The U.S. Environmental Protection Agency (EPA) can no longer ignore that risk, and must take regulatory action, Judge Edward Chen of the U.S. District Court of the Northern District of California wrote in the long-awaited landmark decision.

More than 200 million Americans drink water treated with fluoride at the “optimal” level of 0.7 milligrams per liter (mg/L). However, Chen ruled that a preponderance of scientific evidence shows this level of fluoride exposure may damage human health, particularly that of pregnant mothers and young children.

The verdict delivers a major blow to the EPA, public health agencies like the Centers for Disease Control and Prevention (CDC) and professional lobbying groups like the American Dental Association (ADA), which have staked their reputations on the claim that water fluoridation is one of the greatest public health achievements of the 20th century and an unqualified public good.

Fluoride proponents refused to reexamine that stance despite mounting scientific evidence from top researchers and government agencies of fluoride’s neurotoxic risks, particularly for infants’ developing brains.

Instead, they attempted to weaken and suppress the research and discredit the scientists carrying it out.

Rick North, board member of Fluoride Action Network, one of the plaintiffs in the lawsuit, told The Defender, “What’s false is the CDC claiming that fluoridation is one of the 10 greatest health achievements of the 20th century. What’s true is that ending fluoridation will be one of the 10 greatest health achievements of the 21st century.”

“The judge did what EPA has long refused to do, and that is to apply the EPA standard risk assessment framework to fluoride,” said Michael Connett, attorney for the plaintiffs. “In so doing, the court has shown that the widespread exposure to fluoride that we now have in the United States is unreasonably and precariously close to the levels that we know cause harm.”

The EPA can appeal Tuesday’s decision. The agency told The Defender it is reviewing the decision and has no comment at this time. The U.S. Department of Justice, which represents the EPA in the lawsuit, also said it has no comment.

EPA’s argument ‘not persuasive’

The ruling concludes a historic lawsuit — one that has dragged on for seven years — brought against the EPA by environmental and consumer advocacy organizations like the Fluoride Action Network, Moms Against Fluoridation and Food & Water Watch, along with individual parents and children.

It is the first lawsuit to go to a federal trial under the Toxic Substances Control Act (TSCA), as amended by Congress in 2016. The TSCA allows U.S. citizens to petition the EPA to evaluate whether a chemical presents an unreasonable risk to public health and should be regulated.

If the EPA denies a TSCA citizen petition — which the agency did when the plaintiffs asked it to reexamine water fluoridation in 2016 — the petitioners are entitled to a “de novo” judicial review of the science without the deference to the agency typically afforded it in legal cases.

Chen’s 80-page ruling, issued six months after closing arguments in February, offers a careful and detailed articulation of the EPA’s review process for chemicals that pose a hazard to human health and evaluates and summarizes the extensive scientific data presented at trial.

Chen wrote, “EPA’s own expert agrees that fluoride is hazardous at some level.” He cited a key report issued by the U.S. Department of Health and Human Services (HHS) National Toxicology Program (NTP), which undertook a systematic review of all available scientific research at the time of publication.

The report “concluded that fluoride is indeed associated with reduced IQ in children, at least at exposure levels at or above 1.5 mg/L,” Chen wrote.

The NTP also reported that although there are technical challenges to measuring fluoride’s toxic effects at low levels, “scientists have observed a statistically significant association between fluoride and adverse effects in children even at such ‘lower’ exposure levels,” Chen wrote.

He said that despite recognizing that fluoride is hazardous, the EPA’s defense rested largely on the fact that the exact level at which it is hazardous is too unclear for the agency to determine whether the chemical presents an unreasonable risk.

This argument is “not persuasive,” Chen wrote.

Pregnant women exposed to fluoride in water at levels exceeding the hazard level

The EPA requires a margin of error by a factor of at least 10 to exist between the hazard level for a toxin and the acceptable human exposure level. “Put differently, only an exposure that is below 1/10th of the hazard level would be deemed safe under Amended TSCA, given the margin of error required,” Chen wrote.

That means that even if the hazard level were 4 mg/L — well above the 1.5 mg/L identified by the NTP — the safe level of fluoride exposure would be 0.4 mg/L, well below the current “optimal” fluoride level in the U.S., Chen wrote.

The much lower probable hazard level established by high-quality studies indicates that many pregnant women in the U.S. are already exposed to fluoride in water at levels exceeding the hazard level.

“Under even the most conservative estimates of this level, there is not enough of a margin between the accepted hazard level and the actual human exposure levels to find that fluoride is safe,” Chen concluded.

“Simply put, the risk to health at exposure levels in United States drinking water is sufficiently high to trigger regulatory response by the EPA under Amended TSCA.”

The law dictates that the EPA must take regulatory action, but it does not specify what that action has to be. EPA regulatory actions can range from notifying the public of risks to banning chemicals.

Philippe Grandjean, M.D., Ph.D., adjunct professor in environmental health at Harvard and chair of environmental medicine at the University of Southern Denmark, top researcher on fluoride’s neurotoxicity and expert witness for plaintiffs in the case told The Defender he thought the court’s decision was “well-justified.”

He said the ruling made it incumbent on the EPA to go beyond simply ending water fluoridation.

“EPA will have to consider what to do in the southwestern parts of the country where the fluoride content of groundwater is too high due to minerals in the soil containing fluoride,” he said. “And then there is the question about ingestion of toothpaste.”

The CDC and the ADA did not immediately respond to The Defender’s request for comment.

More than 70 years of controversy

For more than seven decades, U.S. public health officials have steadfastly supported water fluoridation, claiming the practice is a key strategy for maintaining and improving dental health.

Proponents of water fluoridation, with help from the mainstream press, often attempted to cast those questioning fluoride’s benefits and raising concerns about its safety as conspiracy theorists.

The EPA in 1975 recommended adding fluoride to water at an optimal level of 1.2 mg/L for its dental benefits, but recommended a maximum level of 4 mg/L, the ruling said.

As more evidence has emerged about fluoride’s adverse health effects, including skeletal fluorosis, recommended levels were revised.

Surgeon General Vivek Murthy, officially lowered the recommended dosage for water fluoridation in 2015 from 0.7-1.2 mg/L to 0.7 mg/L after considering “adverse health effects” along with alleged benefits.

However, evidence that fluoride poses a neurotoxic risk has existed for decades.

In 2017, after the EPA rejected their citizen petition to end fluoridation of drinking water in the U.S. based on evidence of health risks, namely neurotoxicity, the plaintiffs filed the lawsuit.

A seven-day trial took place in federal court in San Francisco in June 2020, but Chen put the proceedings on hold pending the release of the NTP’s systematic review of research available on the neurotoxic effects of fluoride.

The NTP sought to publish its report — which consisted of a “state of the science” monograph and a meta-analysis — in May 2022, but dental officials at the CDC and the National Institutes of Health National Institute of Dental and Craniofacial Research pressured HHS Assistant Secretary for Health Rachel Levine to prevent the review from being published.

The ADA also sought to suppress the report.

Levine told the NTP to not publish the report but to put it on hold and allow for further review.

Plaintiffs submitted documents obtained via the Freedom of Information Act exposing this intervention to the court. The revelation prompted Chen to rule that the trial should go forward using the draft report from the NTP.

The trial resumed in January in San Francisco, with arguments presented over the course of two weeks.

The NTP’s monograph was finalized and published last month on its website. The meta-analysis is forthcoming in a peer-reviewed journal.

Connett said that Congress created the citizen petition provision in TSCA as a counterweight to bureaucratic lethargy and as a check on the EPA.

The statute, he said, is a powerful tool for overcoming politicized science.

“When science becomes fossilized in political inertia, the citizen petition provision of TSCA is a very powerful tool for citizens,” Connett said. “Through this case, we have been able to, I think we’ve been able to effectuate what Congress had envisioned with this part of the statute.”

The report by the U.S. House of Representatives Committee on Small Business stated:

“The Federal government has funded, developed, and promoted entities that aim to demonetize news and information outlets because of their lawful speech.”

The government’s actions fueled “a censorship ecosystem” that suppressed “individuals’ First Amendment rights” and “the ability of certain small businesses to compete online.”

The report focused on the State Department’s Global Engagement Center (GEC), which promoted and funded “tech start-ups and other small businesses in the disinformation detection space … with domestic censorship capabilities.”

The “fact-checking” firms named in the report include the International Fact-Checking Network — owned by the Poynter Institute — and NewsGuard.

The International Fact-Checking Network, established in 2015, has received funding from another State Department-affiliated group, the National Endowment for Democracy — and from Google, the Open Society Foundations and the Bill & Melinda Gates Foundation.

According to the House report, the federal government “assisted the private sector in detecting alleged MDM [misinformation-disinformation-malinformation] for moderation” and “worked with foreign governments with strict internet speech laws,” including European Union member states and the United Kingdom, to censor speech.

The report determined that the GEC and the National Endowment for Democracy violated international restrictions by “collaborating with fact-checking entities” to assess the content of domestic media outlets.

The “fact-checking” operations targeted independent media outlets, and as a result, “the scales are tipped in favor of outlets which express certain partisan narratives rather than holding the government accountable.”

Whether the State Department’s actions rise to “unconstitutional violations of the First Amendment is currently before the courts,” the report stated.

The State Department and several GEC officials are defendants in Murthy v. Missouri, a lawsuit alleging the Biden administration colluded with social media to censor free speech.

Children’s Health Defense (CHD) and its chairman on leave, Robert F. Kennedy Jr., are plaintiffs in Kennedy v. Biden, a similar lawsuit that last year was consolidated with Murthy v. Missouri.

The Poynter Institute is a defendant in another censorship lawsuit, CHD v. Meta, that CHD filed against Facebook’s parent company.

NewsGuard partnered with CDC, WHO to censor online content

According to the report, NewsGuard used money it received from the GEC and the U.S. Department of Defense to fund efforts to lower the advertising revenue “of businesses purported to spread MDM.”

“A system that rates the credibility of press is fatally flawed as it is subject to the partisan lens of the assessor, making the ratings unreliable,” the report states.

NewsGuard leveraged taxpayer dollars to develop Misinformation Fingerprints, a product that “catalogues what it determines to be the most prominent falsehoods and ‘misinformation narratives’” circulating online, “essentially outsourcing the U.S. government’s perception of fact to NewsGuard,” the report states.

NewsGuard later partnered with dozens of companies, organizations, universities and media outlets, including the Centers for Disease Control and Prevention, the Office of the Surgeon General and the World Health Organization (WHO).

“During the pandemic, the WHO enlisted NewsGuard for its input, including regular reports, on which COVID-19 narratives it determined to be misinformation were prevalent online,” the report states. “The WHO then contacted social media companies and search engines asking them to remove this content.”

‘Nobody wanted’ fact-checkers until ‘actual truths started getting out’

Tim Hinchliffe, publisher of The Sociable, told The Defender, “These so-called ‘fact-checkers’ are not in the business of actually checking facts. They are in the business of controlling narratives … Nobody wanted or needed these organizations until actual truths started getting out.”

Catherine Austin Fitts, founder and publisher of the Solari Report and former U.S. assistant secretary of Housing and Urban Development, told The Defender the government increasingly relies on censorship to promote its favored narratives.

“They need to institute more and more censorship,” Fitts said. “It’s hard to refute the gaslighting that flows from this imagination factory.”

Francis Boyle, J.D., Ph.D., professor of international law at the University of Illinois, told The Defender he wasn’t surprised that the State Department is “working to censor those who disagree with U.S. government policies and their globalist agenda.”

The report recommends that no federal funds “should be used to grow companies whose operations are designed to demonetize and interfere with the domestic press” and that federal agencies “should not be outsourcing their perception of fact to speech-police organizations subject to partisan bias.”

GEC also faces the loss of its government funding. According to the Washington Examiner, “A provision through the annual State Department appropriations bill, which passed the House this summer and will be negotiated in the Senate, aims to ban future checks to the GEC.”

But for Boyle, this is not enough. He said the State Department has, “at a minimum,” committed “the federal crime of conspiracy to defraud the U.S. government.”

Censorship ‘a pendulum that swings both ways’

The Gateway Pundit last week reported on additional links between the International Fact-Checking Network, other “fact-checking” firms and Big Tech.

In 2015, Poynter partnered with Google News Lab, which earlier that year, helped establish First Draft News. Active until 2022, First Draft was a consortium of social media verification groups that shared methods for combating “fake news.”

Another First Draft founder, fact-checking firm Bellingcat, also received funding from the National Endowment for Democracy.

First Draft was previously led by Claire Wardle, Ph.D., a Brown University professor who, according to “Twitter Files” released last year, advised the Biden administration on COVID-19 “misinformation” — despite having no science or medical credentials.

In 2016, Poynter and the International Fact-Checking Network partnered with First Draft “to tackle common issues, including ways to streamline the [news] verification process.” Other partners included Facebook, Twitter, YouTube, The New York Times, The Washington Post, CNN, ABC News, NBC News and BBC News.

In 2017, Google News Lab partnered with the International Fact-Checking Network “to dramatically increase the searchable output of fact-checkers worldwide, expand fact-checking to new markets and support fact-checking beyond politics, such as in sports, health and science.” The following year, Poynter acquired PolitiFact.com.

Google was also one of the original funders of The Trust Project, a consortium of news organizations that developed eight “trust indicators” to help the public “easily assess the integrity of news.”

These “trust indicators” later became “one of the sources being used by NewsGuard Technologies for a new product to improve news literacy,” and formed “a foundation for NewsGuard review development.”

Hinchliffe warned that the beneficiaries of censorship based on today’s “fact-checking” may become its targets in the future.

“One of the problems of censorship that operates under the guise of misinformation and disinformation, apart from stifling free speech and suppressing actual truths, is that it’s a pendulum that swings both ways,” he said. “The people calling for censorship now may be in a greater position of power to do so, but it will one day swing back at them.”

The Defender on occasion posts content related to Children’s Health Defense’s nonprofit mission that features Mr. Kennedy’s views on the issues CHD and The Defender regularly cover. Mr. Kennedy, an independent candidate for president of the U.S., is on leave from CHD. In keeping with Federal Election Commission rules, this content does not represent an endorsement of Mr. Kennedy’s candidacy or his support for President Donald Trump’s campaign.

WHO’s approval of Bavarian Nordic’s vaccine will help governments and international agencies such as the Gavi, the Vaccine Alliance, and UNICEF, buy it, MedicalXpress reported.

The MVA-BN vaccine — short for “Modified Vaccinia Ankara-Bavarian Nordic” — is a smallpox/mpox vaccine. It is sold in the U.S. under the name Jynneos.

WHO Assistant Director-General Yukiko Nakatani said, “The decision can also help national regulatory authorities to fast-track approvals, ultimately increasing access to quality-assured mpox vaccine products.”

Children’s Health Defense (CHD) Chief Scientific Officer Brian Hooker called the WHO’s approval of the shot for infants and children in Africa “a train wreck in the making.”

Hooker told The Defender:

“The safety profile is abysmal in adults (up to 2.1% serious cardiac events in clinical trials) and the vaccine has not been adequately tested for efficacy or safety in pediatric populations.

“In other words, the WHO has no idea whether it will work nor do they know how much damage it will do. The WHO has again abandoned good public health principles and waved their magic vaccine wand on the mpox outbreak.”

Dr. David Bell, a public health physician and biotech consultant, also criticized the WHO for overly focusing on mpox vaccines and neglecting to address broader public health issues in Africa.

“So far this year, about 40,000 children have died from malaria in the DRC [Democratic Republic of Congo] alone, and similar numbers of people from malnutrition, tuberculosis and HIV/AIDs,” Bell said.

Although these numbers “obviously dwarf” the number of mpox deaths, the WHO is allocating fewer resources to addressing them.

Bell — who formerly served as a medical officer and scientist at the WHO — explained what he sees occurring:

“We have become much better at detecting much rarer diseases such as mpox, and addressing these is certainly more lucrative for the growing industry feeding off the WHO’s misinformation regarding rapidly rising pandemic risk.

“However, it is clear that the people of DRC and Africa in general would benefit far more if WHO returned to impactful public health. There has been a move over recent years to a concentration on addressing the symptoms of diseases of poverty (which mpox is) with Western-developed commodities, rather than dealing with underlying causes.

“This signals a return to colonialist-era approaches rather than evidence-based public health. It presumably reflects the way WHO is now funded, with increasing control from the private sector and a few large Western nations with large Pharma industries.”

No clinical trials on kids

In its press release, the WHO said the MVA-BN vaccine can be administered to adults over 18 as a two-dose injection four weeks apart but can also be given as a single dose “in supply-constrained outbreak situations.”

“While MVA-BN is currently not licensed for persons under 18 years of age,” it said, “this vaccine may be used ‘off-label’ in infants, children and adolescents, and in pregnant and immunocompromised people.”

The WHO called for more data on the vaccine’s safety and efficacy in these situations.

The WHO Strategic Advisory Group of Experts on Immunization — which reviewed all available evidence and recommended the use of MVA-BN vaccine — noted in its Weekly Epidemiological Record report that “MVA-BN has not been specifically studied in clinical trials in children.”

However, they said:

“The same non-replicating MVA viral vector is used as a platform for other vaccines that include MVA-filo (Mvabea) against Ebola virus disease (EVD).

“The EVD vaccine is approved by the EU for adults and children aged 1 year and older. Data from 5 published studies on MVA-BN as a viral vector platform for the prevention of EVD, with a total population of 52 229 children, support the favourable safety profile of the product.”

The authors of a new study — published Sept. 11 in The BMJ — presented results on MVA-BN’s effectiveness in adult males but said nothing about children or pregnant women.

In 2023, researchers funded by the UK Health Security Agency looked at the health outcomes of 87 children who received a single dose of MVA-BN.

They reported that the vaccine was “well tolerated” but that larger studies needed to be done to fully assess the shot’s safety and efficacy in kids.

The Defender asked Bavarian Nordic for information about its mpox vaccine in pediatric populations but did not receive a response by the deadline.

The WHO’s process for granting a drug “prequalification” approval for “emergency use listing” requires drugmakers to “commit to continue generating missing information to fulfill prequalification requirements.”

“Once this information becomes available,” the WHO said, “a PQ [prequalification] application should be submitted to complete the full process to achieve  recommendation for international procurement in both emergency and non-emergency settings.”

It is unclear how much pediatric safety and efficacy data Bavarian Nordic has collected so far and what it showed.

Mpox vaccine approved for U.S. kids and teens since 2022

The U.S. Food and Drug Administration (FDA) in 2022 granted emergency use authorization for the vaccine for “in individuals less than 18 years of age determined to be at high risk for monkeypox infection.”

Jynneos has been licensed for use in U.S. adults since 2019.

The Centers for Disease Prevention and Control (CDC)’s mpox vaccination website states that while teens and children at risk for mpox can receive Jynneos, it is not recommended for babies under 6 months.

The CDC also says Jynneos can be given to pregnant or breastfeeding women.

Although it remains unknown if Jynneos may pose risks to a developing fetus if taken during pregnancy, animal studies haven’t shown any harm to developing fetuses when the vaccine was given to pregnant animals, the agency said.

However, the study authors downplayed the finding by reporting that “overall outcomes were good,” according to Dr. Peter McCullough — a cardiologist and author of more than 1,000 publications — who analyzed the study on his Substack.

“In the COVID-19 crisis,” McCullough said, “we have learned to look at the data and the analyses ourselves because there are usually very important results downplayed by the authors — this time it is vaccine myopericarditis mortality.”

McCullough combined the numbers from the study’s results for myocarditis and pericarditis cases to show that 97 of the 1,014 (9.6%) myopericarditis cases were fatal.

Myopericarditis is an umbrella term for myocarditis, inflammation of the heart, and pericarditis, inflammation of the tissue surrounding the heart.

“A 9.6% case fatality rate for a vaccine side effect largely in young healthy men is astronomical and clinically unacceptable,” he said.

McCullough criticized the authors’ conclusion that “overall outcomes were good.”

“This can never be the conclusion when the case fatality rate was 97/1014 cases with followup out to 64 days after the shot,” he said.

The study authors extracted data from April 2004 to December 2023 in the Japanese Adverse Drug Event Report (JADER) — a large database for public reporting of adverse events — among people ages 12 and up who experienced myocarditis or pericarditis after getting an mRNA COVID-19 shot.

Among 759 reports of vaccine-induced myocarditis and 255 reports of pericarditis, 84 (11%) and 13 (5%) individuals died within 64 days of an mRNA COVID-19 shot, respectively.

The study, which is in press, was available online early this month in the Journal of Infection and Chemotherapy.

The Defender reached out to the study’s corresponding author — Kazuaki Taguchi, Ph.D., with the Faculty of Pharmacy at Keio University in Tokyo — for comment about the team’s conclusions but did not receive a response by the deadline.

Japanese males under 30 ‘should promptly seek medical assistance’

Taguchi and his co-authors said they undertook the study to clarify the association between mRNA vaccines and myocarditis/pericarditis.

They concluded that in the Japanese population, COVID-19 mRNA vaccination was “significantly associated with the onset of myocarditis/pericarditis.” They noted that influencing factors included being under 30 years old and male.

Japanese males under 30 should “promptly seek medical assistance for inspection and treatment upon experiencing chest symptoms after vaccination,” they wrote.

For the study, the authors first looked at adverse event reports to determine how soon after an mRNA vaccination people reported the onset of myocarditis or pericarditis.

The majority of cases occurred within a week of getting the vaccine. They noted that prior studies found a similar trend.

“Considering the results of the present study and previous reports,” they wrote, “it is necessary to pay particular attention to the onset of myocarditis and pericarditis within 7 days after SARS-CoV-2 mRNA vaccination.”

The authors then analyzed the outcome of the myocarditis and pericarditis cases — such as full recovery, remission, ongoing or increased symptoms, or death.

Among the cases they analyzed, half of the people who reported getting pericarditis and nearly half (47%) of those who reported getting myocarditis recovered, they said.

Another 37% and 31% of pericarditis cases and myocarditis cases, respectively, reported being in “remission.”

They noted a “severe outcome” or “non-recovery” — but not death — occurred in 8% (20) of the pericarditis cases and 11% (80) of the myocarditis cases. As noted earlier, death occurred in 11% of the myocarditis cases and 5% of the pericarditis cases.

The authors appeared to not investigate the amount of time between onset and outcome. Also, because they examined myopericarditis cases that occurred between one and 64 days after vaccination, their study didn’t report on changes in outcome — such as improvement or worsening in symptoms — that happened more than 64 days post-vaccination.

The Japanese study received no funding from any government agency, for-profit or nonprofit group.

‘These data are just the tip of the iceberg’

According to McCullough, “These data are just the tip of the iceberg,” as prior studies suggest the risk of heart damage goes up roughly 2.5% with each successive booster and that half of myopericarditis cases may be subclinical, meaning asymptomatic.

The Japanese study looked only at the reports from symptomatic myopericarditis cases.

Taguchi and his co-authors said they couldn’t analyze the relationship between the number of vaccinations and the risk of myocarditis/pericarditis “due to the difficulty in determining the timing of the dose.” They called for more research.

McCullough said the Japanese data may not accurately show all cardiac harm caused by mRNA COVID-19 vaccines because some subclinical myopericarditis cases may only manifest later on — beyond the study’s 64-day window of inquiry — as cardiomyopathy, heart failure or sudden death.

Cardiomyopathy is a disease of the heart muscle that causes the heart to have a harder time pumping blood to the rest of the body, which can lead to symptoms of heart failure, according to the Mayo Clinic.

CDC fails to mention risk of death from vaccine-induced myopericarditis

McCullough pointed out that the Centers for Disease Control and Prevention’s (CDC) official guidance to U.S. healthcare practitioners regarding myopericarditis in teens and young adults after receipt of a COVID-19 vaccine fails to mention that the condition can be fatal.

The CDC’s Clinical Considerations website states:

“The severity of myocarditis and pericarditis cases can vary; most patients with myocarditis after mRNA COVID-19 vaccination have experienced resolution of symptoms by hospital discharge.”

McCullough said, “Hospitalization is a concerning outcome for any young person after taking a vaccine that should be safe and have a meaningful health benefit.”

The CDC’s Myocarditis and Pericarditis After mRNA COVID-19 Vaccination website similarly neglects to mention that the condition can be fatal.

The Defender asked the CDC if it plans to update the website by notifying the public about the risk of fatality but did not receive a response by the deadline.

Researchers from the Zucker School of Medicine in New York reviewed a World Health Organization global database of adverse drug effects between November 2000 and August 2023.

They compared reporting rates for semaglutide — the active ingredient in the blockbuster drugs — to other similar weight-loss drugs and all drugs in the database. They found that semaglutide was associated with “disproportionately increased reporting of suicidality.”

“Authorities should consider issuing a warning to inform about this risk,” the authors concluded, particularly given the increasing off-label use of the drug. They said in half of the cases where suicidal thoughts occurred, the drug was being taken off-label.

The signal “warrants urgent clarification,” they added.

The researchers also found a higher risk for suicidal thoughts among people on antidepressants or benzodiazepines, likely prescribed for depression or anxiety, who were also taking semaglutide.

They recommended that physicians who prescribe semaglutide inform patients of the risk and assess their psychiatric history and mental state before prescribing the drug.

‘If you want to check if a drug causes suicidality, you have to interview people’

In more than half of the cases the researchers studied, suicidal thoughts stopped when people stopped taking the drugs.

Dr. David Healy, a psychiatrist who was not involved in the study, told The Defender this was one of the more significant findings. The overall number of suicidal thoughts reported was small, he said, but the proportion of cases where the thoughts stopped when the drug was stopped was high.

This is telling, he said. However, he said investigations must happen at the clinical level to determine causality. “If you want to check if a drug causes suicidality — you have to interview people,” he said.

The researchers also found a slight increase in reports of suicidal ideation in the database for the earlier version of the weight loss medication, liraglutide — sold under the brand name Victoza and Saxenda.

Liraglutide is in the same broader class of glucagon-like peptide-1 (GLP-1) receptor agonist drugs as semaglutide.

Accompanying commentary by authors Francesco Salvo, M.D., Ph.D., of the Université de Bordeaux and Jean-Luc Faillie, M.D., Ph.D., of the Université de Montpellier in France, affirmed that GLP-1 receptor agonists should be prescribed with “great caution in patients with a history of depression or suicidal attempts.”

They added that the drug should be discontinued if new depression symptoms occur when on the drugs.

FDA and EMA claim no evidence of link

The injectable prescription drugs were originally developed to manage blood sugar levels in the treatment of Type 2 diabetes, but they became wildly popular over the last several years for their ability to help people lose weight.

GLP-1 receptor agonists are chemicals derived from lizard venom that can change people’s metabolism and eating behaviors as long as they continue to take the drugs.

When people stop taking the drugs, they typically regain most or all of the weight they lost.

The drugs have been touted by Oprah Winfrey and other celebrities as a key to overcoming the obesity epidemic.

Mainstream health publications like StatNews have advocated for increasing access to the expensive obesity drugs in the name of racial justice, and there has been growing pressure for the drugs to be covered without restrictions by Medicare.

And medical organizations like the American Academy of Pediatrics rushed to recommend the drugs for children as young as 8, just weeks after they were approved by the U.S. Food and Drug Administration (FDA) for children.

And in October 2023, Novo Nordisk announced that it is testing semaglutide in children as young as 6.

The drugs are new to the market. Novo Nordisk, the Danish pharmaceutical company that makes Ozempic, Wegovy and Saxenda only published its clinical trial showing weight loss effects of semaglutide in February of 2021 and the FDA approved Wegovy for weight loss in June 2021.

Between 2020 and 2023, GLP-1 receptor agonists use increased by 594% in young people, particularly among women.

Despite the hype, serious concerns have been raised about the safety of the drugs. They’ve been linked to cancers in the digestive system, thyroid cancer, stomach paralysis, a wide range of other gastrointestinal disorders, among other issues and the drugs pose a serious but little-known risk for pregnant women.

Last year, suicidal ideation linked to Ozempic and Saxenda, and one case of self-harm ideation linked to Saxenda were reported in Iceland, which led to an investigation by the European Medicines Agency (EMA). Similar reports were also made to the FDA.

The EMA reported in April that its follow-up investigation, which reviewed non-clinical studies, clinical trials and postmarketing surveillance data, “does not support a causal association” between GLP-1 drugs and suicidal or self-harm thoughts.

The FDA reported in January that its investigation of reports to the FDA Adverse Event Reporting System (FAERS) showed no safety signal for the drugs and that it had a meta-analysis underway.

A study published in Nature in January found no link between the drugs and suicidal thoughts

The EMA continues to maintain that no warning is warranted, but in U.S. labeling, the product information for semaglutide does list thoughts of suicide as a possible side effect.

Novo flagged “several limitations” of the new study and maintained that it will continue to work with the FDA and other regulators to monitor the safety of the drugs, Fierce Pharma reported.

“We stand behind the safety and efficacy of all of our GLP-1RA medicines when they are used as indicated and when taken under the care of a licensed healthcare professional,” the spokesperson said. “The known risks associated with use of these medicines are reflected in their current FDA- and EMA-approved product labeling.”

Suicidal thoughts and suicides occurred in clinical trials

Despite the EMA and FDA’s continued claims of safety for GLP-1 agonists, in the clinical trials for liraglutide there was a higher incidence of suicidal thoughts versus the placebo, although the number was not statistically significant, the Japanese journal MedCheck reported in its overview of the drug, recommending against its use.

In another liraglutide trial, reported in the New England Journal of Medicine, of 125 trial participants, there were three reported suicidal cases — two attempted and one completed suicide. The suicide was judged by the clinicians not to be related to the drug.

In its reporting to the FDA for Wegovy approval, Novo Nordisk also reported a slightly higher rate of suicide, which they said was not statistically significant, among participants in the semaglutide group.

They also reported four fatal events of suicide — one serious attempt and three completed suicides — in blinded data. Because the data were blinded, they reported that it could not be assessed whether the suicides were linked to the drugs.

Some argue that obese people have a mental illness that leads to an increased risk of suicidal ideation, but research doesn’t support that theory. One recent study showed that obese men in the U.S. actually have lower rates of suicidal ideation.

The issue of suicidal thoughts linked to weight-loss drugs has been a major hurdle to the drug industry’s ability to develop lucrative weight-loss drugs.

An earlier weight-loss drug — Sanofi’s Acomplia (rimonabant) — was pulled from European markets because it caused suicidal ideation. It never won approval in the U.S.

Diet pills Contrave by Currax Pharmaceuticals and Qsymia by Vivus, approved in the U.S. in 2014 and 2012, respectively, also carry warnings on their labels about the increased risk of suicidal thoughts.

Perchlorate is a natural and human-made chemical that’s mostly used in the U.S. as a highly water-soluble salt component for rocket fuel and missiles. It’s also used in the production of other explosives, matches, batteries and plastics.

Perchlorate gets into food through contaminated groundwater used to irrigate crops or make processed foods. It’s also transferred to food from plastic food storage containers and old bleach — which can break down into perchlorate — used at food and water processing facilities.

The chemical is known to cause thyroid issues, which increases risk for metabolic disorders, and disruption of the brain and nervous system development in infants.

Federal regulators responsible for food and water safety have for decades been aware of water and soil contamination at locations where perchlorate has been stored, used or manufactured, according to the report, but haven’t taken the steps necessary to protect public health.

About 67% of the samples had ‘measurable’ levels of perchlorate

To assess perchlorate contamination in commonly eaten foods, researchers from Consumer Reports tested 196 samples of 73 grocery store foods and fast food items and their packaging.

About 67% of the samples had “measurable” levels of perchlorate. Overall, foods consumed by babies and children, along with fast food and fresh fruits and vegetables had the highest levels. In terms of packaging, foods in plastic containers had the highest levels, followed by foods in plastic wrap and paperboard.

None of the foods contained dangerous levels of perchlorate. However, the report said, that several servings of many of the foods in a day could add up to hazardous levels.

Also, because the chemical is present in so many foods, exposure over time can be dangerous — especially for pregnant women and children.

The researchers didn’t name the brands investigated. However, they did contact the manufacturers of the contaminated foods, none of whom responded.

James E. Rogers, Ph.D., director of product safety testing at Consumer Reports said, “Regulators should do more to protect the public from contaminants like perchlorate, but at the same time, parents shouldn’t panic about what we found.”

“Feeding your children a wide variety of healthy foods is the best way to make sure they get the nutrients they need and to minimize the potentially harmful effects of contaminants in food and water,” Rogers said.

Key questions answered by the report:

1. How much perchlorate is safe?

The U.S. Environmental Protection Agency (EPA) in 2005 set a “reference dose” or safe exposure level for perchlorate at 0.7 micrograms per kilogram of body weight per day.

However, according to the European Food Safety Authority, perchlorate is safe at only 0.3 micrograms per kilogram of body weight — less than half the level determined safe by the EPA. Many food safety experts think the EPA’s level is too high, according to Consumer Reports.

Children are particularly at risk, even when the amount of perchlorate in food or water is relatively low because they are small and have lower body weight.

The researchers found perchlorate levels in food ranged from about 2 parts per billion to 79 parts per billion, and food in plastic containers averaged about 54 parts per billion.

The report gave some examples of what those numbers could mean. For a child between the ages of 1 and 2, they found that the boxed mac and cheese they tested would give the child 50% of the European Food Safety limit for perchlorate in a day.

The rice cereal, baby multigrain cereal and organic yogurt they tested each would give a child about 25% of the limit and a serving of cucumbers or baby carrots would provide over 50% of the limit, presumably because it had been irrigated with contaminated water.

2. What are the health risks?

According to the EPA, perchlorate toxicity in humans primarily targets the thyroid gland, which plays an important role in regulating metabolism and is key for normal growth and development in infants and children.

Perchlorate is a known endocrine disruptor that can interfere with the thyroid’s ability to absorb iodide, which the body needs to make thyroid hormones.

In adults, this could lead to hypothyroidism and related issues. But for children, the report said, “Thyroid hormones are critical for brain growth and development, and any disruption to that has the potential for lifelong effects.”

According to the report, research has shown that women with thyroid dysfunction who have higher perchlorate exposures during pregnancy have children who are three times as likely to show negative cognitive effects, including lowered IQ.

3. Why isn’t perchlorate regulated?

Because it is so difficult for consumers to avoid perchlorate, Consumer Reports said it is important for regulators to act — but the EPA and the U.S. Food and Drug Administration (FDA) haven’t done much to protect public health, despite knowing about the problem since 1985.

At that time, perchlorate contamination was identified in wells near California Superfund sites — remnants of weapons testing by the U.S. Department of Defense — according to a report by the National Academies of Sciences, Engineering, and Medicine.

Despite several public controversies over perchlorate, the FDA in 2005 permitted companies to use the chemical in food-contact materials. Within a few years, high levels of the chemical were detected in baby food that uses the packaging, the report said.

In 2019, the FDA for the third time denied a petition by food and environmental advocacy groups to ban the chemical from food packaging.

In 2011, the EPA concluded that between 5.2 and 16.6 million people could be exposed to contaminated water, yet the agency continually delayed plans to set perchlorate limits in drinking water. In 2020, the EPA argued that the chemical didn’t need to be regulated at all, because state and local governments were doing so.

After the Natural Resources Defense Council challenged that decision in a lawsuit, a court ordered the EPA to regulate the chemical. The agency said it will propose new drinking water limits by Nov. 21, 2025.

The EPA should also reconsider its recommended safe level, experts said, and the agency needs to set maximum contaminant levels for perchlorate in water, following the leads of states like Massachusetts, where the limit is 2 parts per billion and California, where it is 6 parts per billion, but with a stated goal to lower it.

Tom Neltner, a chemical engineer and attorney who is the national director for the nonprofit group Unleaded Kids, told Consumer Reports the FDA should revoke permission to use perchlorate in food contact materials.

The report also said the FDA could set a limit for perchlorate in food considering the unique health effects on kids.

The study authors — including Michael Kundi, Ph.D., with the Center for Public Health at the Medical University of Vienna, Austria — said they found “clear evidence for induction of acute toxicity and disturbance of the cell cycle (cytokinesis) as a consequence of exposure” to radiofrequency (RF) radiation levels used by 3G smartphones.

“These processes may possibly lead to the formation of neoplastic cells,” they wrote in their report, published in Environmental Research.

Malignant neoplasms are cancerous tumors, according to the Cleveland Clinic.

Kundi and his co-authors said their study — which used people, not mice — was the “first controlled human intervention trial concerning cytotoxic/genotoxic effects of mobile phone radiation.”

Dr. Rob Brown, a diagnostic radiologist with more than 30 years of experience, told The Defender that the cell damage found in the study “is significant and should be looked at with great concern.”

Brown is also the vice president of scientific research and clinical affairs for Environmental Health Trust (EHT), a nonprofit research and education group focused on the effects of wireless radiation.

He said the study is “particularly valuable” because it is an in-vivo study. “Most research to date exploring the biological effects of electromagnetic fields and radiofrequency radiation has been performed on in-vitro cell cultures, plants and animal models,” Brown said. “Because of this, they have been easier to discount by industry and policymakers.”

Kundi and his co-authors undertook their study because prior research suggests that cellphone radiation “may cause cancer in humans but the underlying molecular mechanisms are currently not known.”

Their results shed light on the molecular mechanisms that may be involved.

For instance, they found that 3G cellphone radiation didn’t cause chromosomal damage, but it did cause the formation of nuclear anomalies that are indicative of “acute cytotoxic effects” and “disturbed cytokinesis.”

Devra Davis, Ph.D., MPH — EHT’s founder and president emerita whose prior research cited “substantial scientific evidence” linking cellphone radiation to cancer — said that just because authors of the Austrian study didn’t find chromosomal damage in the exposed cells shouldn’t be interpreted as suggesting that cancer won’t develop.

“In fact, chromosomal damage is not a necessary precondition for carcinogenesis,” Davis told The Defender. “Carcinogenesis can occur without mutagenesis,” she said, “Factors contributing to cancer include damage to rates of cellular signaling and repair such as were found in this study.”

She said the study — which she called “well-designed” — added to prior studies showing harms from RF radiation by elucidating “additional reasons why phones should not be used close to the head or body.”

Participants wore RF radiation headsets mimicking cellphone radiation exposure

For the study, the authors randomly assigned 41 participants, whose average age was 29, to be in a high RF radiation exposure group — designed to simulate holding a cellphone using 3G next to their head — or a low RF radiation group, ostensibly designed to mimic other real-world exposures to RF radiation.

Participants wore a headset that emitted either high- or low-level RF radiation on one side of the head for two hours on five consecutive days.

The study authors collected buccal smear samples to examine the cells inside both cheeks just before and three weeks after the participants wore the RF radiation headsets.

The researchers also asked the participants to use hands-free devices three weeks before, during and three weeks after the intervention, to minimize other possible cellphone RF radiation to the cheek.

The participants recorded in a journal any potential confounding factors such as gingival bleeding, eating a spicy meal or visiting the dentist during the study timeframe. The journals showed such confounding factors were very rare or not present.

Through scientific analysis of the buccal samples, the researchers found that the cells from the cheeks of participants in the high RF radiation group showed “a significant increase of binucleated cells” — cells that contain two nuclei — “which are formed as a consequence of disturbed cell divisions, and of karyolitic cells, which are indicative for cell death.”

“No such effects were seen in cells from the less exposed side,” they said.

Their analysis revealed increased chromatin fragmentation in the cells, which prior research associated with two forms of cell death: apoptosis and necrosis.

“Both forms of cell death are preceded by condensation of chromatin,” they explained. “Notably in the present study we found also an increase of CC,” or condensed chromatin.

Brown said the findings provide “strong evidence that at least some frequencies emitted by the cellular phone passed through the entire thickness of the cheek’s soft tissue (typically 1 centimeter in thickness or more) to affect the sampled cells.”

He added, “A similar depth of penetration and perhaps even greater should therefore be expected in all parts of the body in which a cellphone may make contact.”

Many young people use a cellphone for more than 2 hours a day

The study authors noted that a limitation of their study was that the participants wore the RF radiation headset for only two hours during each exposure session.

Davis pointed this out, too. “The exposure times used in this study appear much less than those reported in surveys of phone use in many sections of the globe and in younger age groups.”

“For instance,” she said, “Gen Z users report about 6 or more hours daily use of smartphones.”

U.S. Americans on average spend 3 hours and 39 minutes a day on their smartphones, reported ExplodingTopics.com on June 4.

It’s difficult to accurately determine how many of those hours are spent with the phone held close to the head, Davis said.

As a result, insect-containing foods have reached U.S. consumers, even though one of the few existing U.S. laws that address insects in the food supply refers to them as “filth” and a form of “adulteration.”

Crickets and grasshoppers reach U.S. consumers in a variety of forms, from protein bars to protein shakes. They’re also found on restaurant menus and are promoted as pet food and animal feed ingredients.

With few U.S. regulatory barriers to contend with, investors like Bill Gates and Big Food giants such as Tyson Foods have also begun investing in “alternative protein” startups — despite mainstream media “fact-checks” claiming Gates doesn’t support the consumption of insects.

Internist Dr. Meryl Nass, founder of Door to Freedom, told The Defender lax U.S. Food and Drug Administration (FDA) regulations — under which many insect-containing foods can be classified as “Generally Regarded as Safe” (GRAS) — “means they don’t require testing” and enable the FDA to “look the other way.”

“How long will it take before we learn whether these foods are safe? It could take generations,” Nass said.

Gates, U.S. military among backers of ‘alternative protein’ startups

The Bill & Melinda Gates Foundation’s Grand Challenges Explorations program in 2012 funded All Things Bugs, a project to “develop a novel food product made from insects to treat malnutrition in children from famine stricken areas of the world,” according to Eurasia Review.

All Things Bugs has since expanded into the development of genetically modified insects. With funding from the Defense Advanced Research Projects Agency (DARPA), “we are using CRISPR/Cas9 gene editing and other methodologies to develop base technologies for creating insects as a new bioresource,” the company states.

DARPA is a research and development agency that operates under the U.S. Department of Defense.

All Things Bugs said that while insects are “a very sustainable source of protein,” it “is innovating to make them a feasible commodity for the food industry.”

Claire Robinson, managing editor of GMWatch, told The Defender, “With all GMOs [genetically modified organisms], including insects, it’s vital that they are subjected to a pre-marketing risk assessment for health and the environment.”

Robinson said, “This includes testing them for the presence of pathogens, possible allergens and substances that may be toxic to humans. Then they must be clearly labeled for the consumer.”

Gates’ investments in insect-based foods appear to be part of a broader strategy to invest in alternatives to animal-based foods for consumers.

In a February blog post, Gates said he invested in Savor, a startup producing butter made from air (carbon dioxide) and water (hydrogen). And in 2022, the Gates Foundation awarded a $4.76 million grant to Nature’s Fynd, a startup producing foods containing fungi-based protein. In 2020, Breakthrough Energy Ventures, founded by Gates, invested in Nature’s Fynd.

The U.S. government’s National Science Foundation (NSF) also is involved in the insects-as-food space, through its funding of the Center for Environmental Sustainability through Insect Farming (CEIF). Established in 2021, CEIF seeks “to develop novel methods for using insects as feed for livestock, poultry, and aquaculture.”

Institutions participating in CEIF include Texas A&M University, Indiana University-Purdue University in Indianapolis and Mississippi State University — along with Tyson Foods, Protix and Innovafeed, backed by food processing giant ADM, formerly the Archer-Daniels-Midland Company.

Insect protein start-ups raised ‘over $1 billion in venture capital since 2020’

The production of insects for human food is expanding in the U.S. and globally, with support from the United Nations and the World Economic Forum (WEF).

In 2013, the Food and Agriculture Organization of the United Nations released a seminal report, “Edible insects: future prospects for food and feed security,” which promotes the environmental and nutritional benefits of insect consumption.”

A 2022 WEF paper, “5 reasons why eating insects can reduce climate change,” suggests people are “conditioned to think of animals and plants as our primary sources of proteins … but there’s an unsung category of sustainable and nutritious protein that has yet to widely catch on: insects.”

According to a November 2023 Washington Post report, “Insect start-ups have raised over $1 billion in venture capital since 2020.”

A 2021 report by Netherlands-based Rabobank claimed the demand for insect protein, “mainly as an animal feed and pet food ingredient, could reach half a million metric tons by 2030, up from today’s market of approximately 10,000 metric tons.”

A report by Grand View Research forecasted the global insect protein market will expand by an annual compound growth rate of 16.9% by 2030, while European projections estimate “the number of Europeans consuming insect-based food will [reach] a total of 390 million by 2030,” according to EuroNews.

Ynsect, for instance, has built factories in France and the Netherlands, and is erecting factories in the U.S. and Mexico, according to Feed Navigator. The company claims its insect-producing farms are “climate positive,” “benefit biodiversity” and are aligned with the Paris Agreement and the European Union’s “Fit for 55” goal.

In March 2022, Ynsect acquired Nebraska-based Jord Producers — a mealworm farm. And in December 2022, Ynsect signed an agreement with U.S. flour milling company Ardent Mills to build a factory in the Midwestern U.S. Ardent Mills is a joint venture between ConAgra Foods, Cargill and CHS, a global agribusiness cooperative.

Investors in Ynsect include actor Robert Downey Jr.’s FootPrint Coalition and France’s Crédit Agricole bank — along with support from the FAO and the European Commission. The company has raised over $600 million.

Celebrity chefs also are embracing insect food. In November 2023, the Financial Times featured Joseph Yoon, founder of Brooklyn Bugs, whose “goal is to popularise edible insects and build up this food source to help support global food security.”

Your dog can eat insects, too

In addition to a lack of FDA regulations governing the use of insects in foods for humans, the FDA also does not regulate the use of insects for pet food ingredients.

According to Animal Frontiers, “pet food is under the nongovernment Association of American Feed Control Officials (AAFCO)” in the U.S. In January, French firm Ynsect became the first company to receive AAFCO authorization for commercial production of mealworm protein for dog food in the U.S.

In October 2023, Big Food giant Tyson Foods announced the acquisition of an ownership stake in the Dutch insect ingredient producer Protix. Tyson said the new joint venture would construct “the first at-scale facility of its kind to upcycle food manufacturing byproducts into high-quality insect proteins and lipids which will primarily be used in the pet food, aquaculture, and livestock industries.”

Although the announcement did not definitively exclude the production of insect-containing foods for humans, a Reuters “fact check” published in May stated, “Tyson Foods does not put insects into products for human consumption.”

Tyson has invested in Upside Foods, which in June 2023 won approval from the U.S. Department of Agriculture (USDA) to produce lab-grown chicken. Upside garnered more than $600 million in research and development investments, including from Gates, Richard Branson, Elon Musk’s brother Kimbal Musk and Cargill.

Vanguard and BlackRock, the world’s two largest institutional investment firms, are also the two top institutional holders of Tyson Foods shares. BlackRock, and its CEO, Larry Fink, have promoted “sustainable” corporate practices.

Independent journalist Paul D. Thacker, author of “The Disinformation Chronicle” on Substack, analyzed the emails, which were obtained through a Freedom of Information Act (FOIA) request by investigative reporter Jimmy Tobias.

Thacker’s report shows NIH officials discussing how to respond to congressional inquiries about the grant awarded to EcoHealth Alliance.

In a July 2020 email exchange, Adrienne Hallett, then-NIH associate director for legislative policy, outlined a strategy to evade direct answers to congressional inquiries.

“We are going to draft a response to the letter that doesn’t actually answer the questions in the letter but rather presents a narrative of what happened at a high level,” Hallett wrote. “The Committee may come back for other documents but I’m hoping to run out the clock.”

The email chain reveals that top NIH leadership, including then-Director Francis Collins and then-Principal Deputy Director Lawrence Tabak, were aware of and supportive of this approach.

Collins responded, “Sounds like a good plan.” Dr. Michael Lauer, the NIH’s deputy director for extramural research, replied, “Thanks so much Adrienne! I’ll draft something today.”

Incredible (or not)…

An NIH staffer outlines her plans to evade Congressional scrutiny to Collins & Tabak

Collins: "Sounds like a good plan"

From @JamesCTobias' latest FOIAshttps://t.co/EovAm5oxk6@randpaul @RepMGriffith pic.twitter.com/ytN05Bh3LW

— harish seshadri (@harishseshadri2) July 31, 2024

The congressional letter in question was signed by the chairs of the Energy and Commerce and the Science, Space, and Technology committees and the chairs of their respective investigative subcommittees.

EcoHealth refused to answer NIH questions

EcoHealth Alliance, a nonprofit organization focused on emerging infectious diseases, has been at the center of debates surrounding the origins of COVID-19 due to its work with bat coronaviruses and its partnership with the Wuhan lab.

In April 2020, the NIH terminated EcoHealth’s grant amid concerns about its collaborative research project in Wuhan.

Three months later, in July 2020, the NIH reinstated the grant but immediately suspended it. The agency imposed certain conditions, including requiring answers from EcoHealth Alliance on such issues as the disappearance of Wuhan lab scientist Huan Yanling and details on how the Wuhan lab determined the genetic sequence of SARS-CoV-2.

In a July 2020 email, Tabak expressed concerns over potential political blowback from the grant reinstatement.

An August 2020 email from Lauer noted that EcoHealth refused to answer the questions NIH required.

In May 2023, the NIH reinstated a reduced version of the grant. However, a year later, under pressure from lawmakers, the U.S. Department of Health and Human Services suspended all funding for EcoHealth Alliance grants and initiated proceedings to block any future federal research funding.

On Wednesday, the U.S. Agency for International Development (USAID), which operated the Emerging Pandemic Threats Program and had funded numerous EcoHealth Alliance projects, announced it had suspended all funding to the organization.

The EcoHealth Alliance controversy is not an isolated incident. Further evidence from several rounds of FOIA’d documents Tobias received (not discussed in Thacker’s current article) reveals a pattern of concealment and subterfuge within the NIH and related government agencies regarding COVID-19 origins and related research.

Collins ‘pleased’ with early 2020 WaPo article dismissing lab-leak theory

In a separate incident, emails obtained through FOIA requests reveal that Collins actively supported efforts to discredit the theory that COVID-19 originated in a lab.

In February 2020, Collins endorsed a Washington Post article criticizing Sen. Tom Cotton (R-Ark.) for suggesting the possibility of a lab origin for the virus. The article, which stated the lab-leak theory was a debunked conspiracy, was later “corrected” because “then as now, there was no determination about the origins of the virus.”

Despite the correction, the article still refers to a “fringe theory” and the article URL still includes the word “conspiracy.”

Collins endorsed the Post article despite growing scientific evidence and intelligence reports suggesting the lab-leak theory deserved serious consideration.

A FOIA’d email from February 2020 strongly suggested that Collins and Dr. Anthony Fauci, then-director of the National Institute of Allergy and Infectious Diseases, were aware of the gain-of-function research behind the emerging COVID-19 pandemic. Fauci wrote, “?? Serial passage in ACE2-transgenic mice.”

Collins conspired with Fauci to discredit the lab-leak theory through the now-infamous Proximal Origin paper.

It wasn’t until January 2024 during a closed-door interview with the U.S. House of Representatives Select Subcommittee on the Coronavirus Pandemic that Collins finally admitted what he knew all along: SARS-CoV-2 could have leaked from a lab and it was not a conspiracy theory.

Despite the common knowledge of the likelihood of a lab leak, disclosed documents show that people like Tabak continued to deny it:

It always has been unclear whether Tabak's non-answers and false answers have been attributable to ignorance or to willful obstruction. (He is as dumb as a rock, making ignorance a real possibility.)

— Richard H. Ebright (@R_H_Ebright) July 26, 2024

Documents also show the U.S. Department of State by 2019 had knowledge of and cleared the EcoHealth-funded experiments at the Wuhan Lab:

From the new FOIA release by @JamesCTobias. State Department approval for NIH grant by @EcoHealthNYC

Humanized mice
5-6 Novel SARS-related coronaviruses
"All work involving samples and viral isolates from bats
will be performed at the Wuhan Institute of Virology" https://t.co/anXSVlIXdY pic.twitter.com/fnudV4XaYJ

— Louis R Nemzer (@BiophysicsFL) April 2, 2023

Adding to the controversy, a FOIA’d document from June 2020 (see page 164) shows that Sen. Bill Cassidy (R-La.) was likely aware of rumors that EcoHealth’s grant-funded work was being conducted in a Biosafety Level 2 (BSL-2) lab at the Wuhan Institute, despite the risky nature of the research, which typically requires a BSL-4 facility.

NIH ‘a rogue agency’

Thacker’s investigation points to broader issues within the NIH and its evasion of public records laws.

“The National Institutes of Health is a rogue agency,” Thacker wrote. He noted that since the beginning of the pandemic, “The NIH has put up roadblocks to Freedom of Information Act requests, forcing people to sue the agency until they disclose documents, which they then heavily redact.”

U.S. Right To Know agreed:

Our investigation into #COVID_19 origins "is a test case of citizens’ access to government records. If we can’t successfully use our nation’s public records laws to investigate something as important as the cause for the deaths of nearly 1.2 million Americans, then why bother…

— U.S. Right To Know (@USRightToKnow) March 20, 2024

In May, Rep. Brad Wenstrup (R-Ohio), chairman of the House Select Subcommittee on the Coronavirus Pandemic, announced an investigation into “a potential conspiracy at the highest levels” of NIH to evade FOIA and avoid public transparency on issues related to the pandemic.

The revelations about the NIH’s handling of congressional inquiries come amid other controversies involving key figures in the pandemic response.

“Senator Rand Paul has sent two [criminal] referrals to the Department of Justice after catching Anthony Fauci lying under oath about funding he provided to the Wuhan Institute of Virology for dangerous gain-of-function virus research,” Thacker wrote.

Thacker highlighted May 2024 House investigations of “Fauci’s right-hand man” Dr. David Morens, who admitted to deleting communications and using private email with Fauci to hide public records related to the pandemic origins.

The departure of key figures involved in the controversies also raised eyebrows. Thacker noted that Hallett — the NIH staffer who suggested evading congressional questions — after leaving NIH joined the biotechnology company Cambrian Bio as vice president of global policy.

Instead, the authors concluded the major causes of death globally stemmed from the public health establishment’s response, including lockdowns, harmful medical interventions and the COVID-19 vaccines.

The study by researchers from the nonprofit Correlation Research in the Public Interest analyzed excess mortality in 125 countries — about 35% of the global population — during the COVID-19 pandemic, beginning with the March 11, 2020, World Health Organization (WHO) pandemic declaration and ending on May 5, 2023, when the WHO declared the pandemic over.

The investigation concluded that “nothing special would have occurred in terms of mortality had a pandemic not been declared and had the declaration not been acted upon.”

LONG AWAITED: Today here is our research group's latest and massive report about excess mortality in the world during the full Covid period: 521 pages, 40K words, hundreds of figures, top analysis, deep insights, overall understanding…
An absolute reference, some hard… pic.twitter.com/7r69AgQIDs

— Denis Rancourt (@denisrancourt) July 19, 2024

The 521-page analysis — by Denis Rancourt, Ph.D., former physics professor and lead scientist for 23 years at the University of Ottawa, Correlation’s president Joseph Hickey, Ph.D., and Christian Linard, Ph.D., from the University of Quebec at Trois-Rivières — was published July 19.

The paper builds on work Rancourt and his colleagues have been doing since the start of the pandemic tracking and analyzing all-cause mortality to understand the underlying dynamics of mortality during the pandemic.

Their findings led them to challenge dominant scientific models and public health claims used to inform pandemic response policies.

They have published a series of papers on COVID-19 and vaccination in places like India, Australia and Israel, the U.S., Canada and a larger study of 17 countries over the last several years, with this study bringing together that work and adding to it.

In addition to the overarching conclusions that deaths during the COVID-19 period were caused by public health interventions rather than by the SARS-CoV-2 virus, the authors provided a detailed contextualization of the data, explaining how such a large dataset could provide substantial insight into how these interventions led to excess mortality across the world.

Some of those key insights are detailed here.

Five takeaways from largest pandemic excess mortality study to date

1. Vaccines caused approximately 17 million deaths and vaccine toxicity increased with age and number of doses.

Based on their calculations and extrapolated to the world, the researchers estimated the vaccines caused approximately 17 million deaths, confirming the results of their previous research on a smaller data set.

That means vaccines were a primary cause of death, and they found that the vaccine dose fatality rate — the chances of dying from the vaccine — increased with age and with the number of doses.

Consistently, they found, that the more vaccine doses given, the greater the number of excess deaths. There are outliers, Rancourt said, but their graphs consistently showed this proportionality, even for countries that also had all-cause mortality peaks unrelated to the vaccines.

Rancourt told The Defender that they were able to essentially graph vaccine toxicity and that generally speaking, the boosters tended to be more associated with mortality.

“They’re more toxic, they’re more dangerous,” he said.

He added:

“That is a general trend that we see in all the data is that as you have higher and higher doses, the correlation with mortality is stronger and stronger and the peaks are more and more visibly associated. So as the assaults and all the reasons for dying at the beginning [lockdowns, medical interventions] taper off, then it becomes the vaccines that are more the killing agent.”

The researchers wrote that the mechanisms through which the vaccines caused death were complex.

One mechanism for lethality may be death by direct vaccine toxicity from, for example, cationic lipids. Alternatively, the injections could cause death by inducing an immune overreaction to the spike proteins.

Rancourt said they didn’t think those were the primary causes of vaccine-induced death, particularly given that excess deaths were so highly correlated to the boosters. Instead, he said, the initial and repeated injections likely weakened people’s immune systems.

Extensive scientific research has shown how such stressors weaken the immune system, causing a generalized immunosuppression that makes a person less able to fight existing or new infections of any kind, which can lead to death when it wouldn’t have occurred under normal circumstances, he said.

They also noted that such frail people — made frailer by repeated injections — are also more likely to be sick and therefore more infectious, spreading disease.

That meant a lot more people were getting illnesses like lung infections, Rancourt said. And people who were getting lung infections or other illnesses because of their vaccine-induced immunosuppression could also transmit those to unvaccinated people who may also become part of the excess mortality associated with the vaccines, even though they are not vaccinated.

2. Pandemic interventions led to about 30.9 million deaths globally and vaccines didn’t prevent any deaths.

Using the excess all-cause mortality rate for the 93 countries that had sufficient data, the researchers calculated the global excess deaths to be between 30.7 and 31.1 million people, which is significantly higher than the 7.03 million total number of COVID-19 deaths reported by the WHO through Feb. 11, 2024.

They created a figure, showing excess deaths as a percentage of the world population by country, with darker colors indicating a higher percentage of the population and gray indicating places for which they had no data.

There was no single pattern of excess deaths, but there were some strong commonalities across different groups of countries. Only one country analyzed, Greenland, had no excess mortality.

For example, 26 countries had a strong peak at the beginning of the pandemic in March to April 2020, including places like the U.S., Spain, the United Kingdom, Italy, Mexico, Brazil, Kuwait and the United Arab Emirates, and other countries showed a similar pattern but with less intensity.

Eighty-eight countries showed no excess mortality at the start of the pandemic in spring 2020, but some of those countries had excess mortality spikes before the vaccine rollout.

However, there was no evidence of the vaccine rollouts being associated with a reduction in excess deaths in any country.

Instead, in 113 of the 121 countries with sufficient data, the researchers found a significant excess mortality peak within a month of Jan. 1, 2022, which was temporally associated with the rollout of the boosters, and which happened nearly simultaneously across the world.

In some countries, Rancourt said, that was more clear than in others. And sometimes there is a lot of complexity to the data because it’s not, for example, age-discriminated.

To deal with some of that complexity, Rancourt’s team analyzed the data through several filters. For example, they examined age-discriminated data and also correlations between excess mortality and a variety of socioeconomic factors like sex, population-wide income and life expectancy.

Even with the non-discriminated data, there is a clear link between vaccine rollouts and excess mortality in many countries. For example, the graph for Brazil shows there is some excess mortality leading up to the vaccine rollouts that began at the end of 2020. Immediately following the rollouts there was a large spike in mortality.

In French Polynesia, one can see the excess mortality spike correlates to the start of the booster rollouts in mid-2021, whereas the first rollout didn’t affect mortality.

Rancourt also emphasized that excess mortality isn’t something that happens on average across a society — it usually happens among those who are frail enough to die, people who have compromised health — “the vulnerable,” often the elderly — tended to be prioritized in the initial rollouts and the booster campaigns.

3. Many deaths were linked to respiratory viruses that could have been treated, but treatment was withheld.

One key issue Rancourt’s team tried to address in the paper is how to sort out the primary cause of death from the clinical cause of death, which was often identified as a respiratory virus.

Rancourt said they did find that there was excess mortality quantitatively associated with respiratory conditions at death, which he also noted is generally common outside of the pandemic period as well.

One likely cause behind the high number of respiratory viruses could be immune suppression from the vaccines.

Also, he said, people with respiratory infections are typically treated with antibiotics or other appropriate interventions, but during the COVID-19 pandemic period, such treatment was restricted or completely withheld.

For example, they wrote, more than half of the deaths assigned as COVID-19 in the U.S. “could include life-threatening co-occurring bacterial pneumonia, according to CDC [Centers for Disease Control and Prevention] tabulations of death certificates.”

Other respiratory causes of death pervasive throughout the world, like tuberculosis or fungal infections, Rancourt said, couldn’t simply disappear. Instead, they went untreated and likely led to excess deaths.

“Normally in a modern country, we try to identify what the main pathogens are and we treat them in a targeted way with specific antibiotics,” Rancourt said. “We stopped doing all of that and we stopped even recognizing that there was this complexity and that there was this natural fragility and susceptibility to lung infections in the human body.”

Instead, he added, “We just wiped all that out and thought purely in terms of this new virus and that could be the only cause.”

There were respiratory problems associated with excess mortality, they concluded, “but we believe that you had to have suppressed the immune systems of people in order to get them into that state,” and leave those people untreated with interventions that would have saved them.

4. There was essentially no excess mortality before the WHO declared a pandemic.

Overall, they found that there was “essentially no excess mortality” in any of the countries analyzed before March 11, 2020, when the WHO declared a pandemic.

This supports their conclusion that deaths were not related to a pandemic virus, Rancourt told The Defender, because all-cause mortality from a virus would not manifest suddenly and in many places once a pandemic was declared.

Despite flawed epidemiological models claiming otherwise, the timing of deaths from a virus spread doesn’t happen simultaneously in different societies, he said. That’s the case even if a pathogen is “popped down in all the cities in the world,” because how mortality occurs is “extraordinarily sensitive” to different society’s social habits and health structures.

For example, a society with an older and frailer population would have people who were infectious for longer and who die more easily would have a different effect on mortality than in a society that was younger and healthier. Their excess death curves would change on different timelines and with different magnitudes, Rancourt said.

Excess mortality in different places would also be affected by the size of the initial virus introduction.

He added that many researchers claim from genomic measurements that the virus was present for months before it was announced, but there is no evidence of excess deaths during that time.

“So there should have been these rises that were just all over the place in time, but instead the virus waited for the political announcement by the World Health Organization,” he said.

5. An ‘elegant’ methodology for analyzing all-cause and excess mortality.

All-cause mortality — a measure of the total number of deaths from all causes in a given time frame for a given population — is the most reliable data used by epidemiologists for detecting and characterizing events that cause death and for evaluating the population-level impact of deaths from any cause.

Unlike other measures, all-cause mortality data are not susceptible to reporting bias or biases that may exist in subjective assessments of the cause of death. Any event, from a natural disaster like an earthquake to a wave of seasonal or pandemic illness, appears in all-cause mortality data.

For this study, the authors identified baseline all-cause mortality rates by tracking all-cause mortality, where data were available, from 2015 and 2019 to estimate forward what the expected all-cause mortality would have been absent the pandemic conditions for 2020 to 2023.

They compared the baseline data to the actual all-cause mortality data reported in those years to track how mortality changed during that time and identify excess mortality.

Excess mortality refers to the number of deaths from all causes during a crisis above and beyond what we would have expected to see under “normal” conditions.

In an extensive series of graphs for each country, the researchers tracked and statistically analyzed the temporal relationship between spikes in national all-cause mortality rates, stratified by age where data were available, and the COVID-19 pandemic period and the vaccine and booster rollouts.

For example, one graph shows excess mortality for the U.S. during the pandemic period. Gray vertical lines indicate the announced start and end of the pandemic. The blue curve is raw all-cause mortality data by week. The orange curve is the average from Rancourt et al.’s analysis prediction of expected all-cause mortality. The green curve shows total excess mortality, which is the difference between the historic trend and the actual mortality during the pandemic period.

After they established excess mortality in each country, Rancourt and his team analyzed how that excess mortality related to the COVID-19 vaccine doses, graphing how all-cause mortality related to the vaccine and booster rollouts and the cumulative excess mortality over time with increased vaccine doses in hundreds of graphs.

For example, the graph below shows excess mortality in Australia. The graph shows all-cause mortality in blue and the vaccine rollouts in green and orange (from two different data sources). The excess mortality begins to climb just after the start of the booster rollout in fall 2021.

“We really found an elegant way to do this that we think is eventually going to be adopted by virtually all epidemiologists because it’s just so robust and straightforward and easy to interpret and understand and it minimizes the chance of any errors in the extrapolation or the methodology itself,” Rancourt said.