Public Ridicule Hyped Summer Heat Headlines… Meteorologists Losing Credibility
Sensationalist weathermen in Germany losing credibility, get mocked and ridiculed.
By P Gosselin | No Tricks Zone | June 18, 2025
Meteorologists are discovering that if they want to get attention from the media and more clicks and and likes (short term), then all they have to do is announce fictional heatwaves that weather models routinely hallucinate 10-14 days out. “Temperatures could soar to 40°C!”
German online Weltwoche reports on this phenomenon with a recent article titled: “The “heatwave” to be followed by the “red hot wave”: the climate alarmists are taking themselves to the point of absurdity and losing all credibility.”
Legacy media has a meltdown after RFK Jr fires the CDC’s vaccine panel
By Maryanne Demasi, PhD | June 10, 2025
Yesterday, Robert F. Kennedy Jr. fired every single member of the CDC’s Advisory Committee on Immunization Practices (ACIP)—the influential group of experts that decides which vaccines are added to the childhood schedule.
Today, he set fire to the media’s hysterical reaction.
Within 24 hours, legacy outlets and public health institutions lost their collective minds. Former CDC directors, industry-funded doctors, and conflicted public health groups lined up to denounce Kennedy’s move as reckless, anti-scientific, even deadly.
“This is a dangerous and unprecedented action that makes our families less safe,” said former CDC director Dr Tom Frieden.
“Unilaterally removing the entire panel of experts is reckless,” said paediatrician Dr Tina Tan to The New York Times.
The American Academy of Pediatrics (AAP) said it was “deeply troubled and alarmed.” It claimed the move would “stoke distrust in lifesaving vaccines”—this from the same organisation that has spent decades pushing the childhood vaccine schedule while taking money from the very companies that profit from it.
Others framed it as a political purge, a blow to science, or a “coup” that would bring back measles and polio.
But within hours, Kennedy hit back—and this time, he wasn’t the outsider being easily dismissed. He was the Secretary of Health and Human Services. And he came armed with evidence, receipts, and a brutal takedown of the media’s favourite falsehoods.
In a searing post on X, Kennedy explained the decision.
He said the clean sweep was necessary because ACIP had demonstrated its “stubborn unwillingness to demand adequate safety trials before recommending new vaccines for our children.”
And despite the media’s insistence otherwise, Kennedy argued that no routine injected childhood vaccine on the CDC’s schedule had ever been approved based on a placebo-controlled trial using an inert substance.
CNN had tried to prove him wrong last week—claiming it had found “257 placebo-controlled studies” of vaccines on the schedule.
Kennedy dismantled it in forensic detail.
“CNN is wrong,” he wrote. “No routine injected vaccine on CDC’s schedule was licensed for children based on a placebo-controlled trial. That is not conjecture. It is a fact based on FDA’s clinical trial data.”
Then came the body blows.
He pointed out that most of the 257 studies used active substances like aluminium, antibiotics, or other vaccines—not inert placebos.
He linked directly to FDA definitions of “placebo” and to official clinical trial records. Of the few studies that may have used saline controls, none were relied on by the FDA to license a single routine vaccine for American children.
Some studied products that were never approved in the US. Some occurred after licensure. Others involved discontinued vaccines. “CNN’s list ironically proves the lack of adequate safety trials,” Kennedy wrote in a stinging rebuke.
The post was devastating.
It was a clinical takedown of an industry riddled with deception—and it landed—because this time, Kennedy wasn’t being filtered through a hostile press.
He was speaking directly to the public, as a government official, with all the links to back it up. And the media couldn’t handle it.
Predictably, the media rolled out the same tired “experts” to recycle the same tired script—Paul Offit quotes, panic about “undermining trust,” warnings that children would die.
But Kennedy turned the whole thing inside out.
“We’ve gone from three routine injections by age one in 1986 to 25 in 2025,” he wrote. “And not one of them was licensed using a placebo-controlled trial.”
He said it plainly for the cameras: “That is just malpractice. So the people who are in charge of that are now gone.”
For years, the press had written Kennedy off as an anti-vaxxer and moved on. Now, they’ve thrown everything at him—and he threw it right back. Only now, he has the authority, data, and reach.
Kennedy told his followers he’d be announcing replacements in the coming days—no “ideological anti-vaxxers” just “highly credentialed physicians and scientists” committed to evidence, objectivity, and common sense.
Legacy media may still control the headlines, but they can no longer suppress the debate.
And perhaps that’s what really has them rattled.
They’re not defending science. They’re defending a regime of experts who signed off on decades of vaccine approvals without ever insisting on rigorous, inert-placebo safety trials.
When Kennedy calls them out, their only defence is to scream “danger!”—and hope no one checks the fine print.
Yesterday, he fired the gatekeepers. Today, he exposed the game.
US makes sweeping changes to key vaccine group
RT | June 10, 2025
The US Department of Health and Human Services (HHS) has dismissed all the members of a key advisory panel that has helped shape national vaccination policy for decades. Health Secretary Robert F. Kennedy Jr. said on Monday that the move was necessary to reestablish public trust and address longstanding concerns over conflicts of interest.
The Advisory Committee on Immunization Practices (ACIP) was created within the Centers for Disease Control and Prevention (CDC) in the mid-1960s. In an op-ed published on Monday in the Wall Street Journal, Kennedy claimed that the panel has “a history of conflicts of interest, persecution of dissidents, a lack of curiosity, and skewed science.”
The secretary cited reports from a House committee in 2000 and the HHS inspector general in 2009 that detailed financial connections between ACIP members and pharmaceutical companies. He said his decision to replace all 17 current members was driven by the need for a “clean slate.”
“The problem isn’t necessarily that ACIP members are corrupt. Most likely aim to serve the public interest as they understand it,” Kennedy wrote. “The problem is their immersion in a system of industry-aligned incentives and paradigms that enforce a narrow pro-industry orthodoxy.”
ACIP members are appointed to four-year terms, and eight of the most recent appointments were made in the final days of the administration of Joe Biden.
”It was very intentional,” a former senior HHS official told STAT News. “It was our goal to fill every vacancy on every [federal advisory committee] the department has, with particular focus on ones like ACIP where maintenance of our scientific expertise was critical.”
Mandy Cohen, who served as the CDC director under Biden, told NBC News the move “spreads confusion and casts doubt on transparent public health processes that protect Americans.” Richard Besser, who was acting CDC director under Barack Obama, said it “should erase any remaining doubt that he intends to impose his personal anti-vaccine agenda on the American people.”
Kennedy has long criticized aspects of US vaccine programs, arguing they are too closely aligned with industry interests and fail to prioritize public health. His detractors frequently label him an “anti-vaxxer.”
During his confirmation hearings, Kennedy pledged that his decisions would be science-driven. In his WSJ piece, he warned against attributing the American public’s “crisis of trust” solely to “misinformation or anti-science attitudes.”
APPROVE NOW, STUDY LATER: IS THIS SAFE?
The HighWire with Del Bigtree | June 5, 2025
As alarming new data reveals a spike in sudden heart attacks and strokes, the FDA has greenlit Moderna’s latest mRNA COVID shot—no placebo trials, no independent long-term safety data, and post-market studies delayed until 2029 and 2034. Once again, speed trumps caution. Is safety giving way to speed again, or are post-marketing placebo trials a step in the right direction?
FDA branded ‘shameful’ over infant meningococcal vaccine approval
By Maryanne Demasi, PhD | June 8, 2025
“It’s shameful,” said attorney Aaron Siri of Siri & Glimstad LLP, criticising the FDA’s decision to expand use of the meningococcal vaccine MenQuadfi to infants as young as six weeks.
Previously licensed for children over two, the vaccine is now approved for babies aged 6 weeks to 23 months, based on trials in which infants received up to four doses.
Siri, who has represented families affected by vaccine injury, says the move reflects a broader pattern of weak oversight—where flawed trial designs and circular assumptions are used to justify approvals despite serious safety concerns.
Serious adverse events in infants
According to the FDA’s own summary, 5.3% of infants who received MenQuadfi in clinical trials experienced at least one serious adverse event (SAE)—defined as any medical occurrence resulting in death, hospitalisation or disability.
That figure reflects SAEs reported from the first dose through six months after the final dose.
That’s roughly one in every 20 children.
In the comparator group, 3.6% of infants who received Menveo also experienced a serious adverse event during the same period.
Instead of raising concern, the FDA took comfort in the similarity.
The agency concluded that because the rates of serious reactions were “comparable,” the expanded use of the vaccine in infants could be considered safe.
But that logic, Siri argues, is dangerously circular. “Because these rates were ‘similar,’ this product was deemed ‘safe’ by FDA because it assumes Menveo is ‘safe.’”
In the end, Sanofi, the company selling MenQuadfi, chalked up only two cases as possibly related to vaccine—both febrile seizures after the 4th dose, given in combination with MMR, varicella, and PCV13 at 12 months of age.
A placebo problem
The issue, Siri says, lies in the chain of assumptions.
Menveo wasn’t tested against a true saline placebo. It was compared to Menactra—another meningococcal vaccine. Menactra, in turn, was tested against Menomune.
But Menomune—now discontinued—was never tested against a placebo either.
The final twist?
In a bizarre loop of regulatory logic, the package insert for Menomune cites the clinical trial for Menactra—where Menomune was the comparator—as part of its own safety justification.
“I couldn’t even dream of making this stuff up,” Siri said.
What emerges is a kind of regulatory ouroboros—a snake swallowing its own tail—where each new product is built on the presumed safety of the last, and none are ever measured against a neutral baseline.
The vaccine safety pyramid
“This provides a good example of the vaccine safety pyramid scheme,” said Siri.
“Menomune was licensed without a proper placebo-controlled trial and was then used as the control to license Menactra; Menactra is then used as the control to license Menveo; and then Menveo is used as the control to license MenQuadfi,” he added.
Each step is built on the presumed safety of the one before it—but without any solid foundation. No inert comparator. Just a chain of assumptions.
“Hence, we get a trial with 5.3% and 3.6% of infants suffering serious adverse reactions and no one bats an eye—they grant licensure,” Siri said.
How did the FDA allow this?
Under current FDA guidelines, vaccine manufacturers are not required to use a placebo—an inert substance such as a saline injection—in pre-licensure trials. Instead, “active comparators” such as other vaccines are commonly used.
This practice speeds up approval, especially when companies argue the control group must be “protected” from the disease being targeted.
But critics say it undermines transparency and obscures harms.
If both the test vaccine and the comparator cause adverse events, the trial may appear to show no safety signal—even if the absolute rate of harm is high.
In this case, the FDA accepted the MenQuadfi trial design without requiring a true placebo group—despite the high rate of reported serious events.
Who pays the price?
Since MenQuadfi is already on the CDC schedule for older children, the pharma companies profiting from this product already have liability protection under U.S. vaccine injury laws.
“FDA and pharma have nothing to lose here,” Siri said.
“We, as taxpayers, will pay for all of the harms suffered and, worst of all, the children who are injected and harmed and their families will really pay for the harms,” he added.
It’s not the first time critics have accused the FDA of playing fast and loose with vaccine safety data, especially in the wake of Covid-19.
But this case, Siri argues, is a textbook example of how safety assessments are gamed when it comes to childhood vaccine.
Restoring integrity in vaccine testing
At the heart of Siri’s warning is a plea for scientific integrity.
Without true placebo-controlled trials, he argues, there’s no meaningful way to detect harms—just one untested product being measured against another.
“This isn’t science. It’s a shell game,” he said.
As MenQuadfi rolls out to younger babies, public health officials will no doubt emphasise its potential to prevent a rare but deadly disease.
But advocates like Siri want parents and legislators to understand what’s beneath the product label—not just a vaccine, but a regulatory system that is collapsing under the weight of its own shortcuts.
NIH Shuts Down Research Center Founded by Fauci, as DOJ Scrutinizes Key Researchers
By Michael Nevradakis, Ph.D. | The Defender | June 5, 2025
Officials at the National Institutes of Health (NIH) plan to shut down a research center established by Dr. Anthony Fauci that issued grants to embattled researchers who promoted the “zoonotic origin” theory that COVID-19 emerged from wildlife, The Disinformation Chronicle reported today.
Fauci established the Centers for Research in Emerging Infectious Diseases (CREID) in 2020 to conduct “investigations into how and where viruses and other pathogens emerge from wildlife and spill over to cause disease in people.”
According to The Disinformation Chronicle, when CREID launched, it issued 11 grants worth $17 million, with an additional $82 million in expected funding over five years. It’s unclear how much of the money has already been spent.
Two CREID grantees have been the focus of intense scrutiny: Peter Daszak, Ph.D., of the EcoHealth Alliance and Kristian Andersen, Ph.D., of Scripps Research Institute. Both played key roles in publicly promoting the theory that SARS-CoV-2, which led to the COVID-19 pandemic, originated in wildlife.
The U.S. Department of Justice has launched “initial inquiries” into one of the CREID grants Anderson received. Last year, the U.S. Department of Health and Human Services (HHS) suspended all government funding for EcoHealth Alliance.
The Disinformation Chronicle quoted an NIH spokesperson, who confirmed the agency has terminated all outstanding CREID grants.
“Strengthening overall health through proactive disease prevention offers a more resilient foundation for responding to future health threats — beyond reliance on vaccines or treatments for yet-unknown pathogens,” the spokesperson said.
Andersen received a CREID grant after co-authoring zoonotic origin paper
In March 2020, Andersen co-authored “The proximal origin of SARS-CoV-2,” published in Nature Medicine. The paper — widely known as the “Proximal Origin” paper — concluded that COVID-19 had a zoonotic origin. It became one of that year’s most-cited papers, accessed over 6 million times.
Government officials, including Fauci, and mainstream media outlets later cited the paper as part of efforts to discredit proponents of the theory that COVID-19 originated in and escaped from a lab.
The Trump administration is investigating whether the authors and publisher of “Proximal Origin” allowed Fauci and other key public health officials to influence the paper’s conclusions in exchange for funding — a possible quid pro quo.
According to The Disinformation Chronicle, two months after “Proximal Origin” was published, Andersen received a CREID grant.
In testimony to Congress in July 2023, Andersen said, “There is no connection between the grant and the conclusions we reached about the origin of the pandemic.” Later that month, The Intercept published documents showing that Andersen “knew that was false.”
Andersen and other virologists were initially skeptical about dismissing the lab-leak theory. But emails and documents revealed through a congressional investigation and some media outlets revealed that, under pressure from Fauci and other public health officials, Andersen endorsed the zoonotic theory in “Proximal Origin.”
During a Feb. 1, 2020, email and call between Fauci and several virologists, including Andersen, the participants expressed concern that COVID-19 might have been manipulated instead of originating in nature.
Transcripts revealed by The Nation in July 2023 showed that, in a February 2020 Slack thread, Andersen wrote to other virologists that “the main issue is that accidental release is in fact highly likely — it’s not some fringe theory.”
And on April 16, 2020, Andersen sent a Slack message to his “Proximal Origin” co-authors, stating, “I’m still not fully convinced that no culture was involved. We also can’t fully rule out engineering (for basic research).”
Andersen may have misled intelligence agencies on COVID’s origins
Andersen privately questioned the true origins of COVID-19. However, in March 2020 — one week after “Proximal Origin” was published — he participated in a U.S. Department of State briefing with other non-government scientists, where he dismissed the possibility that COVID-19 emerged from a lab leak at the Wuhan Institute of Virology in China.
According to The Disinformation Chronicle, the briefing led the State Department to issue a report concluding there was no evidence that COVID-19 was developed in a lab. In 2023, Andersen testified during a sworn congressional deposition that he also briefed the CIA and FBI regarding COVID-19’s origins.
The DOJ is now likely to examine Andersen’s role in misleading U.S. intelligence agencies, The Disinformation Chronicle reported, quoting a State Department official, who said, “I don’t see how this not a criminal misleading and counterintelligence matter. This is way beyond the threshold needed for a grand jury.”
In April, the Trump administration launched a new version of the government’s official COVID-19 website, presenting evidence that COVID-19 emerged due to a leak at the Wuhan lab. The CIA, FBI, U.S. Department of Energy, U.S. Congress and other intelligence agencies have endorsed this theory.
Daszak has also been under scrutiny for possible improprieties involving his research. According to The Disinformation Chronicle, Daszak was found to have undisclosed ties to the Wuhan Institute of Virology — including issuing a subaward to a researcher at that laboratory, Shi Zhengli, Ph.D., widely known as the “Bat Lady.”
In issuing its decision to bar Daszak’s EcoHealth Alliance from receiving further federal funds, HHS cited the organization’s lack of response “to NIH’s multiple safety-related requests” relating to research performed at the Wuhan lab.
Journalist Paul D. Thacker, a former U.S. Senate investigator and publisher of The Disinformation Chronicle, said that congressional investigations involving Andersen and others have been problematic.
“The congressional investigations into these matters were not well managed. A lot of people are still shocked at how little got done,” Thacker said.
Last month, the NIH introduced a new policy prohibiting NIH grantees from outsourcing parts of their research to foreign entities through subawards.
Facing investigation, is Andersen looking to flee the U.S.?
Andersen, a Danish citizen, is now looking to leave the U.S. “as the noose continues to tighten,” The Disinformation Chronicle reported. He is said to be considering a position at the University of Oslo in Norway.
Sigrid Bratlie, a molecular biologist and senior adviser at Norway’s Langsikt Policy Centre, told The Disinformation Chronicle that “there is an ongoing effort from a group of scientists at the University of Oslo to recruit Andersen, and that this might be finalized in the near future.”
In October 2024, Andersen delivered a lecture at the University of Oslo on the “facts and the fiction” of the COVID-19 pandemic, claiming that critiques of his research were political attacks spread by conspiracy theorists.
The Norwegian Society for Immunology, which sponsored the lecture, later issued an apology. According to The Disinformation Chronicle, the apology stated, “In retrospect, unfortunately, it seems the purpose of his lecture was just as much about stopping the free debate in Norway on this topic.”
Thacker said that Andersen’s possible move to Norway is part of a broader trend where many scientists are expressing public dissent at the Trump administration’s policies.
“The majority of scientists I see complaining are all entrenched in liberal politics. Pretty much every one of them has a large account on [social media platform] Bluesky where allied reporters hang out to find quotes,” Thacker said.
This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.
Their babies died suddenly in their sleep. They now face felony charges for not placing infants on their backs
By Brenda Baletti, Ph.D. | The Defender | June 6, 2025
Parents of two different babies are being charged with felonies in Pennsylvania after police say their babies died because the parents placed them in unsafe sleeping positions, SpotlightPA reported.
In both cases, police allege that the parents failed to follow guidance, including handouts given to them at doctor’s visits, stating that babies should be put to sleep on their backs.
Gina and David Strause of Lebanon County are accused of putting their 3-month-old infant son, Gavin, to sleep on his stomach and allowing him to sleep with stuffed animals in the crib.
They are charged with involuntary manslaughter, recklessly endangering another person, and endangering the welfare of children.
Natalee Rasmus of Luzerne County is accused of putting her 1-month-old daughter, Avaya Jade Rasmus-Alberto, to sleep on her stomach on a boppy pillow, often used for nursing. She is charged with third-degree murder, involuntary manslaughter and endangering the welfare of children.
Rasmus was a 17-year-old mother when her daughter died in 2022. Court records show that she continues to be held at the Luzerne County Correctional Facility with bail set at $25,000 pending resolution of her case.
In both cases, autopsies concluded the babies died of accidental death from asphyxiation. Law enforcement argued in both cases that parents should have known that putting the babies to sleep on their stomachs was unsafe, because they had received paperwork at wellness visits informing them of safe sleeping practices.
They pointed to signed acknowledgements in the babies’ medical records that were created as part of a 2010 state law to educate parents about Sudden Infant Death Syndrome (SIDS).
The law requires hospitals, birthing centers and medical providers to give parents educational materials from the national Safe to Sleep campaign, and ask them to certify that they received them.
Signing the statement is voluntary. The statement doesn’t indicate that parents can be charged with a criminal offense if they don’t follow the campaign advice.
Advocates from national organizations that educate parents about safe sleep practices found the charges shocking. Nancy Maruyama, the executive director of Sudden Infant Death Services of Illinois told Spotlight PA, “To charge them criminally is a crime, because they have already suffered the worst loss.”
Alison Jacobson, executive director of First Candle, a nonprofit that also educates parents about safe sleep practices, told Pennlive, “There is no law against placing a baby on his or her stomach to sleep. How they can charge this family with involuntary manslaughter is completely baffling to me.”
Researcher Neil Z. Miller, an expert on SIDS and the Safe to Sleep campaign, told The Defender, “Parents of a sleeping baby who dies in the middle of the night should never be charged with murder. That’s just cruel.”
Miller, author of “Vaccines: Are They Really Safe and Effective?” added:
“Should parents be obligated to follow every ‘recommendation’ made by their doctor or the Safe to Sleep campaign? Would we as a society prefer that doctors raise our babies instead of the parents? Have other possible causes of death been considered, such as vaccinations? As a society, we can, and must, do much better.”
Does placing infants on their backs make a difference?
The handouts shared with new Pennsylvania parents are based on the National Institutes of Health “Safe to Sleep” campaign, which institutionalized a program initiated by the American Academy of Pediatrics (AAP) in 1992 to inform parents to put children to sleep on their backs rather than on their stomachs.
The campaign is based on the premise that babies who sleep on their backs or sides are less likely to die in their sleep. Until that time, it was common for babies to sleep on their stomachs.
The program was launched in the wake of a rising number of SIDS deaths — and growing concern among some parents that the deaths were linked to vaccination.
In a 2021 article in the peer-reviewed journal Toxicology Reports, vaccine researcher Neil Z. Miller provides a history of the SIDS diagnosis, noting that the rise of SIDS coincided with the first mass immunization campaigns.
Between 1992, when the Safe to Sleep program launched, and 2001, SIDS deaths reportedly declined a whopping 55% — a number touted in articles 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.
Why? The classification system had changed. SIDS deaths were being reclassified by medical certifiers, usually coroners, as one of the other similar categories, not SIDS.
Research published in the journal Pediatrics, the AAP’s flagship journal, concluded that deaths previously certified as SIDs were simply being certified as other non-SIDS causes, such as suffocation — but the deaths were still essentially SIDS deaths.
That change in classification accounted for more than 90% of the drop in SIDS rates.
The Pediatrics paper showed no decline in overall postneonatal mortality after the Safe to Sleep campaign was launched, 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 multiple studies in top journals. 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%.”
Research shows that almost 80% of SIDS deaths reported to the Vaccine Adverse Event Reporting System (VAERS) happen within seven days of vaccination.
Theories linking vaccines to SIDS suggest that, in some cases, underdeveloped liver enzyme pathways may make it harder for some infants to process toxic ingredients in vaccines. Others argue that other, multiple, complex factors can make some infants vulnerable to toxic ingredients in vaccines.
Baby Gavin was ‘a dream come true’
On April 30, Gina and David Strause were charged with involuntary manslaughter, which carries a sentence of up to 10 years, and other lesser charges in the death of their son Gavin.
According to the police report, Gina found her son unresponsive, cold and blue in his crib when she woke up to feed him on the morning of May 8, 2024. She immediately called 911 and performed CPR until the police arrived.
The baby was pronounced dead at the hospital. The autopsy report found the cause of death to be “complications of asphyxia.”
Police said they observed loose items in the crib, “such as blankets and stuffed animals.”
Gina said that after feeding her baby at about 11:30 the night before he died, she placed him in his crib on his belly, because he was a “belly sleeper,” and covered him with a blanket. She said that she had received the recommendation that he should sleep on his back, but that he preferred to sleep on his stomach.
In an interview with Pennlive, Gina said that she typically put Gavin to sleep on his back, but he had gotten into the daily habit of rolling onto his belly.
Davis Stause told police that when he left for work at 5:30 am, he checked on Gavin, who was sleeping on his stomach and moving around a little bit. David said he “patted his butt” to put him back to sleep.
The police reported that they also obtained medical records from birth through death that showed that on the discharge paperwork that the parents received information about safe sleep practices, which included putting the baby on its back, having it sleep in the same room as the parents, and keeping the crib clear of bumper pads and stuffed animals.
They said this paperwork explained how parents could create a safe sleeping environment for their babies to reduce the risk of SIDS.
Baby Gavin also went to the pediatrician for well-child visits on Feb. 7 and 14, March 5 and April 9, a month before he died.
Gina told Pennlive that Gavin, who was born when she was almost 40, was “a dream come true.” She had taken 10 weeks of maternity leave and largely worked at home to spend as much time with him as possible. She said that after she gave birth, she was “overwhelmed” and didn’t remember receiving any paperwork or instructions about sleep.
Gina also said that at the hospital, police treated her and her husband with immediate suspicion, separating and questioning them. They were not allowed to see their baby again before he was taken by the coroner’s office.
The parents created a GoFundMe page, where they shared a copy of the police report, to help cover their legal costs, because they said they do not qualify for a public defender.
The Defender attempted to contact the parents to inquire about the baby’s overall health, if he had any medical conditions, was born prematurely or had recently received any vaccines, but the parents did not respond by deadline.
The district attorney’s office also did not respond to requests for comment.
‘Tragic accident with no criminal intent to harm or kill the baby’
The forensic pathologist who performed the autopsy for Natalee Rasmus’ baby listed the cause of death as accidental. According to the report, the baby died from asphyxiation, the Times Leader reported.
Rasmus discovered her baby had died on the morning of Oct. 23, 2022, when she picked her up to get her ready for a doctor’s appointment.
Pennsylvania State Police in December charged Rasmus, alleging that she placed her baby face down to sleep against the recommendations of medical personnel and prenatal classes at Geisinger Wyoming Valley Medical Center.
At a preliminary hearing on the case in February, a state trooper testified that Rasmus ignored safe sleeping practices because she had placed her baby face down in her bassinet with a Boppy pillow, which has a tag warning, “Do not use for sleeping.”
The trooper, Caroline Rayeski, also testified that a search of Rasmus’ cellphone found that she had searched the internet to see whether it was ok to allow newborns to sleep on their stomachs. The trooper also seized literature from the prenatal classes stating it is “recommended” to put newborns to sleep on their backs.
“Yeah, she wouldn’t sleep, she’ll just scream, so she has to be like propped up,” Rasmus told the investigating officer, according to Spotlight PA, which reported the story.
Assistant attorneys argued in a preliminary hearing that she disregarded safe sleeping practices, and a judge forwarded the criminal case to county court.
Rasmus is being represented by public defenders Joseph Yeager and Melissa Ann Sulima, who told the Times Leader the baby’s death was “a tragic accident with no criminal intent to harm or kill the baby.”
Yeager said the prenatal literature referring to newborn sleep positions are “recommendations,” not mandates.
“As the death certificate says, it was an accident. Clearly, there was no malice in this accidental death,” said Yeager, who also said the case should be dismissed.
Rasmus’ most serious charge, third-degree murder, is a homicide that involves killing someone without intent to kill, but with reckless disregard for human life. In Pennsylvania, it can carry a prison sentence of up to 40 years.
Court documents indicate that Rasmus remains in jail with a $25,000 bail, pending the outcome of her case. Neither the district attorney nor Rasmus’ attorneys responded to The Defender’s request for comment.
How common is it to bring criminal charges against parents in infant deaths?
Attorney Daniel Nevins told SpotlightPA said it is extremely rare for parents to be criminally charged when infants die after sleeping on their stomachs, and that the burden of proof on the prosecutors will be high.
In 2014, Virginia resident Candice Christa Semidey, age 25, was charged with murder after she swaddled her baby and put it to sleep on its stomach, The Washington Post reported. In that case, police similarly did not think that she intended for the baby to die.
She pleaded guilty to involuntary manslaughter and child neglect. She was ordered to serve three years of probation to avoid the five-year prison term she was sentenced to.
Some charges have also been brought against parents in deaths of infants sleeping with Boppy pillows. There have also been several cases of parents charged for sleeping in the same bed as their child.
The Defender recently reported on three SIDS deaths that occurred shortly after vaccination. Police are still investigating the parents of 18-month-old twins who died together a week after receiving three vaccines. Authorities have not yet charged the parents, but initially said they were investigating the deaths as homicides.
Blessings Myrical Jean Simmons, age 6 months, received six routine vaccines at a well-baby visit on Jan. 13. The next morning, her parents found the baby dead in her bassinet. The autopsy SIDS as the infant’s cause of death, and no charges were filed against the parents.
This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.
Critics Slam Fluoride Study by Researchers With Ties to Pro-Fluoride Lobby
By Brenda Baletti, Ph.D. | The Defender | June 2, 2025
Mainstream media outlets are touting a study published May 30 in JAMA Health Forum that predicts ending water fluoridation will worsen children’s oral health and increase national dental healthcare costs.
The study is the most recent attempt by researchers with links to pro-fluoridation lobbying groups like the American Dental Association (ADA) to undermine public confidence in the growing body of scientific evidence that water fluoridation has negative consequences for children’s health.
The study was published by Harvard’s Sung Eun Choi, Ph.D., and Brigham and Women’s Hospital’s Lisa Simon, M.D., D.M.D. Simon receives funding for other research from the ADA, the California Dental Association and other pro-water fluoridation groups, according to the study’s conflict-of-interest disclosures.
Choi and Simon estimated that If everywhere else in the U.S. were to stop fluoridating water, in the next five years, 7.5% more U.S. children ages 0-19 would get cavities — a total of 25.4 million additional teeth would be affected — and it would cost a total of $9.8 billion to treat them.
They also claimed that the number of cavities would more than double in 10 years, to 53.8 million.
The authors argue in the paper and in the press that stopping water fluoridation would disproportionately affect low-income children who are often on Medicaid or without insurance.
Leading fluoride expert Kathy Thiessen, Ph.D., told The Defender there is no good evidence that water fluoridation helps low-income people — it’s just “wishful thinking,” she said, used to justify water fluoridation.
She added:
“Caries development is probably far more related to diet (e.g., sugar) and nutrition (adequate calcium, protein, vitamins) than to fluoride or dental hygiene. That generally translates to higher income, better dental health; lower income, worse dental health.
“The U.S. would be much better off if the money spent on promoting and implementing fluoridation were spent on providing dental care, nutrition, etc., for the lower socioeconomic groups.”
The study authors acknowledged the recent research showing that fluoride exposure has serious negative consequences for children’s neurodevelopment. However, they said that because current federal guidelines haven’t changed to account for such damage, they didn’t consider it in their model.
They didn’t mention that the U.S. Environmental Protection Agency (EPA) is under a court order, which it has yet to appeal, to revise its water fluoridation regulations to account for this risk to children.
Instead, they cited editorials published by members of the ADA and its National Fluoride Advisory Committee, challenging two studies on fluoride’s neurotoxicity to downplay their importance.
Experts on fluoride’s neurotoxic effects who spoke with The Defender were highly critical of the study’s failure to consider fluoride’s neurotoxic effects on children.
Dr. Hardy Limeback, former head of preventive dentistry at the University of Toronto and a fluoride expert said, “Banning fluoridation is a step closer to children’s overall health.”
“Why damage 75 million kids’ brains or the appearance of 9 million kids’ smiles, just to try and save maybe 25 million teeth — if that’s even close to a reliable number — from dental decay?” he asked.
Theissen said the study’s authors don’t include any of the significant costs that result from fluoride’s neurotoxic effects — ranging from immediate healthcare costs, to costs of therapy for disorders such as autism or ADHD, to lifelong earnings reductions associated with lowered IQ.
“A responsible cost-effectiveness analysis really should have included cognitive effects and other adverse effects,” she said.
Fluoride added to drinking water a byproduct of phosphate fertilizer production
Fluoride has been added to community water supplies in the U.S since the 1940s, on the assumption that it would improve children’s dental health.
For decades, scientists and community activists have been raising concerns that fluoride is linked to reduced IQ, behavioral issues, disruption of thyroid functioning and disruption of the gut microbiome.
However, it wasn’t until consumer advocacy groups who sued the EPA in federal court to end water fluoridation won their landmark lawsuit last year that the issue generated national attention.
Soon after Judge Edward Chen ruled that water fluoridation at current U.S. levels poses an “unreasonable risk” of reduced IQ in children and that the EPA must take regulatory action, numerous communities across the country organized campaigns to stop fluoridating their water.
Although most media reports highlight that fluoride is a “naturally occurring mineral,” the fluoride added to water supplies is not.
The fluoride most commonly added to U.S. drinking water supplies is hydrofluorosilicic acid, the byproduct of phosphate fertilizer production, sold off by chemical companies to local water departments across the country.
Overwhelming scientific research shows that fluoride’s benefits to teeth are topical, not the result of ingesting fluoride, and a 2024 Cochrane Review found adding fluoride to drinking water provides very limited dental benefits, especially compared with 50 years ago.
Experts question new study’s model, assumptions and ‘sloppy’ errors
Thiessen called the new JAMA paper “somewhat sloppy,” and cited several outright errors she said reviewers should have caught. She pointed out that the authors confused the roles of different regulatory agencies, provided incorrect citations for some of their model input numbers, and sometimes used outdated cost estimates.
To estimate the effects of ending water fluoridation, the authors created a nationally representative sample using data from 8,484 children, from birth through age 19. The data came from the National Health and Nutrition Examination Survey, which is conducted each year by the CDC and is based on interviews about diet and details from people’s health records.
The study authors used current water fluoridation levels as a proxy for how much fluoride children are exposed to, then predicted the increase in cavities that would occur if that were to stop.
Their model predicted two scenarios: if every public water system fluoridated its water at today’s recommended level of 0.7 milligrams per liter, and if there were a total national ban.
Experts questioned the use of fluoride in water as a proxy for exposure, given that children are exposed to fluoride from many sources other than drinking water, including toothpaste and all processed foods and drinks made with fluoridated water.
They also criticized the “total ban” scenario, in which the researchers estimated that fluoride levels would be reduced to zero in all systems. According to the CDC, almost all water contains some naturally occurring fluoride, so the zero fluoride estimate scenario can’t occur.
It was also “assumed” that children benefit from drinking fluoridated water, but Thiessen said there is no basis for this assumption.
“We badly need some honest and thorough evaluation of whether there is a benefit or not from fluoride or fluoridation,” she said. “If there is no real benefit, then obviously any risk of adverse health effects is not justified.”
The only negative health effect of water fluoridation the researchers considered was dental fluorosis — a discoloration of the teeth that occurs when a child is overexposed to fluoride.
Even their estimate of how many children would have “objectionable” dental fluorosis “completely missed the mark,” Limeback said. According to the Cochrane Review cited by the researchers, every eighth child in fluoridated areas has dental fluorosis that needs repair, Limeback said. Ending fluoridation would result in 9,375,000 (not 200,000 as they reported) fewer cases of dental fluorosis.
Each case of serious fluorosis costs between $2,000 and $20,000 to repair, he said, meaning that ending fluoridation offers potential savings of $18.75 to $187.5 billion dollars.
“America would drastically reduce the dental fluorosis epidemic in the U.S. if all the states banned water fluoridation.”
Thiessen also noted that the authors disregarded other costs borne by the American public associated with water fluoridation, including the costs of fluoridating, and the costs of cleaning up fluoridation overfeeds and spills, which are common, and addressing the health issues they cause.
“I also expect that other health issues will decrease substantially, more than making up for any increase in dental costs,” Thiessen added.
This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.
FDA exposed – hundreds of drugs approved with no proof they work
Two-year investigation reveals a broken approval system, ineffective—and sometimes deadly—drugs fast-tracked to market without evidence
By Maryanne Demasi, PhD | June 5, 2025
The US Food and Drug Administration (FDA) has approved hundreds of drugs without proof they work—and in some cases, despite evidence they cause harm.
That’s the finding of a blistering two-year investigation by medical journalists Jeanne Lenzer and Shannon Brownlee, published by The Lever.
Reviewing more than 400 drug approvals between 2013 and 2022, the authors found the agency repeatedly ignored its own scientific standards.
One expert put it bluntly—the FDA’s threshold for evidence “can’t go any lower because it’s already in the dirt.”
A system built on weak evidence
The findings were damning—73% of drugs approved by the FDA during the study period failed to meet all four basic criteria for demonstrating “substantial evidence” of effectiveness.
Those four criteria—presence of a control group, replication in two well-conducted trials, blinding of participants and investigators, and the use of clinical endpoints like symptom relief or extended survival—are supposed to be the bedrock of drug evaluation.
Yet only 28% of drugs met all four criteria—40 drugs met none.
These aren’t obscure technicalities—they are the most basic safeguards to protect patients from ineffective or dangerous treatments.
But under political and industry pressure, the FDA has increasingly abandoned them in favour of speed and so-called “regulatory flexibility”.
Since the early 1990s, the agency has relied heavily on expedited pathways that fast-track drugs to market.
In theory, this balances urgency with scientific rigour. In practice, it has flipped the process. Companies can now get drugs approved before proving they work, with the promise of follow-up trials later.
But, as Lenzer and Brownlee revealed, “Nearly half of the required follow-up studies are never completed—and those that are often fail to show the drugs work, even while they remain on the market.”
“This represents a seismic shift in FDA regulation that has been quietly accomplished with virtually no awareness by doctors or the public,” they added.
More than half the approvals examined relied on preliminary data—not solid evidence that patients lived longer, felt better, or functioned more effectively.
And even when follow-up studies are conducted, many rely on the same flawed surrogate measures rather than hard clinical outcomes.
The result: a regulatory system where the FDA no longer acts as a gatekeeper—but as a passive observer.
Cancer drugs: high stakes, low standards
Nowhere is this failure more visible than in oncology.
Only 3 out of 123 cancer drugs approved between 2013 and 2022, met all four of the FDA’s basic scientific standards.
Most—81%—were approved based on surrogate endpoints like tumour shrinkage, without any evidence they improved survival or quality of life.
Take Copiktra, for example—a drug approved in 2018 for blood cancers. The FDA gave it the green light based on improved “progression-free survival,” a measure of how long a tumour stays stable.
But a review of post-marketing data showed that patients taking Copiktra died 11 months earlier than those on a comparator drug.
It took six years after those studies showed the drug reduced patients’ survival for the FDA to warn the public that Copiktra should not be used as a first- or second-line treatment for certain types of leukaemia and lymphoma, citing “an increased risk of treatment-related mortality.”
Elmiron: ineffective, dangerous—and still on the market
Another striking case is Elmiron, approved in 1996 for interstitial cystitis—a painful bladder condition.
The FDA authorised it based on “close to zero data,” on the condition that the company conduct a follow-up study to determine whether it actually worked.
That study wasn’t completed for 18 years—and when it was, it showed Elmiron was no better than placebo.
In the meantime, hundreds of patients suffered vision loss or blindness. Others were hospitalised with colitis. Some died.
Yet Elmiron is still on the market today. Doctors continue to prescribe it.
“Hundreds of thousands of patients have been exposed to the drug, and the American Urological Association lists it as the only FDA-approved medication for interstitial cystitis,” Lenzer and Brownlee reported.
“Dangling approvals” and regulatory paralysis
The FDA even has a term—”dangling approvals”—for drugs that remain on the market despite failed or missing follow-up trials.
One notorious case is Avastin, approved in 2008 for metastatic breast cancer.
It was fast-tracked, again, based on ‘progression-free survival.’ But after five clinical trials showed no improvement in overall survival—and raised serious safety concerns—the FDA moved to revoke its approval for metastatic breast cancer.
The backlash was intense.
Drug companies and patient advocacy groups launched a campaign to keep Avastin on the market. FDA staff received violent threats. Police were posted outside the agency’s building.
The fallout was so severe that for more than two decades afterwards, the FDA did not initiate another involuntary drug withdrawal in the face of industry opposition.
Billions wasted, thousands harmed
Between 2018 and 2021, US taxpayers—through Medicare and Medicaid—paid US$18 billion for drugs approved under the condition that follow-up studies would be conducted. Many never were.
The cost in lives is even higher.
A 2015 study found that 86% of cancer drugs approved between 2008 and 2012 based on surrogate outcomes showed no evidence they helped patients live longer.
An estimated 128,000 Americans die each year from the effects of properly prescribed medications—excluding opioid overdoses. That’s more than all deaths from illegal drugs combined.
A 2024 analysis by Danish physician Peter Gøtzsche found that adverse effects from prescription medicines now rank among the top three causes of death globally.
Doctors misled by the drug labels
Despite the scale of the problem, most patients—and most doctors—have no idea.
A 2016 survey published in JAMA asked practising physicians a simple question —what does FDA approval actually mean?
Only 6% got it right.
The rest assumed it meant the drug had shown clear, clinically meaningful benefits—such as helping patients live longer or feel better—and that the data was statistically sound.
But the FDA requires none of that.
Drugs can be approved based on a single small study, a surrogate endpoint, or marginal statistical findings. Labels are often based on limited data, yet many doctors take them at face value.
Harvard researcher Aaron Kesselheim, who led the survey, said the results were “disappointing, but not entirely surprising,” noting that few doctors are taught about how the FDA’s regulatory process actually works.
Instead, physicians often rely on labels, marketing, or assumptions—believing that if the FDA has authorised a drug, it must be both safe and effective.
But as The Lever investigation shows, that is not a safe assumption.
And without that knowledge, even well-meaning physicians may prescribe drugs that do little good—and cause real harm.
Who is the FDA working for?
In interviews with more than 100 experts, patients, and former regulators, Lenzer and Brownlee found widespread concern that the FDA has lost its way.
Many pointed to the agency’s dependence on industry money. A BMJ investigation in 2022 found that user fees now fund two-thirds of the FDA’s drug review budget—raising serious questions about independence.
Yale physician and regulatory expert Reshma Ramachandran said the system is in urgent need of reform.
“We need an agency that’s independent from the industry it regulates and that uses high quality science to assess the safety and efficacy of new drugs,” she told The Lever. “Without that, we might as well go back to the days of snake oil and patent medicines.”
For now, patients remain unwitting participants in a vast, unspoken experiment—taking drugs that may never have been properly tested, trusting a regulator that too often fails to protect them.
And as Lenzer and Brownlee conclude, that trust is increasingly misplaced.
- Investigative report by Jeanne Lenzer and Shannon Brownlee at The Lever [link]
- Searchable public drug approval database [link]
- See my talk: Failure of Drug Regulation: Declining standards and institutional corruption
Australia quietly pivots on Covid-19 vaccine policy
By Maryanne Demasi, PhD | June 3, 2025
It didn’t come with a press conference or a media blitz. In fact, there was no announcement at all.
But sometime around 2 May 2025, the Australian Department of Health quietly removed its recommendation for Covid-19 vaccination in healthy children and adolescents under 18.
The change was tucked into an online update to the Australian Immunisation Handbook—no headline, no ministerial statement, no media campaign to inform the public.
For the first time since the rollout began, Australian health authorities now say that unless a child has underlying medical conditions, they do not need the vaccine.
Australia now joins a growing list of countries backing away from the blanket approach to vaccinating low-risk populations.
In the US, health officials under HHS Secretary Robert F. Kennedy Jr. recently removed routine recommendations for Covid-19 vaccination in healthy children and pregnant women.
The CDC now leaves it up to “shared decision-making”—a tacit acknowledgment that the previous universal approach may have overreached.
Denmark, meanwhile, was ahead of the curve.
It stopped recommending the vaccine for healthy children back in 2022, citing data showing that severe Covid in children was exceedingly rare and that the benefits of mass vaccination did not outweigh the harms.
Australia’s policy reversal might be late, but what makes it striking is how quietly it was done—and how much it implicitly concedes.
For years, anyone who questioned the need to vaccinate healthy children was dismissed as anti-science or dangerous. Now, the same authorities who widely promoted the shots are quietly walking it back.
And the adverse events that critics raised early on—myocarditis, pericarditis, and other post-vaccine complications—are no longer fringe concerns. They’re acknowledged in official risk assessments.
The shift also comes at a time when the legal and regulatory framework that enabled the rapid approval of mRNA vaccines is under growing scrutiny.
In Australia, a case brought by Dr Julian Fidge, a general practitioner and former pharmacist, challenged the legality of the vaccine approvals.
He argued that Pfizer and Moderna’s mRNA vaccines should have been classified as “genetically modified organisms” under the Gene Technology Act 2000, and therefore required a licence from the Office of the Gene Technology Regulator (OGTR) before being rolled out.
But the court dismissed the case on procedural grounds, ruling that Dr Fidge lacked standing to pursue it.
Still, the case drew attention to whether these products were channelled through the wrong regulatory pathway.
That question is now at the centre of a citizen petition in the US, filed with the FDA in January 2025, claiming the agency “wrongfully and illegally” approved the mRNA Covid-19 vaccines by treating them as conventional biologics, not gene therapies.
According to the FDA’s own definition, gene therapy products are those that use genetic material to alter cellular function for therapeutic use.
By that logic, mRNA vaccines clearly qualify – and should have faced far more rigorous safety testing, including environmental risk assessments and long-term follow-up studies.
As of June, the FDA has not responded to the petition—but the implications are enormous.
If regulators in Australia or the US misclassified these products during the emergency rush, it would expose a systemic failure to apply the appropriate safeguards to an entirely new class of biotechnology.
And it’s not just about legal definitions. The public mood is shifting.
The notion that healthy children and adolescents should have been part of a sweeping global experiment with novel gene-based technologies now looks reckless in hindsight. For the public, trust has been damaged—perhaps irreparably.
That shift in perception has consequences far beyond Covid.
Billions of dollars have been invested in mRNA platforms for other diseases—flu, RSV, and cancer. So what happens if confidence in the technology craters?
Already, the US FDA has announced it will require new randomised clinical trials for annual Covid-19 boosters in “healthy” people under 65—setting a higher threshold for evidence (than immunobridging data) that may make future approvals more challenging.
The industry might dismiss this as just a hiccup—but the truth is, mRNA vaccines were never subjected to the kind of long-term scrutiny typically required of products given to healthy people, especially children.
The argument that urgency justified shortcuts has worn thin.
The real emergency now is institutional—one of captured regulators, collapsing public trust, and a health system so entangled with the pharmaceutical industry it can no longer tell the difference between evidence and marketing.
Is the FDA a mutinous ship?
By Dr Clare Craig | Health Advisory & Recovery Team | June 3, 2025
They promised change. They promised transparency. They promised reform. But with the FDA’s latest approval of Moderna’s mNEXSPIKE® covid jab, it is clear the only thing that has changed is the branding.
This so-called “reformed” FDA has just authorised a new mRNA vaccine — without testing it against a placebo. Instead, the comparator was Moderna’s previous product, already associated with a range of known adverse effects.
And yet, somehow, we’re meant to believe this is progress.
Meanwhile, the leaders heading up MAHA, elected on a promise to end the regulatory theatre and restore public trust, appear to be captaining a vessel still drifting in the same dangerous waters. They are on a mutinous ship and are wrestling for the wheel.
While the FDA continues to greenlight successive iterations of mRNA vaccines, other major Western nations long since reduced their ambitions:
- In the United Kingdom, the Joint Committee on Vaccination and Immunisation (JCVI) now recommends boosters only for individuals aged 75 and over, residents of care homes, and those with specific clinical vulnerabilities.
- France and Germany have similarly curtailed their booster programmes, focusing on high-risk populations and refraining from broad recommendations for younger, healthier demographics.
This more cautious approach is not justifiable either given the failure of these product and their safety profile. The “benefit” only ever was – and continues to be – a statistical illusion. No one should be being exposed to this unnecessary risk.
This divergence raises a critical question: How can the same body of evidence lead to such different public health policies?
Latest Inadequate Trials
The Phase 3 trial underpinning mNEXSPIKE’s approval enrolled approximately 11,400 participants aged 12 and older. While this number might seem substantial, it’s important to note that only about half received the mNEXSPIKE vaccine, while the remainder received an earlier Moderna product as a comparator. There was no placebo comparison.
This sample size is insufficient to detect rare but serious adverse events – even with a placebo. Without one you can only see differences between two sets of harm.
For context, previous studies have indicated that mRNA vaccines may be associated with an excess risk of serious adverse events of special interest, estimated at approximately 15.1 per 10,000 vaccinated individuals. This is totally unacceptable for general use even in a product that has significant benefits.
Despite approval, critical safety studies are still pending. One study, assessing safety in pregnant women, is not due until 2032. Another, evaluating vaccine effectiveness for adults aged 50–64, is still in the planning stages.
Are the FDA still pretending there is an emergency to justify these rushed decisions?
A Hollow Reformation
The USA public deserves better from their officials. They are paying for this reckless approach. The question is, can those with a more precautionary, less ideological approach, wrestle the wheel of the ship and steer her to safety?
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