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FDA Advisers Bullish on RSV Shots for Kids, Even as Safety Signals Shut Down Moderna Trials

By Brenda Baletti, Ph.D. | The Defender | December 13, 2024

Advisers to the U.S. Food and Drug Administration (FDA) met Thursday to discuss the future of pediatric respiratory syncytial virus (RSV) vaccines after Moderna was forced to abruptly halt clinical trials for its mRNA RSV vaccine in children ages 5-23 months.

Clinical trial data released earlier this week in an FDA briefing document showed that rather than preventing RSV disease in small children, Moderna’s vaccine likely caused higher rates of severe RSV illness in its Phase 1 clinical trial.

Moderna halted the trial in July after it was informed that two babies in the vaccine group had developed severe RSV disease. The company didn’t publicly announce that the trial was discontinued until September.

The data presented Thursday at the Vaccines and Related Biological Products Advisory Committee meeting showed that 12.5% of vaccinated children developed severe RSV disease as compared to just 5% of children in the placebo group.

Among the children who developed symptomatic RSV disease, 26.3% in the vaccinated group progressed to severe disease, while only 8.3% of those in the placebo group did.

These results were concerning given the history of past attempts to develop an RSV vaccine for infants. In the 1960s, an experimental formalininactivated RSV vaccine for children led to two toddler deaths, and 80% of vaccine recipients required hospitalization for severe RSV.

The illnesses were attributed to vaccine-associated enhanced respiratory disease (VAERD) — a phenomenon that occurs when vaccination promotes immune responses that exacerbate the disease caused by subsequent infection with the pathogen the vaccine was meant to protect against.

In light of that history, and because the mechanisms that cause VAERD are still largely unknown, the FDA convened the advisory committee to discuss the implications of Moderna’s trial outcomes for other pediatric RSV vaccines.

The committee did not vote on Thursday or make any formal recommendations. Members watched presentations from consultants, the FDA, and pharmaceutical companies and discussed the risks and benefits of developing RSV vaccines for children.

They also commended Moderna for reporting its results and the existing clinical safeguards for recognizing early safety signals in pediatric RSV trials.

Vaccine makers developing 26 different RSV vaccines or monoclonal antibodies

The briefing document stated that the FDA was halting enrollment for all investigational trials for RSV vaccines for infants and toddlers under age 2 and children ages 2 through 5 who haven’t previously had RSV.

The FDA clarified at the outset of the meeting that the hold does not apply to vaccine candidates that use live attenuated vaccines, because there is no evidence that vaccines developed on this platform cause VAERD.

Advisers seemed to agree, except for Dr. Karen Kotloff who voiced concerns there was not enough information to assume that live attenuated vaccines don’t carry the same potential risk.

Dr. Pedro Piedra, who presented on clinical and non-clinical aspects of RSV vaccine safety shared a slide listing RSV vaccines and monoclonal antibodies currently in trials.

There are five pediatric vaccines other than Moderna’s — which Moderna’s Christine Shaw, Ph.D., definitively stated is no longer moving forward — in the pipeline. Four of them are for live-attenuated vaccines.

Vaccine makers are developing 26 different RSV vaccines or monoclonal antibodies for all age groups, all vying to enter a rapidly expanding market.

PR Newswire projected in 2023 the global RSV vaccine and antibody market would be worth $2.61 billion dollars in 2024 and rise to $13.59 billion by 2030.

Piedra — who began his presentation with the quick disclosure that he has grants for RSV prevention research from GSK, Icosavax and Merck and is a paid consultant in the field for Merck, Moderna, Pfizer and Sanofi — presented an optimistic picture of RSV vaccine development, citing protection offered by recently approved maternal vaccines and monoclonal antibodies.

Moderna’s results did raise some platform-specific concerns, Piedra conceded.

He listed the types of safety concerns that could be associated with different vaccine platforms — febrile seizures with adjuvanted or high-dose vaccines or when RSV vaccines are co-administered with other vaccines, autoimmunity that could be associated with new adjuvants, respiratory issues with intranasal vaccines, and systemic illnesses with vector-based or mRNA vaccines.

‘Unmet need’ as justification to push for more RSV vaxes for small children

Presenters repeatedly stated that there was an “unmet need” for pediatric RSV vaccines, especially for children between 8 months and 2 years old.

RSV usually causes mild cold-like symptoms, but in some cases can lead to hospitalization and death in infants and the elderly. By age 2, 97% of all babies have been infected with RSV, which confers partial immunity, making any subsequent episodes less severe.

The disease burden for infants can be serious. In the U.S., RSV infection is the leading cause of infant hospitalization among those younger than 6 months, although a very small percentage of children with the virus will die.

An FDA representative said the Centers for Disease Control and Prevention (CDC) estimates that 100-200 infants die per year from the disease. However, internist Dr. Meryl Nass told The Defender that even those low numbers may overestimate mortality.

Nass pointed to a CDC study analyzing RSV deaths in infants between 2005 and 2016 and found a total of 314 deaths in children under age 1, or 25 on average per year, Nass reported. Only 17 of those deaths per year listed RSV as the underlying cause of death.

The FDA also said that maternal vaccines and monoclonal antibodies had begun to reduce those numbers, but emphasized there is still an “unmet need” for a vaccine for children going into their second RSV season — even as it presented data showing hospitalizations in that season are lower.

Moderna said this “unmet need” drove them to develop their failed vaccine. A Sanofi representative, who gave an update on their live-attenuated RSV virus, said the company sought to meet that “unmet need” for children in their second RSV season.

Sanofi also sells nirsevimab — brand name Beyfortus — the monoclonal antibody shot the CDC recommends for all newborns to protect them in their first RSV season.

Sanofi and the National Institutes of Health (NIH) are collaborating on the live-attenuated virus vaccine platform. The NIH developed 16 different vaccine candidates that it trialed in children and currently has one SP-125 in Phase 3 clinical trials.

These vaccines have not shown VAERD after one season of surveillance, the Sanofi representative said. The safety trials showed no safety concerns and SP-125 is currently being tested for efficacy in toddlers 6-22 months of age, but it is not yet fully enrolled.

During the “public comments” section of the meeting, three other vaccine makers promoted their vaccines to the committee.

Goal is more RSV shots for kids to provide passive immunity followed by ‘active immunity’ 

FDA asked the committee members to discuss existing evidence on whether infants and toddlers could eventually get sequential administration of RSV monoclonal antibodies followed by RSV vaccines.

That would mean even more shots on the childhood immunization schedule. The monoclonal antibodies or maternal vaccination would provide babies with “passive immunity” — antibodies to fight the virus that weren’t created by their own immune systems.

Then, in this schema, a two- or three-shot course of an RSV vaccine could protect babies from RSV in the second season, giving them “active immunity.”

Most committee members said more data were necessary to evaluate the safety of such a plan, but they generally agreed that it was a good direction to move in.

Watch the meeting 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.

December 15, 2024 Posted by | Science and Pseudo-Science | , , , | Leave a comment

FDA Has Authority to Recall COVID Vaccines — A Growing Number of Scientists Are Demanding Swift Action

By Brenda Baletti, Ph.D. | The Defender | December 9, 2024

“It’s time for a recall” of the COVID-19 vaccines, epidemiologist Nicolas Hulscher argued on a recent episode of “Brannon Howse Live.” The mounting evidence that the COVID-19 vaccines caused death and other serious injuries are grounds for “Class I recall” by the U.S. Food and Drug Administration (FDA), Hulscher said.

Hulscher is one of the growing chorus of voices among public health officials, scientists and researchers demanding public health officials hit the pause button on the shots until definitive safety studies are performed.

The latest round of calls began in January when Florida Surgeon General Joseph Ladapo called for a “halt in the use of COVID-19 mRNA vaccines” over safety concerns that the mRNA technology is delivering DNA contaminants into people’s cells.

A few weeks later, the journal Cureus published the first peer-reviewed paper to call for a moratorium on the COVID-19 vaccines. The paper included a sweeping review of “lessons learned” from the clinical trial data and the many adverse events associated with the shots.

Just last week, elected officials, organizations — including the World Council for Health and Door to Freedom — and hundreds of doctors and researchers sent a letter to the heads of state of 10 European countries calling for a suspension of the “modified mRNA vaccines,” citing serious health concerns associated with the shots.

Calls for a moratorium or a recall have been widely controversial. Ladapo was accused by The New York Times of peddling “misinformation.” The Washington Post said he had a pattern of making “debunked claim[s],” and FactCheck.org accused him of relying on “faulty science.”

Cureus retracted the “lessons learned” paper in what co-author Dr. Peter McCullough called, a “stunning act of scientific censorship.” The paper was later republished in two parts in a different peer-reviewed journal.

Despite efforts to censor and discredit medical professionals and researchers who draw attention to the harms associated with the vaccines, even mainstream publications have conceded that the COVID-19 vaccines can cause serious injuries and that vaccine-injured people have been ignored. Yet, they continue to push the shots.

Hulscher told The Defender that the mainstream media’s refusal to seriously report on calls to pull the vaccines from the market has serious implications for public health. It’s “a contributing factor to excess mortality” among global populations, he said.

“The FDA has failed to protect Americans from unsafe products because they suffer from corporate capture,” he added.

M. Nathaniel Mead, lead author of the “Lessons Learned” paper, told The Defender the FDA never should have authorized the vaccines in the first place. The “usual safety testing protocols and toxicology requirements were bypassed” and a reanalysis of the trial data showed serious adverse effects. “The ‘safe and effective’ narrative has always been a farce,” he said.

Freedom of Information Act requests have uncovered evidence that top officials at the FDA and Centers for Disease Control and Prevention knew about COVID-19 vaccine injuries early in 2021 — long before making the information public.

Still, U.S. public health agencies continue to authorize and recommend new boosters.

The FDA could easily respond to calls to halt vaccination, Hulscher said, by issuing a Class I recall, where a drug is recalled because it is likely that its use will cause serious health consequences or death — which he said nine studies and the Vaccine Adverse Event Reporting System (VAERS) data show.

“Because criteria for a Class I recall have been far exceeded, it should be an easy and effective way to halt the COVID-19 injection program and begin the process of compensating those who were harmed.”

Hulscher said he expects that calls will grow to withdraw the vaccines from the market until the regulatory authorities finally take action.

How does a Class I recall work?

Drug recalls are mechanisms to remove or amend pharmaceutical products that violate laws under the purview of the FDA.

Recalls range from minor to serious. In a minor case, companies issue a public alert that a medical device may cause harm in some situations or temporarily withdraw a product from the market while addressing a rule violation.

More serious recalls come into play in the case of pharmaceutical products that may, or likely will, cause harm to human health. A Class I recall, the most serious type, typically involves withdrawing a drug from the market completely.

In most cases, the FDA doesn’t recall the product, the company does — either by its own initiative or at the FDA’s recommendation — and the FDA oversees the recall process.

In the case of vaccines and other biologics, medical devices and controlled substances, the FDA has the authority to compel a company to recall a drug.

If a determination is made that a batch, lot or other quantity of a product licensed under the Public Health Service Act presents an imminent threat to public health, the FDA can issue an immediate recall.

However, for most drugs, the FDA doesn’t have the authority to force a company to recall products that violate FDA rules — it can only recommend the drugmaker recall its product.

Federal lawmakers have periodically introduced legislation to provide the FDA with mandatory recall authority for any and all faulty or unsafe prescription and over-the-counter drugs. However, Congress has not yet passed a bill giving the FDA that authority.

In the past, drugmakers have initiated vaccine recalls and informed distributors and facilities that may have purchased a vaccine about issues with the product.

In 2007, Merck recalled 1.2 million doses of Haemophilus influenzae type B (Hib B) vaccines due to concerns the vaccine was contaminated with the Bacillus cereus bacterium. The CDC analyzed VAERS from April 2007 to February 2008 and identified 75 reports related to the Hib B vaccines, including five deaths. The agency said the deaths weren’t related to the reported B. cereus.

Merck also recalled one lot of Gardasil in 2013 because it contained glass.

In 1999, the FDA-approved RotaShield vaccine, meant to prevent rotavirus gastroenteritis, was found to be causing intussusception in infants, an often excruciating and potentially fatal condition in which part of the intestine telescopes into itself.

The CDC withdrew its recommendation after identifying more than 100 reports in VAERS of intussusception following vaccination with RotaShield. Wyeth, now Pfizer, withdrew the vaccine from the market.

The FDA had approved that vaccine as safe, even though the clinical trials showed increased incidences of intussusception in vaccinated infants.

A congressional investigation showed that many of the FDA and CDC advisers who recommended the vaccine had financial ties to pharmaceutical companies developing rotavirus vaccines.

Thousands of FDA-approved drugs and devices are recalled each year, and the number of Class I recalls has been trending upward. Details of each recall are listed on an obscure FDA “enforcement report” website.

There have been some limited recalls for vaccines in 2024, including for COVID-19 vaccines, but these have been Class III recalls of limited lots, and in those cases, the product was deemed unlikely to cause harm.

For example, in November, Pfizer issued a Class III recall of four lots of its Comirnaty vaccine that were shipped at temperatures exceeding refrigeration requirements. The lots went to Alaska and U.S. Pacific island territories.

McKesson Medical Supply issued Class III recalls for lots of polio, Tdap, Hepatitis A and B, shingles, flu and other vaccines after their walk-in refrigerator failed.

The FDA did not respond to The Defender’s request for comment on calls for a Class I recall of COVID-19 vaccines.

Researchers say evidence supports Class I recall of COVID vaccines

Last week, two new peer-reviewed studies presented evidence supporting a moratorium or recall for the mRNA COVID-19 vaccines.

A study published in Science, Health Policy and the Law detected DNA contamination in the COVID-19 vaccines, at levels three-to-four times higher than regulatory limits. The study added to previous findings by other researchers that were also the basis for Ladapo’s concerns. Such contamination could be grounds for a recall.

“The recent paper by Kammerer et al. is another in a series of papers that show very high levels of DNA contamination in modified mRNA vaccines,” Children’s Health Defense Chief Scientific Officer Brian Hooker told The Defender.

“In light of this and the already exhaustive body of literature on the toxicity of these jabs, they need to be recalled as soon as possible and the myriad injuries caused by the shots need to be addressed,” he added.

Another study published last week analyzed COVID-19 vaccine and booster safety data. The authors concluded that “at minimum,” health officials should institute a moratorium on the shots. “But ideally, they should be removed from the market and their use in humans should be stopped.”

In addition to the 38,190 deaths after the COVID-19 vaccine reported to VAERS as of Nov. 29, Hulscher also pointed to recent studies that taken as a whole he said provides enough evidence to trigger a recall.

Analyses have linked 3.1 million excess deaths to vaccines and lockdowns in 47 countries between 2020 and 2022, and 17 million excess deaths globally from vaccines and other pandemic response measures.

A 2023 article in BMC Infectious Diseases, later retracted by the journal, estimated that 278,000 Americans may have died from the COVID-19 vaccine by December 2021. Similarly, Pantazatos and Seligman estimated between 146,000 and 187,000 possible vaccine-associated deaths by August 2021.

Another 2023 study published in the Asian Pacific Journal of Health Sciences found that higher COVID-19 vaccine uptake was associated with increased all-cause mortality. Another recent study published in Bulgarian Medicine found a positive correlation between COVID-19 vaccination rates and excess mortality.

A recent study published in Microorganisms found that all-cause death risk was higher among people who had received the COVID-19 vaccine than those who hadn’t.

Hulscher and colleagues also recently published a study estimating 49,240 excess cardiac deaths possibly due to the COVID-19 vaccination in the U.S. from 2021-2023.

Hulscher and co-authors published a systematic review in Science, Public Health Policy and the Law on Nov. 17 of autopsy-related literature following COVID-19 vaccination. They found that 73.9% of the 325 deaths were linked to the shots, suggesting “a high likelihood of a causal link” between the shots and death.

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.

December 10, 2024 Posted by | Science and Pseudo-Science | , , | Leave a comment

Current Pfizer Board Member and Former Trump Appointed FDA Commissioner, Dr. Scott Gottlieb

His loyalty to Pfizer is so strong he’s willing to be publicly disloyal to Trump and attack Trump’s pick for HHS Secretary with false claims about vaccines

Injecting Freedom by Aaron Siri | December 1, 2024

Pfizer board member and former Trump appointed FDA commissioner, Scott Gottlieb, went on the air to attack Trump’s nomination for HHS Secretary, Robert F. Kennedy, Jr. Here is my response, posted on X, to his comments:

Pfizer board member, @ScottGottliebMD, you look foolish attacking @RobertKennedyJr on CNBC (links to clips below) because it’s clear you lack basic knowledge regarding vaccines. For example:

  • Your claim that in “early 2000s … FDA reformulate[d] the existing MMR vaccine to take some of the preservatives out,” is false. Never happened. You are likely thinking about the removal of thimerosal in the early 2000s from various vaccines but as even CDC explains, “Measles, mumps, and rubella (MMR) vaccines do not and never did contain thimerosal.” https://www.cdc.gov/vaccine-safety/about/thimerosal.html
  • Your claim that a child “can’t get vaccinated [for MMR] until age 2” is simply false. MMR is routinely given at one year of age and sometimes even earlier. https://www.cdc.gov/vaccines/hcp/imz-schedules/index.html
  • Your claims regarding pertussis vaccines nonsensically ignore the fact that these products do not prevent transmission of the pertussis bacteria – they only provide, at best, personal protection. As a recent consensus paper of industry pertussis vaccine “experts” explained, “aPVs [pertussis vaccine] … cannot avoid infection and transmission. … aPV pertussis vaccines do not prevent colonization. Consequently, they do not reduce the circulation of B. pertussis and do not exert any herd immunity effect.” https://pubmed.ncbi.nlm.nih.gov/31333640/
  • Your claims regarding polio nonsensically ignore the fact that the last wild case of polio in the U.S. was in 1979 and that the only polio vaccine used in the U.S. for the last 24 years only provides, at best, personal protection and does not prevent transmission of the polio virus. As CDC explains: “IPV [inactivated polio vaccine] … does not stop transmission of the virus.” https://www.cdc.gov/poliovirus-containment/diseaseandvirus/index.html
  • You claimed that “we [Pfizer] don’t make the pediatric vaccines, Pfizer is not in that market” to deflect the claim that, as a board member of Pfizer, you have a serious conflict of interest in attacking RFK Jr. regarding pediatric vaccines. But, as you no doubt know, Pfizer does sell pediatric vaccines, including the Prevnar vaccine given to babies at 2, 4, 6, and 12 months of age, which was one of Pfizer’s top three selling products in 2023. https://www.pfizer.com/sites/default/files/investors/financial_reports/annual_reports/2023/ Your claim is either a lie or reveals deep ignorance.
  • Your claim regarding measles mortality is based on dubious and unreliable data and ignores the facts that (1) approximately 400 people total died annually in the U.S. in the years before the first measles vaccine in 1963 (amounting to around 1 death for every 500,000 Americans), and (2) mortality from measles declined by over 98% from 1900 to 1960 before the vaccine and was continuing to decline. https://stacks.cdc.gov/view/cdc/6200. In any event, you dutifully ignore the fact that RFK Jr. has made clear he has no intention of taking away vaccines from anyone who wants them.
  • You claim RFK Jr. will cost lives, but I would argue that ignorance regarding vaccine products does and has cost lives. I welcome a public debate in which we can discuss the number of lives ignorance about vaccines has cost versus your speculations about those RFK Jr. will supposedly cause (a man who has actually devoted his life to saving the lives of children).

Your knowledge regarding these products is only matched by your track record as a public “health” official. The plummeting decline in childhood health from the early 1980s (from less than 13% with chronic disease to now well over 50%) continued unabated while you were FDA commissioner. Respectfully, you lack authority or a track record, let alone basic knowledge, to speak on the subjects you address in this interview (let alone to discuss this topic with Senators to dissuade them from confirming RFK Jr.)

If you were being honest, you would reveal that your real concern, as a board member of Pfizer, is that Pfizer’s golden gooses – Covid-19 vaccines, Prevnar vaccines, RSV vaccines, etc. – will have to face the reality of the devastating harms they have caused to families across America. Your interview stinks of self-interest. The time for selling out America’s children so pharma and its leaders, like you, can line their pockets has come to an end.

The above responds to a recent CNBC segment on which you recently appeared and which you tweeted out in two parts:

https://x.com/ScottGottliebMD/status/1862521935994708379

https://x.com/ScottGottliebMD/status/1862521935994708379

December 10, 2024 Posted by | Corruption, Deception, Science and Pseudo-Science | , , | Leave a comment

Trump’s Picks for Surgeon General and Top Posts at FDA, CDC Earn Mixed Reviews

By Michael Nevradakis, Ph.D. | The Defender | November 25, 2024

President-elect Donald Trump’s nominees to lead three key federal public health agencies “would help the incoming president shift the priorities of agencies that are linchpins in public health” — but they’re also “controversial,” according to NPR.

Trump tapped Dr. Marty Makary to head the U.S. Food and Drug Administration (FDA), Dr. Dave Weldon to lead the Centers for Disease Control and Prevention (CDC) and physician Dr. Janette Nesheiwat for surgeon general.

“The roles will be key to helping to enact Trump’s second term health agenda, which could include agency reform and changes to public health policies,” Axios reported.

The three agencies report to the U.S. Department of Health and Human Services (HHS). Earlier this month, Trump nominated Robert F. Kennedy Jr., founder of Children’s Health Defense (CHD), to lead HHS.

Weldon previously criticized COVID-19 vaccines and restrictions. Makary and Nesheiwat first expressed support for vaccines and other pandemic-related policies but have become more critical in recent years.

Kim Witczak, a drug safety advocate who has worked with the FDA as a consumer representative, addressed mainstream criticism of the nominations. She told The Defender that “the pharmaceutical and medical-industrial complex is very worried.”

She added:

“The pharmaceutical and food industries have faced little resistance from regulators and Congress. The strong pushback we’re seeing now suggests they fear what might happen under an administration willing to challenge the status quo.”

Dr. Joseph Varon, president of the Front Line COVID-19 Critical Care Alliance, told The Defender, “Leadership in these agencies is critical for fostering trust in public health and ensuring evidence-based policies. We hope the nominees are committed to transparency, innovation and addressing the ongoing challenges in healthcare, particularly the lessons learned from the COVID-19 pandemic.”

Makary: U.S. government the ‘greatest perpetrator of misinformation’

Makary, a public health researcher and surgeon at Johns Hopkins University, developed the surgical safety checklist, adopted by the World Health Organization and credited with saving many lives. Makary worked with the first Trump administration, including on surprise medical billing, NPR reported.

Earlier this year, Makary published “Blind Spots: When Medicine Gets it Wrong, and What It Means for Our Health.” The book highlighted evidence that many modern-day health crises in the U.S. were caused or hastened by the medical establishment.

According to The Gateway Pundit, “Makary was initially an advocate for the COVID vaccine but changed his perspective as more data became available.” NPR noted that Makary “voiced support for lockdowns early in the pandemic and encouraged universal masking” but later “became increasingly outspoken” against such policies.

In 2021, Makary called the Biden administration’s CDC “the most political CDC in history” for not being forthcoming with the public about COVID-19 and the vaccines. According to the New York Post, he criticized the CDC and Biden administration for their “unsupported claims” about COVID-19 vaccine effectiveness.

Makary has also been vocal about the potency of natural immunity to COVID-19, criticizing the medical establishment’s “complete dismissal of natural immunity.”

In May, he criticized The New York Times for being slow to report on the thousands of people injured by the COVID-19 vaccines.

Last year, Makary said during congressional testimony that “public health officials have made many tragic mistakes during the pandemic.” Those mistakes included ignoring natural immunity, dismissing the possibility of COVID-19 originating from a lab leak, closing schools, masking toddlers and “pushing boosters for young people.”

In September, Makary appeared alongside Kennedy at a congressional roundtable hosted by Sen. Ron Johnson (R-Wis.) on the chronic disease epidemic. During the roundtable, Makary said, “The greatest perpetrator of misinformation has been the United States government.”

In his announcement, Trump said Makary would work with Kennedy to “properly evaluate harmful chemicals poisoning our Nation’s food supply and drugs and biologics being given to our Nation’s youth, so that we can finally address the Childhood Chronic Disease Epidemic.”

Brian Hooker, Ph.D., CHD’s chief scientific officer, told The Defender Makary has a “steep learning curve regarding vaccines in general” but has taken “encouraging stances late in the pandemic about the COVID vaccine and countermeasures.”

Scott C. Tips, president of the National Health Federation, said Makary represents “a mixed bag of mainstream medicine and outside-the-box thinking.” He credited Makary for opposing “mandatory COVID-19 injection boosters” and criticizing the FDA’s rejection of natural immunity.

Epidemiologist and public health research scientist M. Nathaniel Mead praised Makary’s nomination. “You’d be hard-pressed to find a physician with a deeper understanding of what ails our healthcare system and what’s needed to restore integrity to the FDA after six decades of regulatory capture.”

“Makary seems uniquely positioned to bring meaningful change,” Witczak said. “He understands the systemic harm caused by overmedicalization and the corporate capture of healthcare. His history of challenging mainstream narratives during COVID shows he isn’t afraid to speak out.”

Weldon sponsored bill to ban mercury from vaccines

Dr. Dave Weldon is an Army veteran who served as a Republican member of the U.S. House of Representatives between 1995 and 2009.

In a statement, Kennedy praised Weldon’s experience, saying he “will bring the truth and transparency needed to restore the public’s confidence” in the CDC.

In 2007, Weldon sponsored a bill that would have banned mercury from vaccines, expressing concern about “an enormous inherent conflict of interest within the CDC,” because the agency promotes vaccination while assessing their safety.

According to Politico, Weldon also “raised concerns about the safety of the measles, mumps and rubella vaccine and Gardasil, Merck’s papillomavirus virus, or HPV vaccine.

While in Congress, Weldon also introduced legislation outlawing human cloning and helped secure a deal that banned patents on human organisms, including genetically engineered embryos, according to The Associated Press.

According to NPR, Trump said Weldon would “proudly restore the CDC to its true purpose, and will work to end the Chronic Disease Epidemic,” and “prioritize Transparency, Competence, and High Standards.”

John Gilmore, executive director of the Autism Action Network, said Weldon “was sounding the alarm on failures in the vaccine system 20 years ago.” He said Weldon attended conferences like Defeat Autism Now and listened to mothers of vaccine-injured children, which is “not a behavior many doctors are inclined to do.”

Hooker said he was “very encouraged” by Weldon’s nomination, and that he’d like to know more about Weldon’s position on “the bloated vaccine schedule as well as COVID-19 countermeasures.”

He credited Weldon with helping independent thimerosal researchers gain access to the Vaccine Safety Datalink, a collaborative project that monitors vaccine safety and conducts studies on vaccine side effects.

Hooker, who participated in that project, said “Our access to the VSD was rescinded months later because [the CDC] didn’t like our results, which included a definitive link between thimerosal and autism. Weldon indeed will need to implement myriad changes to the flawed and fraudulent process.”

Weldon is the first nominee for CDC director who will face a Senate confirmation process, due to legislation passed in 2022, NPR reported.

Nesheiwat: ‘egregious unethical & harmful’ to add COVID shots to childhood schedule

Nesheiwat, Trump’s nominee for surgeon general, is a medical contributor to Fox News and medical director at CityMD, a network of urgent care centers in New York and New Jersey.

Nesheiwat previously promoted the benefits of getting vaccinated against COVID-19 and other infectious diseases, NPR reported. According to The Gateway Pundit, Nesheiwat has since changed her position and her “recent statements indicate a significant shift in her perspective.”

In October 2022, Nesheiwat tweeted, “If CDC approves a COVID vaccine addition to the routine schedule of vax for kids, it will mark the most egregious unethical & harmful decision to children. No mandates. Especially for a vax that can’t prevent disease.”

Nesheiwat has also questioned the efficacy of the COVID shots, tweeting in February 2023, “Covid vax does not prevent disease like we once thought it did per the cdc /Pfizer etc.,” and has tweeted in support of natural immunity.

In a statement, Trump called Nesheiwat an advocate for preventive medicine and praised her “commitment to saving and treating thousands of American lives.”

Mead said Nesheiwat’s about-face on vaccines “shows she has the ability to think critically,” which could help her “serve as a bridge builder at a time of deep division.”

A ‘historic opportunity to shake up the establishment’

Calling healthcare in the U.S. “horribly broken,” Hooker said the three nominees will face several challenges if confirmed because federal public health agencies require reforms.

Hooker said:

“Corporate influence, including the corporate capture of these agencies, is the biggest problem to be tackled. First and foremost, we need to protect children … from the highly flawed policies of these agencies.

“All influences from Big Pharma, Big Food and Big Ag need to be completely rooted out and the whole edifice should be rebuilt brick-by-brick to include only those policies that help and never harm children.”

Gilmore said public health agencies should publicize “all the data they have available.” He also called for a ban on vaccine mandates. “We have to be able to sue in a real court for vaccine injuries,” he added.

Varon called for independent clinical trials and for “independent scientific inquiry and reducing undue influence from corporate or political pressures.” He also called for promoting early treatment protocols for emerging diseases and giving physicians “the flexibility to treat patients with evidence-based approaches.”

“This moment represents a historic opportunity to shake up the establishment,” Witczak said. “After years of feeling like leaders were paying lip service — or working against the public — I finally see hope for meaningful reform. It’s time to restore these agencies’ missions to serve the public, prioritize safety, and act with integrity.”

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.

November 30, 2024 Posted by | Aletho News | , , , , , | 18 Comments

Trump names RFK Jr. to cabinet position

RT | November 14, 2024

US President-elect Donald Trump will nominate Robert F. Kennedy Jr. to be his Secretary of Health and Human Services (HHS), declaring that the former Democrat will ensure that “everybody will be protected from harmful chemicals [and] pollutants.”

Trump announced his choice in a social media post on Thursday evening. “For too long, Americans have been crushed by the industrial food complex and drug companies who have engaged in deception, misinformation, and disinformation when it comes to public health,” he wrote.

“HHS will play a big role in helping ensure that everybody will be protected from harmful chemicals, pollutants, pesticides, pharmaceutical products, and food additives that have contributed to the overwhelming health crisis in this country,” he continued. “Mr. Kennedy will restore these agencies to the traditions of gold standard scientific research… to Make America Great and Healthy Again!”

The New York Post claimed the previous day that some of Trump’s closest advisers were pushing for Kennedy to be given an advisory position, but that the former Democrat was “stubborn” in demanding control of HHS.

If confirmed, Kennedy would oversee the Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), National Institutes of Health (NIH), and other sub-agencies. Kennedy has been vocally critical of all of these agencies, and vowed to enact sweeping reforms if placed in charge of them.

A long-time vaccine skeptic and proponent of organic agriculture, Kennedy has promised to “get processed food out of school lunch immediately,” to recommend that fluoride be removed from the water supply, and to crack down on the use of chemical pesticides and herbicides in farming.

Kennedy announced last October that he would run for the presidency as an independent candidate, ending his bid to challenge President Joe Biden in the Democratic Party’s primary elections. He suspended his campaign and endorsed Trump in August, citing Trump’s support for free speech, his promise to end the Ukraine conflict, and his willingness to tackle what Kennedy called “the chronic disease epidemic” afflicting American children.

https://twitter.com/MidwesternDoc/status/1854781830693581049

November 14, 2024 Posted by | Science and Pseudo-Science | , , , , | Leave a comment

Vaccine ‘Quietly’ Pulled Off Market in 2007 Now Linked to 19 Diseases

35 Million Babies Who Got the Shot Now at Risk as Adults

By Brenda Baletti, Ph.D. | The Defender | November 7, 2024

The thimerosal-free HibTITER pediatric vaccine marketed by Wyeth from 2003 through 2007 was associated with 19 different medical conditions, according to a study published Tuesday in the International Journal of Risk & Safety in Medicine.

The conditions include life-threatening side effects at rates “significantly higher” than other Hib vaccines.

The study, by Children’s Health Defense (CHD) researcher Karl Jablonowski, Ph.D., and Brian Hooker, Ph.D., CHD chief scientific officer, compared adverse events among children who received HibTITER to those among children who received other Hib vaccines.

Haemophilus influenzae type b (Hib) is a bacterium that can cause illnesses ranging from ear infections to pneumonia to meningitis. Vaccines for Hib in young children were first licensed in 1987. The Centers for Disease Control and Prevention (CDC) recommends Hib vaccines for infants at age 2 months.

Wyeth, now Pfizer, sold HibTITER from the time it was licensed in 1990 until 2007. In 2003, the company reformulated the vaccine to remove thimerosal, a type of mercury, after public outcry over the dangers of mercury in vaccines.

In 2007, Pfizer “quietly” pulled the reformulated HibTITER vaccine off the market, Hooker told The Defender — a move he said was concerning, in light of the vaccine’s “relationship to many adverse events in children.”

To assess those adverse events, Jablonowski and Hooker analyzed data from 277,484 children between 2003-2007 — when the thimerosal-free HibTiTER was available — using the publicly available Florida Medicaid database.

They corroborated their findings by analyzing data for the vaccine from the Vaccine Adverse Event Reporting System (VAERS), a passive public reporting system jointly administered by the CDC and the U.S. Food and Drug Administration (FDA).

The researchers identified medical conditions for infants vaccinated with any Hib vaccine within 30 days of the shot. The Medicaid data revealed 19 different diagnoses associated with HibTITER at frequencies significantly higher than those associated with other Hib vaccines. They also verified 14 of those diagnoses in VAERS.

The adverse events, ranging from mild to life-threatening, included respiratory, gastrointestinal, dermatologic and generalized infections; ear, nose and throat medical contitions; and other conditions.

None of the serious or even life-threatening conditions identified were listed as possible adverse events on the package insert for HibTITER.

The authors’ findings “have profound medical implications for the estimated 35 million Americans between the ages of 16 and 33 who received the vaccine,” they wrote.

VAERS ‘screaming’ problem with HibTITER for decades

The first Hib conjugate vaccine, which combines a weak antigen with a stronger one to elicit a more robust immune response to the weak antigen, was licensed in 1987 for children 18 months and older, and in 1990 for infants 2 months and older.

Following the approval of the first Hib conjugates, rates of Hib disease in young children dropped dramatically — 92%, from 37 per 100,000 in 1989 to 3 per 100,000 by 2008.

While numerous safety studies found the vaccine to be safe and the side effects to be transient, Jablonowski and Hooker wrote that those studies were “underpowered” — meaning the sample sizes were too small to detect potential safety issues.

The clinical trial used to declare the vaccine’s safety consisted of investigators calling families 72 hours after vaccination to see how the infants were doing. On that basis, they concluded the vaccine was “safe and effective,” the authors wrote.

“Since VAERS first went live in July of 1990 the data started screaming that something was wrong with HibTITER,” Jablonowski told The Defender. “In VAERS’ first six months of existence, 30% of mortalities reported in children 6 months old or younger were HibTITER recipients.”

HibTITER dominated the Hib vaccine market between 1991 and 1994 when it began to share the market with other FDA-approved vaccines.

Wyeth allowed the license for the thimerosal-containing HibTITER to expire in 2002, following the CDC’s Simpsonwood retreat. At the meeting of public health officials, vaccine manufacturers and professional medical associations reviewed data from the Vaccine Safety Datalink and privately raised concerns about thimerosal in vaccines.

The license expired just after the Institute of Medicine’s Immunization Safety Review Committee published its 2001 safety review of thimerosal-containing vaccines and their link to neurodevelopmental disorders.

In that report, the Institute of Medicine found insufficient data to confirm or deny the link, yet the CDC recommended removing thimerosal from vaccines “as soon as possible.”

However, even when Wyeth began selling a reformulated non-thimerosal version of HibTITER in 2003, adverse events continued to occur at high rates.

“In the subsequent years, HibTITER accounted for a disproportionately larger number of emergency room visits, serious reports and reports of death,” Jablonowski said. “The FDA and CDC took no known action, and instead allowed the manufacturer, Wyeth, to choose to end production.”

The researchers estimated that approximately 35 million Americans received the HibTITER vaccine during its time on the market.

In 2011, vaccine maker Nuron Biotech Inc. acquired the HibTITER rights from Wyeth/Pfizer and announced it was preparing to rerelease the vaccine in the U.S. and some Asian markets.

However, the shot was never reintroduced to the U.S. market and the company no longer exists.

‘We were stunned at what the data revealed’

The investigators compared the frequencies of new diseases identified within 30 days of vaccination among 152,269 infants who received the thimerosal-free HibTITER to 125,215 infants who received any other Hib vaccine.

They employed the Fisher’s Exact Test statistical model to compare disease frequency in each cohort and used Bonferroni correction, a powerful statistical tool, to eliminate random results. They also set a high bar for statistical significance.

They identified 19 adverse outcomes with the “most prolific, significant signals” for infectious diseases, such as pulmonary tuberculosis, where 99.03% of diagnoses were among HibTITER recipients.

Other respiratory illnesses occurring within 30 days of HibTITER vaccination included asthma, acute upper respiratory infections, influenza and acute bronchiolitis. Additional diseases included laryngopharyngitis, common cold, colitis, enteritis and gastroenteritis.

Of the 19 adverse effects they identified, the most recent package insert for HibTITER named only two: fever and rash. Infectious diseases accounted for nine of the 19 adverse effects.

Jablonowski explained that the HibTITER doesn’t directly cause infections but can create conditions that facilitate them. The presence of so many infections “implicates significant and rapid immunological defense impairment,” he said.

Jablonowski added:

“While we had heard anecdotally of many adverse reactions to the HibTITER vaccine, we were stunned at what the data revealed.

“This vaccine should have been studied much more intensively before being allowed on the market. In fact, it shouldn’t have ever been allowed to be injected into infants in the absence of rigorous studies to support its safety.”

He said analyzing the adverse outcomes was “simple — high-school level math and basic database/programming skills kind-of-simple. There are literally millions of people in this country who could have performed the data science portion of this study, and none of them apparently work for the FDA or CDC.”

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.

November 8, 2024 Posted by | Deception, Science and Pseudo-Science, Timeless or most popular | , , | 1 Comment

New Report Adds to Evidence That Cellphone Radiation May Cause Brain Cancer

By Suzanne Burdick, Ph.D. |The Defender | October 22, 2024

Peer-reviewed studies showing a link between brain cancer and cellphone radiation are piling up — contradicting a recent World Health Organization (WHO)-led study that claimed there’s no evidence of a link.

South Korean researchers — who analyzed 24 studies and published their report on Oct. 10 in Environmental Health — found significantly higher risks for malignant brain tumors, meningioma and glioma on the side of the head where cellphones were held.

They also found heavy, long-term cellphone use was linked to an increased risk of glioma.

The South Korean study brings the number of meta-analyses published since 2016 linking cellphone radiation to an increased risk of brain cancer to seven, wrote Joel Moskowitz, Ph.D., on his website.

Moskowitz — who directs the Center for Family and Community Health at the University of California, Berkeley — has conducted and disseminated research on wireless technology and public health since 2009.

“These seven peer-reviewed meta-analytic studies contradict the conclusion of the recent WHO systematic review,” he said.

“Seven studies is a lot and we anticipate more in the future,” Miriam Eckenfels-Garcia, director of Children’s Health Defense’s (CHD) Electromagnetic Radiation (EMR) & Wireless program, told The Defender.

Eckenfels-Garcia said:

“We encourage the WHO to revise its stance, unlikely as this may be. It’s more likely that the WHO and other captured agencies will label non-industry friendly science as misinformation, even if this puts the public further in danger.”

Moskowitz said there’s evidence that the WHO picked industry-biased researchers to conduct its review.

Lennart Hardell, M.D., Ph.D., a leading scientist who found a link between cellphone use and gliomas, agreed. He told The Defender it was “striking” that the South Korean researchers reached a conclusion that directly contradicted the findings by the authors of the WHO study.

Hardell — an oncologist and epidemiologist with the Environment and Cancer Research Foundation who has authored more than 350 papers, almost 60 of which address wireless radiation — said:

“The WHO study authors should be responsible for their fraudulent behavior violating human health and the environment. Their lack of ethical principles in science gives a ‘green card’ to roll out this technology — and the misinformed layman is the victim.”

Brain tumor rates on the rise in Denmark

The South Korean study was published on the heels of new health data from Denmark showing that central nervous system tumors — including brain tumors — are on the rise.

Denmark is known for its high-quality tracking of cancer cases. So it’s concerning when their data show a clear increase, Mona Nilsson, co-founder and director of the Swedish Radiation Protection Foundation, told The Defender.

The Danish Cancer Registry on Sept. 30 published a report on the number of new cancer cases in Denmark, Nilsson said. It shows that central nervous system tumors have been increasing among both men and women.

Nilsson compared Danish central nervous system cancer diagnosis rates since 1995. “The data show that tumors of the central nervous system, including brain tumors, are increasing and are among the cancers that have increased most rapidly over the past 10 years, between 2014 and 2023.”

Credit: Swedish Radiation Protection Foundation

The Danish statistics contradict the notion that the rate of brain tumors isn’t on the rise, Nilsson said. “That argument has been used to claim that cellphone use is not linked to an increased risk of brain tumors or cancers in general.”

A 2023 study on brain cancer rates worldwide from 1990-2019 found a significant rise in brain cancer among both men and women in nearly all parts of the world. The study authors noted that this increase was largely seen in Western countries.

In the U.S., overall brain and other nervous system cancer rates haven’t increased, according to the National Cancer Institute. However, there are many reasons tumors may go unreported in the U.S. and other countries, according to Moskowitz.

For instance, Hardell in a 2017 peer-reviewed study found indications of underreporting in the Swedish Cancer Register.

Although the incidence of reported glioma diagnoses in U.S. adults has remained steady, Moskowitz noted in a Sept. 25 webinar, there’s been an increase in glioblastoma — “the most common and most serious malignant brain tumor.”

“We have seen increases in brain tumor incidents among children and young adults,” he added. “Clearly, more research is needed to understand these increases in tumor incidents.”

Ellie Marks told The Defender she and her son founded the California Brain Tumor Association after discovering that her husband’s brain tumor was likely caused by long-term heavy cellphone use.

After the tumor diagnosis in 2008, Marks sent her husband’s medical and phone records to wireless radiation experts, including Hardell. “They got back to me and said, ‘Yes, he is the poster boy for the cellphone brain tumor correlation,’” she recalled.

Her husband survived, but it’s not easy living with a brain tumor — and her husband is far from alone, she said. “I know many others who have experienced brain cancer attributed to their cellphone use.”

FDA turned blind eye to research linking wireless radiation and cancer

The uptick in brain cancer cases isn’t surprising, Eckenfels-Garcia said, and U.S. health agencies saw it coming.

The U.S. Food and Drug Administration (FDA) claims there’s not enough scientific evidence to link cellphone use to health problems, including brain cancer — but it rejected the findings of a $30 million study it commissioned on the topic.

At the FDA’s request, the National Toxicology Program (NTP) did a multi-year study, concluding there was “clear evidence” that male rats exposed to high levels of wireless radiation like that used in 2G and 3G cellphones developed cancerous heart tumors, and “some evidence” of tumors in the brain and adrenal gland of exposed male rats.

When the NTP in 2018 released its findings, the FDA rejected the study and in February 2020, released an unsigned literature review that criticized the study.

Commenting on the increased incidence of brain tumors, Eckenfels-Garcia said, “So essentially this is an ‘I told you so’ moment. This is exactly what happens when our captured government agencies ignore science, as the FDA did with the NTP study.”

Moskowitz said the FDA should have followed up on the NTP study by conducting a formal risk assessment of wireless radiation, but that never happened. Instead, the U.S. government shut down NTP’s follow-up work on its 2018 study.

In April, CHD filed a Freedom of Information Act request with the National Institutes of Health (NIH) for documents and communications related to why the U.S. government stopped the work. The NIH has not responded to the request.

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.

November 3, 2024 Posted by | Corruption, Deception, Science and Pseudo-Science | , , | Leave a comment

America’s Medical Monopoly: An Injection of Truth

A failure to learn lessons from history or Money Talks? 

Health Advisory & Recovery Team | October 8, 2024 

HART recently posted an article titled “The Witch Hunt continues”, which discussed self-censorship of doctors, General Medical Council (GMC) overreach, and how medical professionals are being erased from the medical register, despite no wrongdoing. Yet this is not a new phenomenon. If we delve into the history of how our existing ‘medical monopoly’ was established, with its roots firmly in America, it is an all too familiar disturbing playbook of censorship, corruption and subversion of ethics that spans over 130 years in the making. The existing medical monopoly was contrived by the Rockefeller family and their many contacts, which has been so successful in its takeover of medicine in America. Herein, I discuss an excellent book by Eustace Mullins titled “Murder by Injection: The Story of the Medical Conspiracy Against America”. Despite the book’s off putting title, Eustace’s careful research spanning over 30 years provides a detailed and shocking account of how billionaire tycoons have waged tyranny, economic depressions, wars and revolutions as part of a wider plan to usher in a medical care system to enslave the public through an entirely controlled medical monopoly. The whole book is free to download here.

Until the late 19th century, doctors were freelance practitioners who assumed all the risks associated with their medical decision-making. In 1832, the British Medical Association was chartered and provided the impetus for a similar organisation to be established in the United States (US), namely the American Medical Association (AMA), which was founded in 1847 with its headquarters in Chicago. From its inception, the AMA had one objective: to create a total medical monopoly of the practice of medicine, and ensure allopathy was the basis of its practice. Allopathic medicine required practitioners to receive training in a recognised academic school of medicine, which relied heavily on surgical procedures as well as medicines. Allopathy was to rival homoeopathy, which promoted non-toxic doses of natural remedies; in the mid-1800s, homoeopaths outnumbered allopaths two to one in the US – a statistic that had to be overturned when the AMA was created.

The reason this book is so pertinent in our troublesome times is that it catalogues the long, but very calculated and carefully planned demise of healthcare in America. It chronicles how the introduction of a monopoly through any means possible – including, racketeering, abuse, censorship and murder – enabled the takeover of health by federal agencies and governments, which were inextricably linked to industry and big pharma. How was such a monopoly to be achieved? It had to be orchestrated by the richest man in the world at that time, the monopolist John D. Rockefeller, who had triumphed in organising his oil monopoly. Backed by Rothschild and Wall Street colleagues, it was hoped the medical monopoly would provide even greater profits than oil, which has more than proved to be the case. Rockefeller appointed Frederick T. Gates (related to Mr Microsoft Bill Gates) as his ‘philanthropic’ agent, whose task was to dominate the entire medical education system.

In 1907, the AMA requested the Carnegie Foundation to conduct a survey of all medical schools in the US; the Foundation appointed Abraham Flexner to lead the study of medical schools. Coincidentally, Abraham Flexner’s brother, Simon, was head of the Rockefeller Institute of Medical Research, so this was an intentional cosy and conflicted setup from the outset. Flexner, a graduate of Johns Hopkins University, which was founded by Daniel Colt Gilman, completed his report in 1910. The report and AMA decided there were too many doctors and the solution was to create a medical educational system so elitist that most students would be prohibited from considering such a career. The undergraduate training was constructed so that allopathic medicine was central to its teaching, and by 1920 the number of medical schools had declined from 650 to 50 in number.

The book goes on to describe how ‘quackery’ was established, with three key players, Morris Fishbein, George Simmons and Albert Lasker, who all began their careers as journalists. Not one of them had any credentials of practising medicine, but their collective journalist and organisational talents propelled them to the heights of power, as full-time ‘quacks’. They utilised their connections with the corrupt AMA to stifle dissent and opposition. For instance, the AMA would grant pharmaceutical companies a ‘Seal of Approval’ for their products but only if they advertised in AMA-affiliated journals. Those that opposed this, such as Wallace Abbott, founder of Abbott Laboratories, soon found out the hard way that no products would be approved, and his reputation would suffer unless he ‘cooperated’. Simmons’ practices were particularly egregious, with one critic positing: “almost every branch of the Federal Government active in the field of medicine was completely dominated by the AMA”.

Ultimately, the monopolists forced government agencies to act against anyone who posed a threat to their monopoly, including arrests and prison sentences. Simmons and Fishbein collectively controlled the AMA for over half a century, through raising money and using political clout. Fishbein had total control over all publications of the AMA and selection of personnel in various committees. Moreover the AMA was instrumental in concealing beneficial (but non-lucrative) therapies, with products of high value being rejected or their acceptance enduring unwarranted delays. The extent of the corruption detailed in this history of American medicine is remarkable. Federal agents were solicited by charitable foundations to instigate police actions to hundreds of unsuspecting health practitioners throughout the US, in a ruthless operation to arrest and imprison people distributing leaflets about natural or herbal formulas, despite no evidence anyone had been injured or killed by these remedies. Terror raids against competitors were carried out, with heavily armed federal agents breaking doors and seizing any herbal stocks from people’s homes. The book describes terrorisation of anyone active in the alternative healthcare field. Thus, the AMA became an autocracy. Physicians were trained under the Rockefeller-based medical system, which had full control over the medical examination boards. So successful was this endeavour that Americans are now treated with expensive, overpriced, ineffective and potentially dangerous drugs, a corruption that has been routinely covered up by federal agencies.

In 1940, a bill for health insurance was introduced; although it initially suffered setbacks, the seed was sown to create an industry whereby the AMA would fight ‘socialised medicine’, which was the forerunner for Medicare and Medicaid. In the 1960s, the next target for annihilation was the chiropractic sector. No level of intimidation of censorship was spared and many high-profile speakers were forced to cancel lectures and lobby groups were set up to sanction and apply pressure on the Council on Chiropractic Education to the extent that the AMA Joint Committee on Accreditation of Hospitals barred chiropractors and refused accreditation of hospitals that had such practitioners. The AMA also forced the Veterans Administration to refuse payments to veterans for chiropractic services.

With their eyes set on further control, the medical monopolists realised that cancer was a lucrative endeavour and so established the next phase of the monopoly. In 1913, the same year President Woodrow Wilson signed the Federal Reserve Act, a group of doctors met at the Harvard Club in New York to establish a national cancer organisation, the American Society for the Control of Cancer (later renamed the American Cancer Society, ACS). The Rockefellers (with Rothschild and J. P. Morgan backing) funded the ACS. Similarly, funding for the Memorial Hospital (later to become the Memorial Sloan Kettering Cancer Center) was also linked with the National Radium Institute, which stipulated that further funds be permitted, only assuming all cancers were treated with radium. By 1922, more than 100 radiologists had died from X-ray induced cancer. Alfred Sloan, the President of General Motors and Charles Kettering, an inventive genius of electrical systems and auto ignition were deployed. Mullins chronicles in detail how huge industry directors and partners were all interlinked with each other, such as Squibb, Bristol Myers, Johnson & Johnson, Bell Telephone Laboratories, Lehman Brothers, Chase Manhattan Bank and National Geographic. Collaborations with ‘elected’ presidents, industry players, defence industries, CIA, chemical and drug firms go hand-in-hand.

Two key names in patent medicine and journalism were Albert Lasker and Elmer Bobst. One of Lasker’s greatest achievements was his national campaign to persuade women to smoke in public. Lasker became ill with cancer and died in 1952, but before his death, he set up the Albert and Mary Lasker Foundation, which made Mary (Albert’s daughter) the most powerful woman in American Medicine. It is also no coincidence that 18 members of the ACS Board of Directors were executive officers of banks. Pat McGrady, who served as editor of the ACS for 25 years stated “Medicine has become venal, second only to the law”. Since “the fight against cancer” is totally controlled by the Rockefeller medical monopoly, much of cancer research is bogus and filled with falsified results, albeit by well intentioned and unsuspecting researchers. Since Elmer Bobst played a crucial role in making it possible for Nixon to become President, it was not difficult to persuade him to authorise a new and expensive “war on cancer” in 1971.

The book explains how the ACS, AMA and FDA collaboratively staged a war of censorship and intimidation, preventing discussion of effective compounds, such as laetrile, for treating cancer. The ACS, for example, opposed the regulation of potential carcinogens, such as TRIS (trisaminomethane) and DES (diethylstilbestrol). Chemotherapy was promoted as a cancer treatment in the 1960s, despite evidence that it had many serious side effects and was shown to be highly toxic and carcinogenic in animal models, as well as immunosuppressive. Cancer is as much a disease of poor nutrition and one in which the multiplication of ‘simpler’ cells are unable to differentiate because the energy balance of the body is disrupted causing the disease. One of the Director’s of the National Cancer Institute is Mary Lasker, who has close ties with the Pharmaceutical Manufacturers Association, which is not a coincidence.

Mullins goes on to describe several instances of researchers who had discovered cancer cures either by detoxification or a diet low in salt, protein and fats, but the work was buried or destroyed to ensure the chemotherapy, radiation and surgical approaches to cancer were unchallenged. The Laskers built much of their fortune on the promotion of cigarette smoking. Although cigarette smoking is harmful and causes cancer, studies (cited in the book) have shown that there was no link between traditional air-dried tobacco and lung cancer. The tobacco industries, dominated by the Rothschilds, add chemicals and sugar to tobacco, which creates a carcinogenic substance in the nicotine tar. Air-dried tobacco lacks this carcinogen, as noted by the many primitive tribes who have smoked tobacco for thousands of years without any ill effects. Mullins explains that the ACS has vested interests in established forms of cancer treatment, for example owning 50% of the patent rights for the chemotherapy drug 5-fluorouracil. Dr Hardin James addressed the ACS in 1969, noting that “for a typical type of cancer, people who refuse treatment live an average of 12.5 years. Those who accepted surgery and other kinds of treatment, lived an average of 3 years. I attribute this to the traumatic effect of surgery on the body’s natural defence mechanisms.”

In the ‘holy church’ of allopathic medicine, there are what might be termed the four ‘holy waters’, which include immunisation, fluorination of water, use of fertilisers and contamination of the food chain. The practice of immunisation is the most pernicious in terms of its long-term effects. This practice goes directly against the discovery of modern holistic medical experts that the body has a natural immune defence against illness. The greatest heresy any clinician can commit is to publicly voice any doubt about any one of the four ‘holy waters’. The most deeply entrenched in the fabric of modern medical practice, as is glaringly apparent, is the vaccination programmes, as well as being one of the most profitable aspects of the medical monopoly. One physician, Dr Henry R. Bybee of Norfolk, Virginia, stated “My honest opinion is that vaccines are the cause of more disease and suffering than anything I could name.” Additionally, Dr Herbert Snow, a senior surgeon at a cancer hospital in London voiced similar concerns “In recent years, many men and women in the prime of life have dropped dead suddenly. I am convinced that some 80% of these deaths are caused by the inoculation or vaccination they have undergone.” The chilling accounts continue with another practitioner Dr W. B. Clarke of Indiana remarking “cancer was practically unknown until compulsory vaccination when the cowpox vaccine began to be introduced. I have had to deal with at least 200 cases of cancer, and I never saw a case of cancer in an unvaccinated person”. Is this not at least an observation worth exploring? It is unlikely modern medicine advocates will examine this alarming connection. Eventually, the outraged public will bring pressure to abandon the modern ritual of vaccinating children.

Another well-known practitioner from San Francisco, Dr J. M. Pebbles, revealed “The vaccination practice…has not only become the chief menace and the greatest danger to the health of the rising generation, but an outrage upon the personal liberties of the American citizen.” The book tells of how Wyeth laboratories was charged with $15 million in damages to an 8-year-old girl who suffered permanent brain damage after receiving a diphtheria-pertussis-tetanus vaccine. In the US, vaccines are actively and incessantly promoted as the solution for all infectious diseases. It is not a coincidence that agencies, such as the AMA, WHO, FDA, are in favour of the vaccine programmes given the revolving door that exists between Big Pharma and these agencies. It is well known that Edward Jenner ‘discovered’ the cowpox vaccine to purportedly prevent smallpox. However, smallpox was already declining before the introduction of the vaccine and many believe it would have disappeared by the end of the 19th century. After the cowpox vaccine became widespread in England, a smallpox epidemic ensued killing over 22,000 people. By 1872, 44,480 were killed, and the vaccine was finally banned in 1948. This trend is mirrored elsewhere: Japan introduced compulsory vaccination in 1872 and by 1892 there were 165,774 cases of smallpox resulting in nearly 30,000 deaths. Other European countries that submitted to compulsory vaccination saw similar high numbers of cases and deaths, whereas countries (such as Norway) who did not vaccinate had a fraction of the cases. Historians are reluctantly concluding that the 1918 ‘great flu epidemic’ was attributable to the widespread use of vaccines, as survivors were those who had refused the vaccines.

The book chronicles how dissenters and researchers who spoke out lost their jobs, had their laboratory notes seized and burned, and laboratory animals destroyed. In the 1970s, the swine flu vaccination campaign was ushered in, but insurance companies refused to cover against lawsuits as there were inadequate studies. This prompted a propaganda campaign by the monopolists to trick Americans into saving themselves by taking the vaccines, which resulted in billions in damage claims. The next iteration by Dr Jonas Salk in the 1950s was the polio vaccine, which Simon Flexner helped to recommend. It is disturbing that a national conference in Washington in 1988 declared that “all the cases of polio in America come from the vaccine. The naturally occurring (or wild type) polio virus has not been shown to cause a single case of polio in the US since 1979”. Even back in 1955, the Surgeon General of the US highlighted in the AMA conference that “no batch of vaccine can be proven safe before it is given to children”. Moreover, James R. Shannon of the NIH declared “the only safe vaccine is a vaccine that is never used.”

Importantly, the death by injection playbook is not new; rather, a well-orchestrated agenda has been implemented with calculated precision in multiple cycles to gradually harm and decimate populations across the globe. This book further discusses how fluorination of water has been another Rockefeller-deployed monopoly to poison millions of Americans by adding the poisonous chemical sodium fluoride to drinking water. Large quantities of fluorides are waste contaminants and byproducts from large agricultural firms, pesticides and chemical firms, such as Hooker Chemical. Predictably, Hooker Chemical became part of the Rockefeller unit when one of the Hooker family married into the Rockefeller family. Fluorides can cause serious chromosomal damage and animal model studies have shown it promotes cancer development, even at the one part per million threshold in drinking water that has detrimental consequences especially when consumed cumulatively over time. Soviet studies have further shown that fluorides were useful in inducing docile obedience in the general population. Combined with aluminium that was included in many foods, cooking pots and packaging, this has aided in slowly poisoning the mass population and of course produced Alzhiemer’s disease, in what constitutes a build up of toxic levels of aluminium, leading to cognitive and nervous system decline.

Not content with disrupting the medical and water supplies, the Rockefeller-based medical monopoly had its eye on the ‘green revolution’ and agricultural control through the contamination of crops using a ‘co-opted’ carefully constructed money laundering system. This time they developed ‘super crops’ or grains that would serve as an excellent cash cow for the US to sell to ‘developing’ nations. To achieve this goal required the soil to be pumped with huge quantities of fertiliser (the product of nitrates and petroleum), commodities controlled by the Rockefellers that helped to build an entire chemical empire. At the end of the second World War, a concerted effort was made by the monopolists to dump surplus nitrates into the American food chain. Farmers were instructed to increase their use of fertilisers, herbicides and pesticides and create a capital intensive payback scheme for the monopolists. The final sections of the book discuss how fertilisers have been used to reduce nutrients in the soil and how the food chain has been slowly contaminated. Chapter 9 lists and discusses the 18 largest drug firms and their close associations with major banking cartels and federal agencies, such as the CIA.

Collectively, these insidious links with Big Pharma and the medical monopoly, are not only a massive cash cow, but have maimed and decimated the population and continue to do so. Since the rest of the world is intimately tethered to the well-oiled Rockefeller US medical monopoly machine, it is not hard to see how the censorship, corruption and silencing of dissenters has become all too commonplace today.

October 9, 2024 Posted by | Book Review, Corruption, Deception, Full Spectrum Dominance, Science and Pseudo-Science, Timeless or most popular | , , , , | 2 Comments

Policy Imperatives for Health Freedom

By Leslie Manookian | Health Freedom Defense Fund | September 30, 2024

As a requirement for discussing and appreciating the imperative of health freedom in the USA, we must first define what is meant by health freedom. A simple definition is: the right of every American to decide what medical interventions to put into or onto one’s body, the right to access and use the medical and healing modalities of one’s choice, the right to maintain one’s health according to one’s conscience, and the right to live free of involuntary medication be it via the food supply, the water supply, or something airborne.

In a free and moral society, health freedom is not simply a convenience, it’s an imperative. In this vein, in the event of injury or illness, all Americans must possess the absolute right to choose what medical interventions and treatments to accept and what medical or healing modalities to utilize in order to address illness or injury; Americans must be free to choose how to maintain their health whether that be through nutrition, supplements, herbs, drugs, or a myriad of healing modalities; Americans must have access to truthful information regarding how the seeds for plants and animal feed and the food in our food supply has been grown or developed, medicated, processed, and packaged; and Americans have the right to exist in a society free of water and airborne medications, insect vectors, and chemicals.

Health freedom can only exist in a free and moral society which values each and every member of that society. This prerequisite thus excludes medical mandates of any kind. It is immoral to force another individual to risk their life for the theoretical benefit of another. Moreover, government does not have the moral authority or power to dictate what medical products any American puts into or on his or her body. If anyone in government does possess that power, then no American is truly free, nor does he or she possess any meaningful right whatsoever – Americans are merely chattel.

In order to create a society based on true health freedom, the following policy shifts should be implemented, as a first step. There are many more changes which should be implemented as well, but these proposals would address some of the most glaring, pernicious anti-liberty and anti-health aspects of our system as it exists today:

1. Ban all Medical Mandates:

The Declaration of Independence states, “that all men are created equal, that they are endowed by their Creator with certain unalienable Rights, that among these are Life, Liberty and the pursuit of Happiness…”  Medical mandates are prime facie violations of our founding documents.

Health freedom demands prior voluntary informed consent before a medical treatment or intervention is administered. Medical mandates are thus, by definition, antithetical to voluntary consent and therefore must be prohibited in a free and moral society. No single individual in government knows the medical history of any American, knows what is best for Americans, or has to live with the repercussions of any choices made by Americans, thus, medical mandates are never justified in any circumstance.

2. Repeal the Bayh-Dole Act:

“The Bayh-Dole Act, formerly known as the Patent and Trademark Act Amendments, is a federal law enacted in 1980 that enables universities, nonprofit research institutions and small businesses to own, patent and commercialize inventions developed under federally funded research programs within their organizations.”

Under this program, government scientists may receive up to $150,000 per year on their patents.

In theory, Bayh-Dole incentivizes bright scientists to seek employment at federal health agencies rather than entering more lucrative private industry by allowing these taxpayer-funded scientists and other individuals and entities to retain the patent rights to intellectual property developed during their taxpayer-funded research and development activities.

In practice, this Act forever realigned the interests of taxpayer-funded scientists away from the American people and toward their own interests and profits and the profits of the private industries with which they collaborate. Dr. Anthony Fauci and his team at NIAID infamously owned half the Moderna Covid vaccine patent which incentivized the misguided covid era policies leading to a colossal violation of the rights of Americans demonstrating the perverse incentives created by Bayh-Dole and the necessity of repealing the act.

3. Repeal the Prescription Drug User Fee Act (PDUFA) of 1992:

“The Prescription Drug User Fee Act (PDUFA) was created by Congress in 1992 and authorizes FDA to collect user fees from persons that submit certain human drug applications for review or that are named in approved applications as the sponsor of certain prescription drug products. Since the passage of PDUFA, user fees have played an important role in expediting the drug review and approval process.”

In 2022 alone, the pharmaceutical industry paid $2.9 billion in user fees amounting to 46% of FDA’s entire budget including $1.4 billion or 66% for FDA’s drug approvers’ salaries and $197 million or 43% of the biologics (vaccines) program budget. As a direct consequence of PDUFA, the FDA has a vested interest aligned with the profits and success of the pharmaceutical industry rather than the health and wellbeing of the American people.

4. Repeal the Public Readiness and Preparedness Act (PREP Act) which authorizes the Secretary of the Department of Health and Human Services to issue a PREP Act declaration.

“The declaration provides immunity from liability (except for willful misconduct) for claims:

  • of loss caused, arising out of, relating to, or resulting from administration or use of countermeasures to diseases, threats and conditions
  • determined by the Secretary to constitute a present, or credible risk of a future public health emergency
  • to entities and individuals involved in the development, manufacture, testing, distribution, administration, and use of such countermeasures

A PREP Act declaration is specifically for the purpose of providing immunity from liability, and is different from, and not dependent on, other emergency declarations.”

The PREP Act desecrates the ethical principle of informed consent by protecting individuals from liability even when they expressly act contrary to patients’ wishes and instructions and must be repealed.

5. Repeal the Affordable Care Act:

The Affordable Care Act anchors Americans to the pharmaceutical and drug-based medical paradigm even though a majority of Americans used at least one form of “alternative” medicine in 2021 and spent $30.6 billion in out of pocket expenses for those holistic medicine services in 2023 according to Statista. Instead, implement a health savings program which permits Americans to access the health and medical modalities of their choice which in turn would foster more competition and reduce the exorbitant health care costs in the US by breaking the extant monopolies held by the medical and insurance industries.

6. Repeal the National Childhood Vaccine Injury Act (NCVIA):

NCVIA shields vaccine makers and those who administer vaccines from liability (except for willful misconduct), creating a perverse incentive to industry to develop a never-ending stream of vaccines which are then mandated by the states and a perverse incentive to medical professionals to charge for and inject patients irrespective of the harm they may cause. Further, the NCVIA protects industry, medical professionals, and vaccine programs by creating a separate administrative federal court structure lacking due process and discovery, managed by “Special Masters” instead of judges, all in violation of the constitutionally protected right to due process. While NCVIA contains other provisions designed to protect American families and ensure the safety of the national vaccine supply, Congress is not conducting proper oversight and the promises made in 1986 at the time of the Act’s passage have not been upheld. As such, Americans who have been injured or killed by vaccines are left with astronomical medical bills and to fend for themselves.

7. Prohibit Private Donations to Government Entities:

Prohibit private individuals, foundations, corporations, contractors, any other person or entity from donating or otherwise giving money to any agency or entity of the federal government. FDA and the Centers for Disease Control and Prevention (CDC) accept money from private actors such as the Bill and Melinda Gates Foundation and Pfizer thus skewing the interests of the agency in favor of these private actors and away from the American public. Gates has collaborated with FDA and the CDC Foundation takes money from the pharmaceutical industry whose products CDC is responsible for monitoring for safety.

8. Cooling-off Period for Senior Federal Employees:

Enact a 5-year cooling-off period before which agency leadership, deputies, and other key officials may depart federal agencies in order to enter the companies they regulate in the private sector.

9. Prevent Conflicts of Interest:

Eliminate conflict of interest waivers so that no person serving on a health agency committee, board, or other regulatory entity may have a conflict of interest. Disclosure of conflicts of interest is insufficient to ensure the agencies pursue the interests of the American people. Individuals with financial or ideological conflicts of interest should not serve as decision makers in any capacity.

10. Prohibit Government Grants to Nonprofits:

Prohibit government from allocating taxpayer dollars to nonprofit. Nonprofits exists to serve the public interests and should be funded directly by American citizens. If a nonprofit has a worthwhile mission, the public will gladly support it. Government exists to protect our rights and should not be in the business of picking winners and losers nor should it be using third parties to pursue policies outside the reach and review of the public.

11. Ban Water Fluoridation:

While water fluoridation programs are broad spread, they are not only dangerous from a health standpoint, they are forced medication in violation of the ethical principle of informed consent. Research comparing the health outcomes and IQs of communities that do and do not fluoridate their water supply reveal that children in the fluoridated water communities have reduced IQs and therefore inferior prospects in life. Other research has documented the health hazards of fluoride, an industrial waste product.

In addition, as fluoride is added to municipal water supplies, residents of those communities have no way to opt out and therefore are subjected to involuntary forced medication. No one should be forced to consume drugged water in order to maintain a biological necessity.

12. Ban Release of Genetically Modified Insects

Two tenets of good health are abundant exposure to sunshine and fresh air, however in some states, the state governments have collaborated with private business to release genetically modified mosquitoes into communities. While these mosquitoes are often designed to breed with one another and eliminate the “dangerous” species going forward, the health impacts of humans being bitten by these insects is not well understood. Nor should a person have to be risk being bitten by one of these creatures in order to venture outside. This amounts to a form of forced medication absent any form of consent and must be ended.

These recommendations should be understood as necessary first steps to begin correcting the disastrous health policy environment that exists in the United States today and to restore true health freedom in the US which would allow all Americans to decide what medical interventions to allow into or onto one’s body, which health and medical modalities to utilize in maintaining their health, and the ability to live free of involuntary medication be it via the food supply, the water supply, or the air we breathe.

October 3, 2024 Posted by | Civil Liberties, Economics, Timeless or most popular | , , , , , | 1 Comment

FDA Approves Vaccine for Mpox — Warns It May Cause Death in Vaccinated and People They Come in Contact With

By Suzanne Burdick, Ph.D. | The Defender | September 17, 2024

A vaccine approved in August by the U.S. Food and Drug Administration (FDA) for people deemed to be at “high risk” for mpox infection may cause more harm than good, according to the FDA’s own medication guide for the product.

ACAM2000 — made by Emergent BioSolutions, a company specializing in vaccines for biochemical warfare threats such as anthrax and smallpox — was approved for smallpox in 2007.

However, on Aug. 29, the FDA issued an expanded supplement approval for ACAM2000’s use against mpox.

Since then, social media users have been posting clips of the FDA’s ACAM2000 medication guide, which warns the vaccine may cause “serious complications” in both the vaccinated person and those with whom they come into close contact up to 6 weeks after getting the shot.

Karl Jablonowski, Ph.D. — senior research scientist at Children’s Health Defense — told The Defender that the FDA’s approval of the shot is a “public hazard, not the practice of public health.”

“You can call ACAM2000 a ‘vaccine,’ but its impact on the United States will be as a ‘disease,’” Jablonowski said.

He added:

“For instance, the drug’s package insert reveals (see Table 3) that the U.S. Department of Health and Human Services (HHS) found roughly 520 per million ACAM2000 recipients contracted myocarditis or pericarditis.

“That is about 1 in 2,000. But elsewhere in the package insert, the FDA acknowledges that — based on additional studies — the risk is actually 5.7 per 1,000 vaccinations.

“That’s about 1 in every 175 people. If the 262 million adults in the U.S. received this vaccine, an estimated 1,493,000 would contract the serious adverse reaction of myopericarditis.”

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

Dr. Meryl Nass, an internist and biological warfare expert, told The Defender that the CDC also acknowledged this same figure — myopericarditis in 5.7 per 1,000 primary ACAM2000 vaccinations — during a June 23, 2022, meeting.

“It’s a huge number,” Nass said. “The fact that the FDA and CDC are acknowledging it means no one should get the vaccine.”

She explained:

“Myopericarditis is a life-threatening condition. It lowers your life expectancy.

“Most people are never going to be exposed to mpox or smallpox. Vaccines are typically given to healthy people who are never even going to be exposed, therefore the risk posed by the vaccine needs to be low.

“That’s why vaccine safety is critical — even more than drugs, because drugs are given to people who are already sick.

“This risk — 1 in 175 — is higher than all other licensed vaccines for which the CDC acknowledges side effects. This is the worst.”

ACAM2000 can also cause fetal death when taken during pregnancy, the package insert states.

Additionally, the shot contains a “live vaccinia virus” that can be spread to — and possibly cause the death of — people who have close contact with the vaccinated person up to 6 weeks following vaccination, according to the medication guide.

The guide — which the FDA requires to be given to patients before they get the ACAM2000 vaccine — says, “ACAM2000 can cause serious complications in vaccinated individuals and in their close contacts to whom the vaccine virus has spread.”

Jablonowski said, “The spread of vaccinia virus is an infliction and an assault, as an unsuspecting person cannot possibly consent.”

“For good reasons you would not consent to this vaccine,” Jablonowski said, “even if you believed your benefits outweigh your risks, as you become a potential vector of a disease that is damaging to the heart and fatal to both fetus and infant.”

Risk of serious complications and death in vaccinated and those exposed to vaccinated individual

ACAM2000 is a single-dose vaccine administered using a bifurcated needle that’s been dipped into the vaccine solution, according to an Emergent BioSolutions press release.

In its Aug. 30 press release, the FDA stressed that “every person” who receives ACAM2000 is “required” to be given the drug’s FDA-approved medication guide.

“A Medication Guide is necessary,” the FDA said, “for safe and effective use of the vaccine because it could help prevent serious adverse events and inform the vaccine recipient of serious risks relative to benefit that could affect their decisions to be vaccinated.”

The guide lists serious possible complications, including: myocarditis, inflammation of the brain or spinal cord, serious skin infections, spreading the vaccine virus through the blood to other parts of the body and fetal death if taken during pregnancy.

According to the guide, “The risks for serious vaccine side effects are greater for people who:

  • have heart problems or a history of heart problems
  • are taking steroid eye drops or ointment
  • have a weakened immune system
  • have skin problems such as eczema, atopic dermatitis, burns, impetigo, contact dermatitis, chickenpox, shingles, psoriasis, or uncontrolled acne
  • are less than 1 year old
  • are pregnant or become pregnant within 6 weeks after vaccination.”

ACAM2000’s package insert warns of a longer list of possible serious complications, including:

“Myocarditis and/or pericarditis, encephalitis, encephalomyelitis, encephalopathy, progressive vaccinia (vaccinia necrosum), generalized vaccinia, severe vaccinial skin infections, erythema multiforme major (including Stevens-Johnson syndrome), eczema vaccinatum, accidental eye infection (ocular vaccinia) which can cause ocular complications including keratitis and corneal scarring that may lead to blindness, and fetal death in pregnant women.”

The insert also goes into more detail about the risk of death:

“Historically, death following vaccination with live vaccinia virus is a rare event; approximately 1 death per million primary vaccinations and 1 death per 4 million revaccinations have occurred after vaccination with live vaccinia virus.

“Death is most often the result of sudden cardiac death, post-vaccinial encephalitis, progressive vaccinia, or eczema vaccinatum.

“Death has also been reported in unvaccinated contacts accidentally infected by individuals who have been vaccinated.”

U.S. stockpile contains more than 100 million doses

The FDA’s approval of ACAM2000 for use against mox followed just days after Emergent BioSolutions pledged to donate 50,000 doses to address the mpox outbreak in Africa.

On July 2, the U.S. Administration for Strategic Preparedness and Response at the HHS signed a $99.9 million deal with the drugmaker to obtain more ACAM2000 doses this year. Although the exact number of doses was not disclosed, Forbes on Sept. 8 reported that the U.S. currently has over 100 million doses.

HHS did not respond when The Defender asked if these doses are reserved for an emergency smallpox outbreak or are being made available as an mpox vaccine.

The Defender reached out to the Centers for Disease Prevention and Control (CDC) with the same question but was told by a CDC spokesperson, “We defer to the Administration for Strategic Preparedness and Response (ASPR) where the National Stockpile is housed.”

The CDC website on mpox vaccination states that ACAM2000 “has not been used in the ongoing clade II mpox outbreak that started in 2022″ but “has been made available for use against mpox in the clade II outbreak under an Expanded Access Investigational New Drug (EA-IND) protocol, which requires informed consent along with completing additional forms.”

When The Defender asked the CDC to clarify if the agency currently recommends ACAM2000 for mpox, an agency spokesperson said:

“It has not been used for U.S. civilians affected by the clade II global outbreak that began in 2022, and there are no plans to use it broadly during Mpox outbreaks.

“This is because JYNNEOS, the alternate to ACAM2000 in the United States, has fewer side effects.”

The Defender asked Emergent BioSolutions what it wants to tell members of the public who may be concerned about risks associated with ACAM2000 but did not receive a response by our deadline.

This article has been updated to clarify that both the FDA and CDC acknowledge that the myopericarditis risk for ACAM2000 is estimated at 5.7 per 1,000 primary vaccinations.

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.

September 18, 2024 Posted by | Aletho News | , | Leave a comment

Their vaccine injury reports disappeared from VAERS — So they developed a tool for anyone to track their own reports

By Brenda Baletti, Ph.D. | The Defender | September 11, 2024

A team of researchers is developing a tool to track reports in the Vaccine Adverse Event Reporting System (VAERS), so vaccine-injured people can follow what happens to the reports they submit.

As part of a broader effort to hold public health agencies accountable, the tool will also make it possible to audit the VAERS system by identifying what types of reports are deleted, insufficiently updated or contain errors.

The Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA), which jointly oversee VAERS, have refused to do this work despite multiple appeals by advocates for the vaccine-injured, according to React19, the group leading the initiative.

React19, founded by a small group of medical professionals injured by COVID-19 vaccines, works with institutions and providers to increase understanding and awareness of patients experiencing lasting effects following COVID-19 and/or COVID-19 vaccines.

The group is teaming up with computer programmer Liz Wilner, founder of OpenVAERS — a website that provides tools for more easily accessing and searching VAERS data — and Children’s Health Defense (CHD) to develop the tool.

The idea for developing the automatic VAERS report tracking tool came out of a VAERS audit the group conducted in 2022 to assess how the FDA and CDC were following up on COVID-19 vaccine injury reports.

React19 worked with outside experts to review a sample of 126 VAERS reports filed by some of its members who wanted to know what happened to their reports.

After tracking down each person’s reports and following them through the VAERS system, they “were kind of shocked at how bad it is,” members of React19 told The Defender.

They found that only 61% of the reports filed were correctly logged and published in VAERS. Twenty-two percent of the reports were never issued a permanent ID and are therefore not publicly visible, 12% were deleted and in 5% of the cases, a report couldn’t be filed or their report number remains unknown due to system errors.

That means more than 1 in 3 reports searched couldn’t be found in a database that is meant to be publicly accessible and transparent. It also suggests that problems of “omission of data and underreporting may be even greater than estimated,” according to the audit report.

The group also found that the medical status of the deleted reports, “by and large, had a worse outcome than the ones that were still in the system,” they said. For example, they said, in the public-facing VAERS system, 23% of reports were for permanent disabilities — but in the deleted reports, 53% were for permanent disability.

“One of the more alarming things we found out was that not all death reports are investigated,” Brianne Dressen, React19 founder, told The Defender.

The group brought this to the attention of public health officials in their meetings, sharing examples of reports that had been updated by people’s families when they died, but didn’t show up on the public system.

They also found that many follow-up reports containing updates on worsening symptoms were gone from the system.

At the time, the group was meeting regularly with top officials, including Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, to discuss vaccine injuries and why the agencies were doing nothing to address them.

In those meetings, according to Dressen and React19 member Dr. Joel Wallskog, when they raised the issue that the agencies weren’t following up on VAERS reports, the FDA told them VAERS wasn’t a reliable indicator for vaccine injuries, because anyone could file an injury complaint, including “Mickey Mouse or Michael Jackson.”

“We told them we know thousands of people that have not had any follow-up on their VAERS reports that are not Mickey Mouse, and they’re suffering it every single day waiting for you guys to get back to them to investigate what happened to them,” Dressen said.

“And of course then they never did anything. So we were like, OK, fine. If they’re not going to generate the evidence, then we will ourselves.”

The group submitted their findings to Marks during a meeting with him and his team. Based on their findings they also requested an external audit of the entire VAERS system and posed a series of questions listed on their audit report webpage.

They never heard from the agencies again.

“We were like, really?” Dressen said. “We were having these regular meetings with them every one month or every two months, and then after that, they wouldn’t meet with us anymore.”

Dressen, who was injured in the AstraZeneca clinical trials and whose diagnosis of post-vaccine neuropathy and other vaccine-related disorders was confirmed by the National Institutes of Health, said her own VAERS report is not visible to the public. The agencies haven’t told her why.

More recently, still hoping for accountability from the public health agencies, React19 submitted its audit and complaint to the Office of Inspector General at the U.S. Department of Health and Human Services.

The only response they received was an autoresponse confirming receipt of the complaint.

Attempt to ‘bring power back to the people’

In its small pilot audit, React19 found the VAERS system is “obviously broken from top to bottom.” According to Dressen, “One thing we can easily conclude is that the FDA and CDC have no interest in addressing these issues.”

Now, the group is scaling up the project to do a larger audit with more data.

With help from OpenVAERS and CHD, the team built a backend, automated administrative tracking system that eliminates the need to manually search for each report and its journey through VAERS — something the analysts had to do for the first iteration of their audit.

Participants will register on the React19 website and will be invited — if they are interested — to share their stories as part of the organization’s project to collect and publish vaccine injury testimonials.

Users can share any information they have about their VAERS report — their ID number if they have one, or if not, details about their case. Then they will receive a monthly email with the status of their report.

For example, someone who has a user ID and a public-facing report will be informed if their report disappears. In the case of those people who filed a VAERS complaint but never got an ID number, the system will search each month for the record and try to find the ID.

“We’ll be able to track these reports through the system and figure out what happens to them,” Wilner said. “Do they disappear? Do they appear and the person doesn’t get notified? Do they appear incorrectly?”

“So people will be able to track their own reports with less effort and React19 will be able to audit a much larger user base than they initially did.”

Wilner said auditing VAERS in this way also reveals details about how the agencies are “either lying or deliberately obfuscating the process.” In the first audit, it was clear there was no systematic or automated way that, for example, reports were deleted.

The tracker and the audit will provide valuable data that no one else has. Rather than having only the stories, Wilner said, they will have the data backing up those stories. “Now we have a group of injured people that are all talking with one voice.”

“Without more pressure and more discovery,” Wallskog said, “I don’t think we’re ever going to get the truth out. Ultimately, we want to get this information to the masses of people that just don’t know what’s happening, particularly with this data, and that we’ve all been duped.”

Dressen said the project is an attempt to “bring the power back to the people.”

The COVID-19 vaccine produced a large swath of vaccine injuries all at the same time, she said. Auditing the COVID-19 entries in VAERS will provide an opportunity “to show through massive numbers where those problems are, not just with the systems that are supposed to be monitoring vaccine safety, but also the actual harms themselves and what those are, but the government’s not doing their job on that.”

The two faces of VAERS and the problem of accountability

Wilner said Dressen’s injury report, sitting in VAERS limbo, spoke to one of the major issues around claims of transparency in the database — that there are two versions of VAERS, a public-facing database and a private one.

The BMJ reported last year that it investigated the VAERS database and found that the public facing database contains only initial reports. And “a private, back end system containing all updates and corrections — such as a formal diagnosis, recovery, or death.”

The CDC told The BMJ that this was part of patient confidentiality, but the publication found that in the FDA’s Adverse Event Reporting System, they do update the database — “raising the question of why VAERS can’t do the same.”

And during the React19 audit, the group found that VAERS was sometimes deleting people’s legitimate reports or the more detailed updated reports that some people were submitting.

Another problem, Wilner noted, is that a lot of key information — such as race, pregnancy and report provider — is unnecessarily withheld from public VAERS reports. She also said the agencies sometimes leave reports on there that are clearly false or jokes, which then discredits the database in the public’s eyes.

On the CDC website, Wilner said, “you’re basically looking at a doctored set of books.”

Wallskog said the agencies “try to live on both sides of the fence” with VAERS, presenting it as a key tool for monitoring vaccine injuries. But when it shows a safety signal or an issue with vaccines, they discredit it as a problematic surveillance system with a lot of limitations that can’t be trusted.

“It’s incredibly frustrating for injured people,” he said.

The team working on the new VAERS tracking system and audit said they hope it will raise public awareness and force the public health agencies to take responsibility for the vaccine injuries.

Rochelle Walensky said the CDC is charged with finding legitimate vaccine injuries and reporting them,” Wilner said. She added:

“If that’s the case, where is that? We don’t have access to the actual database to figure it out so we want to know where is the report from the CDC on the people that were actually injured by the COVID vaccine that the government accepts were legitimately injured? That report doesn’t exist.”

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.

September 11, 2024 Posted by | Aletho News | , , , , | Leave a comment

The Bird Flu Vaccine Clinical Trials

What the safety data tells us

Injecting Freedom by Aaron Siri | September 11, 2024

Bird flu is all the rage. As this issue heats up, here is a bit of information about each of the three bird flu (H5N1) vaccines licensed by the FDA.

First is Sanofi (National Stockpile), which was licensed for adults based on a clinical trial in which only 103 adults were vaccinated and 48 received the placebo. Worse, there were four serious adverse events in the vaccine group.

Next up is ID Biomedical, which was licensed for adults in a clinical trial in which the vaccine group had four times the rate of new immune-mediated diseases. The trial for ages 6 months to 17 years had only 838 children, making it underpowered and unable to adequately measure safety.

And last but not least is Seqirus, which was licensed for adults in a clinical trial in which 0.5% of the vaccinated group died but only 0.1% of the placebo group died. The trial for ages 6 months to 17 years had only 329 children, making it significantly underpowered and unable to adequately measure safety.

And that is a wrap. Needless to say, if you plan to get pricked, be informed!

September 11, 2024 Posted by | Science and Pseudo-Science | , | Leave a comment