIDS diagnosis, noting that the rise of SIDS coincided with the first <a href="https://historyofvaccines.org/getting-vaccinated/vaccines-children/development-immunization-schedule">mass immunization campaigns</a>.
In the early 1960s, the number of vaccines administered to most U.S. infants took off. The federal government began appropriating money so the CDC could work with local health departments to vaccinate all children. The agency established the CDC Advisory Committee on Immunization Practices (ACIP), which makes the recommendations for vaccines to be listed on the <a href="https://www.cdc.gov/vaccines/hcp/imz-schedules/child-adolescent-age.html">childhood immunization schedule</a>.
By the end of the decade, most <a href="https://www.chop.edu/vaccine-education-center/science-history/vaccine-history/developments-by-year">U.S. infants were receiving</a> the diphtheria, pertussis, and tetanus (DPT), polio and measles vaccines, and mumps and rubella vaccines also became available.
As SIDS rates rose, so did parental concern that SIDS was connected to vaccination, but authorities assured parents that unexplained death following vaccination was “merely coincidental,” Miller wrote.
He also said that before 1979, the ICD included cause-of-death classifications associated with &#8220;prophylactic vaccination&#8221; as an official cause of death. As a result, “medical examiners are compelled to misclassify and conceal vaccine-related fatalities under alternate cause-of-death classifications.”
Instead of examining the link between vaccines and SIDS, public health researchers developed a “<a href="https://safetosleep.nichd.nih.gov/about/causes">triple-risk model</a>” for explaining SIDS. That model says SIDS occurs when a baby has an unknown medical condition, it is going through an important period of development where the body changes quickly, and it encounters an outside stressor, such as sleeping on its stomach.
Enter the ‘back to sleep’ campaign
The <a href="https://www.aap.org/en/patient-care/safe-sleep/">American Academy of Pediatrics</a> (AAP) in 1992 launched a national “Back to Sleep” campaign to inform parents to have children sleep on their backs rather than on their stomachs.
In 1994, the NIH’s National Institute of Child Health and Human Development <a href="https://www.northcountrypublicradio.org/news/npr/nx-s1-5383871/trump-cuts-baby-safe-to-sleep-team-here-s-what-parents-should-know">institutionalized the campaign</a> within the agency, in <a href="https://safetosleep.nichd.nih.gov/campaign/history">partnership with organizations</a> like the AAP, and later, companies including <a href="https://fortune.com/2023/09/28/johnson-johnson-more-lawsuits-baby-powder-cancer-judge-throws-settlement-case/">Johnson &amp; Johnson</a> and <a href="https://childrenshealthdefense.org/defender/baby-food-lawsuits-consolidated-toxic-heavy-metal-contamination/">Gerber</a> — both of which have been sued for poisoning children with their products.
NIH renamed the campaign “Safe to Sleep” in 2012.
Between 1992, when the program was started, and 2001, <a href="https://www.thebump.com/news/safe-to-sleep-program-cut">SIDS deaths reportedly declined</a> a whopping 55% — a <a href="https://www.nytimes.com/2020/04/17/parenting/baby/what-causes-sids.html#:~:text=Before%20the%201960s%2C%20healthy%20infants,%2C%20however%2C%20was%20a%20mystery.">number touted</a> in every article celebrating the program, making it appear that babies sleeping on their stomachs was the cause of SIDS, not vaccines.
However, at the same time deaths from SIDS decreased, the rate of mortality from “suffocation in bed,” “suffocation other,” “unknown and unspecified causes,” and “intent unknown” all increased significantly.
What had happened was that the classification system had changed. SIDS deaths were being reclassified by medical certifiers, usually coroners, as one of the other similar categories, Miller reported.
Research published in the journal <a href="https://publications.aap.org/pediatrics/article-abstract/115/5/1247/67529/Changes-in-the-Classification-of-Sudden-Unexpected?redirectedFrom=fulltext">Pediatrics</a> — the flagship journal of the AAP — concluded that deaths previously certified as SIDs were simply being certified as other non-SIDS causes, such as suffocation, that were still essentially SIDS deaths.
That change in classification accounted for more than 90% of the drop in SIDS rates.
The Pediatrics paper showed there was no decline in overall postneonatal mortality, despite the program’s — and the AAP’s — claims to the contrary.
Others verified the Pediatrics paper’s findings, and the trend continued, as reported by <a href="https://pubmed.ncbi.nlm.nih.gov/11826207/">multiple studies</a> in <a href="https://pubmed.ncbi.nlm.nih.gov/29440504/">top journals</a>. Miller reported that, for example, “From 1999 through 2015, the U.S. SIDS rate declined 35.8 % while infant deaths due to accidental suffocation increased 183.8%.”
In 2020, infant deaths from Sudden Unexpected Infant Death (SUID) — an umbrella category that accounts for both SIDS and other unknown causes began to rise even higher, according to a study published in <a href="https://jamanetwork.com/journals/jamapediatrics/fullarticle/2829642">JAMA Pediatrics</a>.
No codes for vaccine-related sudden deaths
Dr. Paul Thomas, pediatrician and author of “<a href="https://www.amazon.com/Vax-Facts-Consider-Before-Vaccinating/dp/1636984975/">Vax Facts</a>: What to Consider Before Vaccinating at All Ages &amp; Stages of Life,” told <a href="https://childrenshealthdefense.org/defender/us-infant-mortality-rate-higher-16-countries/">The Defender</a> in an interview last year that extensive evidence<a href="https://childrenshealthdefense.org/news/the-plausible-connection-between-vaccines-and-sids/"> links SIDS to vaccination</a>.
Thomas said that because there are no ICD codes for vaccination, the deaths are typically recorded as something else.
“When an infant dies, no matter how soon after vaccination, coroners and pathologists do not have any codes for vaccine-related death available as options, so these deaths are generally coded as SIDS, unknown, or suffocation.”
80% of infant deaths reported VAERS between 1990-2019 happened within 7 days of vaccination
Thomas said pediatricians are not educated about the link, so even when it clearly occurs, they don’t recognize it.
“I was taught that SIDS was due to parents smoking in the room, the room being too hot, babies co-sleeping or sleeping on surfaces that were too soft, or moms smothering their babies while nursing,” he wrote, sharing insights from his new book. “While all these factors may plausibly contribute, the primary cause has been right under our noses for decades. The vaccines!”
<a href="https://pubmed.ncbi.nlm.nih.gov/34258234/">Miller’s analysis of sudden infant deaths</a> in the Vaccine Adverse Event Reporting System (VAERS) showed that nearly 80% of those deaths reported to the system between 1990 and 2019 happened within seven days of vaccination.
A recent peer-reviewed study found a <a href="https://www.cureus.com/articles/134233-reaffirming-a-positive-correlation-between-number-of-vaccine-doses-and-infant-mortality-rates-a-response-to-critics#!/">positive statistical correlation between infant mortality rates</a> and the number of vaccine doses received by babies —<a href="https://childrenshealthdefense.org/defender/infant-mortality-vaccine-doses/"> confirming findings</a> made by the same researchers a decade ago.
The 2018 Health Affairs study reported that the bifurcation of the U.S. mortality rates from those of other wealthy countries began in the 1980s — the same time the country saw a major <a href="https://www.cdc.gov/mmwr/preview/mmwrhtml/su6004a9.htm">uptick in childhood vaccination</a>.
A 2023 study published in the <a href="https://www.cureus.com/articles/164423-neonatal-infant-and-under-age-five-vaccine-doses-routinely-given-in-developed-nations-and-their-association-with-mortality-rates#!/">Cureus</a> Journal of Medical Science found that the developed nations requiring the most neonatal vaccine doses tend to have the worst childhood mortality rates.
The CDC currently recommends <a href="https://childrenshealthdefense.org/defender/cdc-expand-vaccine-schedule-children-pregnant-women/">76 doses of 18 different vaccines</a> for children ages 0-18.
Child mortality researchers have also noted that sudden unexplained childhood deaths in children over 1 year old are often <a href="https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2772374">underestimated</a>, and many such child deaths remain <a href="https://pubmed.ncbi.nlm.nih.gov/30035967/">unexplained</a> due to failure to understand or investigate causes.
A recent study in JAMA Pediatrics found that <a href="https://childrenshealthdefense.org/defender/sids-study-vaccination-preterm-babies-apnea-risk/">hospitalized preterm infants</a> had a 170% <a href="https://jamanetwork.com/journals/jamapediatrics/article-abstract/2828426">higher incidence of apnea</a> within 48 hours of receiving their routine 2-month vaccinations compared to unvaccinated babies, according to the data in a new study.
Higher infant mortality has also been linked to poor<a href="https://childrenshealthdefense.org/defender/maternal-deaths-mental-health/"> maternal health</a> or other perinatal issues, including premature birth.
</li>
</ul></div><h4 id=""><a href="https://childrenshealthdefense.org/authors/brenda-baletti/" id="">Brenda Baletti, Ph.D.</a></h4>Brenda Baletti, Ph.D., is a senior reporter for The Defender. She wrote and taught about capitalism and politics for 10 years in the writing program at Duke University. She holds a Ph.D. in human geography from the University of North Carolina at Chapel Hill and a master's from the University of Texas at Austin.‍<a href="https://childrenshealthdefense.org/defender/media-slam-nih-axing-safe-to-sleep-campaign-evidence-program-never-reduced-sids-deaths/" id="">This article was originally published by The Defender</a> — Children’s Health Defense’s News &amp; Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider<a href="https://childrenshealthdefense.org/about-us/sign-up/" id=""> subscribing to The Defender</a> or<a href="https://childrenshealthdefense.org/about-us/donate/" id=""> donating to Children’s Health Defense</a>.

Media Slam NIH for Axing ‘Safe to Sleep’ Campaign — But Evidence Shows the Program Never Reduced SIDS Deaths

NIH claimed to reduce SIDS deaths by more than 50%; research published in Pediatrics shows SIDS deaths were just reclassified 

Meet the Latest Vaccine Propagandist

Offit has not taken even a minimal amount of time to understand the manufacturing process employed in an mRNA vaccine

Multiple Democrat states are targeting homeschooling families with draconian new laws and policies, raising alarm among advocates of parental rights and educational freedom. The escalating attacks on home education are part of a growing and coordinated movement to control, undermine, and eventually end homeschooling, experts warned.From Minnesota and Illinois to Connecticut and beyond, lawmakers have in recent months been exploiting extremely rare incidents of abuse or neglect as a pretext to target the millions of parents who provide a world-class education for their children outside of state control. It is part of a strategy to bring all children and families under government control.Just this week, <a href="https://www.wtnh.com/news/connecticut/advocates-express-concerns-as-legislators-discuss-changes-to-homeschooling-rules/" id="">thousands of parents were forced to descend</a> on the state Capitol in Hartford to push back against a major assault. Following a state report calling for more government “protection” of homeschooled children — as if they needed protection from their parents — lawmakers held an “informational hearing” designed to demonize home education.No legislation has been formally proposed, yet. But bureaucrats, activists, and far-left media outlets such as NBC News seized on the story of a stepmom in Waterbury who allegedly held her stepson captive for two decades to push for more government oversight. Apparently, the stepmother offered “several explanations” to school officials about why she was withdrawing the then-11-year-old victim, including a mention of homeschooling. &nbsp; &nbsp;The state’s “Office of the Child Advocate” (OCA) released a report this week calling for more control. Among the policy recommendations: “that the parent and child appear annually to provide enrollment documentation, that the child be independently evaluated annually for academic progress, and that the parent provide initial and periodic assurances that the child is in good health.”State Senator Ceci Maher, who leads the legislature’s “Committee on Children,” argued it was just about keeping children safe. “What we’re looking at is, how do we thread this needle of keeping children safe and supporting homeschooling,” she was quoted as saying in news reports, with no reference to the appalling conditions faced by so many victims of government schools.Gov. Ned Lamont, also a Democrat, has echoed calls for more government control of homeschool families. “I’d like to talk with the legislature about ways we can stay in better communication – make sure those kids are being well protected, not just in school, but at homeschool as well,” he said.Republican lawmakers, though, blasted the exploitation of the highly unusual case as a pretext to regulate all innocent homeschool families. “To respond [to the Waterbury case] by targeting the 40,000 law-abiding families who successfully educate their children at home is misguided, unjust and unfair,” argued State Sen. Jeff Gordon.Meanwhile, Senate Minority Leader Steve Harding lambasted the OCA’s proposals for more control and how they were released the same morning as they were going to be discussed in the legislature. “What a disgrace, what a disgrace — what a spit in the face it is to people in this room,” he said.Separately, homeschoolers in Minnesota are under attack as well. On April 24, the Minnesota Senate approved an amendment that the Home School Legal Defense Association <a href="https://hslda.org/post/minnesota-senate-file-1740-amended-bill-proposes-severe-restrictions" id="">warned</a> would “fundamentally alter the state’s homeschool law.” The new restrictions would be among the “most onerous in the nation,” HSLDA added.Among the restrictions included in Minnesota’s <a href="https://www.revisor.mn.gov/bills/text.php?number=SF1740&version=latest&session=ls94&session_year=2025&session_number=0&type=" id="">Senate File 1740</a> is a provision to restrict who can educate the children to just parents or legal guardians. Many homeschooling families also include grandparents, uncles, aunts, and other extended family members in the process. The scheme also prohibits homeschooling by a parent convicted of a broad list of crimes, including misdemeanors. &nbsp; Also alarming is that the measure would restrict home education to a “primary address” in Minnesota. “As any homeschooling parent knows, homeschooling does not exclusively take place at home,” said HSLDA, which represents hundreds of thousands of homeschooling families nationwide. “It can happen on the road, at grandma’s house, at your co-op, or at the park.”“Limiting homeschooling to a residential address is an antiquated understanding of how homeschooling works, and it eliminates much of the flexibility that makes homeschooling so great,” continued the advocacy group. “This bill would prevent families from taking advantage of that flexibility.” It would also restrict coops, online classes, dual enrollment, and many other options that homeschool families frequently use.Because it was adopted as an amendment in the Senate, parents did not even have an opportunity to testify. &nbsp;Urging members to push back against the effort with their representatives, HSLDA said there were numerous ways the scheme could be adopted — even if the House does not take it up. One way would be for it to be approved would be in a conference committee.As The Newman Report <a href="https://www.freedomproject.com/2025/03/21/tnr20250321/" id="">documented in March</a>, lawmakers in Illinois are also pushing hard to impose draconian restrictions on homeschooling families. Under the proposed “Homeschool Act,” homeschool families would be forced to register and provide detailed information to government. Bureaucrats would also be free to investigate parents on a whim, even jailing those who refuse to comply.And yet, despite the hysteria manufactured by well-funded activists and far-left media outlets, the peer-reviewed research shows homeschooled children are safer than children in government school. Indeed, massive amounts of research and data now exist showing that home-educated children do better on every metric, from safety and academics to socialization and tolerance.Unfortunately, even in Republican states, homeschooling is in the crosshairs. The attacks are not as blatant, of course. But as government-funded “school choice” programs proliferate, regulation and controls are following. Even strong Republican states with supermajorities such as Florida are facing more and more efforts to impose control on tax-funded homeschoolers and private schools.At the national level, multiple totalitarian-minded “child advocates” are openly pushing to end home education altogether. Leading the charge is Harvard Law Professor Elizabeth Bartholet with the “Child Advocacy Project.” In an article for the Arizona Law Review, she openly called for a “presumptive ban” on homeschooling.Her sidekick James Dwyer at William and Mary Law School, meanwhile, has sought to “debunk” the idea of parental rights. Yes, seriously. “The reason that parent-child relationship exists is because the state confers legal parenthood on people through its paternity and maternity laws,” he claimed, apparently oblivious to how that sounds to normal people.Beyond the powerful but fringe advocates seeking a total assault on the rights of parents to control the education and upbringing of their children, there are also less obvious threats. The “Coalition for Responsible Home Education” (CRHE), for instance, presents itself as a more moderate group merely seeking to “protect” homeschooled children from their parents. But in reality, parents are virtually always the best protectors of children.<figure id="" class="w-richtext-figure-type-image " data-rt-type="image" data-rt-align=""><div id=""><img src="https://cdn.prod.website-files.com/66450044188dfe741d77c31e/675760085727de303fda4239_3364780_1225x377_2500-1024x315.jpeg" alt="" width="auto" height="auto" loading="auto" id=""></div></figure>There is a dangerous and powerful effort to have the state usurp all control and responsibility over children from parents — the very people who most love the children, and those who the Bible says are responsible for their upbringing. It is not new, of course. From Adolf Hitler and his National Socialists to Mao Zedong and his Chinese Communist Party or Joseph Stalin and his Soviet regime, the goal is always the same. And the results are always horrific.Parents must resist this evil like everything depends on stopping it — because it does.<a href="https://libertysentinel.org/author/admin/" id="">Alex Newman</a> is an award-winning international journalist, educator, author, and consultant who co-wrote the book “Crimes of the Educators: How Utopians Are Using Government Schools to Destroy America’s Children.” He writes for diverse publications in the United States and abroad. Originally published at<a href="https://libertysentinel.org/democrat-states-targeting-homeschoolers/"> Liberty Sentinel</a>.

Democrat States Targeting Homeschoolers

Multiple Democrat states are targeting homeschooling families with draconian new laws and policies

By Maryanne Demasi, Ph.D.<div data-rt-embed-type='true'>Editor’s note: Children’s Health Defense, which has been involved in Robi v. Merck &amp; Co., the landmark Gardasil HPV vaccine lawsuit, is providing ongoing support for the suit.
In what could become one of the most explosive pharmaceutical lawsuits in U.S. history, Robi v. Merck &amp; Co., centered on the <a href="https://childrenshealthdefense.org/defender/merck-california-jury-historic-gardasil-hpv-vaccine-trial/">Gardasil human papillomavirus (HPV) vaccine</a>, is set to resume in Los Angeles in September.
At the core of the case are allegations that <a href="https://childrenshealthdefense.org/defender/trial-alleging-merck-hid-dangers-hpv-vaccine-paused/">Merck</a> misrepresented the safety profile of Gardasil — allegations now supported by powerful evidence.
A newly unsealed <a href="https://www.scientificfreedom.dk/wp-content/uploads/2025/04/2024.09.09-Gotzsche-Peter-Expert-Report.pdf">expert report</a> from Danish physician and world-renowned research methodologist Dr. Peter C. Gøtzsche, submitted as part of the pre-trial motion, underpins the claims against Merck.
His 350-page forensic analysis — now part of the official court record — lays bare a chilling narrative of clinical trial rigging, regulatory failure and global deception.
According to Gøtzsche, Merck distorted its clinical trial data so thoroughly that the results were rendered scientifically meaningless.
Gøtzsche’s assessment is stark and unequivocal.
“The Merck-sponsored trials cannot be used to properly assess the harms of the vaccines,” he writes, adding that the company “squandered the opportunity to legitimately study the safety of Gardasil.”
After examining 112,000 pages of regulatory documents, Gøtzsche concluded that Merck manipulated its data to such an extent that it would be “difficult if not impossible” for any independent scientist — or even government regulators — to accurately assess the vaccine’s harms.
It now raises the fundamental question: Were millions of adolescents misled into consenting to a <a href="https://childrenshealthdefense.org/vaccines">vaccine</a> whose true safety risks were deliberately obscured?
Trials designed to mislead
From the outset, Gøtzsche argues that Merck engineered its clinical trials not to detect harms, but to mask them.
Rather than using an inert placebo, such as saline solution, the gold standard in clinical research, Merck used an <a href="https://childrenshealthdefense.org/defender/merck-knew-gardasil-contained-additional-aluminum-adjuvant/">aluminium-based adjuvant</a> as the control in all but two small trials.
Aluminium adjuvants are known neurotoxins that trigger immune responses and can cause local and systemic side effects on their own.
“It is indefensible that Merck avoided comparing its vaccine with placebo,” Gøtzsche writes.
This tactic had a clear purpose: to minimize the appearance of adverse effects by ensuring that the &#8220;control&#8221; group would experience side effects similar to the vaccinated group, making the vaccine seem safer by comparison.
Even the <a href="https://iris.who.int/bitstream/handle/10665/94056/9789241506250_eng.pdf">World Health Organization</a> (WHO) has warned that using an active comparator like an adjuvant instead of a true placebo &#8220;makes it difficult to assess the harms of a vaccine.&#8221;
Only under pressure from regulators did Merck conduct two small trials using a saline placebo.
And those two trials — marked with a red box below — showed a significantly greater incidence of harm compared to trials that used an aluminium adjuvant or a comparator vaccine as the &#8220;placebo.&#8221;
<img loading="lazy" decoding="async" class="alignnone size-full wp-image-331588" src="https://childrenshealthdefense.org/wp-content/uploads/gardasil-trials-chart.jpg" alt="" width="825" height="446" srcset="https://childrenshealthdefense.org/wp-content/uploads/gardasil-trials-chart.jpg 825w, https://childrenshealthdefense.org/wp-content/uploads/gardasil-trials-chart-300x162.jpg 300w, https://childrenshealthdefense.org/wp-content/uploads/gardasil-trials-chart-768x415.jpg 768w, https://childrenshealthdefense.org/wp-content/uploads/gardasil-trials-chart-196x106.jpg 196w" sizes="(max-width: 825px) 100vw, 825px" />
In short, Gøtzsche’s assessment was that these trials were designed to deceive.
Concealing harms by slicing the data
Beyond trial design, Gøtzsche details how Merck systematically manipulated the recording and reporting of adverse events.
Participants were monitored for harms for just 14 days following each vaccine dose — a relatively short window. <a href="https://childrenshealthdefense.org/defender_category/autoimmune-disease/">Autoimmune</a> reactions and other vaccine-related harms can take weeks or months to emerge, and sometimes years to diagnose, as in the case of conditions like postural orthostatic tachycardia syndrome (POTS).
If an adverse event occurred outside this 14-day window, it was not counted as a vaccine-related effect, but reclassified as a “new medical history,” obscuring any connection to the vaccine.
“By calling adverse events ‘new medical history,’ Merck not only concealed important adverse events but also their severity,” Gøtzsche explains.
Reactions that occurred outside the short observation window were excluded unless they were classified as serious — such as being life-threatening or resulting in disability, hospitalization or permanent damage — but even some of these reactions were omitted by Merck from its reports.
As a result, thousands of adverse events that could have revealed patterns of harm were systematically excluded from the final analysis.
This was not a matter of simply taking their eye off the ball — it was a calculated strategy by Merck.
The disappearing harms
One of the most striking sections of Gøtzsche’s report concerns Merck’s handling of results from Study P001, one of the largest clinical trials for Gardasil.
In this trial, over 14,000 participants were enrolled to compare the original Gardasil vaccine with its newer version, Gardasil 9, which contains twice the amount of adjuvant and five more disease antigens than Gardasil.
The trial data showed that 3.3% of participants receiving Gardasil 9 experienced a serious adverse event compared to 2.6% of those who received the original Gardasil.
Merck dismissed the difference as “low and comparable.”
But Gøtzsche’s analysis revealed that this increase was statistically significant. He calculated that for every 141 people vaccinated with Gardasil 9, one would suffer a serious adverse event — a rate he described as “alarming.”
Navigating the data for this study was no small feat. Gøtzsche describes the trial documents — running over 8,734 pages — as dense, disorganized and deliberately structured to obscure critical findings.
“Important results might easily pass unnoticed,” he warns.
In his view, Merck didn’t simply fail to investigate <a href="https://childrenshealthdefense.org/defender_category/vaccines-2/">vaccine harms</a> — it actively constructed barriers to hide them from public scrutiny.
Post-market red flags ignored
After Gardasil’s release onto the global market, reports of serious side effects began to surface — particularly cases involving neurological syndromes such as <a href="https://childrenshealthdefense.org/defender/cdc-merck-data-gardasil-vaccine-neurological-disorder/">POTS</a> and complex regional pain syndrome.
Rather than conducting independent reviews, regulatory agencies like the European Medicines Agency (EMA) relied on Merck’s internal analyses to assess whether these conditions might be linked to the vaccine.
However, Gøtzsche highlights that Merck’s database searches were narrowly defined and poorly constructed — effectively ensuring that many relevant cases would not even be captured in the search for key terms.
“The EMA’s official report did not mention that the search strategies the manufacturers used to search their databases were inadequate and must have overlooked many cases,” Gøtzsche writes.
Rather than challenging these deficient analyses, regulators accepted them at face value. Gøtzsche calls this what it is — regulatory failure.
“It is remarkable that drug regulators accepted Merck’s contradictory, biased and misleading reports based on trials that were already flawed by design,” he says.
The erosion of informed consent
For Gøtzsche, these issues go beyond mere scientific misconduct — they represent a profound violation of medical ethics.
Participants in the trials were lied to; they were told they were receiving a placebo when in fact they were injected with an aluminium adjuvant. Nor were they adequately informed of the true scope of potential harms associated with the vaccine.
Without honest disclosure, Gøtzsche argues, informed consent — the bedrock of ethical clinical research — was denied.
Millions of adolescents and their families made decisions based on safety data that were incomplete, selectively reported, or actively concealed.
This isn’t just a scientific scandal. It is a betrayal of public trust.
Regulators weren’t just passive — they were complicit
Gøtzsche’s report also shines a harsh light on the regulatory agencies tasked with protecting public health, including the U.S. Food and Drug Administration and the EMA.
“It is well known that regulatory agencies are understaffed, which means it is unlikely they would be able to undertake a thorough review of Merck’s data as presented,” Gøtzsche notes.
When concerns about Gardasil’s safety prompted a formal review in Denmark in 2015, the EMA largely relied on Merck’s self-submitted data to reassure the public.
But buried deep within those submissions were warnings that regulators either missed or chose to overlook.
According to Gøtzsche, this was not simply a failure of vigilance, it reflected a systemic breakdown in regulatory oversight.
A reckoning for public health
The Robi v. Merck <a href="https://childrenshealthdefense.org/defender_category/legal/">lawsuit</a> could mark a historic turning point in pharmaceutical accountability. The case is not just about one vaccine or one company — it is about the broader mechanisms by which drugs are tested, approved and marketed around the world.
If proven, Merck’s conduct would not merely represent corporate misconduct, but a collapse in the systems designed to protect public health.
The Merck-sponsored trials “cannot be trusted,” Gøtzsche concludes.
That simple but devastating conclusion may reverberate far beyond this lawsuit.
If this case succeeds, it could force a long-overdue reckoning — one that reinstates transparency, scientific integrity and the right of every patient to make a fully informed choice.
For now, one urgent question remains — how many were harmed because the truth was hidden?
Originally published on <a href="https://blog.maryannedemasi.com/p/merck-rigged-gardasil-trials-to-conceal">Maryanne Demasi’s Substack page</a>.</div><h4 id=""><a href="https://childrenshealthdefense.org/authors/maryanne-demasi-ph-d/" id="">Maryanne Demasi, Ph.D.</a></h4>Maryanne Demasi, Ph.D. is an investigative medical reporter, speaker and TV presenter/producer.<a href="https://childrenshealthdefense.org/defender/merck-designed-gardasil-trials-mask-hpv-vaccine-harms/">This article was originally published by The Defender </a>— Children’s Health Defense’s News &amp; Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider<a href="https://childrenshealthdefense.org/about-us/sign-up/" id=""> subscribing to The Defender</a> or<a href="https://childrenshealthdefense.org/about-us/donate/" id=""> donating to Children’s Health Defense</a>.

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