Tag: safety

‘Reckless Disregard for the Truth’: Shareholders Sue Moderna for Misleading Investors on RSV Shot Efficacy

A group of shareholders is suing Moderna alleging the company knowingly inflated claims about the efficacy of its RSV vaccine for older adults. When the drugmaker later lowered expectations for the vaccine’s efficacy the stock price dropped precipitously.

A class-action lawsuit accuses Moderna of making “materially false and misleading statements” about the efficacy of its respiratory syncytial virus (RSV) shot, leading to significant damages for investors.

The lawsuit, filed Aug. 9 in the U.S. District Court for the District of Massachusetts, covers investors who owned or purchased Moderna stock between Jan. 18, 2023 — the day that Moderna announced that mRNA-1345, its candidate RSV vaccine, met primary efficacy endpoints in Phase 3 clinical trials — and June 25, 2024.

According to the lawsuit, Moderna misled investors by failing to disclose that “mRNA-1345 was less effective than Defendants had led investors to believe” and that “mRNA-1345’s clinical and/or commercial prospects were overstated.”

“As a result, the Company’s public statements were materially false and misleading at all relevant times,” the lawsuit states.

The lawsuit names Moderna and its key executives, including its CEO Stéphane Bancel, Chief Financial Officer James M. Mock and President Stephen Hoge, as defendants.

“Defendants acted with reckless disregard for the truth in that they failed or refused to ascertain and disclose such facts as would reveal the materially false and misleading nature of the statements made, although such facts were readily available to Defendants,” the lawsuit states.

Brian Hooker, Ph.D., chief scientific officer for Children’s Health Defense (CHD), told The Defender he is not surprised by allegations of fraud concerning Moderna.

“It is unfortunate that Moderna lied about the efficacy of the vaccine and misled investors,” Hooker said. But Hooker said the “bigger tragedy here is the lack of safety testing for modified mRNA products such as their RSV shot.”

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The emasculation of the American male: Testosterone-crushing chemical herbicide banned in Europe gets sprayed freely on U.S. crops and ends up in our food

We’ve all heard about the historic drop in male testosterone levels over the past 50 to 60 years but rarely does anyone delve into the causes of this disturbing trend.

A recent guest on the Joe Rogan podcast blew the whistle on a chemical herbicide widely used on large swaths American croplands that has wrought catastrophic effects on the reproductive hormones and organs of the American male.

Atrazine, a herbicide sold under various brand names such as Bullet, Lariat, Guardsman Max, Bicep II Magnum, Dual II Magnum, Medal II, and others, is proven to have harmful effects on boys and men of all ages.

Dr. Casey Means explained that atrazine is widely present in American foods. It has even found its way into some public water systems. This testosterone-crushing chemical is banned across Europe but not the United States.

What is atrazine, and how does it do this?

The Vigilant News Network reports that Atrazine is a widely-used herbicide sprayed on crops like corn and sugarcane to control weeds. It disrupts hormone function by increasing the activity of an enzyme called aromatase, which converts testosterone into estrogen.

In men, this can contribute to conditions like decreased muscle mass, low libido, and even feminization.

U.S. farmers spray 70 million pounds of this tasteless, odorless, chemical on our food, while it’s illegal to do so in Europe.

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‘Should Not Be Used in Any Infants’: Higher Death Risk in Beyfortus RSV Shot Clinical Trials

Infants treated for RSV with the monoclonal antibody nirsevimab have significantly higher mortality rates than those treated with a different monoclonal antibody or with a placebo, according to an analysis by the Japanese journal Med Check of three major randomized control trials.

The report reanalyzed clinical trial data showing that nirsevimab — marketed by Sanofi and AstraZeneca as Beyfortus — reduced RSV-associated lower respiratory tract infection and hospitalizations in both high-risk and healthy infants.

However, babies treated with the drug had a higher mortality rate likely linked to adverse effects — including thrombosis (blood clotting) — from the drug itself, the study found.

“Due to the increased mortality, nirsevimab should not be used in any infants,” the study concluded. “Do not use nirsevimab for universal immunization.”

Shortly after its approval by the European Medicines Association in October 2022, and fast-track approval by the U.S. Food and Drug Administration in July 2023, the U.S., France, Spain and Luxembourg launched universal Beyfortus infant immunization campaigns for the 2023-24 RSV season.

Med Check published its appraisal of the clinical trials shortly after France’s National Agency for the Safety of Medicines and Health Products (ANSM) published its first pharmacovigilance data on the drug, compiled during the 2023-24 season.

The ANSM report tracked adverse events related to Beyfortus in France between Sept. 11, 2023, and April 30, 2024. Of 244,495 doses delivered, 198 adverse events were reported to the pharmacovigilance system, of which 153 were considered serious.

The report identified safety signals for stroke, respiratory conditions and hypotonic-hyporesponsive episodes — when an infant suddenly loses muscle strength and becomes “floppy.” Hypotonic-hyporesponsive episodes also are associated with the diphtheria-tetanus-pertussis, or Tdap, vaccine and other vaccines.

There were also three reports of sudden infant death syndrome (SIDS), although researchers said at least one of them was likely not linked to the drug.

The ANSM said each of the signals would be closely monitored in the future, but that a causal link between Beyfortus and those adverse events had not yet been established. The agency concluded the results confirm that the benefits of using the drug to treat bronchiolitis, an RSV infection, outweigh the risks.

The ANSM continues to recommend all newborn babies receive the Beyfortus shot this RSV season.

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‘An Act of War’: Big Food Intentionally Addicting Kids to Toxic Foods

Big Food targets young consumers in the U.S. to get them addicted to unhealthy products — which frequently contain ingredients banned by other countries — according to two food safety and nutrition advocates interviewed on SiriusXM’s “Megyn Kelly Show.”

Vani Hari, an author and blogger known as the “Food Babe,” and Grace Price, an investigative journalist and filmmaker who produced “Cancer: A Food-Borne Illness,” are calling on U.S. food manufacturers to change their practices and produce foods with the same healthier ingredients the companies use in identical products they sell in other countries.

Last month, Hari and Price participated in a Senate roundtable on nutrition and the chronic disease epidemic in the U.S.

“We have an opportunity right now to let the American public know” about unsafe ingredients in foods sold in the U.S., Hari said during the interview. “We are under a massive experiment. If any other country was doing this to us, it would be considered an act of war … We’ve got to do something about it.”

Price, who is 18 years old, said American food manufacturers are using tactics that Big Tobacco pioneered to market harmful products to youth. “My generation is so clearly being targeted by these Big Food companies,” she said.

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EPA Knows These Commonly Used Pesticides Affect Brain Development

Rodent studies given to U.S. regulators by insecticide makers close to 20 years ago revealed the chemicals could be harmful to the animals’ brain development — data worrisome for humans exposed to the popular pesticides but not properly accounted for by regulators, according to a new research report published on Oct. 1.

The analysis examined five studies that exposed pregnant rats to various types of insecticides known as neonicotinoids (commonly called neonics). The studies found that the offspring born to the exposed rats suffered shrunken brains and other problems.

Statistically significant shrinkage of brain tissue was seen in the offspring of rats exposed to high doses of five types of neonics – acetamiprid, clothianidin, imidacloprid, thiacloprid, and thiamethoxam, the paper states.

The authors said the impacts on the brain appeared similar to the effects of nicotine, which they said is known to disrupt mammalian neurological development.

The animal studies also support the possibility of a link between neonic exposure and attention-deficit/hyperactivity disorder (ADHD), the authors said.

In most cases, the companies submitting the studies did not submit data for all dosage levels, leading the U.S. Environmental Protection Agency (EPA) to assume negative effects were only seen at the high dose, according to the study.

“We found numerous deficiencies in the Environmental Protection Agency (EPA)’s regulatory oversight and data analyses,” the authors state in the paper, published in the journal Frontiers in Toxicology.

The industry studies, which the EPA used to determine what neonic exposure levels are considered safe for humans, were not publicly available and were obtained through a Freedom of Information Act request.

“Consistently, effects were found at the high dose and EPA did not demand data for the lower doses, therefore leaving it unclear how little of a substance it takes to actually cause adverse effects such as reduced size of certain brain regions,” said Bill Freese, the science director for the environmental advocacy group Center for Food Safety and an author of the study.

The study found that the EPA consistently made determinations about what levels of neonic exposure were “safe” for humans without enough data to support its conclusions.

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City of Abilene stops adding fluoride to water, citing recent court decision

During a media briefing Monday morning, the City of Abilene announced they will no longer add fluoride in the water.

City Manager Robert Hanna said they will immediately stop adding fluoride in the water as an abundance of caution.

The decision was made based on a recent federal court ruling in California that may result in changes to theEnvironmental Protection Agency’s recommendations regarding fluoride levels in drinking water.

In a press release, the City stated it follows federal standards and theAmerican Dental Association’s recommendation of maintaining fluoride levels at 0.7 parts per million.

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Environmental Protection Agency accused of retaliating against scientists who voiced concerns about toxic chemicals

A group of government scientists say they were pressured by management at the Environmental Protection Agency (EPA) to present new chemicals they were investigating as being safer than they actually were.

When they failed to delete evidence of the serious dangers associated with the chemicals, their managers did it themselves.

The scientists claim that after pushing back, they were hit with negative performance reviews, while some lost their positions in the new chemical division and were reassigned to other parts in the agency.

Last week, the Inspector General of the EPA announced their finding that three of the scientists’ treatment can be considered retaliation, confirming that their negative reviews and reassignments were retaliatory. They also concluded that the scientists being denied a work-related incentive that can be used to take time off or traded for cash was retaliatory as well.

The report instructed the EPA to take “appropriate corrective action” as a result, including a potential three-day minimum suspension for supervisors who violated the Whistleblower Protection Act.

In response to the report, EPA assistant administrator Michael Freedhoff sent a letter to the Office of Chemical Safety and Pollution Prevention explaining that all managers would be undergoing “refresher training” on the Whistleblower Protection Act as well as scientific integrity in general and that their office would be reviewing the reports to see if additional action is needed.

Further reports are expected to be released about the scientific allegations made by the whistleblowers.

The three whistleblowers in question – Sarah Gallagher, William Irwin and Martin Phillips – maintained that the chemicals they were vetting for the agency could cause damages ranging from neurological problems and miscarriages to cancer.

The EPA appears to be trying to shift the blame for what happened to former President Donald Trump as the incident took place during his administration. They say that the agency was under pressure to push chemicals through the approval process more quickly.

“The events covered by these reports began during the previous administration when the political leadership placed intense pressure on both career managers and scientists in EPA’s new chemicals program to more quickly review and approve new chemicals,” the agency claimed.

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Fluoride in Water Poses ‘Unreasonable Risk’ to Children, Federal Judge Rules

In a decision that could end the practice of water fluoridation in the U.S., a federal judge late Tuesday ruled that water fluoridation at current U.S. levels poses an “unreasonable risk” of reduced IQ in children.

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.

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The National Guard Knows Its Armories Have Dangerous Lead Contamination, Putting Kids and Soldiers At Risk

The matches came in rapid-fire succession on four pitches squeezed next to each other beneath a cavernous roof. Five boys per team, four matches at once, each 18 minutes, with only 90 seconds between them. Twelve hours later, the boys were gone, but the games went on. Eight teams, four fields, a sea of bouncing ponytails.

It was peak soccer simultaneity. A vicious shot hit the crossbar on one pitch; on the next, a midfielder streaked past defenders on a breakaway; a corner kick on the third field; and on the fourth, a straight shot found the back of the net. In the stands, cheers went up for “Dani!” and “Ari!” and “Kylie!” and “Amber!” And as the night wore on, more and more of these young women stood with flushed faces and hands on hips, breathing deeply whenever a stoppage gave them a chance.

The Soccer Coliseum bills itself as the “leading youth soccer arena in America, attracting more teams … than any other indoor facility.” Since 1996, this fútbol mecca — which rents space inside New Jersey’s Teaneck Armory — has offered youth soccer programs, including tournaments, classes, and camps, for kids as young as 3, introducing a generation of children to the beautiful game.

Under the 35,000 square feet of red, artificial turf and the site-mandated rubber-soled shoes, however, lurked a hidden danger. The basement had housed an Army National Guard indoor firing range, or IFR, for decades. Each time a citizen-soldier fired a rifle or pistol, it emitted an extremely dangerous form of lead: toxic dust that research shows is frequently tracked around armories on soldiers’ clothing and dispersed through ventilation systems.

Exclusive documents obtained by The Intercept show that the Army National Guard knowingly endangered the health and safety of soldiers and civilians at armories — also known as readiness centers — across three, and possibly 53, states and territories. A Soccer Coliseum director told The Intercept that he was never informed about a potential source of lead contamination in the basement below the playing fields.

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Japan’s Emergency Press Conference Highlights Urgent Concerns About mRNA Replicon Vaccine Approval

On September 12, 2024, Japanese Member of Parliament Ryuhei Kawada led a highly charged emergency press conference in Japan, voicing deep skepticism about the country’s upcoming launch of mRNA replicon vaccines, or what some call self-amplifying mRNA vaccines. The event set off alarm bells among critics of government policies, accusing authorities of prioritizing pharmaceutical profits over public health.

What are mRNA Replicon Vaccines?

As you know, mRNA COVID vaccines, like those developed by Pfizer and Moderna for COVID-19, use a small piece of genetic code (mRNA) to instruct your cells to produce a piece of the virus known as the spike protein.

On the other hand, self-amplifying mRNA vaccines, or replicon vaccines, represent a more advanced version where the mRNA not only instructs your cells to produce the spike protein but also makes copies of itself (yay! more mRNA…) once inside the cells.

ARCT-154, scheduled to be administered to the population in October 2024, is a self-amplifying mRNA COVID-19 vaccine from the dynamic duo of Arcturus Therapeutics and Duke-NUS Medical School in Singapore. In Japan, Arcturus Therapeutics found an ally in CSL Seqirus for crafting and distributing their vaccines through a local pharma company called Meiji Seika Pharma.

Arcturus Therapeutics is a biotech company located in San Diego, California, established in 2013. Just like Moderna, which didn’t release any products to the market until their mRNA experimental COVID vaccine, Arcturus also hasn’t launched any medical products yet, and their self-amplifying mRNA vaccine will be their first.

Arcturus was formed through a merger with Alcobra Pharma, an Israeli pharmaceutical company, after Alcobra faced difficulties during clinical trials, which led to their merger with Arcturus Therapeutics in 2017. Interestingly, Alcobra translates to “The Cobra.” You have to wonder who decided that naming their pharma company after a snake was a good idea. At this point, my eyes are rolling all the way to the back of my head, so I will stop talking about the company’s history here.

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