What Does a Fraudulent Vaccine Safety Study Look Like?
By Dr. William H. Gaunt | The Defender | August 26, 2024
New vaccines should be proven safe before they are accepted onto the Centers for Disease Control and Prevention (CDC) vaccine schedule.
Here is what is actually happening: Vaccine companies are doing studies that claim to demonstrate the safety of new vaccines but are carefully designed and conducted to intentionally hide the toxicity of these vaccines.
To see how this is done, read on.
What does an honest vaccine safety study look like?
An honest safety study must have a test group that gets the vaccine and a control group that gets a harmless placebo. Injuries and deaths are compared in the two groups.
If the test group has many more adverse events than the placebo control group, the vaccine is not safe.
Most people would be shocked to learn that none of the vaccines on the CDC vaccine schedule have been safety tested in this way.
What does a fraudulent vaccine safety study look like?
Rule No. 1 for conducting a fraudulent study: Do not have a placebo control group. Here is where the fraud is happening: The “control group” is deliberately given something that is as toxic as the vaccine being tested. It can be an older vaccine or the vaccine ingredients minus the antigen.
The results will show that the injuries and deaths are similar in both groups. That is because they are both receiving toxic ingredients. The new vaccine is then illogically declared safe.
If there is no placebo control group, the toxicity of the vaccine is hidden. This is both clever and diabolical. Can you see it?
The public is unaware of this subterfuge
“Turtles All The Way Down: Vaccine Science and Myth” is the most thorough and brutally honest book ever written about vaccines.
The authors tell us on page 81:
“As we have seen in this chapter, vaccine trials are designed and performed in such a way as to ensure that the true extent of adverse events is hidden from the public. There is not a single vaccine in the US routine childhood vaccination schedule whose true rate of adverse events is known.”
Two examples of how unsafe toxic vaccines got on the CDC vaccine schedule
Prevnar-13 (a pneumococcal vaccine) was given to the test group of children and the “control group” was given the older Prevnar vaccine.
Severe adverse events occurred in 8.2% (one out of every 12 children) in the test group. Severe adverse events also occurred in 7.2% (one out of every 14 children) of the control group.
What percent of a placebo control group would have had severe adverse events? Probably 0% because they would have received something harmless. We can’t know because the authors of this study chose not to have a placebo control group.
The Prevnar-13 vaccine was declared “safe” and was approved for use by the U.S. Food and Drug Administration (FDA). You don’t have to be a doctor or scientist to suspect that both the Prevnar and the Prevnar-13 vaccines are unsafe. “Turtles All The Way Down” covers this fraudulent vaccine safety study on pages 60 and 61.
Here is the second example, which the authors describe on pages 77 and 78:
“In one of the DTaP vaccine trials, 1 in every 22 subjects in the trial group was admitted to the hospital. A similar hospitalization rate was also reported in the ‘control group’ (which received the older-generation DTP vaccine).”
Again, there was no placebo control group. Both vaccines appear to be decidedly unsafe yet the newer DTaP vaccine made it onto the CDC vaccine schedule. DTP and DTaP vaccines contain antigens for diphtheria, tetanus and pertussis.
Why is this happening?
Ultimately, the answer is greed. It is enormously profitable to get a vaccine on the CDC schedule. Vaccine companies will do whatever it takes to accomplish this. If it takes a little scientific fraud, so be it.
The vaccine companies are cheating on vaccine safety studies by omitting placebo control groups, thereby lying about the safety of vaccines. The FDA and CDC are complicit because they are doing nothing to stop this fraud.
Corporate capture or regulatory capture
The FDA and CDC are regulatory agencies. The original function of these agencies was to protect the public from dangerous drugs and vaccines.
Unfortunately, these agencies have been captured by Big Pharma. They no longer focus on protecting the public. They focus on protecting and promoting the interests of pharma companies.
Can we compare the health outcomes of vaccinated versus unvaccinated children?
Theoretically, yes but not if we expect our health authorities or pharma companies to do these types of studies. Chapter 6 of the “Turtles” book is titled “The Studies That Will Never Be Done.”
On page 207 the authors tell us:
“No study that compares the health of vaccinated children to that of unvaccinated children has ever been done by the medical establishment.”
If such a study showed that vaccinated children are healthier than unvaccinated children, it would have been published and been headlined in every newspaper and been the lead story on the nightly news. That hasn’t happened. We suspect that such a study has been done internally at the CDC.
The unwanted conclusion that they won’t allow to see the light of day is that unvaccinated children are far healthier than vaccinated children. This study has likely been done and buried instead of published. Such a study is verboten because it would be a disaster for the vaccine companies.
Private studies show that unvaccinated children are healthier
Here are two privately funded studies:
- “Relative Incidence of Office Visits and Cumulative Rates of Billed Diagnoses Along the Axis of Vaccination” by Dr. Paul Thomas and James Lyons-Weiler, Ph.D.
- “Analysis of health outcomes in vaccinated and unvaccinated children: Developmental delays, asthma, ear infections and gastrointestinal disorders” by Brian S. Hooker, Ph.D., and Neil Z. Miller.
Another great resource is the book “Vax-Unvax: Let the Science Speak,” by Robert F. Kennedy Jr. and Hooker. They report on many studies where unvaccinated children have better health outcomes compared to vaccinated children.
Science is for sale
The book “Science for Sale: How the US Government Uses Powerful Corporations and Leading Universities to Support Government Policies, Silence Top Scientists, Jeopardize Our Health, and Protect Corporate Profits” by David L. Lewis, Ph.D., tells the story of how corporate profits can frequently trump true science.
This happens in many industries, not just in vaccines. It is not unusual for government agencies to take the side of the corporations. The author was fired from the EPA for revealing details of how this happens.
The health of the public is subverted by powerful corporations in these situations. Does that sound familiar? Lewis doesn’t cover vaccines in his book except in Chapter 7 where he describes how Dr. Andrew Wakefield was unjustly crushed for questioning the safety of the measles-mumps-rubella or MMR vaccine.
Are vaccines the main cause of autism?
If the answer is yes, that would be very bad for vaccine companies. The “Turtles” authors point out on page 209 how our health authorities are trying hard not to find the correct answer to this question:
“Over the past 15 years, dozens of epidemiological studies have been conducted examining the association between vaccines and autism, but not a single one compared the rate of autism in fully vaccinated and fully unvaccinated children.”
If they actually wanted to answer this question, they would do vax/unvax studies. Such studies are easy to do but our health authorities refuse to do them.
Why do health authorities favor epidemiological studies?
The “Turtles” authors provide the answer on page 198:
“Epidemiological studies are the tool of choice for health authorities and pharma companies to maintain a facade of vaccine safety science. They are cheap, relatively simple to conduct, and, above all, their results are easily manipulated.”
It is entirely possible to get an epidemiological study to conclude whatever its authors want it to conclude. These types of studies are not the gold standard.
What caused the drastic decline in infectious disease mortality?
We are supposed to believe that vaccines have been our saviors. Not true. The huge decline in infectious disease mortality was largely due to sanitation, hygiene and improved nutrition (the availability of fresh fruits and vegetables year-round).
The “Turtles” authors make this clear on page 293. They reference a report by the American Institute of Medicine, which states:
“The number of infections prevented by immunization is actually quite small compared with the total number of infections prevented by other hygienic interventions such as clean water, food, and living conditions.”
The claim that vaccines alone saved us is false and our health authorities know it is false.
Below is a simple graph that causes cognitive dissonance in those who believe that vaccines saved us from high rates of infectious disease mortality.
We can clearly see that deaths from measles were reduced to near zero by the interventions mentioned above BEFORE the measles vaccine was introduced.
Similar graphs for other infectious diseases are shown in the book “Dissolving Illusions: Disease, Vaccines, and the Forgotten History” by Dr. Suzanne Humphries and Roman Bystrianyk. The mortality rate for all infectious diseases was dropping rapidly before vaccines were introduced.
Do you smell a rat?
Yes. And it has been dead for quite a while. We have been bamboozled (deceived, cheated, swindled and defrauded).
Vaccines are now doing far more harm than good by causing a huge increase in chronic diseases like autism, asthma, attention-deficit/hyperactivity disorder or ADHD, Type 1 diabetes, learning disabilities, seizures and much more.
It is way past time to use honest unbiased science to sort it out. Imagine what will happen when honest science is applied to vaccine safety studies.
Here is how the ‘Turtles’ authors sum it up
On page 518:
“Science belongs to the people. It belongs to humanity, not to corrupt government agencies and pharmaceutical giants who collude to rewrite the principles of science in order to continue the decades-long cover-up of their crimes against humanity.
“The magnitude of these crimes is enormous — these entities are in way too deep to ever be able to admit any wrongdoing. They will do whatever is necessary to protect the great vaccine hoax. For them, it is a matter of life and death — literally. And so it is for us.”
The lie that vaccines are safe and effective and that serious adverse events are exceedingly rare is still believed by many people — yet trust in pharma and our coopted regulatory agencies is now rapidly eroding. For example, only a tiny percentage of people are continuing to take the COVID-19 vaccine boosters.
Also, the percentage of parents who are choosing to obtain an exemption to vaccines for their children is increasing. This can be done in almost all states.
It is becoming obvious to a growing number of people that we are being intentionally misled regarding vaccines and vaccine safety.
CDC USES ‘COVID SURGE’ TO STOKE FEAR
The HighWire with Del Bigtree | August 22, 2024
The CDC is using new, questionable techniques to declare a ‘COVID surge’ and stoke fears. Coincidentally, a new booster hits the market as students head back to school. Jefferey Jaxen reports.
Dr. Peter McCullough: COVID Shots for Kids ‘the Last Straw’
By Brenda Baletti, Ph.D. | The Defender | August 19, 2024
“A child today faces well over a hundred shots,” cardiologist Dr. Peter McCullough told host Mat Staver on a recent episode of “Freedom Alive.” Many of those shots are for infectious diseases of the past or contemporary illnesses that don’t pose a risk to infants.
McCullough said the “inflection point” was the 1986 National Childhood Vaccine Injury Act, which freed vaccine manufacturers from liability for vaccine injuries. “We saw essentially a vaccine bonanza develop,” he said, and “excessive, unnecessary” vaccination could be leading to serious side effects.
Those vaccines start just after a baby is born, he said, when they are given the hepatitis B vaccine.
As a cardiologist, dealing with blood and body fluids, McCullough said the vaccine is appropriate for him, but babies are not at risk for it unless their mother has the illness or is an active IV drug user. For most babies, he said, it is a “completely unnecessary shot on the first day of life.”
The Centers for Disease Control and Prevention (CDC) in October 2023 recommended newborns receive Beyfortus, the monoclonal antibody shot meant to protect babies from RSV-related illness.
“This has no safety track record,” he said. “We’ve never given a synthetic antibody to a baby ever in the history of medicine, and now it’s being given uniformly with no idea of what is going to happen to the baby’s immune system over the next several weeks or months.”
The clinical trials were inconclusive as to whether Beyfortus is safe, and evidence from France shows increased mortality among infants after the shot was introduced, he said.
McCullough said the broader safety concerns stem largely from the fact that so many are given in combination. “For some babies, it’s too much,” he said.
Excessive vaccination, he explained, sends the immune system into overdrive, which can lead a baby to develop a fever and a febrile seizure (convulsion).
Research shows febrile seizures have about a 40% chance of causing permanent neurologic injury, ranging from epilepsy to attention-deficit/hyperactivity disorder to autism spectrum disorder.
Staver said many parents who saw their children develop autism post-vaccination are told either that it isn’t true or it’s just a coincidence because there is no evidence of such a link.
“The direct observation by a mother and father of their child is the strongest evidence,” McCullough said, citing Dr. Andy Wakefield’s controversial 1998 study.
McCullough also cited a recent study by the Children’s Health Defense science team, which showed that combining multiple vaccines is dangerous. Spacing them out and giving them individually — rather than combining three vaccines into one shot, like the measles-mumps-rubella, or MMR, vaccine — is safer, he said.
And, he said, all children do not need all vaccines. Which vaccines a child gets should be determined on a risk basis. For example, a child with cystic fibrosis might need the respiratory illness vaccines, but healthy kids probably don’t.
Yet these vaccines are given to all children in part, he said, because the people who advise the CDC on which vaccines should be recommended for children have serious conflicts of interest — most take money from Big Pharma. Then schools enact mandates based on those recommendations, leaving parents feeling as if they have no choice.
Vaccine makers lobby state legislators to continually increase the list of mandatory vaccines.
McCullough said:
“Can you imagine if you had a product that treats an illness? You would have to treat a small number of people in a population. But if you have a vaccine, that means the whole entire population has to receive the product.
“A product that must be purchased by the entire population with no liability is an absolute boon to any purveyor of that product.”
McCullough said the CDC has turned a blind eye to vaccine safety. For example, none of the childhood vaccines have been studied for safety when given in combination.
He added that Dr. Paul Thomas reported in The Defender that pediatricians receive substantial incentives from insurance companies to vaccinate certain high percentages of their patients.
For lower-income kids, there is also government financial support to ensure that the vast majority of the population is vaccinated against legacy diseases like diphtheria, tetanus, polio and other diseases that are either no longer commonly circulating or for which good treatments exist.
For many, McCullough said, the recommendation that children take the COVID-19 vaccine, given its alarming safety data, was “the last straw.”
“That act was irresponsible. It triggered the World Council for Health, which is an evidence-based, consensus-driven body to recommend waiting on all the childhood vaccines,” he said.
Vaccines are not safe or effective enough to mandate, McCullough said. “Every parent and child unit should be able to make their own decisions free of any pressure, coercion, or threat of reprisal.”
Watch the interview here.
This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.
Health Officials Push Whooping Cough Vaccine Amid Uptick in Cases, But Scientists Say Shots Don’t Prevent Transmission
By Suzanne Burdick, Ph.D.John-Michael Dumais | The Defender | August 14, 2024
Public health officials are urging families to get vaccinated against whooping cough, citing an uptick in cases, particularly among adolescents. However, critics say the vaccine doesn’t prevent transmission and contains dangerous toxins that may harm human health.
Connecticut Department of Public Health Commissioner Manisha Juthani said that there were 111 confirmed cases of pertussis in the state so far in 2024 — nearly a 10-fold increase compared to 2023, NBC Connecticut reported this week.
Juthani told The Hour that public health officials are concerned the spread will increase when school begins in just a few weeks.
“We are raising attention to this, both to providers and to families,” she said, “so that theoretically, people can get back up to date on their vaccines before children potentially are going back to day care, are going back to school.”
Other states, including New York and Pennsylvania, have also seen an uptick in whooping cough cases this year, Newsweek reported in early June. Outside the U.S., the United Kingdom and Australia have also reported increases.
Whooping cough, also known as pertussis, is a highly infectious respiratory tract infection, according to the Mayo Clinic. Deaths from it are rare and typically occur in infants.
It’s caused by a bacteria called Bordetella pertussis, according to the Centers for Disease Control and Prevention (CDC).
The CDC recommends that “everyone” — from babies as young as 2 months old to adults, particularly pregnant women — vaccinate against the illness by getting either a DTaP or Tdap vaccine, which also ostensibly protect against tetanus and diphtheria.
According to the CDC, the vaccine is “the best way to prevent whooping cough.”
Pertussis can be treated with antibiotics
However, Karl Jablonowski, Ph.D., senior research scientist at Children’s Health Defense (CHD) told The Defender the pertussis vaccine may contribute to the spread of the infection — because it doesn’t prevent transmission.
“The pertussis vaccine is one of those that breaks the mold of what we think a vaccine is,” Jablonowski said. “Pertussis is probably the best case I can think of for a vaccine that does not prevent transmission.”
He added, “Every time there is a case of it, health officials will get on TV urging people to get vaccinated — wrongfully believing it will stop transmission.”
As The Defender recently reported, the CDC has been tracking changes in the prevalence of bacteria causing whooping cough for years.
Although the CDC’s whooping cough website still says the illness is caused by Bordetella pertussis, the most recent CDC data found that the Bordetella parapertussis type of whooping cough has significantly overtaken Bordetella pertussis in prevalence — and according to research published in Vaccines in March, the existing vaccines “scarcely provide protection” against this strain.
Brian Hooker, Ph.D., CHD chief scientific officer, told The Defender pertussis can be treated with antibiotics — “erythromycin and azithromycin are standard,” he said — and high doses of vitamin C.
The CDC’s website acknowledges whooping cough can be treated with antibiotics and fails to explain why the agency favors vaccination over antibiotics.
Pertussis vaccine may prevent herd immunity
Earlier this year, Jablonowski spoke on the poor efficacy and high-risk profile of the pertussis vaccine before Tennessee lawmakers as they weighed a bill to prohibit the state’s Department of Children Services from “requiring an immunization as a condition of adopting or overseeing a child in foster care if an individual or member of an individual’s household objects to immunization on the basis of religious or moral convictions.”
During March testimony before the Tennessee General Assembly Civil Justice Committee, Jablonowski cited scientific studies that debunk the notion that the vaccine is the best way to prevent whooping cough.
For instance, a 2016 review published in JAMA that reviewed more than 10,000 whooping cough cases found that more than half the cases in the five largest statewide outbreaks occurred in individuals who were partially or fully vaccinated against pertussis.
A 2019 review published in the Journal of the Pediatric Infectious Disease Society concluded that “all children who were primed by DTaP vaccines will be more susceptible to pertussis throughout their lifetimes, and there is no easy way to decrease this increased lifetime susceptibility.”
Another review, also published in 2019, concluded that pertussis vaccines “do not reduce the circulation of B. pertussis and do not exert any herd immunity effect.”
Jablonowski told lawmakers that not only does the pertussis vaccine not “exert” a herd immunity effect, but the vaccine “has a negative effective on herd immunity.”
He explained:
“A vaccinated person can asymptomatically carry and transmit the disease, and cannot then learn how to fight it naturally.
“If you accept that in order to achieve herd immunity 90% of the population needs to not retransmit the bacteria once exposed to it, then once you have vaccinated more than 10% of the population herd immunity becomes impossible, as the vaccinated citizens will be contracting and transmitting the disease.”
Jablonowski told The Defender the only two scenarios in which getting the vaccine might protect someone else is when it’s given during pregnancy or to a nursing mother.
According to the CDC, pregnant women should get the Tdap vaccine to provide their babies with the “best protection” from whooping cough, ideally between 27 and 36 weeks gestation. Protective antibodies pass from the pregnant woman’s body to the fetus, the agency said.
Researchers funded by the pharmaceutical company Sanofi — which sells pertussis vaccines — in 2022 published a statement saying that vaccination against pertussis during the second or early third trimester of pregnancy is “highly protective” against pertussis in young infants.
Both the CDC and Jablonowski said that vaccinating nursing mothers doesn’t appear to be effective in protecting babies from whooping cough.
A 2012 study conducted in a Houston area hospital found that giving postpartum moms the Tdap vaccine didn’t reduce the number of infections in babies when compared to prior years in which the hospital didn’t readily give the vaccine postpartum.
The hospital implemented a standing order that all new mothers get Tdap, Jablonowski said.
The researchers looked at health data from moms and babies 7.5 years before and almost 1.5 years after this standing order, he said. “Cases of infant pertussis practically doubled and the mortality rate practically tripled” after the standing order.
Vaccine contains aluminum and formaldehyde
Both of the two current formulations of the pertussis vaccine contain toxins known to harm human health, including aluminum and formaldehyde, Jablonowski told the lawmakers.
Aluminum is a known neurotoxin that can affect more than “200 important biological reactions” and cause “negative effects on [the] central nervous system,” according to a 2018 paper published in the Journal of Research in Medical Sciences.
Formaldehyde is a known carcinogen that is toxic to the respiratory system, central nervous system, optic nerve, kidney, liver, testicles and other body systems.
The pertussis vaccine, typically administered as part of combination vaccines like DTaP or Tdap, contains several other potentially harmful ingredients. These typically include inactivated B. pertussis toxin and several of its components, polysorbate 80, gluteraldehyde, 2-phenoxoyethanol and in some cases, trace amounts of mercury, according to the National Vaccine Information Center (NVIC).
Some researchers suggest the chemically inactivated pertussis toxin in DTaP may retain some bioactivity, potentially inducing brain inflammation in certain individuals.
CDC didn’t follow up on 2012 report on adverse events following DTaP/Tdap vaccines
For the past 70 years, researchers have used the pertussis toxin in animal studies to purposefully trigger various physiological responses. Responses include heightened sensitivity to histamine, serotonin and endotoxins. Researchers also used the pertussis toxin to induce experimental autoimmune encephalomyelitis.
The toxin’s ability to penetrate the blood-brain barrier under certain conditions has long been a concern. This property makes brain inflammation, or encephalitis, and its potential for lasting neurological damage a particularly severe complication associated with both whooping cough infection and pertussis vaccination.
According to the Vaccine Adverse Event Reporting System (VAERS), from 1990 to 2024, there were 190,994 injury reports following pertussis-containing vaccines, including 3,377 deaths, according to NVIC. Over 85% of these deaths occurred in children under age 3.
While this data includes pre-1996 reports, when the whole-cell pertussis portion of the DTP vaccine formulation was changed due to its serious side effects, it’s important to note that a significant portion would be related to the DTaP vaccine given its widespread use since 1996.
Over 6,000 claims for injuries from pertussis-containing vaccines were submitted to the federal Vaccine Injury Compensation Program (VICP) as of Aug. 1, 2024. The cases include 872 deaths and over 5,000 serious injuries. Pertussis-containing vaccines comprise the highest number of VICP death claims and the second most compensated vaccine injury claims.
A 2012 study published in JAMA found an increased risk of febrile seizures in children 3-5 months old on the day of or day after receiving the first two doses of DTaP-containing vaccines.
The Institute of Medicine’s (IOM) 2012 report, “Adverse Effects of Vaccines: Evidence and Causality,” evaluated 26 reported adverse events following DTaP/Tdap vaccination. They included encephalopathy, encephalitis, chronic hives, autism, sudden infant death syndrome, arthritis, Guillain-Barré syndrome, diabetes mellitus, immune thrombocytopenic purpura, transverse myelitis and others.
For 24 of the 26 adverse events, the committee said there was not enough data either to support or reject vaccine-related causality, primarily due to a lack of adequate studies.
To date, the CDC has not conducted any additional studies in response to IOM’s recommendations, according to the authors of “Vax-Unvax: Let the Science Speak,” Hooker and Robert F. Kennedy Jr., CHD’s chairman on leave.
A 2017 study led by Dr. Anthony Mawson published in the Journal of Translational Science, compared the health outcomes of vaccinated and unvaccinated children ages 6-12. The study found that while vaccinated children had fewer cases of chicken pox and pertussis, they had significantly higher rates of other health issues.
According to the study, vaccinated children were more likely to be diagnosed with allergic rhinitis, eczema and neurodevelopmental disorders. The vaccinated group also showed higher rates of attention-deficit/hyperactivity disorder, autism, learning disabilities and chronic health problems.
Additionally, the study reported that vaccinated children had a higher incidence of pneumonia and ear infections compared to unvaccinated children.
This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.
Too Little, Too Late, Wrong Science: A Critique of Salmon et al.
40 years of failed science is enough. I’m asking Siri, Kennedy and Bigtree to make the right science happen. They can do it.
By James Lyons-Weiler | Popular Rationalism | July 11, 2024
In their recent publication in the New England Journal of Medicine, Salmon et al. finally acknowledge what many of us have known for years: the so-called comprehensive vaccine safety studies have been woefully inadequate. However, their proposed solution—relying on post-market surveillance—misses the mark entirely in a stunning manner that cannot stem from a lack of self-awareness – and raises more questions than it answers. This critique will expose the fundamental flaws in their approach and underscore the urgent need for long-term, randomized clinical trials.
Historical Context: Decades of Malfeasance and Fraud
For over three decades, the medical establishment, spearheaded by figures like Dr. Stanley Plotkin, has assured the public that vaccines are the most rigorously tested medical products using retrospective studies. Yet, Salmon et al. now concede that prelicensure clinical trials often have “limited sample sizes and follow-up durations” and that there are “no resources earmarked for post-authorization safety studies.” This admission not only undermines the credibility of these long-standing claims but also highlights a systemic failure to prioritize safety.
They ignore, however, all of the work done over the years by critics like Brian Hooker, Mark Blaxill, myself, and many, many others that not only demonstrate the fatal flaws in reliance on retrospective studies, but their intentional and therefore criminal abuse in the hands of people working in and for the CDC bent on hiding vaccine risk.
The Mirage of Distorted Retrospective Studies
Retrospective observational studies, the cornerstone of Salmon et al.’s proposed solution, are a poor substitute for robust, prospective research. These studies are rife with potential biases, including selection bias, selective reporting, recall bias, and confounding variables. The findings of such studies are highly dependent on who conducts them, the study design, and adherence to the data analysis plan. Repeated analyses and adjustments for presumed confounders often lead to the convenient disappearance of associations with adverse events via p-hacking.
The Case of Aluminum and Asthma
Consider the association between aluminum exposure from vaccines and persistent asthma, as detected and reported by Daley et al. Despite identifying a positive association, the authors acknowledge the potential for residual confounding and the small effect sizes. This illustrates the inherent limitations of retrospective studies. Moreover, Frank DeStefano’s study on his way out of the CDC linked aluminum to asthma, raising serious questions about the integrity of the surveillance data. Denialists like Paul Offit tried to arm-wave away the result, preventing the next necessary steps, and 1) Finding safe ways to help patients remove aluminum, and 2) Removing aluminum from vaccines.
Ignored Historical Evidence
Before the Vaccine Injury Compensation Program (VICP) was established in 1986, adverse events like eczema were recognized following vaccinations. Post-1986, it seems there was a collective amnesia within the medical community regarding these associations. Similarly, Guillain-Barré syndrome (GBS) was first noticed after the swine flu vaccination campaign in 1976. It took 30 years for HHS to put GBS on the table of vaccine injuries. This pattern of intentional lost knowledge is unforgivable. These historical data points should not be ignored or downplayed, yet they have been consistently overlooked in favor of maintaining the vaccination status quo.
The Mechanistic Black Box
One of the most glaring deficiencies in vaccine safety research is the lack of understanding of the biological mechanisms underlying vaccine-related adverse events. Salmon et al. admit this gap, yet they continue to rely on epidemiological data without pushing for mechanistic studies. Yet, in my experience, in reading the literature, these claims result in appeals to ignorance. It is almost certain that knowledge exists that can link vaccines to these conditions; the same authors use argumentation and influence to cast doubt on such studies, or, again, in my experience, they ignore them altogether.
This approach is akin to trying to solve a puzzle with half the pieces missing. Without a thorough understanding of the mechanisms at play, we cannot develop safer vaccines or provide accurate risk assessments. By arguing from ignorance, they reveal their goal.
The Danger of Mandates
The insistence on full-population vaccination mandates, without adequately addressing safety concerns, puts public health and public trust at risk. The denial of potential vaccine risks and the imposition of mandates ignore the very real experiences of vaccine-injured individuals and, of course, studies that have found associations. Found associations via retrospective studies become “mere associations”, and are dismissed. In Popperian terms, the retrospective studies fail to provide a critical test. This approach not only fuels vaccine hesitancy but also undermines the credibility of health authorities. Mandating vaccines without comprehensive safety data is a reckless disregard for individual health and autonomy.
Call for Accountability
It is high time we hold those who have held the keys to databases and conducted sham studies accountable for decades of inadequate safety surveillance and research, as well as for scientific fraud. A prosecutorial investigation into potential scientific fraud at the CDC over the past 40 years is warranted. This investigation should focus on whether there has been success at efforts designed to provide systematic destruction of scientific findings via study manipulation and records destruction, a systematic failure to conduct and report comprehensive safety studies, and whether conflicts of interest have influenced vaccine policy and research. I would also investigate the VSD for data manipulation; the CDC and the vaccine industry have had exclusive control over that dataset far too long.
By exposing these issues and demanding scientific rigor, we can begin to rebuild public trust and ensure that our vaccine policies genuinely serve the best interests of public health. In a sane world, readers would be encouraged to contact their congressional representatives and the Office of Inspector General (OIG) to demand an investigation into these long-standing issues.
A New Approach: Independent, Prospective RCTs
Recognizing the failures of the current system, independents and advocates have long proposed an alternative: a large, prospective randomized controlled trial (RCT) funded by the government. I disagree. Such studies should only be done by independent research institutions funded through grassroots fundraising. These trials would run for four years and match vaccinated and unvaccinated children to avoid confounding variables and isolate the effects of childhood vaccines on chronic health conditions. This rigorous approach is necessary to provide definitive answers about vaccine safety and to restore public trust. I’m calling on well-funded individuals and organizations like those run by my friends Siri, Kennedy, and Bigtree to pull together, perhaps under the Vaccine Safety Foundation, and fund the studies needed.
We’ve built the infrastructure to do it, including independent journals and an independent IRB. Siri, Kennedy, and Bigtree have sufficient limelight to raise the millions needed to conduct these studies. Lawsuits, reporting, and campaigns are priorities, but I will never trust a study conducted by or funded by CDC. Neither should you.
Aaron, Bobby, and Del – Let’s hold a podcast and raise the funds. I’d be happy to participate in the design of the study and design of analysis.
I’ve tried for ten years to raise funds for such studies via IPAK. I’ve done my part for the sake of objectivity and science for the kids. You guys have the public’s attention. Use the systems we’ve built to safeguard objective science.
Conclusion: A Demand for Real Science
Salmon et al.’s admissions are too little, too late. Their reliance on flawed retrospective studies and post-market surveillance is inadequate. What we need are long-term, randomized clinical trials that can provide definitive answers about vaccine safety. The public deserves transparency, accountability, and a commitment to rigorous, unbiased research. Anything less is an abdication of our responsibility to protect public health.
References
1. Daley MF, et al. Association Between Aluminum Exposure From Vaccines Before Age 24 Months and Persistent Asthma at Age 24 to 59 Months. Acad Pediatr. 2023;23(1):37-46.
2. DeStefano F, et al. Childhood vaccinations and risk of asthma. Pediatr Infect Dis J. 2002;21:498-504.
3. Institute of Medicine. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: National Academies Press; 2011.
4. McNeil MM, et al. The Vaccine Safety Datalink: successes and challenges monitoring vaccine safety. Vaccine. 2014;32:5390-5398.
5. Glanz JM, et al. Cumulative and episodic vaccine aluminum exposure in a population-based cohort of young children. Vaccine. 2015;33:6736-6744.
AND JUST LIKE THAT, THE CLAIM VACCINES ARE THE WORLD’S BEST STUDIED PRODUCT DIES
The world’s leading vaccinologist, Dr. Stanley Plotkin, and company have just capitulated…
Injecting Freedom by Aaron Siri | July 10, 2024
Wow. After decades of Dr. Stanley Plotkin and his vaccinologist disciples insisting vaccines are the most well studied products on the planet, they just penned an article admitting precisely the opposite.
They just admitted vaccines are not properly studied—neither pre-licensure nor post-licensure. They admitted, for example, “prelicensure clinical trials have limited sample sizes [and] follow-up durations” and that “there are not resources earmarked for postauthorization safety studies.”
That is an incredible reversal. But let me provide context so nobody is fooled at what they are clearly up to:
For decades, the medical community insisted vaccines are the most thoroughly studied product ever; for example, Dr. Paul Offit said, “I think we should be proud of vaccines as arguably the safest, best tested things we put in our body.”
For decades, parents of vaccine injured children, vaccine injured adults, and other stakeholders contested these claims only to be shunned and attacked by the medical community and health agencies.
In 2018, I had the unprecedented opportunity to depose the architect of our vaccination program and the Godfather of Vaccinology, Dr. Plotkin, and lay bare the evidence that showed what these authors are now finally admitting about the utter lack of vaccine safety trials and studies. See https://thehighwire.com/ark-videos/the-deposition-of-stanley-plotkin/.
After this deposition is made public, Dr. Plotkin goes on a tirade, making demands that FDA add “missing information on safety and efficacy” in vaccine package inserts and that CDC exclude harms from its Vaccine Information Sheets, “lobbying the Gates Foundation to support pro-vaccine organizations,” working to have WHO list vaccine hesitancy as a global threat, lobbying AAP, IDSA and PIDS to “support training of witnesses” to support vaccine safety, etc. See https://icandecide.org/article/dr-stanley-plotkin-the-godfather-of-vaccines-reaction-to-being-questioned/.
The problem is, it doesn’t work. It doesn’t work because, at bottom, there are no proper safety studies. So, there is no safety data to add to the FDA package inserts, and hiding harms by removing them from CDC inserts doesn’t make them go away. Parents and other adults don’t simply stop believing what they have seen with their own eyes because CDC, WHO, the Gates Foundations, etc., won’t acknowledge them, or worse, they attack them.
That brings us to the present in which Plotkin and his disciples realize they can’t cast voodoo on the public. They can’t hide the truth. So, their only option is to try and co-opt the truth they have lied about for decades by now admitting that the studies to show vaccines are safe do not exist. But in making that admission, they conveniently fail to admit that for decades they lied, gaslit, defrauded (and I don’t use that word lightly) the public by claiming that vaccines are probably the most thoroughly safety tested products on the planet and that people should rest assured, no stone on vaccine safety was left unturned.
Thus, in their article just published, they pretend they never lied about vaccine safety. They pretend they are now just pointing out vaccine safety has never really been conducted, as if that was not known to them before.
Don’t be fooled. Their real agenda is plain, and it is not to study vaccine safety, but rather to confirm that which they already believe. This is crystal clear from the fact that, while their article admits the studies have not been done, they write in the same breath that serious vaccine harms are “rare.” But if the studies have not been done, how do they know that? The answer is, they don’t, and they don’t care to know the truth. Their goal is to protect the products they have spent their careers defending and worshipping and that have brought them fame and riches.
They also ignore the mountain of studies and data which already exist that clearly show serious vaccine harms. Just take a moment to review the large body of science around one of the adjuvants used in vaccines which multiple studies show can cause serious harm. See https://pubmed.ncbi.nlm.nih.gov/38788092/.
Finally, just look at their proposed solution. After making the a priori conclusion that harms are “rare,” ignoring all the existing studies showing harm, these folk have the audacity to want to raid the federal vaccine injury compensation fund to presumably pay themselves and their compatriots hundreds of millions of dollars to conduct the studies that would, no doubt, seek to confirm their prior conclusion that vaccine harms are “rare,” while ignoring the studies that already show serious harm.
So, with that in mind, and sorry for the long wind-up, here are the things they admit in this article for maybe the very first time:
“[T]he widespread vaccine hesitancy observed during the Covid-19 pandemic suggests that the public is no longer satisfied with the traditional safety goal of simply detecting and quantifying the associated risks after a vaccine has been authorized for use.”
Comment: The parents of vaccine injured children, vaccine injured adults, and others were never “satisfied” with seeking to assess “risks after a vaccine has been authorized.”
“Postauthorization studies are needed to fully characterize the safety profile of a new vaccine, since prelicensure clinical trials have limited sample sizes, follow up durations, and population heterogeneity.”
Comment: Let me translate: the clinical trials relied upon to license childhood vaccines are useless with regard to safety since they virtually never have a placebo control, typically review safety for days or weeks after injection, and often have far too few participants to measure anything of value, just see www.icandecide.org/no-placebo; amazingly, I just had a dispute with a Plotkin disciple not long ago in which they were clearly still not ready to admit the above truth https://x.com/AaronSiriSG/status/1673483027618623489.
“It is critical to examine adverse events following immunization (AEFIs) that have not been detected in clinical trials, to ascertain whether they are causally or coincidentally related to vaccination.”
Comment: No shit and you have been claiming for decades this was being done!
“When they are caused by vaccines (vaccine adverse reactions), the risk attributable to vaccination and the biologic mechanism must be ascertained. That science becomes the basis for developing safer vaccines, if possible, and for determining contraindications to vaccination and the compensation that should be offered for AEFIs.”
Comment: Again, no shit, and you have also been claiming for decades this was being done!
“Currently in the United States, when the Advisory Committee on Immunization Practices (ACIP) recommends a new routine vaccine, the only automatic statutory resource allocations that follow are for vaccine procurement by Vaccines for Children (VFC) and for the Vaccine Injury Compensation Program (VICP). Although the ACIP acknowledges the need, there are currently no resources earmarked for postauthorization safety studies beyond annual appropriations, which must be approved by Congress each year.”
Comment: Again, no shit! But nice of you to finally admit it after decades of gaslighting.
“Progress in vaccine-safety science has understandably been slow — often depending on epidemiologic evidence that is delayed or is inadequate to support causal conclusions and on an understanding of biologic mechanisms that is incomplete — which has adversely affected vaccine acceptance.”
Comment: More gaslighting because had a proper clinical trial been conducted pre-licensure, we would know the safety before it is unleashed on babies and we wouldn’t need to rely on confounded-biased-conflicted-post-authorization “epidemiological” studies you now want to conduct which you make clear you only suggest because you want to avoid “public concern and consequent decreases in immunization coverage,” not because you actually care about safety.
“In 234 reviews of various vaccines and health outcomes conducted from 1991 to 2012, the IOM found inadequate evidence to prove or disprove causation in 179 (76%) of the relationships it explored, illustrating the need for more rigorous science.”
Comment: Again, no shit, and I would appreciate if you would please properly cite to the ICAN white paper from 2017 from which you have plainly lifted this point https://icandecide.org/wp-content/uploads/2019/09/VaccineSafety-Version-1.0-October-2-2017-1.pdf.
“Identifying the biologic mechanisms of adverse reactions — how and in whom they occur — is critical for developing safer vaccines, preventing adverse reactions by expanding contraindications, and equitably compensating vaccinees for true adverse reactions.”
Comment: Shameless to pretend you have not for decades ignored or attacked those calling for these studies while pretending a mountain of such studies showing the foregoing don’t already exist.
“[T]he budget for vaccine-safety monitoring at the CDC (which is responsible for the majority of U.S. federal efforts) has remained stagnant … at about $20 million per year” which they write is an “inadequate level of funding.”
Comment: Again, shameless to pretend parent groups have not been yelling about this issue for decades only to be ignored and attacked.
“The public [now] also wants public health authorities to mitigate and prevent rare but serious adverse events – which no longer seem rare when vaccines are given to millions or billions of people.”
Comment: They have always been given to millions or billions of people, and the studies showing the harms they cause are not rare and they already exist, but you don’t really care about that reality as vaccine safety is not really the goal.
If they are really interested in the truth about what injuries vaccines cause and the rate at which these injuries occur, then they should welcome convening a bipartisan panel which could first review all the very concerning studies and hard data that already exists on this topic (often by scientists not on pharma’s dole) and we could design additional studies together and have them run in the open so everybody has to live with the result.
(Among other reasons to demand the study be conducted in the open is that I have witnessed firsthand what happens when a study comparing vaccinated and unvaccinated children in large multi-million person datasets, using historical insurance data, showed vaccinated children had multiple times the rate of numerous chronic diseases – the study gets buried hence the need to do it in the open.)
Plotkin and company should welcome studies which can show vaccines have not contributed to the rise in chronic childhood disease (many of which are immune mediated diseases) from 12% of children in the early 1980s (when CDC recommended 7 routine childhood injections) to over 50% of children now (when CDC recommends over 90 routine childhood injections).
And I think they do welcome such studies if they can assure that the outcome would show vaccines do not cause these harms. Alas, the reality is that (as they know) studies showing vaccines contribute to this rise already exist. But their goal, in any event, is not to really study safety. Rather it is to prove their prior assumption that vaccines are safe and harms are “rare.” This approach is how they designed VAERS, V-SAFE, VSD, and every other “safety” system.
As is transparent from their article, the only reason they even pretend to care about vaccine safety is that they want to avoid reduction in vaccine uptake – not actually assure safety.
That all said, if they are really well-meaning, I would welcome collaborating. To be fair, I will email all four of them to request a meeting to review existing science and design studies mutually agreed upon. If they are really interested in vaccine safety, they should welcome that (I have no hard feelings despite their attacks on me and I hope they can rise above any hard feelings they have for the sake of protecting children). Most importantly, I’m willing to live with the results of those studies. Are they?
Two Infants Died Within Hours of Receiving RSV Shots, CDC Internal Emails Show
By Brenda Baletti, Ph.D. | The Defender | July 8, 2024
At least two infant deaths reported to the Vaccine Adverse Event Reporting System (VAERS) as occurring after the babies mistakenly received Pfizer’s adult respiratory syncytial virus (RSV) vaccine were likely caused instead by nirsevimab, the monoclonal antibody shot approved for infants and meant to prevent RSV.
Freedom of Information Act (FOIA) documents obtained by Children’s Health Defense (CHD) from the Centers for Disease Control and Prevention (CDC) show that both babies died on the day they received the shots.
According to the reports in VAERS, a 27-day-old boy died immediately upon receiving the shot in the doctor’s office and an infant girl was found not breathing by her father seven hours after receiving the shot. The infant was pronounced dead soon after.
The deaths were reported in VAERS as resulting from mistaken administration of Pfizer’s adult RSV vaccine, but the CDC internal emails obtained by CHD indicate the babies had been administered Beyfortus, the brand name for nirsevimab, manufactured by AstraZeneca and Sanofi.
The U.S. Food and Drug Administration (FDA) approved the drug in July 2023 and the CDC recommended it in August 2023 for infants under 8 months or high-risk infants up to 24 months of age.
In clinical trials for the drug, 12 infants died, but an FDA spokesperson told CNBC when the drug was approved that “none of the deaths appeared to be related to nirsevimab.”
After the CDC recommended the drug, it expanded the 2024 childhood vaccine schedule and included nirsevimab for infants whose mothers did not receive the RSV vaccine — also recently approved — during pregnancy.
The CDC’s childhood immunization schedule lists the CDC-recommended shots for children from birth through age 18. Pediatricians and other clinicians typically use the schedule to make recommendations to parents, and schools use it to set vaccine requirements.
Monoclonal antibodies are not technically vaccines. Vaccines stimulate the individual’s immune system to trigger an immune response. Monoclonal antibodies are proteins cloned in a lab that act like antibodies, seeking out antigens in the body to destroy them just like people’s own antibodies do, according to the Cleveland Clinic.
When the CDC expanded the 2024 vaccine schedule, it changed the description of the schedule to be for “vaccines and other immunizing agents,” before adding the RSV monoclonal antibodies to the list.
Even professionals confused about how to report injuries related to infant RSV shots
When people experience vaccine injuries, they can report them to the CDC using VAERS, a passive surveillance system available to anyone — including doctors, other vaccine administrators and the public — for reporting adverse events.
The CDC also has other systems for monitoring vaccine safety. It monitors COVID-19 and adult RSV vaccines through the V-safe system, a different voluntary reporting system, and most vaccines through the Vaccine Safety Datalink (VSD), which analyzes healthcare data, often investigating concerns initially raised in VAERS.
However, according to the internal emails obtained by CHD, and reported by the CDC to its advisory committee, the CDC doesn’t monitor injuries from medications that are not vaccines. The FDA recommends those injuries be reported to MedWatch, the FDA’s adverse event reporting system.
That means adverse events from all medical treatments on the immunization schedule are not monitored through the same system. This can generate confusion, even among medical professionals, who treat monoclonal antibodies as vaccines.
For example, even people at the CDC in internal emails referred to the monoclonal antibodies as the “RSV (Sanofi Pasteur) Vaccine.”
Data analyst and VAERS expert Albert Benavides told The Defender this also presents a challenge to people who want to report nirsevimab injuries, because VAERS does not have a category for the drug, so people have submitted their claims as “unknown vax type” or selected one of the existing RSV vaccines, which are different drugs.
In analysis, they may fall through the cracks or be underreported, rather than forwarded to the FDA’s MedWatch system.
The emails obtained by CHD support Benavides’ claims that there is confusion between RSV vaccines approved for adults and RSV monoclonal antibodies approved for infants.
For example, Carol Ennulat, VAERS project coordinator, on March 21 emailed Pedro Moro, M.D., M.P.H, who headed up the accidental infant RSV vaccination study, informing him that one of the infants — a 1-month-old girl in Texas — died after receiving the “RSV (Sanofi Pasteur) Vaccine,” which is actually Beyfortus, the monoclonal antibody.
She told Moro the baby had been misclassified and therefore mistakenly assigned to the adult RSV project.
Moro forwarded the email to others and said the FDA was following up on nirsevimab reports, so they should take no action on the report.
In a second email the following day, Ennulat informed Moro that a second infant death — a 27-day-old New York boy — was misclassified as having received the Pfizer Abrysvo vaccine according to documents that had become available.
“The case was misclassified,” Ennulat wrote. Although the sentence indicating what drug he received was redacted, she added, “I assume FDA follows this,” which would indicate the drug administered to the infant and then reported to VAERS was likely also nirsevimab.
500 pages of FOIA documents largely redacted
CDC researchers in May published an article in Pediatrics reporting that at least 34 babies were mistakenly given the RSV vaccine — made by either Pfizer or GSK and authorized for adults — and one of those babies was hospitalized.
Thirty-one of the children under age 2 identified in the study who were mistakenly vaccinated between Aug. 21, 2023, and March 18, 2024, were less than 8 months old. Seven reports described adverse health events including fevers, vomiting, coughing and injection site swelling.
One baby was hospitalized for cardiorespiratory arrest within 24 hours of receiving the GSK RSV vaccine. The baby had a history of congenital heart disease and was hospitalized at the time of the VAERS report.
When the paper was published, The Defender worked with Benavides and identified at least two other babies in the VAERS system reported to have received the RSV vaccine and died within hours of vaccination.
The Defender reached out to the CDC in a series of emails inquiring about why the babies were not included in the study, but the CDC declined to provide details about its knowledge of the reports.
The agency said only that the VAERS reports were mistaken — neither infant had received the shot.
In response, CHD filed FOIA requests with the CDC for communications related to the two reports.
The CDC recently responded to the request, sending 556 pages of largely redacted response materials. Redactions included portions of emails sent by The Defender to the CDC and the agency’s responses — which CHD clearly already had in its possession.
Two largely unredacted emails included in the documents, however, did pertain to the babies’ deaths.
No mention of infant deaths in CDC advisory committee meeting
In the last research presentation session of the June 26-28 meeting of the CDC’s vaccine advisory committee, the RSV work group presented data on nirsevimab, touting its effectiveness — how well it prevents disease under real-world conditions — with limited discussion of safety issues.
The CDC reported in the presentation that 41% of eligible infants received the nirsevimab shot as of March 2024, 24% of parents indicated they would definitely get the shot for their children and 23% indicated they would probably get it or were unsure. Twelve percent indicated they would never give their children the shot.
The agency also said it was meeting with manufacturers to ensure they would ramp up production for the coming year after shortages of the drug were reported last year.
The committee presented a range of different effectiveness numbers from different observational studies. Overall, real-world data found the shot was “well above 50%” effective against RSV infection. Committee members said this corresponded to the European published literature that found effectiveness against hospitalization of 70-89% and against emergency room visits of 55-88%.
They said observational data showed the duration of protection was unknown.
In the presentation on nirsevimab safety, the CDC’s Dr. Jefferson Jones informed the committee that VAERS is not the primary system for monitoring the drug’s safety, because it is not a vaccine, so the data had not been previously presented. Instead, he said, adverse events should be reported to MedWatch.
Same-day events are reported to VAERS, he said, and then reviewed by the FDA.
He did, however, review the adverse events reported to VAERS.
Jones said the most frequently reported adverse events were RSV breakthrough infections. He also said, “Cases of serious hypersensitivity reactions with nirsevimab were identified and the product labeling was updated in February 2024” to indicate that.
The reactions include hives, shortness of breath, low blood oxygen levels causing blue skin, lips and nailbeds and muscle weakness. “And no additional safety signals have been identified at this time,” he said.
Jones did not mention the two infant deaths that the FOIA documents obtained by CHD reveal happened immediately following the shots.
The committee did emphasize several times that newborn deaths reported to VAERS “is of course devastating for that family, but reporting to VAERS does not necessarily mean that vaccine caused that.”
However, in that case, they were discussing neonatal death associated with the maternal RSV vaccine.
Jones concluded that the RSV work group was “very happy and pleased with the evidence that shows nirsevimab to be highly effective.”
Known safety Issues with nirsevimab/Beyfortus
RSV is a common respiratory virus that usually causes mild cold-like symptoms but can lead to hospitalization and, in rare cases, death in infants and the elderly.
By age 2, 97% of all babies have been infected with the RSV virus, which confers partial immunity, making any subsequent episodes less severe.
Yet last year as the media hyped a dangerous “tripledemic” of COVID-19, flu and RSV, new RSV vaccines were approved and recommended for pregnant women and older adults, and nirsevimab was approved for infants.
The Biden administration rushed to work with Sanofi and AstraZeneca to make hundreds of thousands of doses of the antibodies available.
According to the CDC, approximately 58,000 to 80,000 children younger than age 5 are hospitalized due to RSV infection annually and 100 to 300 deaths occur annually in that group.
Those numbers are also disputed within the CDC’s own data.
In an Aug. 4, 2023, Substack post, Dr. Meryl Nass, an internist and biological warfare epidemiologist, cited 2021 CDC data showing that over 12 years, on average 25 babies up to age 1 die annually in the U.S. from RSV.
Although RSV can be a serious event for infants, with so few deaths among that age group, both researchers and practitioners have raised questions about administering vaccines to pregnant mothers and monoclonal antibodies to babies, especially given the serious risks evident in clinical trials, and now, in post-trial follow-up.
According to the Cleveland Clinic, reactions to monoclonal antibody treatments are common and occur during or shortly after they are administered. There are also “more serious but less common risks linked to unwanted immune system reactions, such as acute anaphylaxis, cytokine release syndrome (CRS) and serum sickness.”
Nass noted that no monoclonal antibody product has ever been given on a mass scale to children. She also said that the Beyfortus label doesn’t provide information about side effects and don’t address the infant deaths in the clinical trials.
Of the 12 infants that died in the nirsevimab trials, “four died from cardiac disease, two died from gastroenteritis, two died from unknown causes but were likely cases of sudden infant death syndrome, one died from a tumor, one died from Covid, one died from a skull fracture and one died of pneumonia,” CNBC reported.
“Most deaths were due to an underlying disease,” the FDA’s Dr. Melissa Baylor said.
According to the drug’s label, no drug interaction studies — that, for example, might identify safety risks if the antibodies are given with other vaccines — have been done for Beyfortus.
Researchers have been trying and failing to develop an RSV vaccine for children for 60 years, but have encountered serious safety issues. One version developed in the 1960s worsened symptoms for children. In that case, when two infants died, the vaccine distribution was stopped.
Beyfortus is being promoted for babies by governments globally, particularly in Europe, where it was first approved in November 2022.
French independent scientist and author Hélène Banoun, Ph.D., and French statistician Christine Mackoi found that data from France’s National Institute of Statistics and Economic Studies indicates an improbably high rate of deaths of babies between 2 and 6 days old in France during September and October 2023.
Those dates correspond with the introduction of Beyfortus in French hospitals, which began on Sept. 15, 2023, The Defender reported.
Beyfortus costs $519.75 per dose for 50-milligram (mg) and 100-mg doses and $1,039.50 for a 200-mg dose. That doesn’t include administration costs.
This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.
CDC Director Said All the Right Things in Commencement Address. So Why Does Her Agency Get Things so Wrong?
Reform Pharma Team | The Defender | May 23, 2024
On Monday, Dr. Mandy Cohen, director of the Centers for Disease Control and Prevention (CDC), delivered a commencement speech at Wake Forest University.
Although she was there to inspire, her overly rehearsed speech epitomized everything wrong within the healthcare system.
Cohen shared a story from early in her career when she did what she thought was right, but both her actions and the system she worked in failed.
“I didn’t do a good enough job learning about the person in front of me,” Cohen told the audience.
Cohen explained that she was treating “Jennifer” for unexplained hair loss, lethargy, weight loss and bloating. After running a series of tests over eight weeks — all of which came back normal — she was stumped by the patient’s results.
It wasn’t until a nurse tech instructed Cohen to ask the patient if she had had enough to eat that Cohen realized she missed the patient in front of her.
Cohen allowed her patient to needlessly suffer for eight weeks because she failed to ask the most basic foundational medical question. She, like many other doctors, followed protocol — or what Reform Pharma calls the Big Pharma agenda — rather than practice medicine.
While Cohen admitted she failed in caring for her patient, today she sits as the director for the CDC, the very organization creating the kinds of protocols that lead to patients being overlooked, misdiagnosed and victims of pharmacide — death and injury caused by Big Pharma corruption.
Doctors follow Cohen’s CDC recommendations. They treat patients as if they were products on an assembly line, giving the same treatment to everyone.
Patients are tossed into the “Pharma Sell Cycle” that guarantees continuous profits for Big Pharma and dependency on our failed healthcare system.
“The system I worked in made it super easy for me to miss the person in front of me,” Cohen said during her speech.
It’s the same system that makes it super easy for her and other healthcare providers to dismiss vaccine injury.
It’s the same system that watches and wonders why the rates of chronic disease and illness in children are skyrocketing while the system pushes toxic vaccines on children, pregnant women and adults, causing serious injury and death.
Cohen pointed out that it is easier to prescribe than it is to heal. It was easier to order tests than it was to be a doctor and connect a patient’s lifestyle to their health.
Who taught her to think like that? She said she is a “pretty smart person” with a “very pricey education.” Yet, she failed to look at the basic needs of her patient and instead, prescribed a Big Pharma solution.
“It was really easy to spend money on the wrong things, ordering blood tests, CAT scans. But it actually was really hard to connect her to the housing, counseling and food resources that she really needed to keep her healthy and thriving,” Cohen said.
Cohen’s story was intended to give testimony to how she now shows up for people and delivers “health in a way that puts people and their health at the center.”
But her claims ring hollow, as she has not had an active license to practice medicine in over 10 years and now works for an agency that only creates one-size-fits-all protocols.
Here is the advice Cohen shared:
- Actually show up.
- Look people in the eye.
- Listen.
- Bring your full self to the table
- Build trust by demonstrating your trustworthiness.
Cohen touts truth and transparency but so far, her words have been nothing more than scripted speeches and vague, dismissive testimonies that continue to erode the public trust.
Dr. Cohen has an opportunity to build trust by bringing her full self to the table as a mom, public servant and doctor to talk with Reform Pharma.
Reform Pharma has invited Cohen to have an open and frank, mom-to-mom conversation to discuss the disturbing and declining state of children’s health in the U.S.
The CDC responded by asking for additional information, which was provided. Reform Pharma hopes that Cohen will take this important opportunity to talk with us. We will come to Atlanta to make it easy for her.
Meanwhile, while she parades across the country, we sit in solace with those who have been and will be injured by her organization’s protocols — and we wait for Cohen to “actually show up,” “look us in the eyes” and “listen.”
Reform Pharma is an initiative of Children’s Health Defense. Our mission is to remove Big Pharma corruption and restore healthcare integrity. For more information visit ReformPharmaNow.org.
Informed Dissent
Medical Dissidents, Agency Capture, and Dr. Mary Talley Bowden’s Battle with the FDA over Ivermectin
BY M.C. ARMSTRONG | HONEST MEDIA | APRIL 18, 2024
Dr. Mary Talley Bowden recently sued the FDA for stepping beyond their charter, defaming Ivermectin prescribers, and, thereby, interfering with the doctor-patient relationship. Last month, Dr. Bowden resolved her suit, receiving a substantial undisclosed settlement from the government agency.
Dr. Pierre Kory has been an early and staunch defender of the use of Ivermectin to treat COVID-19 in humans. Kory believes the FDA settled this case with Bowden because they had likely hired the PR firm Weber Shandwick to create the now infamous “horse dewormer” campaign (detailed below) to smear Ivermectin and its proponents. If true, once Bowden’s lawsuit went into the phase of discovery then this information would have been revealed, but we will never know since the case is now settled. Weber Shandwick lists the CDC, Pfizer, and Moderna as their clients.
Honest Media covered Ivermectin and the “horse dewormer” controversy in a letter sent to the Associated Press documenting the lies the AP published about the drug. We have also recently received a trove of emails between Dr. Bowden and the Arizona Mirror, an outlet that smeared Dr. Bowden and her colleague, Dr. Peter McCullough. After reviewing them, we can say that these documents illustrate the media’s contempt for medical dissidents.
But why this fear of letting dissenting doctors speak? There has been virtually no coverage of Dr. Bowden’s case. Where there is documentation, like with Jen Christensen’s reporting for CNN, nobody gives voice to the victor and victim, Dr. Bowden. Why?
Dr. Bowden, a Stanford-trained ear, nose, and throat doctor from Houston, has treated more than 6,000 patients suffering from COVID. She is a strong and intelligent woman of science speaking truth to power. Here, in Dr. Bowden, is that “gutsy woman” who Americans were told to admire by leaders like Hillary Clinton. But there’s an implicit caveat in the cult of Clinton’s “gutsy woman:” Such women are to be ignored (and even pilloried and censored) if they challenge the orthodoxies of the Democratic Party or the DNC-aligned Big Pharma industry.
For prescribing Ivermectin and dissenting against the dominant COVID narratives, Dr. Bowden was forced to resign from Houston Methodist Hospital. And she wasn’t the only doctor to face such consequences. Dr. Robert Apter and Dr. Paul Marik, two other Ivermectin physician-advocates, joined Dr. Bowden in her suit against the FDA. Marik, for his part, was forced to resign from Eastern Virginia Medical School as well as Sentara Norfolk General.
Last month, Dr. Bowden traveled to the Supreme Court to stand in solidarity with activists as SCOTUS listened to Murthy v. Missouri. The Murthy case concerns the suppression of medical dissidents, specifically, and online censorship, more broadly. Dr. Bowden addressed the crowd of protesters about her four-year battle with the captured government agency:
How many COVID patients did they examine? How many histories did they take? How many prescriptions did they write? Zero. None of them have cared for a single COVID patient, but because they had the full support of Big Pharma, the government, and, most importantly, the media, they became the scientific authority on a novel disease they had zero first-hand experience in treating.
Bowden has a point. The FDA’s campaign against doctors such as herself gained purchase with the public, in part, because the agency’s claims were amplified by a mainstream media that is shaped and funded – captured – by Big Pharma. Due to the massive influx of advertising dollars and the perfect storm of misinformation and disinformation summoned by Russiagate, the 2020 election, and the COVID-19 pandemic, the American public’s trust in the mainstream media has reached record lows. Bowden’s case reveals another example of why the public is justified in its skepticism.
Let the Doctors Speak
I recently spoke with Dr. Bowden about her fight with the government.
“This was a war on Ivermectin,” she said. “But it was also a war on the doctor-patient relationship.”
I asked her what precipitated the suit against the FDA. Dr. Bowden told me that never before in her career had she witnessed interference with the doctor-patient relationship from the FDA or her local pharmacies. When I asked about prescribing a drug that wasn’t FDA-approved, she told me that she’d often prescribed off-label in the past, with no problems, and that she approached Ivermectin, initially, with hesitancy and skepticism. She said she preferred prescribing monoclonal antibodies at the beginning of the pandemic, but sought new options when access to these treatments became restricted.
“I was nervous to start using it,” she said. “Before I started, I looked at the FDA’s website and the toxicity data. Once I was assured that it worked (maybe not as quickly as monoclonal antibodies), I started offering it to patients.”
Not only did Dr. Bowden prescribe Ivermectin to her patients and witness positive results, but she used it herself. She’s had COVID three times. And in every instance of Ivermectin treatment, both with herself and her patients, she observed either efficacy or minimal side effects.
“I haven’t lost one patient due to Ivermectin,” she said.
In 2015, the Nobel Committee for Physiology honored the discovery of Ivermectin with a Nobel Prize. The NIH lauded this “multifaceted drug,” which was largely unknown in American public discourse prior to the outbreak of the COVID-19 pandemic.
Then, suddenly everyone and their grandmother was an expert on the dangers of Ivermectin. Seemingly overnight, the American people absorbed a viral propaganda campaign from the very government agency (the FDA) that they supported with tax dollars. And if you were a doctor or patient seeking this low-cost, award-winning therapeutic treatment, you were suddenly in the crosshairs of the “war on Ivermectin.” This policing of the poor and the independent all started, according to Dr. Bowden, “with the horse tweet.”
On August 8, 2021, the FDA weaponized its social media account to stigmatize physicians like Dr. Bowden and skeptical and underprivileged patients seeking affordable alternative care. The agency issued a tweet with two images: a veterinarian outdoors caring for a horse, coupled with a physician in an office caring for a masked human. The text for the tweet reads: “You are not a horse. You are not a cow. Seriously, y’all. Stop it.” This tweet, with its careful use of the colloquial and the second person, supplemented with a juvenile binary logic, became the most popular tweet in FDA history.
Hate wins clicks. Fear creates fog. Shortly after the tweet’s publication and viral propagation, Dr. Bowden’s life came undone.
“I never had a pharmacy deny a prescription before,” she said.
Dr. Bowden’s struggle with the pharmacy was just the tip of the iceberg, revealing the stranglehold Big Pharma now has on health care in America. Dr. Bowden suffered (and still suffers) from vicious attacks online, as well as alienation from her peers. She was forced to resign from her workplace, Houston Methodist Hospital. She explained to me that the “war on Ivermectin” was more vitriolic than anything she’d ever seen before in the discourse on public health. And whereas most doctors bent the knee, stayed silent, and complied with government mandates, Dr. Bowden (and others) fought back. Her case represents what one might call a scientific profile in courage.
What does fighting back look like? Well, for starters, perhaps it begins with telling the truth in public and revealing the whole story of Dr. Bowden’s struggle, along with that of fellow medical dissidents like Dr. Kory, Dr. Robert Malone, Dr. Jay Bhattacharya (co-author of the Great Barrington Declaration), and Dr. Peter McCullough.
In Dr. Bowden’s and Dr. McCullough’s recent email exchanges with the Arizona Mirror, one can see, firsthand, a publication that ignores the opportunity to correct factual errors. The Mirror instead willfully litters its reporting on Dr. Bowden and Dr. McCullough with misinformation, ad hominem attacks, bizarre references to Qanon, constant allusions to shadowy conspiracy theories, and the slanderous insinuation that Dr. McCullough is antisemitic.
The Association Fallacy
One of the most recurrent disinformation patterns we have witnessed in studying the defamation of populist voices, broadly, and Dr. Bowden’s case, specifically, is what scholars of rhetoric call the association fallacy. In short, the association fallacy describes claims where even oblique social connection to a stigmatized individual or organization (like QAnon) is used to poison the claims of the targeted speaker. Simply associating the terrifying name of the poisonous organization with the speaker scares the reader and creates an irrational – fallacious – connection.
What’s troubling, in the case of the Arizona Mirror reporting, is that Dr. Bowden and Dr. McCullough have no ties to QAnon. Furthermore, Dr. Bowden and Dr. McCullough both reached out to Jim Small, the paper’s editor, and politely asked that these fallacies be removed from the Mirror’s articles.
For example, Dr. Bowden and Dr. McCullough called attention to the Mirror’s repeated use of the ad hominem “anti-vaxxer” to label Dr. McCullough and associate the doctor with the world of “anti-vaxxers.” In their email exchange, Dr. McCullough confides in Small that he has “accepted dozens of vaccines during the course of my life.”
But the Mirror refused to mirror the truth and remove the slur. The Mirror refused to interview these doctors, refused to correct their reporter’s mistakes when alerted by the victims, and, furthermore, sought to defame the doctors through ad hominem attacks and the association fallacy.
To witness how the association fallacy works, consider the following sentence about Dr. Bowden’s colleague, Dr. McCullough, from the Arizona Mirror’s Jerod Macdonald-Evoy: “McCullough has become a darling to those in both Qanon and the broader conspiracy world, appearing regularly on shows like the one hosted by antisemite Stew Peters, who said the COVID vaccine is a bioweapon.”
In one sentence, the reporter has accused the doctor (without directly accusing him) of antisemitism and conspiracy theory simply by virtue of association with other human beings, mostly unnamed, who populate “the broader conspiracy world.”
What is happening to people like Dr. McCullough and Dr. Bowden rarely happens to those in power. It happens to those who challenge power.
The Arizona Mirror and CNN should be ashamed. They punished informed dissent. They refused to contextualize Dr. Bowden’s struggle as part of a subculture of dignified scientists and physicians. They erased and defamed Dr. Bowden and her colleagues. They published fear porn and called it journalism. They left out this gutsy woman’s voice. Honest Media has chosen a different path. We let the doctor speak.
Fauci’s Inquisition Against Safe and Effective Anti-COVID-19 Drugs
By Richard Gale and Dr. Gary Null | Global Research | April 6, 2024
A question needs to be asked. Were the novel experimental drug treatments for SARS-CoV-2 viral infections that Anthony Fauci, the CDC and FDA advocated for and funded responsible for worsening the contagion and countless deaths?
However, at that time there were plenty of studies confirming there were pre-existing safe, inexpensive medications known to have highly effective antiviral properties to treat Covid-19 patients. Among these were ivermectin and hydroxychloroquine (HCQ).
There were also specific nutrients such as vitamin D and zinc, known to strengthen the immune system against viral infection and yet there was no recommendation from the government about the benefits of proper nutrition. So why did Fauci along with other federal health officials choose to intentionally ignore the scientific evidence and rather condemn these repurposed drugs? In Fauci’s case, over a year and half into the pandemic, he continued to lie outright on CNN that “there is no clinical evidence whatsoever that [ivermectin] works.”[1] And could millions have been saved if these generic medications were prescribed rather than the feds doing nothing but recommending social isolation and quarantines as the world awaited an experimental Covid-19 vaccine to enter the market?
To date, between ivermectin and HCQ alone, there have been 670 published studies, analyses and papers involving over 9,800 scientists and over 682,000 patients supporting the use of these drugs over and beyond those the FDA has approved under Emergency Use Authorization (EUA) statutes. Despite this, four years later, the FDA continues to fiercely deny ivermectin’s and HCQ’s efficacy and safety under proper administration. Why this blatant cover-up?
Every CDC effort to approve a novel drug treatment for SARS-CoV-2 infections has been a dismal failure. Aside from monoclonal antibody therapy, only three anti-Covid-19 drugs have been approved under an EUA in the United States. None met their promised expectations from either the manufacturer or our federal health agencies. With their poor efficacy rates, safety profiles and a black box warning slapped upon Pfizer’s anti-Covid-19 drug Paxlovid, the CDC is scrambling to find new viable alternatives in the pharmaceutical pipeline. Bloomberg amplifies the fake Covid-19 treatment crisis by lamenting that repurposed drugs such as ivermectin are gaining global popularity as “the world needs effective Covid drugs.”[2]
Shortly after the pandemic was formally announced, the FDA recommended the cheap over the counter anti-malarial drug hydroxychloroquine but then quickly reversed its decision after Fauci publicly announced the future arrival of Gilead Sciences’ novel intravenous drug Remdesivir. The FDA’s and European Union’s approvals of Remdesivir baffled many scientists, according to the journal Science, who questioned its therapeutic value and kept a close watch on the drug’s clinical reports about a “disproportionally high number of reports of liver and kidney problems.”[3] Even an earlier Chinese study published in The Lancet found that remdesivir had no impact on the coronavirus. The Science article notes that the “FDA never consulted a group of outside experts that it has at the ready to weigh in on complicated antiviral drug issues.”[4] Six months before remdesivir received EUA approval, Anthony Fauci had already hailed the drug as a major breakthrough that would establish a new “standard of care” in Covid-19 treatment.[5]
Today, remdesivir is being increasingly recognized as a debacle in antiviral therapeutic care. Even the WHO released a “conditional recommendation against the use of remdesivir in hospitalized patients, regardless of disease severity, as there is currently no evidence that remdesivir improves survival and other outcomes in these patients.” An Italian study observed a 416 percent increase in hepatocellular injuries among hospitalized Covid-19 patients treated with Remdesivir.[6] And a smaller Taiwanese study of hospitalized unvaccinated patients reported a 185 percent higher mortality during late remdesivir treatment.[7]
Earlier this year, Pfizer’s novel oral Covid-19 medication Paxlovid was given an FDA black box warning for clinically significant adverse reactions that can potentially be fatal. Because the company does not permit independent random-controlled trials to investigate its drug, other than retrospective studies, we only have Pfizer’s own data to rely upon. Nevertheless, The Lancet published a study by a team of Chinese scientists at Shanghai Jiao Tong School of Medicine that managed to look at Paxlovid’s use among critically ill patients hospitalized with Covid-19. The study reported a 27 percent higher risk of the infection progressing, a 67 percent increased risk in requiring ventilation, and 10 percent longer stays in ICU facilities.[8]
Paxlovid is a combination of a novel SARS-CoV-2 protease inhibitor and the HIV protease inhibitor ritonavir. The FDA approved Paxlovid under a EUA with the claim it was safe. However, on the government’s HIV.gov website for ritonavir it is clearly stated that the drug “can cause serious life-threatening side effects. These include inflammation of the pancreas (pancreatitis), heart rhythm problems, severe skin rash and allergic reactions, liver problems and drug interactions.”[9] Perhaps due to the drug’s serious side effects, it is no longer used solely against HIV, but rather is given in smaller doses as a booster for AZT-related drugs. Being highly toxic, ritonavir is also not recommended for pregnant women and has been shown to interfere with hormone-based birth control efficacy.
Paxlovid only received FDA EUA approval in May 2023. At that time, the agency claimed there was no evidence that patients who were treated with the drug rebounded and came down with Covid. However, shortly thereafter this was determined to be untrue.[10] A Harvard analysis found that 21 percent of Paxlovid recipients will remain contagious and likely succumb to a viral rebound compared to only 1.8 percent who did not take the drug.
Merck’s anti-Covid-19 drug molnupiravir (Lagevrio) also has an FDA black box warning for potential fetal harm when administered to pregnant women. Why the drug was ever approved under an EUA seems to be an enigma. The drug’s antiviral activity is based upon a metabolite known as NHC, which for many years has been known to create havoc in an enzyme crucial for viral replication by inserting errors into the virus’ genetic code. The theory is: produce enough errors and the virus kills itself off. However, molnupiravir can cause hundreds of mutations thereby “supercharging” the manufacturing of new Covid-19 viral strains. Moreover, according to a Forbes article, the drug’s mutagenic powers may also interfere with our own body’s enzymes and DNA.[11] Another Forbes article points out that Merck’s clinical trial only enrolled around 1,500 participants, which is far too “small to pick up on rare mutagenic events.”[12]
Molnupiravir has a poor efficacy rate across the board including viral clearance, recovery, and hospitalizations/death (68 percent).[13] One trial, funded by Merck, concluded the drug had no clinical benefit.[14] More worrisome, the drug also has life-threatening adverse effects including mutagenic risks to human DNA and mitochondria, carcinogenic activity and embryonic death.[15]
Each of these drugs have been outrageous cash cows for their manufacturers. Remdesivir is priced at $3,120 per treatment and earned Gilead $5.6 billion in sales for 2021.
Pfizer’s Paxlovid is priced at $1,390 per treatment. Last year, the company’s revenues for its Covid products—Paxlovid and the Comirnaty vaccine—came in at $12.5 billion, and, according to Fierce Pharma, Pfizer wrote off an additional $4.7 billion on its overstocked Paxlovid inventory.[16] Merck’s molnupiravir’s sales for 2022 cashed in almost $5.7 billion. Despite their profits, none of these drugs have been shown convincingly to have measurably lessened the pandemic nor the spread of SARS-CoV-2.
Despite all the attention and medical hype about novel experimental antiviral drugs to treat Covid-19, Anthony Fauci and other federal officials had full knowledge that other FDA-approved drugs existed that could have been quickly repurposed at minimal expense to effectively treat Covid-19 infections. Repurposing existing drugs to treat illness is a common occurrence. The antiparasitic and antiviral drug Ivermectin best stands out. Its effectiveness was observed to be so remarkable and multifaceted that researchers started to investigate its potential.
The mainstream media, including many liberal news sources who pride themselves on their independence, continue to channel the voices of Anthony Fauci, the CDC and FDA to demonize ivermectin and other generic drugs for treating Covid-19 and to reduce hospitalization and deaths. This propaganda campaign, however, has completely ignored the large body of medical literature that shows ivermectin’s statistically significant efficacy against symptomatic and asymptomatic SARS-2 infections.
Originally developed for veterinarian use, in 1987, the FDA approved ivermectin for treating two parasitic diseases, river blindness and stronglyoidiasis, in humans. Since then an enormous body of medical research has grown showing ivermectin’s effectiveness for treating other diseases. Its broad range of antiviral properties has shown efficacy against many RNA viruses such avian influenza, zika, dengue, HIV, West Nile, yellow fever, chikungunya and earlier severe respiratory coronaviruses. It has also been shown to be effective against DNA viruses such as herpes, polyomavirus, and circovirus-2.[17]
Unsurprisingly, ivermectin’s inventors Drs. William Campbell and Satoshi Omura were awarded the 2015 Nobel Prize in Physiology and Medicine.
It has been prescribed to hundreds of millions of people worldwide. Given its decades’ long record of in vitro efficacy, it should have been self-evident for Fauci’s NIAID, the CDC and the WHO to rapidly conduct in vivo trials to usher ivermectin as a first line of defense for early stage Covid-19 infections and for use as a safe prophylaxis.
For example, if funding were devoted for the rapid development of a micro-based pulmonary delivery system, mortality rates would have been miniscule and the pandemic would have been lessened greatly.[18] Repurposing ivermectin could have been achieved very quickly at a minor expense.[19] However, despite all the medical evidence confirming ivermectin’s strong antiviral properties and its impeccable safety record when administered properly, we instead witnessed a sophisticated government-orchestrated campaign to declare war against ivermectin and another antiviral drug, hydroxychloroquine (HCQ), in favor of far more expensive and EUA approved experimental drugs. Unlike the US, other nations were eager to find older drugs to repurpose against Covid-19 and protect their populations. A Johns Hopkins University analysis offered the theory that a reason why many African countries had very few to near zero Covid-19 fatalities was because of widespread deployment of ivermectin. In February 2020, the National Health Commission of China, for example, was the first to include hydroxychloroquine in its guidelines for treating mild, moderate and severe SARS-2 cases. Eight Latin American nations distribute home Covid-19 treatment kits that include ivermectin.[20] Why did the US and most European countries swayed by the US and the WHO fail to follow suit?
Early in the pandemic, physicians in other nations where treatment was less restricted, such as Spain and Italy, shared data with American physicians about effective treatments against the SARS-2 virus. In addition, there was a large corpus of medical research indicating that older antiviral drugs could be repurposed. Doctors who started to prescribe drugs such as ivermectin and HCQ, along with Vitamin D and zinc supplementation, observed remarkable results. Unlike the dismal recovery and high mortality rates reported in hospitals and large clinics that relied upon strict isolation, quarantine, and ventilator interventions, this small fringe group of physicians reported very few deaths among their large patient loads. Even reported deaths were more often than not compounded by patients’ comorbidities, poor medical facilities and other anomalies.
Very early into the pandemic, medical papers indicated ivermectin was a highly effective drug to treat SARS-2 infections.
In April 2020, less than a month after the WHO declared Covid-19 as a global pandemic, Australian researchers at the Peter Doherty Institute of Infection and Immunity published a paper demonstrating that a single ivermectin dose can control SARS-CoV-2 viral replication within 24-48 hours.[21] Monash University’s Biomedicine Discovery Institute in Australia had also published an early study that ivermectin destroyed SARS-2 infected cell cultures by 99.8 percent within 48 hours. But no American federal health official paid any attention.
As of March 2024, a database for all studies and trials investigating ivermectin against Covid-19 infections records a total of 248 studies, 195 peer-reviewed, and 102 involving controlled groups reporting an average 61 percent improvement for early infections, a 39 percent success rate in treating late infections, and an 85 percent average success rate for use as a preventative prophylaxis.[22] Moreover, prescribing ivermectin reduced mortality by 49 percent, compared to remdesivir’s 4 percent, Pfizer’s Paxlovid’s 31 percent, and molnupiravir’s 22 percent. Even hydroxychloroquine well outperforms these drugs mortality risk for early treatment at 66 percent.
A noteworthy study conducted in Brazil and published in the Cureus Journal of Medical Science prescribed ivermectin in a citywide prophylaxis program in a town of 223,000 residents. 133,000 took ivermectin. The results for a population of this size are indisputable in concluding that ivermectin is a safe first line of defense to confront the pandemic. Covid mortality was reduced 90 percent. There was also a 67 percent lower risk of hospitalization and a 44 percent decrease in Covid cases. Garcia-Aquilar et al reports a Mexican in vitro analysis showing a definitive interaction between ivermectin and the SAR-CoV-2 spike protein, which would account for its high efficacy in Covid-19 cases.[23]
The All India Institute for Medical Science (AIIMS) and the Indian Council of Medical Research (ICMR), two of India’s most prestigious institutions, acted against the WHO and launched an ivermectin treatment campaign in several states. In Uttar Pradesh there was a 95 percent decrease in morality (a decline from 37,944 to 2,014). The Indian capital of New Delhi witnessed a 97 percent reduction. During the same time period, the state of Tamil Nadu, which followed the WHO’s ban on ivermectin, had a 173 percent increase in deaths (from 10,986 to 30,016 deaths).
There have been many concerted efforts to discredit ivermectin and other repurposed drugs’ effectiveness. Most notable is the large TOGETHER Trial Brazil study published in the New England Journal of Medicine (NEJM) that concluded both ivermectin and another repurposed drug fluvoxamine showed no beneficial signs for treating Covid-19 patients. The study was widely reported in the mainstream media. However, a Cato Institute analysis discovered the study in fact showed its benefits and the results were in agreement with 87 percent of other clinical trials investigating ivermectin. The Cato analysis identifies many odd anomalies in how the trial was conducted including an unspecified placebo—although it is suspected it was Vitamin C, which has itself been shown to be mildly effective against the SARS-CoV-2 virus, and protocol changes as the study was underway including inclusion/exclusion criteria. By his own admission the TOGETHER Trial’s principal investigator Dr. Ed Mills at McMaster University in Ontario “designs clinical trials, predominantly for the Bill and Melinda Gates Foundation.”[24] In a McMaster University press release, the Gates foundation is listed as a funder for the study to debunk ivermectin and fluvoxamine.[25] Oddly, Gates is nowhere listed among the several funders in the NEJM study’s disclosure. In addition, TOGETHER Trials is owned by the Canadian for profit startup Purpose Life Sciences, founded by Mills; legal documents showed Mills’ PLS is largely funded and controlled by Sam Bankman Fried’s FTX who invested $53 million into the project. Administrators of FTX’s bankruptcy are suing PLS for fraud.[26]
In short, the ivermectin/fluvoxamine TOGETHER Trial was a complete medical sham and intentionally designed for one single purpose: to fuel media disinformation in order to undermine ivermectin’s superior efficacy and safety profile to Big Pharma’s more profitable designer drugs.
In 2004, the US Congress passed an amendment to the Federal Food, Drug and Cosmetic Act known as Emergency Use Authorization (EUA). This piece of legislature legalized an anti-regulatory pathway to allow experimental medical interventions to be expedited and bypass standard FDA safety evaluations in the event of bioterrorist threats and national health emergencies such as pandemics. At the time, passage of the EUA amendment made sense because it was partially in response to the 2001 anthrax attacks and the US’s entry into an age of international terrorism. However, the amendment raises some serious considerations. Before the Covid-19 pandemic, EUAs had only been authorized on four occasions: the 2005 avian H5N1 and 2009 H1N1 swine flu threats, the 2014 Ebola and the 2016 Zikra viruses. Each of these pathogen scares proved to be false alarms that posed no threat of pandemic proportions to Americans. The fifth time EUAs were invoked was in 2020 during the Covid-19 pandemic, which at the time seemed far more plausible.
Before the government can authorize an EUA to deploy an experimental diagnostic product, drug or vaccine, certain requirements must be fulfilled. First, the Secretary of the Department of Health and Human Services (HHS) must have sufficient proof that the nation is being confronted with a serious life-threatening health emergency. Second, the drug(s) and/or vaccine(s) under consideration must have sufficient scientific evidence to suggest they will likely be effective against the medical threat. The evidence must at least include preclinical and observational data showing the product targets the organism, disease or condition. Third, although the drug or vaccine does not undergo a rigorous evaluation, it must at least show that its potential and known benefits outweigh its potential and known risks. In addition, the product must be manufactured in complete accordance with standard quality control and safety assurances.
When we look back at the government’s many debacles during the Covid-19 pandemic, other EUA requirements warrant the spotlight. On the one hand, an EUA cannot be authorized for any product or intervention if there is an FDA alternative approved product already available, unless the experimental product is clearly proven to have a significant advantage. Moreover, and perhaps more important, EUAs demand informed consent. Every individual who receives the drug or vaccine must be thoroughly informed about its experimental status and its potential risks and benefits. Recipients must also be properly informed about the alternatives to the experimental product and nobody should be forced to take it.
Finally, an EUA requires robust safety monitoring and reporting of adverse events, injuries and deaths potentially due to the drug or vaccine. This is the responsibility not only of the private pharmaceutical manufacturers but also the FDA, physicians, hospitals, clinics and other healthcare professionals.
Obviously important cautions must be considered after approving a medical intervention under the EUA requirements. Foremost are the inherent health risks of any rapid response of experimental medical interventions, especially novel drugs and vaccines. As we observed during the FDA approval process and roll out of Pfizer’s and Moderna’s mRNA Covid-19 jabs, no long-term human trials were conducted to even estimate a reliable baseline of their relative efficacy and safety. The American public has blindly placed its trust in our federal health authorities decision-making. It is expected that under a national health emergency, the authorities would be completely transparent and act only by the highest ethical standards. However our institutions betrayed public trust and either ignored or transgressed cautions underlying EUA approved medical interventions in every conceivable way. Moreover, conflicts of interests have been discovered to have plagued the entire EUA review process.
Although the EUA amendment provides some protections to authorized drug and vaccine manufacturers, it was the Public Readiness and Emergency Preparedness Act (PREP) in 2005 that expanded liability protections. In addition to protecting private corporations, PREP also shields company executives and employees from claims of personal injury or death resulting from the administration of authorized countermeasures. The only exceptions for liability are if the company or its executive offices are proven to have engaged in intentional and/or criminal misconduct with conscious disregard for the rights and safety of those taking their drugs and vaccines.
During the pandemic, the FDA issued widespread EUAs with liability immunity for the PCR diagnostic kits for SARS-2, the mRNA vaccines and the anti-Covid-19 drugs. Curiously, the Secretary of the Department of Health and Human Services invoked the PREP Act on February 4, 2020 giving liability protections; this was over a month before the pandemic was officially announced, which raises serious questions about prior-planning before the viral outbreak in Wuhan, China.
From the pandemic’s outset, Fauci embarked on the media circuit to promise Americans that federal health agencies were doing everything within their means to get a vaccine on the market because there was no available drug to clear the SARS-2 virus. As we have seen with respect to ivermectin alone, this was patently false. Rather the government placed an overriding emphasis on vaccination with a near total disregard for implementing very simple preventative measures to inhibit viral progression. Once mass vaccinations were underway, we were promised that the SARS-2 virus would be defeated and life would return to normal. In retrospect, we can look back and state with a degree of certainty that American health authorities and these products’ corporate manufacturers may have violated almost every EUA requirement. Everything that went wrong with the PCR kits, the experimental mRNA vaccines and novel drugs could have been avoided if the government had diligently repurposed effective and safe measures as pandemic countermeasures. Very likely, hundreds of thousands of lives, perhaps millions, would have been saved.
Similarly the FDA issued a warning statement against the use of ivermectin. Even ivermectin’s manufacturer Merck discredited its own product. Shortly after ridiculing its drug, the Alliance for Natural Health reported, “Merck announced positive results from a clinical trial on a new drug called molnupiravir in eliminating the virus in infected patients.”[27]
And still the FDA considers these novel patented drugs to be superior to ivermectin. Favoring a vaccine regime and government-controlled surveillance measures to track every American’s movements, American health officials blatantly neglected their own pandemic policies’ severe health consequences. Ineffective lockdowns, masks, social isolation, unsound critical care interventions such as relying upon ventilators, and the sole EUA approvals of the costly and insufficiently effective drugs brought about nightmares for tens of millions of adults and children. This was all undertaken under Fauci’s watch and the heads of the US health agencies in direct violation of the EUA requirements to only authorize drugs and medical interventions when no other safe and effective alternative is available. Alternatives were available.
The 4-year history of the pandemic highlights a sharp distinction between dependable medical research and pseudoscientific fraud. The CDC adopted a common Soviet era practice to redefine the very definition of a vaccine and the parameters of vaccine efficacy in order to fit economic and ideological agendas. This explains Washington’s aggressive public relations endeavors to silence medical opponents. According to cardiologist Dr. Michael Goodkin’s private investigations, several of the most cited studies discrediting ivermectin’s antiviral benefits were intentionally manipulated in order to produce “fake” results.[28] These studies were then widely distributed to the AMA, American College of Physicians and across mainstream media to author “hit pieces” to demonize ivermectin and other repurposed drugs. The government’s belligerent and reactive diatribes, brazenly or casually advocating for censorship, were direct violations of scientific and medical integrity and contributed nothing towards developing constructive policies for handling a pandemic with a minimal cost to life. The consequence has been a less informed and grossly naïve public, which was gaslighted into believing lies.
The FDA’s EUAs for the Covid-19 vaccines and novel experimental drugs were in fact an attack on the amendments and PREP directives. Neither the vaccines nor drugs warranted emergency authorization because effective and safe alternatives were readily available. No doubt a Congressional investigation would uncover criminal misconduct and conscious fraud. Moreover, these violations of the PREP Act may have the potential to lead directly into medical crimes against humanity as outlined in the Nuremberg Code.
Although the Nuremberg Code has not been officially adopted in its entirety as law by any nation or major medical association, other international treaties, such as the Universal Declaration of Human Rights, the World Medical Association Declaration of Helsinki (which is not legally binding), the International Covenant on Civil and Political Rights (ICCPR) and the International Ethical Guidelines for Biomedical Research on Human Subjects incorporate some of Nuremberg’s main principles that aim to protect people from unethical and forced medical research. Although the US signed the ICCPR as an intentional party, the US Senate never ratified it. The ICCPR’s Article 7 clearly states, “No one shall be subject to torture or cruel, inhuman or degrading treatment or punishment,” which can legally be interpreted to include forced medical experimentation implied as cruel, inhuman treatment. Other ICCPR articles, 6 and 17, are also applicable to medical experimentation to ensure ethical conduct, obtaining proper informed consent and the right to life and privacy. For a moment, consider the numerous senior citizens in nursing homes and hospitals who were simply administered experimental Covid-19 vaccines without full knowledge about what they were receiving. And now how many children are being coerced by the pseudoscience of health officials’ lies to be vaccinated without any knowledge of these mRNA products’ risk-benefit ratio?
The US is also a signatory to the Helsinki Declaration, which, although not directly aligned with Nuremberg, shares much in common. The Declaration shares some common features with the EUA amendment and PREP Act. These include voluntary informed consent—which is universally accepted, adequate risk and benefit information about medical interventions, and an emphasis on the principle of medical beneficence (promoting well-being and the Hippocratic rule of doing no harm). It also guarantees protections for vulnerable groups, especially pregnant women and children, which the US government and vaccine makers directly violated by conducting trials on these groups with full knowledge about these vaccines’ adverse events in adults. In addition, weighing the scientific evidence to assess the risk-benefit ratios between prescribing ivermectin and HCQ over the new generation of novel experimental drugs conclusively favors the former. This alone directly violates the ethical medical principles noted above.
However, the failure to repurpose life-saving drugs is less criminal than the questionable unethical motivations to usher a new generation of genetically engineered vaccines that have never before been adequately researched in human trials for long term safety. This mass experimentation, which continues to threaten the health and well-being of millions of people, is global and can legally be interpreted as a genocidal attack on humanity.
If the emerging data for increasing injuries and deaths due to the Covid-19 vaccines is reliable—and we believe it is—the handling of the pandemic can be regarded as the largest medical crime in human history. In time, and with shifting political allegiances and public demands to hold our leaders in government and private industry accountable, the architects of this medical war against civilization will be brought to justice.
*
Richard Gale is the Executive Producer of the Progressive Radio Network and a former Senior Research Analyst in the biotechnology and genomic industries.
Dr. Gary Null is host of the nation’s longest running public radio program on alternative and nutritional health and a multi-award-winning documentary film director, including his recent Last Call to Tomorrow.
Notes
[1] https://www.cnn.com/videos/health/2021/08/29/dr-anthony-fauci-ivermectin-covid-19-sotu-vpx.cnn
[4] https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31022-9/fulltext
[6] https://www.dldjournalonline.com/article/S1590-8658(21)00923-3/fulltext
[8] https://www.thelancet.com/action/showPdf?pii=S2666-6065%25252823%25252900012-3
[9] https://clinicalinfo.hiv.gov/en/drugs/ritonavir/patient
[10] https://www.yalemedicine.org/news/13-things-to-know-paxlovid-covid-19
[13] https://www.medrxiv.org/content/10.1101/2023.01.20.23284849v1.full.pdf
[14] https://evidence.nejm.org/doi/pdf/10.1056/EVIDoa2100044
[15] https://c19early.org/waters.html
[17] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7290143/
[18] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7539925/
[19] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7564151/
[21] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7129059/
[22] https://c19ivermectin.com
[23] https://www.mdpi.com/1422-0067/24/22/16392
[25] https://www.eurekalert.org/news-releases/855535
[26] https://c19ivm.org/tallaksen.html
[27] https://anh-usa.org/fda-ensures-pharma-profits-on-covid/
[28] https://www.trialsitenews.com/a/are-major-ivermectin-studies-designed-for-failure
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The Paris Massacre of 40 Algerians on October 17th 1961 – Some were herded into the Seine River, others thrown from bridges
American Herald Tribune | October 16, 2016
Some 30,000 pro FLN (National Liberation Front) Algerians gathered for a peaceful demonstration in the Streets of Paris. Under orders from the head of the Parisian police, Maurice Papon, the French police attacked the demonstration. The Paris Massacre of 17 October 1961 appears to be intentional. After 37 years of denial the French government admitted the acts, and acknowledged 40 deaths in 1998. Estimates of deaths exceed 200.
Historian Jean-Luc Einaudi won a trial against Maurice Papon in 1999. The latter, according to official documents, seems to have directed the massacre. He assured officers in one station that they would be protected in prosecution if they participated in quelling the demonstration.
The protestors were killed in many different methods. Some were herded into the Seine River, others thrown from bridges after being beaten unconscious. Other still were delivered to the Paris police headquarters after being arrested and killed there.
The estimates of the deaths range between 70 and 200.
A few days after the massacre on 31 October, some anonymous policemen published a text stating… continue
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