ARE THE KIDS OK?
The video, created by VSRF, that Twitter does not want you to watch.
U.S. Lawyers Claim Ivermectin was never prohibited for treating COVID-19. FDA merely recommended not using it.
No legal prohibition authorized or justified hospitals to withhold the drug from dying patients. Let the lawsuits begin.
FDA tweet against using ivermectin. Not a prohibition, merely a recommendation.
By Dr. McCullough & John Leake · Courageous Discourse · November 22, 2022
The Epoch Times recently reported an astonishing statement by a U.S. government lawyer in a federal court in Texas, where the FDA is being sued by Dr. Paul Marik of Virginia, Dr. Mary Bowden of Texas, and Dr. Robert Apter of Arizona. The three plaintiffs claim the FDA illegally prohibited them from prescribing the drug to their patients. At a November 1 hearing, U.S. lawyer Isaac Belfer argued for the defendant:
The cited statements were not directives. They were not mandatory. They were recommendations. They said what parties should do. They said, for example, why you should not take ivermectin to treat COVID-19. They did not say you may not do it, you must not do it. They did not say it’s prohibited or it’s unlawful. They also did not say that doctors may not prescribe ivermectin.”
If Belfer’s assertion is true, it raises a very urgent question: On what legal grounds did hospitals all over the United States refuse to administer ivermectin to severely ill COVID-19 patients, even when patients and their family members begged for the drug to be administered?
If ivermectin was not prohibited by the FDA or any other U.S. medical authority for treating COVID-19, why did Dr. Paul Marik’s hospital prohibit him from administering the drug to his dying patients? Why was Dr. Mary Bowden reported to the Texas Medical Board for disciplinary action when she prescribed it? Why did many pharmacists fear losing their licenses if they filled ivermectin prescriptions for treating COVID-19?
In our book, The Courage to Face COVID-19: Preventing Hospitalization and Death While Battling the Bio-Pharmaceutical Complex, Dr. McCullough and I document numerous instances of hospitals flatly refusing to grant the wishes of dying patients and their family members for ivermectin.
All these patients asked for was to be allowed to try the drug (FDA-approved for River Blindness, Elephantiasis, and Scabies) for COVID-19. The patients and their kin gladly indemnified the hospitals and arranged to have their independent primary care doctors deliver and administer the drug. Nevertheless:
- Hospital administrators absolutely refused to grant this wish.
- Hospital attorneys fought tooth and nail against using ivermectin to treat COVID-19 patients, doing everything in their power to challenge patient lawsuits and appeal court orders to administer the drug.
- Even when hospital doctors acknowledged that the patients were dying, they insisted it was better to let the disease take its natural course rather than allow patients to try ivermectin.
- Even when patients’ families succeeded in getting a court orders to administer the drug, many hospitals still refused, even at the risk of being held in contempt of court.
Several readers have told us that our chapters covering this shameful scandal— Chapters 38: Begging for the Wonder Drug and Chapter 40: Graduating into Eternity—are horrifying beyond belief.
Now we hear U.S. government lawyers arguing in court that the FDA never prohibited using ivermectin to treat COVID-19 patients, but merely recommended not using it. This indicates that hospitals had no legal grounds for denying sick patients a drug that could have helped them. How is withholding medicine from a sick man any different from withholding a life ring from a man who has fallen overboard in high seas?
For families who watched their loved ones slip away after being denied the right to try ivermectin, U.S. attorney Isaac Belfer’s statement may be interpreted as declaring open season for lawsuits against hospital administrators and doctors.
US FDA Willfully Blind on the Safety of COVID-19 Vaccination
How Our Regulatory Agency Got Out of the Way from the Beginning
By Dr. Peter McCullough | Courageous Discourse | November 18, 2022
When the US HHS invoked the Emergency Use Authorization and the Department of Defense offered COVID-19 vaccination to be administered by the US FDA and CDC, it was clear the FDA was going to play no role in stopping the vaccination freight train that was about to steamroll America. A recent paper from Dr. Maryanne Demasi points out that the FDA “checked-out” early in the COVID-19 pandemic:[i] “Regulatory documents show that only nine out of 153 Pfizer trial sites were subject to FDA inspection before licensing the mRNA vaccine. Similarly, only 10 out of 99 Moderna trial sites and five of 73 remdesivir trial sites were inspected. Now, facing a backlog of site inspections, experts have criticized the FDA’s oversight of clinical trials, describing it as “grossly inadequate.” They say the problem, which predated covid-19, is not limited to a lack of inspections but also includes failing to notify the public or scientific journals when violations are identified—effectively keeping scientific misconduct from the medical establishment. The FDA is “endangering public health” by not being candid about violations that are uncovered during clinical trial site inspections, says David Gortler, a pharmacist and pharmacologist who worked as an FDA medical reviewer between 2007 and 2011 and was then appointed as a senior adviser to the FDA commissioner in 2019-21.”
Demasi goes on to point out the FDA suspended inspections and despite having vast resources, does not utilize their discretionary budget to protect Americans from product safety threats. “With a total budget of $6.1bn in 2021, he [Gortler] suggests the agency needs to be leaner and more efficient, with employees interested in improving public health.” “The bottom line is that the FDA has over 18,000 full time employees, more than any other drug regulatory agency by far, so it could have retrained and retooled anybody to tackle the need for increased inspections,” he says. “Half of its budget, about $3bn, is discretionary, which means it could have hired contractors, retirees, or repurpose existing workers. It chose not to. The FDA was just yawning its way through the pandemic. The entire agency is broken.” “The lack of full transparency and data sharing does not allow physicians and other medical scientists to confirm the data independently and make comprehensive risk-benefit assessments,” continues Gortler, who is now a fellow at the Ethics and Public Policy Center thinktank in Washington DC.”
The most egregious example of FDA malfeasance is the intent to withhold release of the Pfizer regulatory dossier on its COVID-19 vaccine for 55 years knowing it contained reports of 1,223 deaths shortly after administration of their vaccine. In a continued set of historic blunders, the FDA approved the COVID-19 bivalent vaccines with no randomized trials powered for clinical outcomes with Omicron, and no information on safety. I believe Drs Demasi and Gortler are correct, the FDA is broken beyond repair, officials and staff involved in malfeasance should be named as targets in federal investigations since so many lives have been impacted by their malfeasance.
[i] Demasi M. FDA oversight of clinical trials is “grossly inadequate,” say experts BMJ 2022; 379 doi: https://doi.org/10.1136/bmj.o2628 (Published 16 November 2022) Cite this as: BMJ 2022;379:o2628
Swissmedic and Vaccinating Doctors Criminally Sued for Authorizing and Administering Covid-19 mRNA Jabs
Do not underestimate the Swiss diligence
By Andreas Oehler | Live To Fight Another Day | November 14, 2022
The detail-oriented Swiss are taking their medical establishment to task in a big way for authorizing and administering the Covid-19 mRNA jabs, in a formal criminal complaint.
“That is what the criminal complaint against Swissmedic is about” (SRF, 2022.11.14):
That’s what it’s all about: On July 14, 2022, a lawyer submitted a 300-page criminal complaint to the responsible cantonal public prosecutor’s office on behalf of six people allegedly injured by mRNA vaccinations. It is directed against three representatives of the Swiss licensing and supervisory authority for medicinal products and medical devices (Swissmedic) and five vaccinating doctors from the Inselspital in Bern. A criminal investigation is to be opened against them. The lawyer has now gone public with a media conference.
These are the plaintiffs: The lawyer for those affected, Philipp Kruse, is a declared opponent of vaccination and Covid measures. He represented people who refused to wear masks or parents who didn’t want their children to take part in pool tests. Doctors who were noticed as corona skeptics also appeared at the media conference.
This is what the indictment says: The defendants are accused of violating basic drug law due diligence by allowing and administering the Covid 19 vaccination. There are a number of other charges listed, including intentional or possibly negligent bodily harm, endangering life, killing and abortion.
These are the alleged damages: According to lawyer Kruse, the damages range from circular hair loss, derailment of the menstrual cycle to polyarthritis, muscle weakness and chronic exhaustion to the death of a 20-year-old person. Some of the six victims listed are still unable to work. The connection to the Covid 19 vaccination was confirmed by experts in five cases. In the case of the deceased, the causal connection must be proven on the basis of pathological examinations. However, these investigations are not yet complete.
What Swissmedic says: Nothing. Swissmedic does not want to comment on the ongoing court proceedings. The Federal Office of Public Health and the Federal Vaccination Commission also do not want to comment.
What may fly under the radar in other countries, in terms of the lack of accountability and responsibility for Covid-19 jabbing injuries, is unlikely to pass muster in Switzerland. The Swiss pride themselves on being OBJECTIVE, diligent, thorough and just. Because of these very high public expectations, it is impossible to sweep under the carpet, gaslight, or outright ignore the laws on the books over there, let’s hope:
It is about these articles of the Medicines Act
Art. 3 Duty of care 1 Anyone who handles medicinal products must take all the necessary measures based on the current state of science and technology to ensure that the health of humans and animals is not endangered.
Chapter 8: Penal Provisions Art. 86233 Crimes and misdemeanors 1 Anyone who willfully: a. manufactures, places on the market, uses, prescribes medicinal products without the necessary authorization or authorization, contrary to the terms and conditions associated with an authorization or authorization or contrary to the due diligence obligations stipulated in Articles 3, 7, 21, 22, 26, 29 and 42, imports, exports or trades abroad; (…).
Link to the Medicines Act .
Also of note here is that Swissmedic is the key conduit of the global vaccination programmes in partnership with Bill&Melinda Gates Foundation and WHO, and also FDA.
Good luck in court!
Pfizer to fast-track more vaccines for pregnant moms, despite mounting evidence rushed COVID shots harmed babies
The Defender | November 9, 2022
On Nov. 1, Pfizer issued a press release about an investigational vaccine for pregnant women the company said will protect babies from respiratory syncytial virus (RSV).
Not coincidentally, RSV is the latest viral bugaboo to hit the headlines, with frantic news accounts of “overwhelmed” hospitals sounding eerily reminiscent of the early coronavirus fear-mongering.
Buoyed by the successful global marketing of its COVID-19 jabs — an estimated 49% of pregnant women worldwide reportedly views the vaccines favorably and almost 1 in 4 pregnant women in the U.S. took them — Pfizer is hoping to hit another home run with the RSV vaccine.
The vaccine maker said it intends to seek U.S. Food and Drug Administration (FDA) approval by the end of the year.
The FDA, meanwhile, has been busy handing out “Breakthrough Therapy” designations to Pfizer as if they were papal dispensations, signaling a regulatory willingness to speed up approval not only for Pfizer’s RSV vaccine but also for a maternal Group B Streptococcus (GBS) vaccine the company is developing.
To this expedient end, the FDA allowed Pfizer to “stop the [RSV] study short,” halting enrollment at about 7,400 participants — though the trial was supposed to involve 10,000 pregnant women.
Researchers devoted to vaccine orthodoxy pay lip service to the need for an extra-high evidentiary bar for pregnancy vaccines — stating that such vaccines should not only prove they reduce illness, with minimal reactogenicity in the woman, the fetus and the neonate, but should also “demonstrate safety or lack of evidence of harm.”
However, those turn out to be empty words.
In fact, the influenza and Tdap (tetanus-diphtheria-acellular pertussis) vaccines that public health agencies have long recommended for pregnant women never underwent any clinical trial safety testing in that population, and the FDA never licensed those vaccines specifically for pregnant women.
Moreover, flu shots and Tdap shots have never even resulted in any statistically significant reduction in the outcomes they are supposed to address.
With the advent of Emergency Use Authorization COVID-19 vaccines, the FDA, Pfizer and other manufacturers barely made any pretense of assessing maternal safety, and likely “colluded together to conceal damaging data” about high rates of fetal death.
Other researchers, however — and even vaccine insiders — began to speak out in 2021.
For example, Canadian researchers writing in late 2021 worried that many of the systemic reactions commonly reported after COVID-19 vaccination might be “sufficient to affect fetal/neonatal development.”
Those authors included vaccinologist Byram Bridle, Ph.D., who earlier in 2021 characterized the COVID-19 vaccines’ disturbing biodistribution and accumulation in vital organs as “a big mistake,” and neurology professor Dr. Steven Pelech, who expressed repeated concerns about myocarditis and the vaccines’ risks to young people.
Now, as horrified pregnant women who took the COVID-19 jabs experience skyrocketing miscarriages, stillbirths and fetal malformations, they are wondering why regulators issued no warnings.
But as Pfizer’s exuberant RSV press release and the FDA’s complacent endorsement of clinical trial shortcuts suggest, vaccine makers and regulators not only intend to ignore or bulldoze even the most outsized safety signals but are clearly positioning themselves to go after pregnant women in an even bigger way.
‘Quibbles’ and questions
The details provided — or omitted — about Pfizer’s RSV clinical trial exemplify manufacturers’ and regulators’ cavalier approach toward pregnant women.
Commenting on Pfizer’s announcement, family physician Dr. Buzz Hollander — who clarified that he is predisposed to celebrate the new RSV vaccine offering — nonetheless noted a number of serious criticisms:
- Pfizer released “just a press release” but no data, making it “impossible to pick [the vaccine’s declared efficacy] apart.”
- Pfizer offered no explanation as to how it defined “severe” disease, its primary endpoint.
- A year into the trial, Pfizer fishily altered an important endpoint, defying a fundamental clinical trial design principle that “involves setting out in advance the endpoints that will be assessed.”
- In Hollander’s words, Pfizer “switched their secondary (critical!) endpoint of RSV hospitalizations to 360 days from 180 days… and then inspired my suspicion by not reporting any hospitalization data, interim or otherwise, in their breathless press release.”
- Researchers have published only one small safety study for the RSV shot, about which Hollander said: “I quibble with studies finding >40% of placebo participants reporting systemic symptoms; when queried enticingly enough, half of us might recall a headache or some fatigue the day after our placebo shot, and that can bury a difference in real adverse reactions compared to the vaccine group.”
- Curtailing study enrollment was unwise, Hollander said, because “bigger is better when it comes to … finding safety signals.”
- Earlier this year, GlaxoSmithKline (GSK) “stopped cold” a three-times-bigger trial of a similar RSV vaccine for pregnant women after detecting a safety signal, yet there has been no discussion as to why Pfizer’s maternal RSV vaccine is “fine” while GSK’s was deemed “untouchable.”
Hollander’s modest conclusion: “We should have all learned by now that even the appearance of cutting corners in the vaccine approval process will carry its own unknown costs.”
Readers reacting to Hollander’s post were less circumspect. One acerbically remarked, “The problem here is Pfizer. They’ve paid billions in fines for shady practices and data manipulation. And that was before the Covid vaccines (for which they’re indemnified).”
Another reader expressed his reservations even more succinctly: “Trust Pfizer numbers? You must be joking.”
Adverse pregnancy outcomes after COVID vaccination — no joke
As Pfizer, with the FDA’s help, tees itself up to “dominat[e] the maternal RSV vaccine market,” OB-GYNs on the front lines of maternal care are stepping forth to sound the alarm about the COVID-19 shots’ infanticidal fallout.
Dr. Kimberly Biss recently tweeted, “Since the vaccine rollout started, we have seen in our practice a decrease in new OB numbers, which would be infertility, by about 50%; we’ve also seen an increase in miscarriage rate by about 50%, and … probably about a 25% increase in abnormal pap smears as well as cervical malignancies.”
Similarly, Dr. James Thorp, in multiple interviews, described an “off-the-charts” rise in sudden fetal death and other adverse outcomes, including fetal malformation and fetal cardiac arrest.
Asked to comment on information recently leaked from a California hospital, Thorp characterized the uptick in fetal deaths — from under 6 per 1,000 in 2020 to more than 29 per 1,000 following the rollout of COVID-19 injections — as being “way way beyond” what the Centers for Disease Control and Prevention ordinarily would consider a safety signal.
Thorp published a preprint in September (along with co-authors who include Children’s Health Defense’s Megan Redshaw) describing “significantly more frequent” pregnancy-related adverse events reported to the Vaccine Adverse Event Reporting System, or VAERS, after COVID-19 shots than in the aftermath of flu shots — which themselves are far from benign.
Cataloging significant increases in “miscarriage, fetal chromosomal abnormalities, fetal malformation, fetal cystic hygroma, fetal cardiac disorders, fetal arrhythmia, fetal cardiac arrest, fetal vascular mal-perfusion, fetal growth abnormalities, fetal abnormal surveillance, fetal placental thrombosis, low amniotic fluid, and fetal death/stillbirth” and also menstrual abnormalities, Thorp and co-authors called for a “worldwide moratorium on the use of COVID-19 vaccines in pregnancy.”
For children who survive, Thorp suggested they may suffer from lifelong “vaccine-induced acquired immune deficiency syndrome.”
In Scotland, meanwhile, the government ordered an investigation into the “spike in newborn baby deaths” in 2021 and 2022, an increase “larger than expected from chance alone.”
Even in a gerrymandered study clearly designed to exonerate the COVID-19 shots during pregnancy — focusing on immediate reactions after a first or second dose and hampered by “limited perinatal outcome assessment” — researchers found that 4.4-7.5% of pregnant women reported obstetrical symptoms.
Careless and worse
As Substack writer Etana Hecht wrote last May, “The topic of pregnant and nursing moms getting vaccinated under encouragement and coercion is painful,” particularly once one becomes aware of “how carelessly the most precious among us are being treated.”
That carelessness is evident as we witness some of the same players involved in the COVID-19 vaccine fiasco now circling back around to help build the case for Pfizer’s RSV vaccine.
That includes figures such as Dr. Robert Frenck, the Pfizer-beholden principal investigator of the Cincinnati Children’s Hospital clinical trial that tested the company’s COVID-19 shot in children. Frenck reported 12-year-old Maddie de Garay’s serious vaccine injuries to the FDA as a mere “stomachache.”
Graphs clearly show that none of the vaccines pushed on pregnant women are safe for babies or moms — but given that from one-fourth to one-half of pregnant women acquiesce to getting them, those who know the truth need to work even harder to get the word out.
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.
No balanced coverage of covid vaccines in legacy media, says Peter Doshi
By Maryanne Demasi, PhD | October 16, 2022
Peter Doshi, associate professor at the University of Maryland School of Pharmacy and senior editor at The BMJ, has spoken out about how the mainstream media has ignored important data on covid-19 vaccines.
In a recent interview with German TV, Doshi said, “Our legacy media has not done a good job in providing balanced coverage about the vaccines.”
He said there has been “a lot of nervousness” about how to communicate vaccine harms to people and is concerned that “we’re not getting the information we need to make better choices and to have a more informed understanding of risk and benefit.”
Doshi’s concerns extended to the over-confidence of public health authorities engaged in promoting the covid-19 vaccines.
“It was very unfortunate, that from the beginning, what was presented to us by public health officials was a picture of great certainty… but the reality was that there were extremely important unknowns,” said Doshi who has written and spoken about these unknowns, highlighting that even public health officials were aware of these limitations.
“We entered a situation where essentially the stakes became too high to later present that uncertainty to people.” He added, “I think that’s what set us off on the wrong foot. Public officials should have been a lot more forthright about the gaps in our knowledge.”
Doshi was part of an international group of eminent academic researchers and physicians who went back and re-analysed the safety data from the original randomised clinical trials that underpinned the FDA’s decision to authorise the mRNA vaccines in December 2020.
I reported on the pre-print study, but since then, it has been published in the peer-reviewed journal, Vaccine.
The authors focused on serious adverse events that occurred in the Moderna and Pfizer vaccine trials, events the sponsors classified as “serious” generally because they resulted in hospitalisation.
In short, their analysis showed that mRNA vaccines were associated with 1 additional serious adverse event for every 800 people vaccinated, which Doshi said is “much more common” than what we’ve traditionally observed for other vaccines where the adverse event rate is in the range of 1 to 2 per million vaccinees.
“Just to put that in some perspective, a rate like that in past years has had vaccines taken off the market. In 1976, we saw Guillain Barre Syndrome after influenza vaccines that were then withdrawn.”
The authors of the study also found the trial data showed that the increase in serious adverse events following mRNA vaccination surpassed the reduction in risk of ending up hospitalised with covid-19.
Despite public assurances that covid-19 vaccines would save lives and protect the community by preventing transmission, Doshi knew from the outset that it was never properly tested. In Oct 2020, Doshi published an article in The BMJ:
Hospital admissions and deaths from covid-19 are simply too uncommon in the population being studied for an effective vaccine to demonstrate statistically significant differences in a trial of 30 000 people. The same is true of its ability to save lives or prevent transmission: the trials are not designed to find out [emphasis added]
It was, therefore, unsurprising to Doshi that the vaccines failed to stop the spread.
“One of the big reasons is that it’s an intramuscular vaccine, and this doesn’t produce mucosal immunity. Infections of covid, influenza and other acute respiratory infections, start in the mucosal membranes, a place where these vaccines are not particularly good, historically, at producing immunity antibodies” said Doshi.
Doshi and his colleagues have called on public health authorities and drug manufacturers to release the raw data so that we can better understand who is most at risk of a serious adverse event.
“There’s no reason to think that these risks are going away and if it’s in the low-risk population, that’s very bad news, because low-risk people have much less to potentially gain from covid vaccines, so the side effect profile in such people has to be extremely low,” said Doshi, pointing out that Denmark now recommends against routine covid-19 vaccination for people under 50.
The FDA and the vaccine manufacturers have the raw ‘patient level’ data, but they have not released it and we’re now almost 2 years into the roll out of the product.
“They should immediately be warning people about this safety signal that we found, and they should immediately be replicating our analysis — the data are indicating there’s increased risk at a level that is much higher than has previously been realised,” said Doshi.
Throughout the pandemic, we’ve been told to “trust the science” but Doshi says, “How can one recommend responsibly that these products are based on science if the data are not available? Science is about sharing data. We’re in an era of open science, not secret science.”
Doshi and colleagues have penned an open letter to the CEOs of the vaccine companies asking for the raw data, but as yet, they have not received a reply.
See the full interview on mdr.de
Latest COVID Shots Sold as Genetic Software Update
By Dr. Joseph Mercola | September 20, 2022
Just when you thought the U.S. Food and Drug Administration couldn’t possibly get any worse, they prove you wrong. Here are two recent COVID booster campaign messages tweeted out by the FDA:
“It’s time to install that update! #UpdateYourAntibodies with a new #COVID19 booster.”1 “Don’t be shocked! You can now #RechargeYourImmunity with an updated #COVID19 booster.”2
FDA Now Pushes Transhumanist Pipe-Dream
That’s right. The FDA now wants you to believe that your immune system is something that needs to be “recharged,” as if it were a battery, or “updated” with mRNA injections like a piece of software.
This is transhumanist lingo that has no bearing on real-world biology or physiology, and proves beyond doubt that the FDA is fully onboard with the transhumanist ideas of technocracy pushed by the globalist cabal. The human body is basically viewed as nothing more than a biological platform equipped with genetic software that can be altered and updated at will.
The problem, of course, is that your body doesn’t work that way. You cannot turn your body into a “bioreactor”3 or an internal “vaccine-production facility”4 and expect it to work as intended. The massive increase in disability and sudden death among COVID jab recipients is a testament to the fact that allowing Big Pharma to play God is a bad idea.
Transhumanism as a whole is a pipe-dream, as it fails to take into account just about everything that actually makes us human, including the nonlocality of consciousness, which they irrationally believe can be uploaded to a cloud-based system and merged with AI, or downloaded into an artificial body construct, such as a synthetic body.
False Advertising
The Federal Trade Commission is responsible for addressing fraudulent advertising. According to law, an ad must be “truthful, not misleading, and, when appropriate, backed by scientific evidence.”5 The FDA itself also requires drug ads to be “truthful, balanced and accurately communicated.”6
“Balanced” refers to promotional materials that include efficacy and benefit claims, which must include a balance between benefit information and information about risks. In my view, the FDA’s most recent COVID booster ads are clear examples of false advertising, because:
- They’re not truthful and accurate, as there’s no basis for the claim that your antibodies need to be updated with a drug, or the claim that immunity must be recharged at regular intervals
- They’re not backed by scientific evidence, as the FDA is a) ignoring massive evidence of harm from the original shots, and b) the bivalent boosters are being released based on data from a few mice alone. The FDA is advertising the boosters for the prevention of disease, even though it has zero data to prove it prevents anything
- They’re not balanced, as the FDA fails to warn people about any of the many side effects reported to the Vaccine Adverse Event Reporting System (VAERS)7
Was No-Test Drug Approval the Plan All Along?
While I cannot prove it, I suspect Operation Warp Speed (OWS) — devised in the spring of 2020 by a dozen top officials from then-President Trump’s health and defense departments to expedite the development of a COVID-19 vaccine8 — may have been intended to normalize the approval of drugs without proper testing.
Even if the normalization of expedited drug approval wasn’t originally intended, it certainly has been used and abused to that aim since. In June 2022, the FDA quietly implemented a “Future Framework” scheme9 to speed up the delivery of COVID boosters. This is what allows for the authorization of reformulated COVID shots without human trials.10,11,12
The FDA basically rewrote the rules on the fly, deciding that mRNA gene therapies are equivalent to conventional influenza vaccines and can be updated and released without testing.
The idea here is that the safety of the mRNA COVID shots has already been proven by the original shots, which they claim have harmed or killed no one. Hence, safety is a given, and the effectiveness of reformulated boosters can be assessed simply by checking the antibody levels in a few mice, which is what Pfizer and Moderna did.
In reality, however, millions of people around the world have been harmed and killed by the original shots, the human trials for those shots were riddled with fraud, antibody levels tell us nothing about the jab’s ability to protect against infection, and the two technologies (conventional flu vaccines and mRNA gene therapy) have no common ground.
I have no doubt this “Future Framework” will also, over time, be widened to include other vaccines and drugs that drug makers may want to tinker with. It may even lower standards for drug trials in general, which historically have required at least 10 years of multiphase testing.13 The dangers of this trend really cannot be overstated.
Analysis of US Booster Policy
In a September 12, 2022, article, Kaiser Health News raised several questions about the FDA’s authorization of the new bivalent COVID boosters:14
“… in the real world, are the omicron-specific vaccines significantly more protective — and in what ways — than the original COVID vaccines so many have already taken? If so, who would benefit most from the new shots? Since the federal government is purchasing these new vaccines … is the $3.2 billion price tag worth the unclear benefit? …
The FDA could have requested more clinical vaccine effectiveness data from Pfizer and Moderna before authorizing their updated omicron BA.5 boosters. Yet the FDA cannot weigh in on important follow-up questions: How much more effective are the updated boosters than vaccines already on the market? In which populations?
And what increase in effectiveness is enough to merit an increase in price (a so-called cost-benefit analysis)? Other countries, such as the United Kingdom, perform such an analysis before allowing new medicines onto the market, to negotiate a fair national price …
As population immunity builds up through vaccination and infection, it’s unclear whether additional vaccine boosters, updated or not, would benefit all ages equally … The CDC’s Advisory Committee on Immunization Practices considered limiting the updated boosters to people 50 and up, but eventually decided that doing so would be too complicated.”
Shocking Jab Study Decimates Safety Claims
In related news, a shocking risk-benefit analysis15 looking at the impact of booster mandates for university students concluded that:
- Between 22,000 and 30,000 previously uninfected adults (aged 18 to 29) must be boosted with an mRNA vaccine to prevent one COVID-19 hospitalization
- For each hospitalization prevented, the jab will cause 18 to 98 serious adverse events, including 1.7 to 3 “booster-associated myocarditis cases in males, and 1,373 to 3,234 cases of grade ≥3 reactogenicity which interferes with daily activities”
That means mandating a third COVID shot for university students will result in “a net expected harm.” The authors also stress that “Given the high prevalence of post-infection immunity, this risk-benefit profile is even less favorable.” The authors go on to state that “University booster mandates are unethical because:”16
“1) no formal risk-benefit assessment exists for this age group;
2) vaccine mandates may result in a net expected harm to individual young people;
3) mandates are not proportionate: expected harms are not outweighed by public health benefits given the modest and transient effectiveness of vaccines against transmission;
4) U.S. mandates violate the reciprocity principle because rare serious vaccine-related harms will not be reliably compensated due to gaps in current vaccine injury schemes; and
5) mandates create wider social harms. We consider counter-arguments such as a desire for socialization and safety and show that such arguments lack scientific and/or ethical support.”
Government Study Reveals COVID Jab Problems
A small observational study17,18 led by neurology researchers at the National Institutes of Health also brings bad news, as they found “a variety of neuropathic symptoms” occurring within three to four weeks of COVID injection:
“We studied 23 patients (92% female; median age 40 years) reporting new neuropathic symptoms beginning within 1 month after SARS-CoV-2 vaccination. 100% reported sensory symptoms comprising severe face and/or limb paresthesias, and 61% had orthostasis, heat intolerance and palpitations …
Biopsies from randomly selected five patients that were evaluated for immune complexes showed deposition of complement C4d in endothelial cells. Electrodiagnostic test results were normal in 94% (16/17). Together, 52% (12/23) of patients had objective evidence of small-fiber peripheral neuropathy …
This observational study suggests that a variety of neuropathic symptoms may manifest after SARS-CoV-2 vaccinations and in some patients might be an immune-mediated process.”
FDA Refuses to Release Key COVID Jab Safety Analyses
In July 2022, The Epoch Times asked the FDA to release “all analyses performed by the agency for the COVID-19 vaccines using … Empirical Bayesian data mining, which involves comparing the adverse events recorded after a specific COVID-19 vaccine with those recorded after vaccination with non-COVID-19 vaccines.”19
The FDA has so far refused, claiming the data is tied to “internal discussions protected by law.” September 10, 2022, The Epoch Times reported:20
“According to operating procedures laid out by the agency and its partner in January 202121 and February 2022,22 the FDA would perform data mining ‘at least biweekly’ to identify adverse events ‘reported more frequently than expected following vaccination with COVID-19 vaccines.’ The agency would perform the mining on data from the Vaccine Adverse Event Reporting System (VAERS).
In a recent response, the FDA records office told The Epoch Times that it would not provide any of the analyses, even in redacted form. The agency cited an exemption to the Freedom of Information Act that lets the government withhold inter-agency and intra-agency memorandums and letters ‘that would not be available by law to a party other than an agency in litigation with the agency.’
The agency also pointed to the Code of Federal Regulations, which says that ‘all communications within the Executive Branch of the Federal government which are in written form or which are subsequently reduced to writing may be withheld from public disclosure except that factual information which is reasonably segregable in accordance with the rule established in § 20.22 is available for public disclosure.’
It’s not clear why the FDA could not produce copies of the analyses with non-factual information redacted. The Epoch Times has appealed the determination by the records office.”
CDC Also Refuses to Release Its Safety Analyses
According to the VAERS standard operating procedures cited above, the Centers for Disease Control and Prevention is also required to perform data mining analyses, using Proportional Reporting Ratio (PRR) data mining. PRR23 measures how common an adverse event is for a specific drug compared to all the other drugs in the database.
When The Epoch Times asked the CDC to release its results, it too refused. According to The Epoch Times, the CDC “has also twice provided false information when responding to questions”:24
“The agency initially said that no PRR analyses were done and that data mining is ‘outside of th[e] agency’s purview.’ The agency then said that it did perform PRRs, starting in February 2021. Later, the agency acknowledged that wasn’t true.
The agency did not begin performing PRRs until March 2022, a spokesperson told The Epoch Times. Roger Andoh, a records officer, gave the initial response, citing the CDC’s Immunization and Safety Office. Dr. John Su, a CDC official, gave the second response.
It remains unclear with whom the information originated. The Epoch Times has submitted Freedom of Information Act requests for internal emails that may provide answers.”
So far, the FDA has insisted the data show no evidence of serious adverse effects from the COVID jab. The only possible signal they’d found through April 16, 2021, was for raised body temperature. In the article, The Epoch Times cites several papers in which the FDA and/or CDC claim their data mining efforts have come up empty handed.
But if that’s true, why the reluctance to release the data? Don’t they want us to be reassured that these shots are as safe as they claim them to be? Why sit on exculpatory evidence? Unless, of course, the data proves the FDA and CDC have been lying all along.
Senators Calling for Special Grand Jury
In other related news, naturopath Henry Ealy and two Oregon state senators, Kim Thatcher and Dennis Linthicum, have been trying since March 2022 to compel the impaneling of a special grand jury to investigate decisions by federal officials that “significantly compromise[d] the accuracy and integrity of COVID-related data.”25
According to the March 7, 2022, petition,26,27 filed in Portland, Oregon, the 30 defendants manipulated statistics to create “a significant hyperinflation of COVID-19 case, hospitalization and death counts,” which in turn resulted in $3.5 trillion in fraudulent taxpayer expenditures.
Defendants specifically named28 are former CDC director Robert Redfield and current CDC director Rochelle Walensky, former Health and Human Services (HHS) secretary Alex Azar, HHS director Xavier Becerra, and National Center for Health Statistics director Brian Moyer.
As explained by Ealy in the video update above, the defendants were given 60 days to reply to the March 7 petition. As it happened, the U.S. Attorney for Oregon, Scott Asphaug, was assigned by the Department of Justice (DOJ) to be the defending attorney — an interesting choice, considering Ealy, Thatcher and Linthicum had in 2021 asked Asphaug to investigate the listed defendants, which he refused to do.
Asphaug immediately filed for an extension, which gave them another 60 days. The defendants now had until August 26, 2022, to respond. Suddenly, July 13, the DOJ reassigned Asphaug to Nairobi, Kenya. Asphaug resigned from his post as U.S. attorney, effective July 17, at which point U.S. Attorneys Natalie Wight and Dianne Schweiner took over the CDC’s defense.
When the defendants missed the August 26 deadline, Ealy, Thatcher and Linthicum filed for default judgment.29 Two days later, August 29, Wight and Schweiner opposed default judgment.30
Schweiner’s excuse for missing the deadline was that she’d been busy caring for her acutely sick dog. As noted by Linthicum in his newsletter,31 “no self-respecting sci-fi editor would allow something this outlandish past his desk when trying to make a story about integrity and transparency sound believable.”
Ealy is now convinced the CDC is feeling the heat, and urges Americans to sign Stand for Health Freedom’s petition to convene a special grand jury to investigate the CDC’s conduct during COVID-19.
The more signatures there are on this petition, the stronger the argument that the court must order a grand jury investigation, as it demonstrates that this investigation is important to the American public, and isn’t just some pet grievance by Ealy, Thatcher and Linthicum.
As noted by Ealy, the CDC has committed criminal data fraud. There are laws prohibiting data manipulation by federal agencies, and laws meant to prevent it from happening in the first place.
The CDC violated those laws, not just once, but repeatedly, and those in charge must be held accountable. We cannot have a public health agency flouting data laws in order to justify harming the public. So, please, add your name to the grand jury petition.
Sources and References
- 1 Twitter FDA September 7, 2022
- 2 Twitter FDA September 9, 2022
- 3 MIT Technology Review February 5, 2021
- 4 Nature Biotechnology 2022; 40: 840-854
- 5 FTC Truth in Advertising
- 6 Compliance Online Drug Ads
- 7 OpenVAERS
- 8 Politico January 17, 2021
- 9 FDA Briefing Document June 28, 2022
- 10 The Defender June 27, 2022
- 11 The Epoch Times June 28, 2022 (Archived)
- 12 New York Times June 27, 2022 (Archived)
- 13 Phrma.org Biopharmaceutical research and Development
- 14 KHN September 22, 2022
- 15, 16 SSRN September 12, 2022
- 17 medRxiv May 17, 2022
- 18 Trial Site News September 1, 2022
- 19, 20, 24 Epoch Times September 10, 2022
- 21 VAERS Standard Operating Procedures January 2021
- 22 VAERS Standard Operating Procedures February 2022
- 23 All About Pharmacovigilance PRR
- 25, 26, 28 Petition to impanel special grand jury March 7, 2022
- 27 Stand For Health Freedom
- 29 Application for entry of default August 27, 2022
- 30 Opposition to entry of default August 29, 2022
- 31 Dennis Linthicum Newsletter
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From the Archives
Chris Matthews got it: Neocons want to destroy the Middle East for Israel
By Jonas E. Alexis | Veterans Today | August 4, 2107
Chris Matthews attacked the Neocon project in 2015 by saying that the Neocons and warmongers in the United States aspire to create complete chaos in the Middle East, presumably for Israel. His words are worth quoting in full:
“Why were the people in the administration like [Paul] Wolfowitz and the others talking about going into Iraq from the very beginning, when they got into the white house long before there was a 911 long before there was WMD. It seemed like there was a deeper reason. I don’t get it. It seemed like WMD was a cover story.
“The reason I go back to that is there’s a consistent pattern: the people who wanted that war in the worst ways, neocons so called, Wolfowitz, certainly Cheney.. it’s the same crowd of people that want us to overthrow Bashar Assad, .. it’s the same group of people that don’t want to negotiate at all with the Iranians, don’t want any kind of rapprochement with the Iranians, they want to fight that war. They’re willing to go in there and bomb.
“They have a consistent impulsive desire to make war on Arab and Islamic states in a never-ending campaign, almost like an Orwellian campaign they will never outlive, that’s why I have a problem with that thinking. … we’ve got to get to the bottom of it. Why did they take us to Iraq, because that’s the same reason they want to take us into Damascus and why they want to have permanent war with Iran.”
Yours truly and many others have been saying the same thing for years. We would not have perpetual wars in the Middle East if the Neocons did not take their orders from Israel. Even George W. Bush implicitly admitted this.
George W. Bush once asked his father to define Neoconservatism. “‘What’s a neocon?’ ‘Do you want names, or a description?’ answered [the elder Bush]. ‘Description.’ ‘Well,’ said the former president of the United States, ‘I’ll give it to you in one word: Israel.’”[1] … continue
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