Tag: safety

FDA Leadership Refuses to Add Black Box Warning to mRNA Injections—Despite FDA Scientists Recommending It

A few days ago, CNN reported that the FDA intended to place a black box warning on COVID-19 mRNA injections for serious adverse events, including death.

However, in a striking reversal first reported by Maryanne Demasi, FDA Commissioner Dr. Marty Makary appeared on Bloomberg and claimed the agency now has “no plans” to implement a black box warning—despite the FDA’s own Center for Safety and Epidemiology formally recommending one. He claimed that Dr. Vinay Prasad and “leadership” thought it would be a bad idea.

Dr. Makary stated:

Now, when it comes to the black box warning, we have no plans to put that on the COVID vaccine. The Safety and Epidemiology center within the FDA did recommend that it was a recommendation formally put out. But some of our scientists and leadership, like Dr. Vinay Prasad, have said it may be different today than it was in the first year of COVID when the shot came out.

Because when you have those two doses three months apart, that’s when you see the side effects go way up, like myocarditis in young people. Now that it’s annual, you may not see that same prevalence.

So we don’t want to extrapolate findings to today if it’s not transferable.

This rationale is deeply flawed—and gravely worrisome. It assumes that cardiotoxic injury from mRNA injections is acute, transient, and dose-interval dependent, rather than structural, cumulative, and capable of causing delayed fatal outcomes. That assumption is directly contradicted by the peer-reviewed literature.

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FDA Set to Give COVID Vaccines Serious ‘Black Box’ Designation: Report

The U.S. Food and Drug Administration is reportedly preparing to place a serious “black box” warning on COVID-19 vaccines, according to a CNN report citing people familiar with the agency’s plans.

A black box warning is the most serious safety designation the FDA can require — appearing in bold at the top of a drug or vaccine’s prescribing information to alert doctors and patients to potentially serious risks.

According to CNN, the FDA’s proposed action would highlight major risks such as serious side effects and usage restrictions that should be weighed against benefits before administering the shots.

The report says two people familiar with the agency’s internal planning confirmed the intention to add the warning, though the plan has not yet been finalized and could change before it is publicly announced.

Dr. Vinay Prasad, the FDA’s chief medical and scientific officer and head of the Center for Biologics Evaluation and Research, is said to be leading the review of the COVID vaccine warning label.

CNN’s account indicates that officials are still determining whether the black box warning would apply to all COVID vaccines, only mRNA-based shots from manufacturers like Pfizer and Moderna, or specific age groups.

The warning is expected to be unveiled before the end of 2025, though agency officials have not publicly confirmed plans.

Black box warnings are typically reserved for medicines with evidence of serious or potentially life-threatening adverse reactions that must be clearly communicated to providers and patients.

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Exposing the vaccine industry: How corruption, fraud and coercion endanger public health

In a damning exposé, lawyer Aaron Siri’s book “Vaccines, Amen: The Religion of Vaccines” reveals how the American public has been systematically deceived by institutions they were taught to trust—namely, the Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA) and pharmaceutical giants. Through meticulous legal battles, Siri uncovers a web of corruption, scientific misconduct and outright fraud that has allowed unsafe vaccines to flood the market while silencing dissenters.

The dogma of vaccines: Faith over science

Vaccines have been elevated to near-religious status, with proponents demanding blind faith rather than critical scrutiny. As Siri explains, people say they “believe in vaccines” without examining the data—because the data, when scrutinized, often doesn’t support the industry’s claims. Instead, vaccine advocates rely on flawed studies, industry-funded research and outright deception to push their agenda.

One of the most shocking revelations is the lack of placebo-controlled trials for childhood vaccines. Despite claims from figures like Dr. Paul Offit—who insists all vaccines undergo rigorous placebo testing—Siri proves that not a single vaccine on the CDC’s childhood schedule was approved based on such trials. Instead, new vaccines are compared to older ones, masking their true risks. This is akin to declaring cigarettes safe because they’re no worse than cigars.

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The Trump Administration’s Top Nuclear Scientists Think AI Can Replace Humans in Power Plants

During a presentation at the International Atomic Energy Agency’s (IAEA) International Symposium on Artificial Intelligence on December 3, a US Department of Energy scientist laid out a grand vision of the future where nuclear energy powers artificial intelligence and artificial intelligence shapes nuclear energy in “a virtuous cycle of peaceful nuclear deployment.”

“The goal is simple: to double the productivity and impact of American science and engineering within a decade,” Rian Bahran, DOE Deputy Assistant Secretary for Nuclear Reactors, said.

His presentation and others during the symposium, held in Vienna, Austria, described a world where nuclear powered AI designs, builds, and even runs the nuclear power plants they’ll need to sustain them. But experts find these claims, made by one of the top nuclear scientists working for the Trump administration, to be concerning and potentially dangerous. 

Tech companies are using artificial intelligence to speed up the construction of new nuclear power plants in the United States. But few know the lengths to which the Trump administration is paving the way and the part it’s playing in deregulating a highly regulated industry to ensure that AI data centers have the energy they need to shape the future of America and the world.

At the IAEA, scientists, nuclear energy experts, and lobbyists discussed what that future might look like. To say the nuclear people are bullish on AI is an understatement. “I call this not just a partnership but a structural alliance. Atoms for algorithms. Artificial intelligence is not just powered by nuclear energy. It’s also improving it because this is a two way street,” IAEA Director General Rafael Mariano Grossi said in his opening remarks.

In his talk, Bahran explained that the DOE has partnered with private industry to invest $1 trillion to “build what will be an integrated platform that connects the world’s best supercomputers, AI systems, quantum systems, advanced scientific instruments, the singular scientific data sets at the National Laboratories—including the expertise of 40,000 scientists and engineers—in one platform.”

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Journal Retracts ‘Ghost Written’ Monsanto Study Claiming Glyphosate Is Safe

Over the past year massive scandals involving academic research have come under the microscope, after dedicated researchers uncovered rigged studies that made it through peer-review with flying colors, and are now being retracted. 

On Friday, the Regulatory Toxicology and Pharmacology journal announced that it has retracted a review, safety evaluation, and risk assessment of the herbicide Roundup and its active ingredient, glyphosate, after it emerged that Monsanto was heavily involved in its production. 

“This decision has been made after careful consideration of the COPE guidelines and thorough investigation into the circumstances surrounding the authorship and content of this article and in light of no response having been provided to address the findings,” the journal said in a statement. 

“Litigation in the United States revealed correspondence from Monsanto suggesting that the authors of the article were not solely responsible for writing its content,” and contributions by Monsanto employees were not disclosed, including in the acknowledgements section of the review. 

The journal also said that the authors may have been paid by Monsanto – which was also not disclosed. 

The Regulatory Toxicology and Pharmacology had been frequently cited in defending glyphosate, an ingredient in Roundup, including citations on Wikipedia, researchers said in a paper published in September. Since 2017, multiple juries have concluded that Roundup exposure has resulted in non-Hodgkin lymphoma in people. Bayer took over legal cases involving the matter after it purchased Monsanto in 2018, including a case that may be adjudicated by the Supreme Court. -Epoch Times

Meanwhile the study’s lead author, Gary Williams – a former pathologist at New York Medical College, is MIA, according to an Epoch Times inquiry. 

An internal email from February 2015 presented as evidence in a 2017 court case revealed that Monsanto employees worked with the authors of the review, with one employee writing that it would be expensive to involve experts from all major areas in a review – and would be cheaper to simply involve certain experts and “we ghost-write” other sections. 

“We would be keeping the cost down by us doing the writing and they would just edit & sign their names so to speak. Recall that is how we handled Williams Kroes & Munro, 2000,” the employee wrote. 

So of course, the journal retracts the dodgy study almost 10 years later – even as other journals – including Critical Reviews in Toxicology, attached expressions of concern co-authored by Williams because they said they authors didn’t disclose the involvement of Monsanto employees and contractors in authoring their research.

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Federal Vaccine Advisory Committee Votes to End Universal Hepatitis B Vaccine Recommendation for Babies

A federal advisory committee voted on Friday to end the universal hepatitis B vaccine recommendation for newborn babies – a decision which will now go to the U.S. Centers for Disease Control and Prevention (CDC) director for final approval.

The Advisory Committee on Immunization Practices (ACIP), the CDC’s vaccine advisers, determined in an 8-3 vote to narrow the recommendation. Instead of recommending the shot for all newborn babies, the advisory board is opting to recommend it only for newborns whose mothers test positive for the virus. “Women whose hepatitis B status is negative or unknown should talk with their doctors about vaccination, the recommendation says,” according to NPR.

“If you are a baby that was born to a mother that was tested negative for Hep B, you need to realize, as a parent, that your risk of infection throughout your early stage of life and probably throughout most of your childhood, is extremely low to the extent that it’s even hard to quantify how low. It is, it’s probably one in several millions [sic],” Professor Retsef Levi – a member of the ACIP – said in a clip shared by the CDC.

“And that means that, as a parent, we encourage you, in consultation with your physician, to think very carefully. Do you want to expose your child, your baby, to an intervention that could have some potential harms when the risk is so low?” he asked. “And mind you that we are talking about a very, very young baby in the first few months of their life, where they are not fully developed.”

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Hep B Shot: Not Proven Safe or Effective for Kids

I. Junk Science Clinical Trials as the Basis for FDA Licensure of Hepatitis B Vaccines in the U.S. 

The Advisory Committee on Immunization Practices (ACIP) will discuss hepatitis B vaccines at their meeting on December 4 and 5. In this article I will lay out the case for removing hepatitis B vaccines from the CDC childhood schedule altogether.

As the Informed Consent Action Network has demonstrated, the hepatitis B vaccines Recombivax and Engerix — injected into the vast majority of American children at birth, one month, and six months of age — never should have been licensed by the FDA in the first place. 

The clinical trials for Recombivax and Engerix:

  • did not include a proper saline placebo control group; 
  • were too small to detect uncommon adverse events; and
  • were too short to detect the majority of harms (the Recombivax trials monitored safety for just five days, the Engerix trials monitored solicited adverse events for just four days).

II. Hepatitis B Vaccines Are Associated with Autism 

The real world data that are available on the safety of hepatitis B vaccines are horrifying. When autism rates in the US exploded in the 1990s, the CDC looked into the possible role of vaccines. They assigned one of their senior scientists, Thomas Verstraeten, at the Epidemic Intelligence Service, to do the analysis. At the time, hepatitis B vaccines had mercury (thimerosal) in them. Dr. Verstraeten found that children in the highest exposure group had an 11.35x increased relative risk of autism.

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Bovaer has been suspended in Norway and Sweden

3-Nitrooxypropanol (“3-NOP”), marketed as Bovaer, is, so it is claimed, a feed additive used to reduce methane emissions in ruminants.  UK residents will recall the suspicious product from an Arla trial of feeding it to dairy cows that began in November 2024.

Peter Imanuelsen gives an update on developments in Sweden.  It seems the Bovaer project has come to an end in Sweden, he says.

The largest dairy supplier in Norway has suspended the use of Bovaer after multiple reports from Denmark of collapsing cows.  Now, it seems like the Bovaer project has come to an end in neighbouring Sweden. 

The dairy producer Gäsene has now ended their Bovaer project, the last remaining dairy producer that still used Bovaer in the country. Earlier, the dairy producer Norrmejerier discontinued their ”climate milk.” So now there is no known dairy producers giving their cows Bovaer in Sweden anymore. This is very telling…

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There may not be a safe off-ramp for some taking GLP-1 drugs, study suggests

The popularity of GLP-1 weight-loss medications continues to soar—and their uptake is helping to push down obesity rates on a national scale—but a safe, evidence-based way off the drugs isn’t yet in clear view.

An analysis published this week in JAMA Internal Medicine found that most participants in a clinical trial who were assigned to stop taking tirzepatide (Zepbound from Eli Lilly) not only regained significant amounts of the weight they had lost on the drug, but they also saw their cardiovascular and metabolic improvements slip away. Their blood pressure went back up, as did their cholesterol, hemoglobin A1c (used to assess glucose control levels), and fasting insulin.

In an accompanying editorial, two medical experts at the University of Pittsburgh, Elizabeth Oczypok and Timothy Anderson, suggest that this new class of drugs should be rebranded from “weight loss” drugs to “weight management” drugs, which people may need to take indefinitely.

Some studies have found that about half of people who start taking a GLP-1 drug for weight loss stop taking it within a year—for various reasons—and many people think they can stop taking anti-obesity drugs once they’ve reached a desired weight, Oczypok and Anderson write. But that’s not in line with the data.

“It may be helpful to compare them to other chronic disease medications; patients do not stop their anti-hypertensive medications when their blood pressure is at goal,” they write.

In the trial, researchers—led by Eli Lilly scientists—followed 670 participants with obesity or overweight (but without diabetes) who were treated with tirzepatide for 36 weeks. Then the participants were split into either continuing with the drug for another 52 weeks (88 weeks total) or getting a placebo for that period of time. Both groups were told to continue a reduced-calorie diet and an exercise plan.

In all, 335 participants were randomized to switch to a placebo, and the researchers monitored changes in their weight and cardiovascular health metrics after the switch. Not everyone in the first phase of the trial lost significant amounts of weight on the drug. So, the researchers only closely tracked the 308 of the 335 who lost at least 10 percent of their body weight on the drug.

Of the 308 who benefited from tirzepatide, 254 (82 percent) regained at least 25 percent of the weight they had lost on the drug by week 88. Further, 177 (57 percent) regained at least 50 percent, and 74 (24 percent) regained at least 75 percent. Generally, the more weight people regained, the more their cardiovascular and metabolic health improvements reversed.

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NHS Doctors Were Paid to Knowingly Implant Deadly Heart Device

Two of the UK’s leading transplant centres continued fitting a heart device that they knew was deadlier than its rival product. Medtronic’s HeartWare HVAD was a pump surgically implanted for end-stage heart failure – and it was well documented that its mortality rate was significantly higher than other options. But top cardiologists at both hospitals were found to be paid consultants for Medtronic, the hospitals were aware of their involvement, and the NHS had already raised concerns. Were leading doctors deliberately implanting deadly devices? 

The Staggering HVAD Mortality Rate

Patients with a weakened heart can be offered a Left Ventricular Assist Device (LVAD) if they are deemed unsuitable for a transplant, or stuck waiting for one. For many people, the LVAD helping to pump blood around the body is their only chance of survival outside of a transplant.  

LVADs have saved lives for decades and the two top competitors were Medtronic, who produced the HVAD device, and Abbott, who made the Heartmate III. In 2018, an audit was conducted by NHS Blood and Transplant (NHSBT) to compare the pumps’ performance, and shocking results were published in 2019: 

  • Medtronic: 54 of 119 patients (45%) died within two years 
  • Abbott: 15 of 97 patients (15%) died within the same period 
  • The number of strokes and instances of people requiring a new pump was also significantly higher for Medtronic 

They Knew – and Kept Implanting

The Freeman Hospital in Newcastle and Harefield in London continued using the pump for years, deciding to question the data rather than prioritise patient safety. Other hospitals, such as the Royal Papworth Hospital in Cambridge, made the call before the NHS analysis was even shared – they had picked up on the pattern themselves and stopped using the Medtronic device in February 2018, considering the Heartmate III to be superior. 

The Newcastle and London hospitals, however, continued to solely use the Medtronic device until 2021 when the manufacturer withdrew it from sale “in the interest of patient safety”. In the three years between the 2018 audit and 2021 withdrawal, 50% of patients with the Medtronic device died, compared to 19% of recipients of the Abbott device. 

Were They Paid to Implant It?

Until recently, the head of Freeman’s cardiothoracic department was Prof Stephan Schueler, also known as “king of the castle” by former colleagues. Public records later revealed that he had a decade-long relationship with the Medtronic manufacturer. Patients were not made aware of his financial relationship with the company, despite disclosure being a requirement of the General Medical Council (GMC) – the doctor’s regulator. 

The Freeman Hospital stated publicly that it was “aware” of the NHS data published in 2019, but felt its scientific reliability was lacking. 

At Harefield Hospital, André Simon was the director of heart and lung transplantation and ventricular assist devices. He had a similarly long-standing relationship with Medtronic, dating back to 2014. The hospital said it was “aware” of his work for Medtronic, and that it had been declared in multiple papers. They also confirmed that he was one of a number of senior people “involved” in deciding which devices are used and that there was “collective support” for the continued use of the Medtronic device until 2021.  

Dr John Dunning, who replaced André Simon at Harefield, said they continued to use the Medtronic device as “it was the preference” of his predecessor.  

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