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Federal Court Rules Against FDA Over Anti-Ivermectin PostsBy Zachary Stieber
The U.S. Food and Drug Administration (FDA) likely overstepped its authority when it told Americans to “stop” using ivermectin against COVID-19, a federal court ruled on Sept. 1.
“FDA can inform, but it has identified no authority allowing it to recommend consumers ‘stop’ taking medicine,” U.S. Circuit Judge Don Willett wrote in the ruling.
The FDA has authority under the Federal Food, Drug, and Cosmetic Act to convey information to consumers. The FDA during the COVID-19 pandemic has issued multiple statements discouraging people from taking ivermectin against COVID-19.
Accompanied by a picture of a horse and a link to an FDA webpage on ivermectin, the agency wrote in one social media post: “You are not a horse. You are not a cow. Seriously, y’all. Stop it.”
The page it linked to is titled, “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19.”
Three doctors sued the FDA over its statements on ivermectin, arguing the agency cannot advise doctors on which drugs to prescribe.
Ivermectin is approved by the agency as an antiparasitic drug for both humans and animals. Federal law gives the government immunity against legal actions, with some exceptions. One exception, known as ultra vires, is when an official acts outside their authority. Plaintiffs challenging the acts must show that the official was “acting ‘without any authority whatever,’ or without any ‘colorable basis for the exercise of authority,'” according to an earlier court ruling.
The FDA does have the authority to share data and facts, the parties agree. But they diverge on whether the FDA can issue recommendations on medical matters, such as treatments.
The FDA has claimed that the posts do not contain advice, stating in one brief that they were “informational statements” that “do not ‘direct’ consumers, or anyone else, to do or refrain from doing anything.” At the same time, the FDA acknowledged that the statements “provided recommendations” and “advise[d] consumers.”
“Despite these concessions, FDA never points to any authority that allows it to issue recommendations or give medical advice,” Judge Willett wrote.
“Rather, FDA argues that some posts included a hyperlink that leads to the update. The update, in turn, directs consumers to “[t]alk to your health care provider.” But not all of the social-media posts included such a link. And even for those posts that did include a link, the posts themselves offer advice, not mere information.”
The update itself is problematic because of its title, “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19,” the judge said. Even though it later says that people can take ivermectin if prescribed by a health care provider, “the trailing qualifier does not lessen the opening instruction’s imperative character,” he said. Exposing the FDA’s Orwellian Lie About Ivermectin | CLIP | Facts MatterU.S. District Judge Jeffrey Brown ruled against the doctors in 2022, finding that doctors had not proven an exception to sovereign immunity and that there was no indication the FDA acted outside of the authority conferred by the Federal Food, Drug, and Cosmetic Act. Judge Brown erred on the second point as well, according to the new ruling. “Nothing in the Act’s plain text authorizes FDA to issue medical advice or recommendations,” Judge Willett said. The judge, who sits on the U.S. Court of Appeals for the Fifth Circuit, was joined by U.S. Circuit Judges Edith Brown Clement and Jennifer Walker Elrod.
Judges Willett and Brown were appointed under President Donald Trump. Judges Clement and Elrod were appointed under President George W. Bush.
The appeals court panel remanded the case back to Judge Brown to decide on whether the doctors have standing. The ruling followed oral arguments before the panel.
Dr. Robert Apter, one of the plaintiffs, called the ruling “a big win for doctors and for patients!” “This case has broad implications for protecting the practice of medicine from unlawful interference by the FDA,” added Jared Kelson, a lawyer at Boyden Gray who is representing the plaintiffs. “It’s about ensuring that federal agencies act only within their statutory authority. The FDA crossed a bright line here.” The U.S. government has not yet reacted to the ruling.
Zachary Stieber Zachary Stieber is a senior reporter for The Epoch Times based in Maryland. He covers U.S. and world news. |
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Doctor: Pharmacists Continuing to Refuse Ivermectin Prescriptions, Raising Ethical ConcernsCOVID Treatments & Remedies
The continued refusal of pharmacists nationwide to fill prescriptions for controversial COVID medications has raised questions over medical autonomy and who ultimately has control over patient care, according to a prominent doctor.
Dr. Mary Talley Bowden, a practitioner and founder of Coalition of Health Freedom, told The Epoch Times that many pharmacists nationwide are still refusing to fill prescriptions issued for ivermectin issued to patients for the treatment of COVID, despite statements from the Food and Drug Administration (FDA) affirming that right to doctors.
“This needs to come to an end. In telling my patients what medicines they can and cannot have access to, we effectively have a large group of pharmacists practicing medicine without a license,” said Dr. Bowden. “They have no accountability for this yet they are allowed to dictate patient care.”
“I see it every single day. Enough is enough,” Dr. Bowden added. Ivermectin has been around for decades but became the center of controversy in 2020 after medical opinion became divided over its effectiveness as a treatment for COVID. In the aftermath, many pharmacists refused to fill prescriptions for the medication.
By 2023, the issue had made its way into a courtroom when on Aug. 8 a lawyer representing the FDA confirmed that doctors were free to prescribe ivermectin to treat COVID.
“FDA explicitly recognizes that doctors do have the authority to prescribe ivermectin to treat COVID,” Ashley Cheung Honold, a Department of Justice lawyer representing the FDA, told the U.S. Court of Appeals for the 5th Circuit.
The government lawyer made the statement in defense of the FDA’s repeated calls for people to not take ivermectin for COVID. The FDA on Aug. 21, 2021, wrote on X, formerly known as Twitter: “You are not a horse. You are not a cow. Seriously, y’all. Stop it.”
On Aug. 17, the FDA issued clarification, this time stating that while it had approved ivermectin for certain uses in humans and animals, it had not issued any statement affirming the safety or effectiveness of the drug for treating COVID. However, the agency again affirmed that it would be left to individual doctors whether or not to prescribe the medication for the treatment of COVID.
“Health care professionals generally may choose to prescribe an approved human drug for an unapproved use when they judge that the unapproved use is medically appropriate for an individual patient,” the FDA said.
The National Institutes of Health COVID-19 treatment guidelines recommend against using ivermectin for COVID treatment, citing a purported lack of evidence supporting its effectiveness. Other studies have found ivermectin to be effective.
Dr. Bowden, who is one of three plaintiffs in the case, had hoped the FDA’s acknowledgment would have put an end to the objections at the pharmacist counter. However, earlier this week another one of her patients who she had been treating was refused service. Complicating the situation, the patient was elderly and couldn’t easily access other options and in the time it took to find a pharmacy that would honor the prescription the patient’s health began to deteriorate, according to Dr. Bowden.
“It’s hard to believe, but pharmacists are still blocking these potentially life-saving medications,” said Dr. Bowden. “The pharmacist didn’t talk to the patient and won’t know if the patient lives or dies yet had control of his care.”
Dr. Bowden believes that in most cases individual pharmacists aren’t the ones to blame, and are often carrying out orders from corporate leadership. However, claims to have seen examples where pharmacists prevented her patients from getting their medication as a result of their own “personal agenda.”
“It’s an outrage. I would have thought we were beyond this but it continues to happen,” said Dr. Bowden. If this newfound power isn’t checked, it could lead down a slippery slope that diminishes patient’s rights, according to Dr. Bowden.
“Prior to COVID, I never had a pharmacist refuse a prescription. This is a new phenomenon and it needs to come to an end. This is going beyond their role and it’s a dangerous trend,” said Dr. Bowden.
Sen. Ron Johnson (R-Wis.), believes that the widespread denial of ivermectin could have resulted in untold COVID deaths. “The doctors I’ve been dealing with and talking to for years now, they believe that probably hundreds of thousands of Americans lost their lives because they were denied early treatment and they were denied because the FDA sabotaged, for example, ivermectin,” Mr. Johnson told FOX News on Aug. 11.
“We are going down a very dangerous path, but it’s a path that is being laid out and planned by an elite group of people that want to take total control over our lives, and that’s what they’re doing bit by bit,” he added. |
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‘FDA Is Not a Physician’: Appeals Court Sides With Doctors on Ivermectin for COVID-19COVID Treatments & Remedies
A federal appeals court in New Orleans ruled on Friday that the Food and Drug Administration (FDA) had overstepped its authority in their ruling that three doctors will be able to move forward with their lawsuit over the use of ivermectin off-label to treat COVID-19.
Dr. Mary Talley Bowden, one of three doctors who initially filed the petition, trumpeted the ruling as a victory for not only the truth, but patient rights.
“The FDA misled the public into thinking it has more authority than it does,” Dr. Bowden, a practitioner and founder of Coalition of Health Freedom, told The Epoch Times. “This decision confirms that the FDA is not your doctor and has no authority to tell doctors how to practice medicine.”
Judge Don Willett wrote for the three person panel that also included Jennifer Walker Elrod and Edith Brown Clement. “The Doctors have plausibly alleged that FDA’s Posts fell on the wrong side of the line between telling about and telling to.”
“FDA is not a physician. It has authority to inform, announce, and apprise—but not to endorse, denounce, or advise. The Doctors have plausibly alleged that FDA’s Posts fell on the wrong side of the line between telling about and telling to. As such, the Doctors can use the APA to assert their ultra vires claims against the Agencies and the Officials.”
The anti-ivermectin messaging put out by FDA officials also drew the ire of Judge Willett, who wrote that “Left unmentioned in most of that messaging: ivermectin also comes in a human version. And while the human version of ivermectin is not FDA-approved to treat the coronavirus, some people were using it off-label for that purpose.”
In the ruling social media posts made by the agency were cited as evidence, citing that “Even tweet-sized doses of personalized medical advice are beyond FDA’s statutory authority,” he wrote.
The FDA on Aug. 21, 2021, wrote on X, formerly known as Twitter: “You are not a horse. You are not a cow. Seriously, y’all. Stop it.”
The National Institutes of Health COVID treatment guidelines recommend against using ivermectin for COVID treatment, citing a purported lack of evidence supporting its effectiveness. Other studies have found ivermectin to be effective.
The lawsuit was initially filed in June 2022 by Dr. Bowden, Drs. Robert L. Apter, and Paul E. Marik for interfering with both their authority to prescribe an approved medication and the doctor-patient relationship. All three alleged their reputations were harmed by the FDA campaign. Dr. Bowden lost admitting privileges at a Texas hospital while Dr. Marik alleged he lost his jobs at a medical school and at a hospital for promoting the use of ivermectin.
The ruling comes as a blow to the FDA. The agency had argued that the case should not be allowed to move forward, claiming that the complaints didn’t overcome the FDA’s “sovereign immunity,” which protects government entities from many civil lawsuits regarding their responsibilities.
The FDA did not immediately respond to requests for comment. The refusal of pharmacists nationwide to fill prescriptions for ivermectin has become a hot-button issue, raising questions over medical autonomy and who ultimately has control over patient care.
Ivermectin has been around for decades but became the center of controversy in 2020 after medical opinion became divided over its effectiveness as a treatment for COVID. In the aftermath, many pharmacists refused to fill prescriptions for the medication.
On Aug. 8 a lawyer representing the FDA confirmed that doctors were allowed to prescribe ivermectin to treat COVID. “FDA explicitly recognizes that doctors do have the authority to prescribe ivermectin to treat COVID,” Ashley Cheung Honold, a Department of Justice lawyer representing the FDA, told the U.S. Court of Appeals for the 5th Circuit.
FDA Detects Serious Safety Signal for Covid Vaccine Among KidsDr. Bowden claims that despite the endorsement from the FDA, the practice of pharmacists refusing to fill prescriptions for ivermectin continues.
“This needs to come to an end. In telling my patients what medicines they can and cannot have access to, we effectively have a large group of pharmacists practicing medicine without a license,” said Dr. Bowden told the Epoch Times on Friday. “They have no accountability for this yet they are allowed to dictate patient care.”
“I see it every single day. Enough is enough,” Dr. Bowden added.
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FDA Has ‘Gone Rogue’ in Its Approval of New COVID-19 Boosters: Dr. Robert MaloneDr. Malone accused the FDA of flouting its own rules and “going rogue” by green-lighting updated COVID-19 vaccines with limited clinical trial data. Dr. Peter McCullough, a cardiologist, speaks at the Conservative Political Action Conference at the Hilton Anatole in Dallas on Aug. 5, 2022. (Bobby Sanchez/The Epoch Times) By Tom Ozimek and Joshua Philipp The Food and Drug Administration (FDA) has “gone rogue,” according to virologist Dr. Robert Malone, who accused the federal agency of sacrificing its own rules and regulations with its decision to recommend the latest batch of COVID-19 boosters, which only have limited clinical trial data attesting to their efficacy and safety.
Dr. Malone made the remarks in an interview with EpochTV’s “Crossroads” program on Sept. 11, the day that the FDA cleared new COVID-19 vaccines in a bid to counter the waning effectiveness of the currently available shots.
“It’s difficult to conclude anything other than the FDA is no longer feeling bound by their own rules and regulations,” Dr. Malone said. “The term is—they’ve gone rogue.”
Dr. Malone said the lack of human clinical trial data demonstrating effectiveness and safety of the updated vaccines should have precluded their approval by the FDA.
He said that, essentially, the FDA authorized the new vaccines on the premise that “neutralizing antibodies as detected in mice and their cross-reactivity are correlative protection,” which he said “is a lie, there are no established correlates of protection for SARS-CoV-2.” FDA officials didn’t respond by press time to a request by The Epoch Times for comment.
The agency cleared Moderna’s and Pfizer’s newest mRNA vaccines on Sept. 11 without analyzing data from any human trials.
In a statement announcing its approval, the FDA said that the decision was supported by its evaluation of “manufacturing data” from vaccine producers and “non-clinical immune response data on the updated formulations including the XBB.1.5 component.”
The benefit-risk profile of earlier versions of the vaccines is “well understood,” the FDA claimed, adding that the similar manufacturing process for the updated vaccines “suggests that the vaccines are a good match for protecting against the currently circulating COVID-19 variants.”
The Centers for Disease Control and Prevention (CDC) followed with its own recommendation on Sept. 12, urging nearly all Americans to get the new vaccines. The shots will be available to children as young as 6 months old this month. Dr. Robert Malone: The Coordinated Propaganda Narrative Around COVID-19 | CLIP
The new vaccines target XBB.1.5, a sub-type of the Omicron variant of the SARS-CoV-2 virus, which causes the disease COVID-19. However, the XBB.1.5. subvariant has already largely been displaced by newer strains of the quickly evolving virus, including EG.5, according to the CDC.
While FDA documents show the agency did not include any trial data in its review of the new shots, data from a Moderna trial was considered by the CDC before it issued its recommendation. The trial featured just 50 people receiving a new shot, and found the vaccine induced levels of neutralizing antibodies that authorities said would protect against COVID-19. One of the 50 people suffered a vaccine-related adverse reaction.  Florida Surgeon General Dr. Joseph Ladapo in Tampa, Fla., on Oct. 15, 2022. (York Du/The Epoch Times)
‘Lot of Red Flags’“There’s essentially no data,” Florida Surgeon General Dr. Joseph Ladapo said at a recent news conference, where he suggested that people might be better off passing on the new round of shots.
“Not only that, but there are a lot of red flags,” Dr. Ladapo added, while pointing to studies finding that the effectiveness of the vaccines turns negative over time.
“There’s been no clinical trial done in human beings showing that it benefits people, there’s been no clinical trial showing that it is a safe product for people.”
He also noted that studies have linked previous versions of the COVID-19 vaccine to cardiac problems such as heart inflammation.
“It’s truly irresponsible for FDA, CDC, and others to be championing something … when we don’t know the implications of it,” Dr. Ladapo said.
Asked to comment on Dr. Ladopo’s remarks, Dr. Malone pointed to a growing body of studies that show negative vaccine effectiveness, which he said suggests that, in the risk-benefit analysis, “there’s no discernible benefit, or there’s negative benefit, but there’s clearly risk.” ‘Most Americans Take Them’While acknowledging the current vaccines’ waning effectiveness, CDC Director Mandy Cohen penned an op-ed in The New York Times on Sept. 13, in which she called the updated COVID-19 vaccines “one of the most effective tools in combating the virus.”
“Covid-19 vaccines are the best way to give the body the ability to keep the virus from causing significant harm. Extensive studies and real-world experience have shown that they are safe and they work,” she wrote. “And most Americans take them.”
Dr. Cohen said the vaccines were put through extensive clinical trials before they were introduced in 2021 and “since then, their safety has been intensely monitored.”
She didn’t address criticism, such as the little trial data that’s been made available.
That FDA and CDC moves have been questioned by a number of doctors. Dr. Paul Offit, an FDA adviser, suggested to the UK’s Daily Mail that younger, healthy people who have already been vaccinated don’t need one of the new doses.
“We are best served by targeting these booster doses to those who are most at risk of severe disease,” such as people older than 75, Dr. Offit said. “Boosting otherwise healthy young people is a low-risk, low-reward strategy.”
In his remarks at the news conference, Dr. Ladapo asked people to make decisions based on their “resonance of truth” rather than depending on “very educated people telling you what you should think.”
“When they try to convince you to be comfortable and agree with things that don’t feel comfortable and don’t feel like things you should agree with, that’s a sign … And I encourage you and certainly beg and hope that you do listen to it, because it will serve you right,” he said.
A January–July 2023 study that analyzed data from 33 California state prisons found that individuals who received new COVID-19 booster shots were more likely to contract COVID-19 compared to those who didn’t receive the jabs.
The infection rate among the group that received the bivalent booster shots came in at 3.2 percent—higher than the 2.7 percent among the unvaccinated.
Late last month, the CDC conceded that the new BA.2.86 strain can cause infection even among people who have previously been vaccinated against COVID-19.
“The large number of mutations in this variant raises concerns of greater escape from existing immunity from vaccines and previous infections compared with other recent variants,” the agency said in its assessment.
Zachary Stieber contributed to this report.
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British Court Rules That Competent & Conscious Patient Can Be Denied Life-Sustaining Treatment Against Her Willby Tyler Durden, 04September2023 – https://www.zerohedge.com/medical/british-court-rules-competent-conscious-patient-can-be-denied-life-sustaining-treatment In my torts class, I often compare the different approaches and doctrines in the United States and the United Kingdom. One of the most pronounced is the position and authority of physicians on issues like consent and malpractice. This week produced a particularly striking example.
British doctors are seeking to take a 19-year-old critically ill female patient off the intensive care despite her objections and those of her parents.
Unlike most such cases, the woman known only as “ST” is conscious and communicative. Yet, the doctors argue that she is not being realistic about her chances of survival from a rare disorder. Now a British court has agreed and ordered that she can be placed on end-of-life care against her will. ST is suffering from a rare genetic mitochondrial disease that is progressively degenerative. The case has similarities to that of Charlie Gard, an infant who was removed from life support at the insistence of doctors despite objections from the parents. The Gard family was seeking to take Charlie to the United States for experimental treatment.
ST has been in the ICU for the past year, requiring a ventilator and a feeding tube. She also requires regular dialysis due to chronic kidney damage from her disease. She wants to be allowed to travel to Canada for an experimental treatment but the doctors oppose the plan and say that she is not accepting the realities of her terminal illness. They say that she is “actively dying” without any hope of resuming life outside of intensive care. Her deeply religious family have spent their entire life savings on her care and has complained that a “transparency order” requested by the hospital barred their ability to give details on the case to help raise public funds.
What is so remarkable about this case is that it is not an infant or a comatose patient. The court found that ST “is able to communicate reasonably well with her doctors with assistance from her mother and, on occasion, speech therapists.”
Moreover, two psychiatrists testified that she is mentally competent to make decisions about her own care.
Nevertheless, the judge found that she is mentally incapable of making decisions for herself because “she does not believe the information she has been given by her doctors.”
The court appears to reject her ability to make this decision because she is making the wrong decision:
Accordingly, the court ruled that decisions about ST’s further care should be determined by the Court of Protection based on an assessment of her best interests. Her “best interest,” according to the doctors, is to die. Thus, the courts have declared that ST cannot choose to continue life-extending treatment and can be forced into palliative care against her will. The logic of the decision is chilling.The court is told that ST has cognitive and communicative abilities to make such decisions. However, because the court disagrees with her desire to continue to fight to live, she is treated as effectively incompetent. It seems like the judicial version of Henry Ford’s promise that customers could pick any color car so long as it is black. Here is the opinion: In the Matter of ST
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Malice Aforethought on the COVID-19 Pandemic: “This is a global coup d’etat and intentional mass murder.” Dr. Mike YeadonBy Dr. Mike Yeadon
*** A message written to a trusted campaigning friend, who is struggling to accept that what is happening is intentional. It is indeed a big step to move from justifiable criticism of presumed incompetent politicians and industrialists to putting the pieces together in such a way that they can point only to intentionality. See what you think. * Dear X, I find that attempting to put all the information together in such a way as to allow for the whole even to be benign or at least not wholly malevolent is impossible.
That’s because, as you’ve no doubt heard me say, I believe it is malevolent! I too struggled early on, arguing “surely they must have known this!?” Etc. Once I allowed for the possibility that all the bad things were intentional, I find all the rest falls into place. Obviously that alone doesn’t prove that it was intentional.
Some early clues to intentionality are the coordinated responses of scores of governments to the alleged pandemic: lockdowns, masking, mass testing of the well, the misapplication of PCR-based techniques to bulk testing of clinical samples, selective business & school closures, border restrictions etc.
Not a single country had any of this as a core part of their own pandemic preparedness plan. Even the WHO’s scientific evaluation of NPIs concluded none of them worked & the only changes worth a dime were asking those with symptoms to remain at home until recovered & to increase the frequency of hand washing (because the route of transmission wouldn’t initially be known for sure).
I argued at the time that the only way all the countries could have adopted all these useless yet damaging & costly NPIs is if there was supranational coordination.
Whether that from WHO, WEF, etc., I don’t know. But illegitimate in any case. We now know that they knew that imposing these restrictions would save nobody, yet the negative consequences would be devastating, even lethal for some, who would no longer have access to the medical care they needed. Additionally, the use of furlough was obviously going to be enormously damaging to sovereigns who were already borrowed to the hilt.
I note the widespread adoption of an American term, furlough, into public discourse. In U.K. we never previously used the term. Nobody remarked on its arrival, which telegraphed the leading role played by Americans.
Then we have the imposition of radically altered medical protocols. Because of my long exposure to matters respiratory, I knew immediately they began panicking about needed 30,000 mechanical ventilators that something truly demonic was at hand. It’s never appropriate, in a patient with an unobstructed airway & an intact chest wall to sedate, intubate and ventilate them. Mechanical ventilation is certainly a marvellous, life-saving thing, but it comes with serious risks to the frail patient, in the form of ventilator acquired pneumonia, lung injury from use of pressure to inflate the lungs and more. The appropriate treatment would be an oxygen mask, single, low dose benzo, a cup of tea and a biscuit and a caring hand upon an arm.
In the USA as well many, once in this vulnerable state, were given remdesivir & not given total, intravenous nutrition. In most cases it was just a matter of time before they died.
In care homes, there was indiscriminate use of inappropriately high doses of midazolam and morphine. Not only high doses but repeatedly given to their elderly charges. They’d been told to do it by the highest medical authorities in the land and so few questioned it.
My PhD by coincidence was in this area, the effect of opiates on respiratory function. The discovery of multiple opiate receptors raised the possibility that it might be possible to invent receptor selective ligands that would relieve pain with reduced respiratory depression. Unfortunately, both are mediated primarily by mu opiate receptors, both centrally and in the periphery.
The combination of opiate agonists and benzodiazepines is contraindicated in patients unless close monitoring (for signs of respiratory depression) was in place.
It isn’t & cannot be in a care home. They too were murdered in large numbers. Finally, in the community, the family doctors were cautioned not to prescribe antibiotics in cases of covid “because antibiotics cannot treat viral illnesses”. It’s well known that what is usually termed secondary bacterial infection is generally what actually leads to death in this situation. However, the records show that prescriptions for antibiotics for suspected bacterial infection of the lungs fell by 50% & large numbers of people died avoidable deaths (and rather horrible deaths, too).
It’s not possible to regard all of this evidence without concluding that malice aforethought was at work here. It’s literally diabolical, what they did.
How it was done with so little pushback still confuses me. I do know that from the late-1990s right through late-2019, there was a sequence of tabletop simulations of global pandemic scenarios & bioterrorism scenarios, which allowed the perpetrators to hone their craft in the responses & control measures imposed. I believe some of these were translated onto the ground, giving emergency response team a chance to form & to rehearse what most of them thought were appropriate, given the fictional set up, though this is speculative.
Then we come to the “vaccines”. Given a career in pharma and biotech, I knew that it was impossible to create a vaccine in under 5-6 years if they were going to demonstrate clinical safety and hone manufacturing to yield the customarily high quality manufacturing necessary to produce tightly defined final drug product. If the latter if not done, it’s pointless doing the former, because what would otherwise be injected wouldn’t be what had been used in the clinical trials.
In other words, if there was a need for a new vaccine, you would never even contemplate running such a program, because no pandemic in history lasts a fraction of the minimum time necessary to create a safe and effective new vaccine.
Yet they went ahead. This too is malevolent, let alone the extraordinary lying, censorship & smearing of dissenters. Given my entire career used “rational drug design” principles to design and test molecules, I was able to put myself in the shoes of the designers of the jabs.
There are several, completely obvious safety issues built into these products. One is the axiomatic induction of “autoimmune” responses, regardless of which antigen was selected. The next was choice of antigen, where no one would pick spike protein, because it was highly likely to be directly toxic, it’s subject to the most rapid mutation (so a vaccine might lose efficacy) & also it’s the least different from human proteins (and so might trigger bystander attacks on even somewhat similar self proteins).
Yet all four leading players chose this antigen. What a coincidence! I’d have called up my peers in the other companies to endure we didn’t do that. That’s because it would be highly undesirable to have common risks to all programs.
On formulation, the mRNA-based products both selected LNPs to encapsulate their message. Yet there was industry knowledge that these not only travel all over the body including into the brain but that they accumulate in the ovaries.
Yet, knowing this, the companies & regulators went ahead and then others compounded the toxicity risk by recommending these injections in pregnant women and children.
I was still slow to piece together all this evidence of carefully thought out harms. But eventually I got there and have been speaking in what many regard as extreme terms ever since.
I’m afraid there’s no hiding from the reality that this is a global coup d’etat and intentional mass murder. Worse, we see the encroachment of surveillance technology and legal powers to introduce digital ID & CBDC as well as to eliminate cash.
It’s not difficult to come up with scenarios where presentation of digital ID will become mandatory. * Note to readers: Please click the share button above. Follow us on Instagram and Twitter and subscribe to our Telegram Channel. Feel free to repost and share widely Global Research articles. Dr. Michael Yeadon, PhD, was Formerly Vice President & Chief Scientific Officer Allergy & Respiratory at Pfizer Global R&D. He holds Joint Honours in Biochemistry and Toxicology and a PhD in Respiratory Pharmacology. He is an Independent Consultant and Co-founder & CEO of Ziarco Pharma Ltd.
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Steve Kirsch’s newsletterUS Nursing home data shows clearly that the COVID vaccines were a disaster for the elderly; they increased the risk of dying from COVIDI’m going to drill into more detail on this analysis of the CDC “gold standard” database which shows that the vaccines were a huge failure. There is no way to put a positive spin on this.Steve Kirsch  COVID dead: survived odds ratio vs. week ending 6December2020 (at arrow)
Executive summaryThe US Nursing Home data is the “gold-standard“ record level data for what happened in nursing homes after the COVID vaccine rolled out.
The signal from this data is clear and unambiguous: both the primary series and booster COVID vaccines increased the risk of death from COVID. The bivalent vaccines did absolutely nothing for the elderly (at least it didn’t make things worse, but it didn’t make things better).
The two things that reduced the infection fatality rate (IFR) were:
We can see both effects very clearly in the data shown in Figure 1 above. This is why the CDC isn’t touting this database as proof that the vaccines work. Neither is anyone on the pro-vax side of the narrative despite the fact that this data has been in public view for 2 years now.
So since nobody from their side wanted to analyze the data, I thought it would be a good idea if someone from our side took a look.
The reason why they never wrote about this to prove their case is that it shows the opposite. The so-called “misinformation spreaders” have been right all along: the vaccine clearly significantly increased the risk of an elderly person getting COVID for around 4 months. This is a huge problem because this was the time when the vaccine was supposed to be most effective (since we now know from FOIA requests that the FDA knew that the vaccine protection waned after 4 months).
Health officials claimed the vaccine could reduce risk of death by 10x. It’s right here in this tweet from an Australian government health authority NSW Health on August 17, 2021:  Estimated effectiveness of COVID-19 vaccines The data they never told us about (the US Nursing Home data) shows a completely different story: it did the opposite and increased the risk of death by as much as 1.6 times higher odds of dying.
The attempts to attack my analysis, to date, are addressed here. They are weak hand-waving arguments with no evidentiary support. At no time did anyone ever justify their arguments with any numbers derived from the data. None of the attackers will publish their “correct” analysis of this data or their investigations showing anomalies.
The fact is that this is “gold standard” data. It doesn’t get any “closer to the source” than this. There were over 2M records to analyze from over 15,000 elderly care facilities in the US. These are large numbers and the effect size was huge.
The Fisher exact p-value for the 1.7 OR peak on 2/28/21 is 2.6e-109 and the Z-score for the odds ratio is 23.53. In other words, this difference didn’t happen because I cherry picked a result or it happened by chance. It was caused by something. If it wasn’t the vaccine, what caused this statistically significant difference in the rate of death from the virus (it was the same variant as before the vaccines rolled out).
Equally important is that Apple Valley Village had a 0% death rate from COVID prior to the vaccine rollout: 26 infections and not a single death. Just 3 weeks after the week of the shots, they had 90 COVID infections which resulted in 28 deaths from COVID. My hypothesis can easily explain that. Theirs cannot. So you can throw all the FUD you want at the Nursing Home data, but the bottom line is that this one anecdote is very powerful because it is verifiable in the database and with employees, but it cannot be explained how the death rate in this nursing home suddenly got at least 9X worse after the shots rolled out that should have made the death rate 10X better. That is a 70X swing. This is why Professor Morris simply ignores this because he cannot explain it. In science, you can’t ignore data you don’t like. You have to be able to explain it or admit you cannot. Morris does neither.
Don’t you find it strange that this data has been publicly available for two years now and not a single pro-vaccine advocate has analyzed it and is touting it as “proof” the vaccines work? At this point, the medical community has a choice: embrace the data and admit you were wrong or try to fight it. History will not look kindly on attempts to dismiss this data. The first rule of holes: if you find yourself in a hole, stop digging. They are in a big hole. What will they do now? Data availabilityCode: You can find everything in my github repo here. Nursing home data: You can download the data from my repo or directly from CMS. Now, where are the repos of others who have analyzed this data? They do not exist as far as I know. How is that possible? Why can’t we see their work? Key documentsPreparing for COVID-19 in Nursing Homes shows that the policy in effect on November 20, 2020 and beyond was to test all new admissions into nursing homes and anyone who is symptomatic. I verified this practice was followed by talking to people who work in the nursing care homes. So the claim that people who transferred into nursing homes didn’t get tested is without evidentiary support.
Boosters were rolled out starting on September 20, 2021. See: Nursing homes charging ahead to administer COVID-19 vaccine booster shots The bivalent booster was first available in the United States nearly one year later on September 1, 2022. Nursing homes site of 40% of US COVID-19 deaths shows that nursing homes are ground zero for the vaccine. If it doesn’t work there, it is a failure. What I foundEverything is summarized in the Executive Summary at the start. The key point is that, in aggregate, when compared to pre-vax infection fatality rates, the odds of death climbed for months after the vaccines were delivered when they were “supposed to” have fallen like a rock. In particular the odds of death ( deaths from covid:survivors from COVID) increased post-vaccine. So did the absolute risk reduction; it went south which means the vaccines increased your risk of death. In short, the vaccine made things worse. The reference point chosen (the week prior to vaccine rollout) is immaterial; the slopes all went the wrong way. There is no doubt about this. This is a huge failure of the vaccine.
In addition, the virus has mutated to Omicron which isn’t killing anyone. Boosters are silly. They should be ashamed of themselves for pushing this when there clearly isn’t a problem.  Cases and deaths in US nursing homes
Could this analysis be wrong? Could the vaccine have saved lives?No. Anecdotes like Apple Valley Village (mentioned above) are unexplainable. The Pfizer Phase 3 clinical trial had more all-cause deaths in the treatment group than the placebo group, but the numbers were too small to be statistically significant. So the trials provide no visibility into the death “benefit.”
There are many others who have pointed out issues with the vaccines including this amazing video by John Beaudoin and the 1,200 articles I’ve written on my Substack. Why did this happen?Is there a biological basis for how the vaccine can make things worse? Yes! The vaccine damages your immune system. See this article by Igor Chudov for a clinical trial done on kids with healthy immune systems. Previous articlesSee:
The attempts to discredit the data and/or analysisHere are the attempts to discredit my analysis of this data. At no point do any of these people point to the “correct” analysis showing that the data shows the vaccines reduced the death rate. Nor do any of the attacks actually have any numbers. They are all hand-waving attacks with no evidentiary support. The attack is in bold, the responses follow.
If you want to read Professor Morris’s critique in his own words, you can find it here. Here are the quick answers to each item.
I found his arguments lacking in any data or numbers to back them up. And he completely failed to explain AVV; he wouldn’t even attempt it.
I also invited him to submit to me his anecdote of a success case where the IFR in the nursing home dropped by 9X or more. I’d love to see it. After all, there should be hundreds of such homes. Can he name one? The NSW government promised the OR would drop like a lead balloonAs noted above, the NSW Health authority claimed that risk of death drops by 10X. I’d love to see how the OR of death goes to .1 after the vaccine. Where is the data? Where is their analysis of the CMS Medicare data?This is gold standard data. They should be touting it. It’s been up for 2 years. Nothing. Not a peep. Nobody touched it. It’s basically a third rail for the narrative.
40% of the COVID deaths were in US nursing homes, so this is the #1 demographic to examine. The data was there. Why did they ignore it? If there is a mortality benefit, where is the benefit curve post-vax and why is this kept hidden?Where is their curve of the odds ratio of death from COVID post vaccine? I haven’t seen it anywhere. I asked Professor Morris for the correct IFR since he claims mine is wrong. He could not provide it. If he doesn’t know the correct numbers, how can he know my numbers are wrong? For more infoSee my previous article where it talks about the only paper published referencing this data See also my Twitter post:
 Steve Kirsch-tweet-7September2023-US Nursing Home data from the CDC shows the COVID vaccines were a huge failure SummaryThe vaccines made things worse for the very population that it was supposed to help.
That’s why nobody ever published a favorable analysis of the US Nursing Home Data even though it has been out for 2 years.
The vaccines shouldn’t be used by anyone, especially those with a compromised immune system. It damages your immune system. People with a damaged immune system will be left with an even more damaged immune system.
When will the medical community acknowledge they made a huge mistake?
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They Suffered Myocarditis After COVID-19 Vaccination. Years Later, Some Still Haven’t Recovered.By Zachary Stieber, Lia Onely | 20September2023 Updated: 21September2023 https://www.theepochtimes.com/article/they-suffered-myocarditis-after-covid-19-vaccination-years-later-some-still-havent-recovered-5478652
Under pressure from the military and his mother, Jacob Cohen was feeling increasingly cornered. Mr. Cohen did not want to receive a COVID-19 vaccine. He knew the shots had not been available for long. He was worried about their safety. While Mr. Cohen initially resisted receiving a shot, he faced restrictions such as being forced to remain on base while vaccinated soldiers left. He was also pressured by military commanders, who scheduled a vaccination appointment for him and contacted his mother as part of a multipronged campaign. “They told me, ‘Come on. It’s your mother. She’s crying. She’s worried. What wouldn’t you do for her?'” Mr. Cohen, who asked to be identified by a pseudonym because of concern about repercussions for going public, told The Epoch Times. “I didn’t want to take the vaccine. I didn’t believe in it,” he said. But he wanted to appease his mother. “I would do anything for her.” Mr. Cohen received his first shot, manufactured by Pfizer, on Sept. 22, 2021. He was 21. Two weeks later, he was awakened by a sharp pain at 3 a.m. “I felt like my heart was trying to get out of my chest,” Mr. Cohen said. The soldier has felt pain before. “I never felt something like this,” he said. Mr. Cohen went with a friend to the hospital, where he was placed in quarantine because he wasn’t fully vaccinated. Thirty minutes ticked by. “I felt like it was the first time in my life I actually started seeing flashbacks of things that I did in my life—I felt like I was truly dying,” Mr. Cohen said.
Doctors finally came in and ran tests. They diagnosed Mr. Cohen with perimyocarditis, or inflammation of the heart muscle and the tissue around the heart. They said Mr. Cohen was lucky. If he had come just a little later, he would have needed open heart surgery. He spent three days in the hospital, taking medication and pills. When he was discharged, he was told not to engage in any physical activity for at least six months. He also needed to report for regular checkups and take a pill every day. Six months after leaving the hospital, Mr. Cohen’s cardiac MRI showed concerning results. His heart still hadn’t recovered. Doctors gave him more pills. “They told me maybe I will need them for the rest of my life,” Mr. Cohen said. The military marked him as unable to serve for the rest of his life, and released him. To this day, he suffers. “I’ve been feeling, I’m not sure if it’s trauma or something, but it feels sometimes like a sting there, a short sharp pain,” Mr. Cohen said. He’s also unable to do all he used to do before. “I was training. I was playing soccer. I did a lot of physical things, which now I can’t afford … to do anymore,” Mr. Cohen said. ‘Continued Pain’Dr. Adam Hirschfeld was among the first people to receive a COVID-19 vaccine in the United States The orthopedic surgeon was motivated by a desire to prevent his patients from becoming sick. “I didn’t want to put any of my patients at risk,” Dr. Hirschfeld told The Epoch Times. He received a Moderna primary series, composed of two doses, in January 2021. He was 36. Three days after the second shot, Dr. Hirschfeld felt discomfort in his chest and numbness in his left arm. A cardiac MRI confirmed evidence of heart inflammation. Dr. Hirschfeld was prescribed medicine and discharged two days later. Dr. Hirschfeld has since undergone about a dozen electrocardiograms, another half a dozen echocardiograms, and a follow-up cardiac MRI. “I went from being completely healthy—no issues, no medications—to seeing 10 different doctors in the blink of an eye,” Dr. Hirschfeld said. The follow-up MRI, conducted about 18 months after the vaccinations, showed normal cardiac function. But Dr. Hirschfeld still experiences pain. “I have continued chest pain on the right side, and then I have neuropathic type pains in my neck and shoulder areas,” he told The Epoch Times. “I have it when I wake up, and it’s there when I go to sleep.” The suffering affects the doctor physically and mentally. “Having chest pain every day for two and a half years is very disconcerting,” he said. Pfizer and Moderna didn’t respond to requests for comment. Shots Cleared; Cases AppearMr. Cohen lives in Israel. Dr. Hirschfeld lives in the United States. The first myocarditis cases after COVID-19 vaccination were reported in those countries in January 2021. Only a few weeks had elapsed since authorities cleared and recommended the shots for large portions of the population, including many young, healthy people.
At first, authorities hid reports of myocarditis from the public. Israel first acknowledged there was a likely link between the shots and the inflammation. The United States finally followed in June 2021, when the U.S. Centers for Disease Control and Prevention (CDC) said there was a “likely association.” Even after the association was made public, officials and many experts claimed that the myocarditis cases were mild. Most patients were hospitalized, authorities acknowledged, but they said patients could expect to recover without treatment and with rest. The myocarditis is “rare but mild,” Dr. Rochelle Walensky, the CDC’s director at the time, said on “Good Morning America” on June 24, 2021. Dr. Walensky said the cases were “self-limited,” or didn’t require treatment to resolve. Then-Centers for Disease Control and Prevention Director Dr. Rochelle Walensky speaks to reporters at a COVID-19 mass vaccination site at Hynes Convention Center in Boston on March 30, 2021. (Erin Clark-Pool/Getty Images)Dr. Jeremy Faust, editor-in-chief of MedPage Today and a teacher at Harvard Medical School, on Twitter two days later described the cases as “self-limited troponinemia,” or elevated troponin levels that would resolve on their own. Troponin is a protein in the heart that’s a marker of heart injury. Those claims were already wrong at the time, based on case reports alone. A previously healthy 24-year-old man in Massachusetts, for example, experienced chest pain so serious that he went to an emergency department, doctors reported on May 18, 2021. He was eventually discharged with a prescription for a beta-blocker and anti-inflammatory drugs and told not to engage in strenuous activity for three months. Another early case involved a previously healthy 16-year-old boy in California who experienced “stabbing chest pain” and went to the emergency department for help. He described the pain as 6 to 8 on a scale of 1 to 10. The symptoms prompted doctors to admit him to intensive care. He spent six days in the hospital before being discharged. Like many early case reports, no follow-up data were reported, making it impossible to say that the cases had fully resolved. “Unless you’ve experienced it individually, you can’t tell somebody that their case was mild,” Dr. Hirschfeld said. “If you have elevated troponin, that’s your cardiac muscle breaking down. “That’s something that’s permanent. And so to tell me that my cardiac muscle breaking down is mild is pretty insulting.” Signs of persistent symptoms appeared in the literature before long. U.S. military researchers, for instance, stated on June 29, 2021, that seven of 23 patients continued to have chest discomfort weeks or even months later. Dire outcomes were known even earlier. Two deaths were reported to U.S. authorities in February 2021, while another two were reported in Israel in the spring. Both of the Israelis who died were previously young and healthy. Professional Biker AffectedKyle Warner was a professional mountain bike racer when he received his first COVID-19 vaccine in May 2021. He completed a primary series the following month. Mr. Warner, who lives in the western United States, teaches older people and wanted to protect them from COVID-19. The CDC and others promoted the idea that the vaccines curbed or even prevented transmission based on observational data. “The sentiment was these are safe and effective. If you get them, you don’t need to wear a mask anymore, and you can’t transmit COVID or catch COVID,” Mr. Warner told The Epoch Times. “I spend quite a bit of time around older people and help them learn. “I wasn’t necessarily afraid of COVID myself. Not that I did respect it, but I wasn’t worried it was going to kill me,” he added. “But I was worried about getting someone else sick, especially when I’m with our older clients.”
Mr. Warner was diagnosed with myopericarditis after COVID-19 vaccination and was hospitalized. After being discharged, Mr. Warner was bedridden for weeks. “There’s points where I was unable to even get up out of bed without passing out or blacking out,” Mr. Warner told The Epoch Times. “It was really eye-opening. I felt like I went from being 28 years old to being 88 years old.” Mr. Warner was diagnosed with myopericarditis and two other conditions—postural orthostatic tachycardia syndrome and mast cell activation syndrome—that others have also been diagnosed with following COVID-19 vaccination. Hyperbaric oxygen, which has relieved some of Dr. Hirschfeld’s pain, helped bring Mr. Warner’s energy levels back up. But the cyclist, who didn’t ride again until February 2022, still struggles with pain, especially when he exercises in the summer. Mr. Warner utilizes a heart rate monitor, which he became familiar with in his racing career. During a recent ride, Mr. Warner pushed himself, trying his hardest for four minutes. That sent his heart rate up to 189 beats per minute—the highest since the injury. “I did OK, but then the next few weeks, I had a kind of a lingering chest pain and tightness. And about four days after, it was pretty significant where I was having a hard time sleeping and my heart felt like it was palpitating every once in a while, and then—even more than a week later—I still had a little bit of chest tightness and pain,” Mr. Warner said. “It kind of scared me because it’s been well over a year since my last treatment with hyperbaric and I’m still dealing with it. And when I do try to push myself harder, then I have to pay for the next few days to a week. “Back in the day, I would be able to do that with no problem at all.” Doctors who have spoken to Mr. Warner have told him that when his heart becomes stressed, it signals his immune system to attack and inflame it. He tries to keep his heart rate under 160 beats per minute.
14-Year-Old Rushed to HospitalAiden Ekanayake woke up in the middle of the night. “Every breath deeper in was like knives in my chest,” Aiden, who is from Georgia, said during a podcast appearance. It was June 12, 2021, two days after Aiden received a second shot of Pfizer’s vaccine. He was 14. Aiden was able to fall asleep through shallow breathing, but was soon awakened. He went to his mother, who rushed him to the hospital. Tests revealed abnormalities. Aiden was taken to the acute cardiac unit, where more tests confirmed that the vaccine was the cause. Aiden spent four days in the hospital. After being discharged, he was inactive for more than four months. “I don’t know where they get this ‘two days and you’re done, you’re good.’ That’s a crock of [expletive],” Emily Ekanayake, Aiden’s mother, told The Epoch Times. Ms. Ekanayake had read early studies from Israel that found an elevated risk for myocarditis among young males who had received the Pfizer vaccine, but concluded with her son that the benefits of the vaccine outweighed the risks. “I was really scared of COVID,” Ms. Ekanayake said. Aiden said he wanted to get vaccinated to help protect himself and his brother, both of whom have asthma. Aiden’s doctor also recommended the shot. Shortly before Aiden was vaccinated, the CDC director said the agency found no safety signal for myocarditis. U.S. officials cleared and recommended the vaccine to virtually all children aged 12 to 15, after initially only making it available to those 16 and older.
Aiden eventually resumed exercise after being cleared by a cardiopulmonary stress test. The result of the test was “probably more like that of an old man,” Ms. Ekanayake said. “His CO2 was low. He wasn’t able to run much. He’s got a lot of work in that way to go still. But he does like walking. “I still worry about strenuous activity. I can’t help it. I don’t know that that will ever go away.” ‘Half a Human Being’Alon was a competitive swimmer who trained every single day before he received his Pfizer vaccine. But in addition to the round trip to get to the pool, the Israeli boy needed to stand in line to take a test for COVID-19. School also was an issue. Fellow students would often get sick, triggering a quarantine of those who weren’t vaccinated. “There was no chance to arrive to school and not be informed the next day that someone is sick and you [need to] be in quarantine,” Alon’s mother, who spoke on condition of anonymity due to fear of professional repercussions, told The Epoch Times. “It’s impossible. It’s like putting a child in prison for doing no wrong.” Alon’s mother saw vaccinated people become sick despite the vaccine, erasing her belief that the shot protected people. But she heard little about possible side effects and decided that the benefits, including keeping her son in school, meant he should receive the shot. “He was tired of the quarantines and tests,” she said.
The first shot was injected on Dec. 3, 2021; the second shot was on Dec. 24, 2021. Alon was 9. A few days later, Alon fell into a deep sleep. “It was scary,” Alon’s mother said. Doctors ran tests, including checking his heart. They couldn’t discern what was awry. “The child is not functioning,” Alon’s mother said. “He was like half a human for the whole month.” The breakthrough came when Alon said, “My heart hurts.” Fresh testing revealed myocarditis. It was induced by the vaccination, doctors concluded. Alon spent the night at the hospital before being discharged. He returned a week later with chest pain. Tests showed normalization. Alon suffered from other problems over the months that followed. He lost his sight. His leg swelled. His lymph nodes became enlarged. Follow-up visits found no heart problems. The other symptoms eventually resolved and Alon was cleared to resume sports. He plays for hours each day. But nearly two years later, he still suffers. “He has periods when his heart hurts,” Alon’s mother said. “Sometimes for a few months, everything is fine. And then suddenly, it comes back.” She has opted to take her son to the doctor only when emergencies arise. Any time he sees a doctor, he becomes sick. And he refuses to take any more blood tests. “Maybe it is a sore muscle there. The heart is normal and suddenly, it is very tight for a few seconds,” Alon’s mother said. “It goes away. We avoid tests of any sort. If I don’t feel it’s life and death, I don’t take him to the doctor.” Worst Pain in His LifeBen Cutler loved to go to the gym. He worked out five days a week. Because he didn’t want to become infected by the new Omicron variant, Mr. Cutler received a Moderna booster shot on Dec. 14, 2021. He was 26. The next day, Mr. Cutler began to experience symptoms such as fatigue. He went to sleep early, but at 2:30 a.m., he was startled awake.
“I woke up and have never felt so terrible in my life,” Mr. Cutler wrote in a summary of his experience. After several days of trying to sleep the pain away, a family member convinced the Massachusetts resident to go to the hospital. Doctors ran tests and found troponin-T levels almost 90 times the normal maximum levels. Mr. Cutler was diagnosed with myopericarditis. He was eventually discharged, but his ordeal wasn’t over. “It was good that I could work from home. And I could start working at 7 or 8 a.m. and then work until like 2ish and then just lay on my couch for like seven hours,” Mr. Cutler told The Epoch Times. A 10-minute walk to the grocery store, Mr. Cutler said, would have been the only exercise he could manage in a day. He described having to “budget” his energy. After about two months, his condition started to improve. The pain dropped to 3s on some days. Then 2s. Then zeros. By the end of April 2022, Mr. Cutler was able to begin lifting weights again. A follow-up cardiac MRI revealed a small fibrosis, or scar, but he feels he has recovered. “I haven’t been having any major issues,” he said. “Everything’s pretty good.” Evidence BuildsThe stories bolster the growing body of evidence that has found a significant portion of people who suffer vaccine-induced myocarditis are affected for months or years, if they survive. U.S. researchers who followed up with 15 children hospitalized with myocarditis after COVID-19 vaccination revealed on Aug. 10, 2021, that four of the patients had “persistent symptoms.” Other U.S. researchers announced on Nov. 1, 2021, that seven of 54 young patients who suffered myocarditis after vaccination still experienced symptoms, including chest pain.
Nearly half of myocarditis patients who responded to a U.S. government survey said that months after COVID-19 vaccination, they continued to experience symptoms, including chest pain, government researchers said on Sept. 21, 2022. Meanwhile, 35 percent of 28 young myocarditis patients followed up with at least 61 days after COVID-19 vaccination reported continued symptoms such as shortness of breath, Hong Kong researchers said on Sept. 23, 2022. “Although post-COVID-19 vaccination myocarditis has a favorable prognosis and is considered curable, it may leave abnormalities in the myocardium, as observed in this case; it may therefore be premature to declare it as a complication with a good prognosis,” Japanese researchers said in 2022. More recent data have shown that some patients still haven’t recovered. That includes 23 percent of 60 people who told the CDC that at least one year after being diagnosed with myocarditis, they were still experiencing chest pain. Other papers have found that even when symptoms abate, follow-up testing reveals abnormalities.
Heart scars were detected in cardiac MRIs conducted seven to eight months after the myocarditis diagnoses, Israeli researchers said on March 23, 2022. U.S. researchers described similar results in a study published around the same time. Other U.S. researchers who imaged 15 adolescents at least 76 days after they were discharged from a hospital found persistent late gadolinium enhancement in 80 percent of the patients. Researchers often use abnormal levels of late gadolinium enhancement as an indication of heart scarring. In myocarditis cases before the pandemic, the enhancement was often a sign of poor outcomes such as heart transplantation or death. “It’s going to be a small percentage of the people that recovered from myocarditis, but some of them could be in for longer-term problems and morbidity, and some of them may develop actual disability,” Dr. Andrew Bostom, a U.S. heart expert, told The Epoch Times. While most patients experienced “mild myocarditis, which is mostly gone, it’s true that scars can remain, because it’s an inflammation of the heart muscle,” Dr. Yehuda Adler, a member of the Israeli Ministry of Health’s National Council for Prevention and Treatment of Cardiovascular Diseases, told The Epoch Times. “I’m definitely following these people even today, two years later, and I’ll continue to follow them.” Not all patients have persistent symptoms or abnormalities. Some have seen a full resolution of their symptoms, combined with no abnormal signs in follow-up testing. Dr. Rabea Asleh, director of the heart failure unit and the cardiovascular research center at the Hadassah University Medical Center in Jerusalem, said his team is also following patients to make sure they’re OK. He told The Epoch Times that all but one of his patients have stopped experiencing symptoms. “If this has any clinical significance regarding the flare-up of the disease later on or the deterioration in function after a few years, we do not know,” Dr. Asleh said, “but deterioration in function after a few years is unlikely.” Dr. Bostom said he wasn’t so sure. “One thing that I’m certain of is that the jury is out,” he said. “We need to collect a lot more information and see how people are really doing long term, particularly the young people.” Questionable PressureMany young people received COVID-19 vaccines under pressure, such as Mr. Cohen. Israeli military authorities punished the unvaccinated with actions ranging from taking away their leave to making them wear a special vest and isolate in their quarters.
“This is a population of young and healthy soldiers, in whom COVID is mild and transient, and there is no justified reason to vaccinate them,” Dr. Yoav Yehezkelli, a specialist in internal medicine and medical management, said on Facebook. “Vaccinating the soldiers was not only folly but a lack of professionalism and a violation of medical ethics.”
Others, like Alon, faced repeated interruptions to their daily lives if they didn’t receive a vaccine, despite evidence suggesting that post-infection immunity is broad and superior to that from vaccination. CDC studies later found that the immunity that develops following recovery, known as natural immunity, was better than vaccination against the Delta and Omicron virus variants. Top U.S. officials made false claims about vaccine effectiveness, such as claiming vaccinated people couldn’t become sick or transmit the virus, in their bid to convince fence-sitters to get vaccinated.
“You can’t make that logical leap even in December of 2020. And yet, they made that logical leap,” Dr. Jay Bhattacharya, professor of health policy at Stanford University’s School of Medicine, told EpochTV’s “American Thought Leaders.” “They premised their policy recommendations—the vaccine passports, the mandates, the coercion, and also the gaslighting of people who are actually vaccine-injured, on this idea that we have to get a sufficient fraction of the population vaccinated for the disease to go away.” The hype around the vaccines led to a number of U.S. universities to mandate them, even after researchers concluded that booster mandates were unethical, in part because they were associated with more serious adverse events than hospitalizations caused. The federal government also imposed mandates on the military, workers, contractors, and private health care facilities. “Our administration’s vaccination requirements helped ensure the safety of workers in critical workforces including those in the healthcare and education sectors, protecting themselves and the populations they serve, and strengthening their ability to provide services without disruptions to operations,” it said in a recent statement. Common Symptoms and TreatmentsNearly all people who develop myocarditis after COVID-19 vaccination suffer from chest pain, doctors have found. A meta-analysis of reports describing 200 cases, for instance, found that 98 percent of patients presented with chest pain. Fever and difficulty breathing were also common symptoms. Patients often suffer symptoms within a week of vaccination, according to case reports, surveillance databases, and patients. Early detection and treatment can be critical to prevent further deterioration. Exercise restrictions are imposed on most patients until they pass a cardiac stress test. The point of the test is to detect lingering problems in a controlled setting, in which the patient exercises at less than maximum capacity, Dr. Anish Koka, a U.S. cardiologist, told The Epoch Times. Problems detected on the test may preclude participation in competitive sports and may require invasive therapies such as defibrillator placement. Some health officials and doctors have said the myocarditis resolves without treatment, but many patients have received drugs. Colchicine, typically used to treat gout, has been favored by many doctors. Mr. Cohen was initially prescribed colchicine. He was directed later to daily take Tritace, an angiotensin-converting enzyme inhibitor that’s meant to treat hypertension following serious problems such as heart failure. Mr. Cutler took aspirin for two weeks. He replaced colchicine with ibuprofen after experiencing back pain. Other treatments include intravenous immunoglobulin, a pooled antibody; beta-blockers; anti-inflammatory medications such as methylprednisolone; and rampiril, another angiotensin-converting enzyme inhibitor.
‘Ignored’Several common themes link the myocarditis patients who are speaking out. That includes the feeling that they were tricked into receiving the shots. “You start to realize that basically the authorities, first of all, they knew about these possible side effects. They just chose not to disclose it, or disclose it only in the few websites in the small letters,” Mr. Cohen said. Mr. Warner recounted growing up on welfare and coming to see the government as being there to help him. He now views parts of the government as corrupted by financial incentives, including the kickbacks it allegedly received from Moderna. Patients also feel abandoned.
“A lot of us are still dealing with significant issues that I think are being ignored,” Dr. Hirschfeld said. It hasn’t helped that U.S. authorities, who have aggressively promoted the vaccines, have refused to provide compensation to many sufferers or otherwise assist them. Just three people who suffered post-vaccination myocarditis have been compensated by U.S. authorities, who are responsible for compensation because the vaccine manufacturers are shielded from liability. The highest payout was just $3,957.66. Both Ms. Ekanayake and Mr. Cutler applied for compensation, but still haven’t heard back. While the bulk of Aiden’s medical bills were covered by insurance, his parents have still had to pay close to $10,000 out of pocket. Mr. Cutler paid about $5,000 due to high deductibles. An enormous backlog of applications remains, and some who have been diagnosed with vaccine injuries have been denied. The myocarditis patients largely spoke about receiving the support of family and friends as they recovered. But not all. “I was disowned by many of my friends for speaking out about this early on,” Mr. Warner said. “It’s been interesting to see so many of them come back around and apologize to me.”
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Amish Paradise?The Amish have discovered the fountain of youthDoc Anarchy
Turns out, the Amish are healthy people. For some reason, this made national headlines, despite everyone with a functioning brain knowing this to be true.
The reason this story blew up is Steve Kirsch’s testimony to the Pennsylvania State Senate a few weeks back. In his testimony, he argued that the Amish were an excellent control group for the vaccinated vs unvaccinated populations. We’ll cover that later in the article.
That same testimony is what I have repeatedly found as the source of the claim that the Amish have zero autism, very little chronic disease, and very little cancer.
Let me start by saying, I haven’t been able to find the actual study. I searched for quite a while and the only thing I could find was this article by The Vigilant Fox . If you aren’t reading Fox’s work, you should. Amish HealthcareEveryone knows the Amish have some peculiar lifestyle traits. They follow strict rules as to what they can and cannot do, live far away from modern civilization, and have a tight-knit community.
Turns out, healthcare isn’t something they are forbidden from accepting. They are welcome, and in some cases encouraged, to seek medical care when needed.
The difference between the Amish and the average American is the Amish seek medical care when they actually need it. Before going to the doctor they seek guidance from elders and other experienced people in the community. They prefer to try natural remedies or home remedies before medicine. They give the body time to heal whatever ails it first.
If the body cannot heal itself and the natural remedies don’t work, they seek medical care from modern healthcare practitioners.
Compare this to the average American who goes to the hospital every time they stub their toe, blasted with X-rays, put on antibiotics, and then transferred to Hospice.
Yes, that’s an exaggeration. But the healthcare utilization rate in most of America is off the charts. Simply staying away from modern healthcare is a good way to extend your life. That means fewer unnecessary tests, a healthier environment, and less risk of medical error.
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Florida Doctor Reinstated After Losing Board Certification for Criticizing COVID-19 VaccinesWith money raised for legal fees, physician plans to help medical students under pressure to submit to ‘woke’ ideology Dr. John Littell speaks at a press conferencein Kissimmee, Fla., on Oct. 13, 2022, about people he says were injured by COVID-19 vaccines and government-recommended treatment protocols for the disease. (Nanette Holt/The Epoch Times) By Natasha Holt
A Florida physician known for being outspoken about COVID-related topics has regained his board certification that was stripped because he publicly criticized COVID vaccines.
Now, Dr. John Littell is moving forward from the experience with plans to help future physicians defend themselves when disciplined for voicing viewpoints that are not in the majority, he told The Epoch Times.
Dr. Littell, a longtime family physician in Ocala and a medical school professor, began posting videos sharing his thoughts about COVID-19 testing, treatments, and vaccines early in the pandemic. He was frustrated to find his content often was pulled down from his YouTube channel.
But he fought against what he saw as censorship by moving the content to other platforms, such as Rumble, he said. Then, in January 2022 and again five months later, he received warning letters from the American Board of Family Medicine (ABFM), the organization that issued his certification for his medical specialty.
The letter stated that his videos on YouTube and Rumble spread “medical misinformation” and could put his board certification in jeopardy, he said.
The ABFM declined to comment on the matter because the board’s “policy indicates we are unable to comment about professionalism cases,” an unidentified spokesperson said in an email to The Epoch Times.
The ABFM is the third largest of the 24 boards of the American Board of Medical Specialties. More than 100,000 family medicine doctors are certified by the board, according to its website.  Protesters concerned about treatment of people who died while being treated for COVID-19 stand outside a board meeting at Sarasota Memorial Hospital in Sarasota, Fla., on Feb. 21, 2023. (Courtesy of Tanya Parus) To keep their certification, physicians must uphold the board’s ethical standards and “guidelines for professionalism, licensure, and personal conduct,” the website states.
In letters from the board, Dr. Littell was told his public statements violated those guidelines. Dr. Littell responded to the letters and continued to speak publicly and post videos about the subjects, he said.
Months later, when he didn’t hear back, he said he thought the threat was gone. “I was very happily under the radar,” he said.
Exposing the FDA’s Orwellian Lie About Ivermectin | CLIP | Facts MatterOutrage Over Ivermectin
That changed after he was escorted out of a Sarasota Memorial Hospital board meeting in February for approaching a board member behind the dais. He wanted to thank the board member, he said, for letting him speak at the meeting. He didn’t realize that move would be seen as inappropriate, he said.
Though he’s cared for many patients in hospitals, he’d never attended a hospital board meeting, let alone a contentious one, he said.
That day, medical freedom activists filled the boardroom to speak against the public hospital’s policies during the COVID-19 pandemic. Many were angry their loved ones were denied the opportunity to try ivermectin, an antiparasitic for humans and animals widely used by some in treating COVID-19, and other treatments.
Dr. Littell spoke cordially to board members from the podium, an Epoch Times reporter confirmed. He told board members how treating patients with ivermectin had been his key to success in helping them recover. And he praised hospital personnel for their work during the pandemic.
Shortly after that, security guards escorted him outside.  Retired Army Gen. Michael Flynn, who served briefly as national security advisor for former President Donald Trump, attended a board meeting of Sarasota Memorial Hospital in Sarasota, Fla., on Feb. 21, 2023 (Chris Nelson for The Epoch Times) A video of Dr. Littell’s removal from the meeting by security guards was posted to social media and received millions of views and media coverage. And that thrust him back in the spotlight as a doctor vocal about COVID-19 policies. He questioned whether someone else would have been removed for the same reason.
Many doctors have faced consequences for questioning the efficacy and safety of COVID-19 vaccines and for advocating for the use of medicines such as ivermectin in the treatment of the disease.
The U.S. Food and Drug Administration (FDA) wrote in one social media post about ivermectin: “You are not a horse. You are not a cow. Seriously, y’all. Stop it.” It linked to a page entitled “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19.”
Three doctors sued the FDA over the statements, saying it had no power to tell doctors which drugs to prescribe. On Sept. 1, a federal court ruled that the agency likely overstepped its authority when it told Americans to “stop” using ivermectin against COVID-19. The FDA can inform, but has “no authority” to recommend consumers “stop” taking medicine, U.S. Circuit Judge Don Willett wrote in the ruling. Accused of ‘Spreading False’ InformationThe month after Dr. Littell spoke in Sarasota, the board sent a letter saying he’d been de-certified for “spreading false, inaccurate, and misleading materials about COVID-19, COVID-19 vaccination, and treatment and mitigation of the virus,” The Epoch Times confirmed.
A letter reviewed by The Epoch Times stated that if Dr. Littell appealed the decision within 20 days, he would continue to be represented by the board, pending a review of his case by the professionalism committee of the ABFM board of directors.
The reason for the decision to review his record was because of his past suggestions the COVID-19 vaccine was a product of genetic engineering, causing deaths in children and causing the rise of the Delta variant, the letter indicated. It also referenced “false” statements made by Drs. Ryan Cole and Robert Malone, who spoke at a medical freedom conference Dr. Littell organized in October 2022.
In the letter, the board also criticized Dr. Littell for “offering to provide medical exemptions from vaccination” to patients across the country and “publicly comparing the U.S. public health system’s response to the COVID-19 pandemic to Nazi Germany.”
After receiving the troubling letter, Dr. Littell sought the help of attorney Jeff Childers, a business attorney in Gainesville, Florida. Since the COVID-19 lockdowns began, Mr. Childers has become active in lawsuits around the country related to medical freedom. He authors a daily blog called Coffee and Covid, which started by chronicling COVID-19 issues and now tracks other social and political issues, as well.
Mr. Childers crafted a 64-page appeal to the board, dissecting every accusation made against Dr. Littell, an Epoch Times reporter confirmed. And as word of the threat to Dr. Littell’s board certification spread—a move that would prevent him from practicing medicine—medical freedom activists rose up to take his side.  Florida attorney Jeff Childers. (Amber Bertrand for The Epoch Times) A GiveSendGo.com campaign was started to collect donations to fund his legal fees. More than 6,400 people donated almost $255,000. And more than 1,900 pledged to pray for Dr. Littell.
The Global Covid Summit, an international group of doctors focused on medical freedom in COVID-19 treatment, sent a letter signed by 169 doctors to the ABFM in support of Dr. Littell. In the letter, they argued that the board was false in every accusation made against Dr. Littell.
Florida Surgeon General Joseph Ladapo also voiced support for Dr. Littell. “What they’re doing is being a bully,” he said in an interview with The Floridian. “It’s not going to age well. “I read the letter from the Board, and it’s dripping with political animosity.” Both Rep. Pete Sessions (R-Texas) and Dr. Littell’s congresswoman, Rep. Kat Cammack (R-Fla.) sent letters in his defense to the board, Dr. Littell said.
“I’ve got to believe it’s not in the dozens, but probably in the hundreds of people who called and sent letters to the American Board of Family Medicine,” Dr. Littell said. “I never asked them to, but that is what was happening.”
In July, Dr. Littell received word that the board had reviewed his case and retroactively de-certified him for three months, from March 16 to June 16. He never stopped seeing patients.
“It’s like a slap on the wrist so they’d feel good about it, but wouldn’t, presumably, have to face any legal action,” he said. His attorney agreed. “They did it in a very face-saving way,” Mr. Childers said. But ultimately, he’s pleased with the decision. “We were really surprised and gratified that we were able to achieve that result,” Mr. Childers said. Dr. Littell credits it to being “a God thing” that he was able to keep caring for patients and face a decertification period only retroactively.
“If they had said I was decertified, I would not have been able to do what I was doing. I mean, especially with the hospital care patients. I could have gotten into big trouble.”
He still may face consequences for having the blemish on his record, he said. He’ll have to report it to the hospitals at which he works and explain what happened, he said.
“Every time I go up for privileges with a hospital or any other institution, they’re going to say, ‘Well, has your license ever been suspended or revoked, and has your board certification ever been revoked?’ So, it’s still an issue. It’s not like you can just forget about it.”
He’s been advised by some other doctors, such as cardiologist Peter McCullough, to pursue legal action for the disciplinary measure they feel was wrong, he said. Continuing to Speak OutDr. Littell continues to speak out about the same topics. So he suspects he’ll face retribution again, he said. “The way I read the letter, it’s sort of like a warning,” Dr. Littell said. The board, he said, seemed to be sending the warning, “If you act up again, we know it’s a privilege to have this board certification, and it can be removed at any time.” And the next time, the punishment is likely to escalate. “The implication is that if it happens again, it’s going to be more than just three months,” Mr. Childers said. Around the country, a slew of doctors had board certifications removed and licensure threatened for sharing their COVID-related opinions.
“Most people would probably be surprised to find out there’s a lot of this going on, now that the pandemic is over,” Mr. Childers said. “From what I’ve heard, there’s probably more challenges to doctor licensing right now than at any other time.”
But because most doctors aren’t vocal about receiving discipline, it’s hard to know exactly how often it’s occurring, he said. Doctors who have been active on social media seem to be targeted more often by medical authorities, he said.  Dr. Peter McCullough speaks in the Mississippi capitol building on COVID-19 vaccine adverse events. (Courtesy of Charlotte Stringer Photography) Doctors who were not actively posting their thoughts about COVID-19 on social media “should feel very confident that if they follow a similar approach to what Dr. Littell did, they could hope for a good result at this point,” he said.
Obtaining good legal advice is key, he said. It also helps to spread the word. “All too often doctors either ignore these kinds of letters until it’s too late because they’re embarrassed, or they try to handle it on their own,” he said.
“It’s important that people know when this happens. And if they’ll let folks know, they’ll find that they get a lot of support.” Dr. Littell has no plans to keep quiet about what he feels went wrong during the COVID-19 pandemic “I’m not letting up,” he said. He’s organizing his third annual medical freedom summit in November called “Food, Family & Medical Freedom” in Ocala, Florida at the World Equestrian Center. Helping Future DoctorsHe intends to use the remaining money donated to his legal fund to help others respond to similar licensure problems, especially threats faced by medical students, he said.
He’s trying “to come up with a legal, legislative, and public relations strategy that helps future physicians,” he said. When they see practicing doctors disciplined and “raked over the coals” for speaking out about medical freedom issues, it deters good people from pursuing a degree in medicine, he said.
“I would like the medical freedom fighters, as I’m calling them, to create a sanctuary for pre-med, especially, and medical school students.”
“Early on, even in the colleges, they weed out the physicians who dare to question the narrative or challenge it,” he said, of those who insist that doctors decrees made by federal health agencies.
But asking questions and challenging prevailing thought is important to the goal of continually improving medical treatments, he said.
“And that intellectual curiosity is what we’re so desperately lacking now in medicine, and in most professions.” He also envisions the network expanding to help connect like-minded educators in colleges, universities, and medical schools to share their ideas without fear of being in opposition to “woke” ideology, he said.
He hopes to see that network push back against “lockstep mentality” and help students who are suffering because of it. Medical students taught by Dr. Littell often tell him how difficult it is to be entering the field of medicine at this time, he said.
One student told him that his second-year class was forced to be vaccinated for COVID-19, he said. Classmates were told by their university they’d be “thrown out” of medical school in two weeks if they didn’t comply, Dr. Littell said.  Medical freedom activists upset about COVID-19 vaccines and other issues gather to voice concerns to lawmakers on the first day of the Florida Legislature’s annual regular session at the Capitol in Tallahassee on March 7, 2023. (Courtesy of Justin Harvey) The student told him that, although more than half the class didn’t want the vaccine, they felt they had no other option, Dr. Littell said. Weeks later, the mandate was lifted. But it was too late—many students already had submitted to getting the shot they didn’t want.
“It’s like they [university officials] were playing games,” he said. “And the students didn’t know any better. “They just don’t have enough support,” Dr. Littell lamented. “They want to say things, but they’re afraid they’re going to get disciplined if they speak out.”
He sees bringing people together to unite in their pushback against prevailing opinions as a revolutionary concept. “It’s really no different than what our Founding Fathers did,” Dr. Littell said. “They realized that they were victims of repression. But there also were people comfortable with the status quo. That’s what is in our medical schools right now and is what we all need to fight against.
“People should be allowed to question and use their God-given intellect, and not be censored or disciplined for doing so.” Zachary Stieber contributed to this report. Natasha Holt |
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People Rarely Transmit COVID-19 Before Experiencing Symptoms: Lancet Studyby Tyler Durden, 06September2023 – https://www.zerohedge.com/medical/people-rarely-transmit-covid-19-experiencing-symptoms-lancet-study
Authored by Tom Ozimek via The Epoch Times (emphasis ours),
In a blow to the COVID-19 “silent spreader” narrative that has been used to push for universal masking, including controversially among schoolchildren, a recent study published in The Lancet suggests that people who are non-symptomatic rarely have the ability to infect others.
Silent transmission is the idea that those who are infected with COVID-19 but show no symptoms can still spread the virus to other people.
While all relevant studies show that presymptomatic and asymptomatic “silent spreaders” account for some proportion of infections in other people, the degree of silent transmission is less clear.
A number of early studies—in some cases affected by limitations that may have led to their proportion of presymptomatic transmission to be “artifactually inflated”—suggested that silent transmission accounted for around half of secondary infections, or even more.
The early studies led public health authorities to argue that everyone should wear a mask at all times when out in public or crowded places. This, in turn, helped drive draconian universal masking policies, including in schools, in a bid to reduce the spread of COVID-19.
For instance, Dr. Anthony Fauci, former director of the National Institute of Allergy and Infectious Diseases (NIAID), initially discouraged universal mask-wearing early in the pandemic but later did a U-turn.
Initially, “we didn’t realize the extent of asymptotic spread,” Dr. Fauci said in July 2020, adding that later, “we fully realized that there are a lot of people who are asymptomatic who are spreading infection.”
“So it became clear that we absolutely should be wearing masks consistently,” Dr. Fauci said at the time. But new research calls into question the significance of the threat of silent transmission, which comes as COVID-19 cases are on the rise in America, driving what some are calling a renewed pandemic “hysteria” and calls for a fresh round of restrictions, including mask mandates. ‘Very Few Emissions’ Before Symptom OnsetThe new study, published in the August issue of The Lancet’s Microbe journal, shows that people who are sick with COVID-19 but don’t show any symptoms have a limited ability to spread the virus to other people.
Participants in the British study, which was carried out by researchers at Imperial College London, were unvaccinated healthy adults aged 18-30 who were intentionally infected with COVID-19.
The subjects were monitored under controlled circumstances while self-reporting symptoms three times per day, and researchers collected nose and throat swabs from them daily, checking for the presence of the virus.
The researchers also tested the inside of masks worn by the participants, checked their hands, and examined the air and surfaces of rooms that the subjects were kept in for a minimum of 14 days. Ultimately, the researchers found that less than 10 percent of the viral emissions from infected participants took place before the first symptoms emerged.
“Very few emissions occurred before the first reported symptom (7%) and hardly any before the first positive lateral flow antigen test (2%),” the authors of the study wrote.
The new study—which takes the form of a rigorous, controlled “challenge study” rather than the earlier modeling studies that relied on subjective inputs and assumptions of researchers—contradicts earlier research that set the tone for much of the prevailing narrative. That early research appears to have inflated the perceived threat of presymptomatic spread.
The latest study, suggesting that silent transmission is far less significant, comes amid a growing drumbeat of alarm as COVID-19 cases, hospitalizations, and deaths are on the rise—along with calls in some circles for renewed restrictions.
By contrast, many are calling for cool heads to prevail—or are urging civil disobedience if lockdowns or other mandates are reimposed. ‘Artifactually Inflated’?Some early studies, such as one published in August 2020 called “Temporal Dynamics In Viral Shedding and Transmissibility of COVID-19,” suggested that people who were presymptomatic or asymptomatic accounted for a large proportion of secondary infections.
This particular study estimated that 44 percent of secondary cases were infected during the presymptomatic stage, while concluding that “disease control measures should be adjusted to account for probably substantial presymptomatic transmission.”
The authors of the study admitted that it had several limitations, however, including potential “recall bias” that may have tended towards a delay in recognizing first symptoms.
“The incubation period would have been overestimated, and thus the proportion of presymptomatic transmission artifactually inflated,” meaning that the study may have exaggerated the proportion of people who spread the virus before showing symptoms, they said.
Another study from July 2020 called “The Implications of Silent Transmission for the Control of COVID-19 Outbreaks” went even further, suggesting that people were most infectious during the presymptomatic phase and concluding that silent transmission was the “primary driver of COVID-19 outbreaks and underscore the need for mitigation strategies, such as contact tracing, that detect and isolate infectious individuals prior to the onset of symptoms.”
That study relied on a range of assumptions and models, with different presymptomatic, asymptomatic, and symptomatic transmission rates calculated based on a complex mathematical model from another study.
Findings from earlier studies like the ones cited above led public health officials to argue that silent spreaders were a big factor in COVID-19 transmission and so to recommend that everyone should mask up. |
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COVID-19 Vaccines Revealed as ‘Neither Safe, Nor Effective’: WatchdogThe vaccines were hastily approved through an ‘interim order’ that enabled pharma companies to bypass approved procedures.By Naveen Athrappully
COVID-19 vaccines were authorized in Canada during 2020 and 2021 without being subjected to the country’s safety tests as required under established drug regulations, an accountability watchdog revealed.
An investigation into COVID-19 vaccines found that they were “neither safe nor effective,” according to the nonprofit organization National Citizens Inquiry (NCI). The organization published a report on Sept. 14 detailing the flawed mechanism through which the vaccines were granted “approval” in Canada.
“It is important to understand that the COVID-19 vaccines were never approved under the traditional approval process for drugs in Canada,” the report states (pdf). Instead, Health Canada, the federal agency responsible for national health policy, approved the vaccines through an alternative authorization process—an interim order.
“Under the alternative authorization process, the necessity to establish the safety and efficacy of COVID-19 vaccines through an objective manner appears to have been set aside,” the report states.
Canada’s Food and Drug Regulations require that a drug can only be approved in the country after its safety and effectiveness are demonstrated to the minister of health. Then, the minister considers whether the benefits outweigh the risks, following which, approval is granted.
Instead of following regulations, the minister of health sanctioned an interim order on Sept. 16, 2021, which exempted all COVID-19 vaccines from normal review and approval. This provision usually allows the minister to override normal regulations in situations of “significant risk” to health, safety, or the environment.
In Canada, four COVID-19 vaccines were authorized by the health agency under an interim order—Pfizer-BioNTech, Moderna, Janssen, and AstraZeneca.
The report notes that under the order, vaccines were authorized under a “subjective test.” In this situation, authorization is granted by simply proving that the benefits of vaccination outweigh the risks.
“This cannot be an appropriate standard for approving a drug that the Government intends to administer to the entire population. It is difficult to conceive of a less-scientific test for drug authorization than that found in the Interim Order,” the report states.  A child receives a dose of the Pfizer-BioNTech COVID-19 vaccine at the Fairfax County Government Center in Annandale, Va., on Nov. 4, 2021. (Chip Somodevilla/Getty Images) Moreover, the order made sure that the vaccine authorizations couldn’t be revoked even under evidence that they were unsafe and ineffective. Once an interim order is issued, the typical Food and Drug Regulations don’t apply.
The order thus exempted manufacturers from having to effectively demonstrate “objective evidence of safety and effectiveness” of their COVID-19 vaccines.
“The result was that while chief medical officers across the country repeatedly assured Canadians that the COVID-19 vaccines were ‘safe and effective’—the general Canadian population had no understanding that their authorization process had not required objective proof of safety nor efficacy,” the report states. ‘Not Safe for Human Use’The NCI report was supported by cardiologist Dr. Peter A. McCullough. “Excellent work @Inquiry_Canada with exhaustive testimony and evidence review. Conclusion: all COVID-19 vaccines unsafe for human use and must be removed from the Canadian market immediately to protect the public,” he wrote in a Sept. 16 post on X. Dr. Peter McCullough, a cardiologist, speaks at the Conservative Political Action Conference at the Hilton Anatole in Dallas on Aug. 5, 2022. (Bobby Sanchez/The Epoch Times) Dr. McCullough recently asked European lawmakers to take COVID-19 vaccines off the market due to concerns about illnesses such as heart inflammation, blood clots, and neurological diseases.
“COVID-19 vaccines and all of their progeny and future boosters are not safe for human use. I implore you, as a governing body, European Medicines Agency, to apply all pressure and due urgency to remove the COVID-19 vaccines from market,” Dr. McCullough said in Sept. 13 testimony to the European Parliament.
The NCI report comes as the U.S. Food and Drug Administration (FDA) approved new COVID vaccines on Sept. 11 for children as young as 6 months old.
“Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” Dr. Peter Marks, a top FDA official, said in a statement.
However, many experts have questioned the push for new vaccines. Earlier this month, Florida Surgeon General Dr. Joseph Ladapo criticized the updated vaccines.
“We all know there’s a new vaccine that’s coming around the corner, [a] new mRNA COVID-19 vaccine. And there’s essentially no evidence for it,” he said during a press conference.
“There’s been no clinical trial done in human beings showing that it benefits people, there’s been no clinical trial showing that it is a safe product for people. And not only that, but then there are a lot of red flags.”
Dr. Ladapo said that mRNA COVID-19 vaccines have “caused cardiac injury in many people.” Not Actually ‘Interim’Canada’s interim order for COVID-19 vaccines “has become permanent,” according to the NCI report. An interim order typically only lasts for one year. In March 2022, the order was replaced with permanent regulations, which codified the “subjective authorization” of the vaccine.
“Thus, under the permanent test, Health Canada no longer has to be swayed by urgency, but simply by the public health need related to COVID-19. In this way, it seems that so long as COVID-19 is a circulating virus, Health Canada must authorize any vaccine for which there is an argument to support the conclusion that its benefits outweigh its risks,” the report states.
“In effect, we fear that there will never be a need for COVID-19 vaccine manufacturers to prove [the] safety or efficacy of their products.”
NCI also alleged there was a “conflict of interests” while approving the COVID-19 vaccines, with the government being involved.
The Epoch Times reached out to Health Canada for comment but didn’t receive a reply by press time. Political Interests, Letter to TrudeauCanada usually doesn’t allow drugs to be imported into the country unless approved by Health Canada. However, the interim order allowed the unapproved COVID-19 vaccines to be imported “as long as the Canadian Government was the purchaser,” according to the report.
This pre-purchasing and distribution of COVID-19 vaccines were done to make sure that they were available for dissemination as soon as they were authorized.
“This created a tremendous conflict of interest,” the report states. “Once the vaccines were purchased, imported and ready for distribution, the Government of Canada would have suffered significant political blowback if it was unable to authorize them. Thus, it needed to authorize the COVID-19 vaccines, and it needed to do it quickly.
“The Government of Canada ordered the vaccines, imported them, created new regulations to authorize them, and then took significant measures to convince and coerce every Canadian to take multiple doses. The political stakes were high, and the federal government had every motivation to get the vaccines authorized, regardless of their actual efficacy or safety.”
On Sept. 14, the NCI sent a letter (pdf) to Canadian Prime Minister Justin Trudeau highlighting the issue of COVID-19 vaccine approval.
“Canadians are relying on representations as to the safety and effectiveness of COVID-19 vaccines,” which Health Canada has never determined, the letter said. “Some might draw the conclusion that the misrepresentation to Canadians of proven safety is intentional, made while knowing it to be false and intending it to be relied upon.
“As a matter of common sense, the objective falsity of the ‘proven safe’ claim brings into question the basis for informed consent to the administration of the injections, creating potentially enormous liabilities.”
In the current context, the organization pointed out that the population immunity has increased along with the latest variants being “milder.”
“In the face of your government’s reported intention to promote booster injections in coming months, the urgency now lies in telling the truth to Canadians and taking corrective action,” the letter reads.
The NCI asked the prime minister to withdraw COVID-19 vaccines “until the normal rigorous evaluation can be completed” and to reinstate the traditional objective test for safety.
Naveen Athrappully
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Pfizer-Funded Study Shows Poor Effectiveness for COVID-19 Vaccine in Young ChildrenThree doses of the Pfizer vaccine provided little protection against emergency room visits, urgent care encounters, or outpatient visits.By Zachary Stieber
A new study funded by Pfizer found the company’s COVID-19 vaccine did not perform well in children under 5.
Children aged 6 months to 4 years are supposed to receive three shots of the Pfizer-BioNTech vaccine. The number was increased from two when early testing showed little effectiveness.
Three doses of the Pfizer vaccine provided little protection against emergency room visits, urgent care encounters, or outpatient visits, according to the new study.
Researchers with and funded by Pfizer analyzed records from Kaiser Permanente Southern California. They included patients who tested for COVID-19 at an emergency department, urgent care, or outpatient setting along with being diagnosed with acute respiratory infection. The date range was July 23, 2022 through May 19, 2023.
Positive cases were those with a positive test result. Controls tested negative and had no evidence of prior infection in the past 90 days. Children were only counted as vaccinated if they received a second or third shot two or more weeks before being exposed to COVID-19. Children were excluded if they only received one dose, received any doses from a different company, or did not follow the recommended dosing schedule.
After adjusting for factors such as age and sex, researchers estimated just 12 percent effectiveness against medically-attended encounters for children who completed the three-dose primary series.
Confidence intervals crossed well over one, indicating that the effectiveness might actually be worse or even negative.
The effectiveness was estimated to be higher, or 44 percent, for children who received two doses of the regimen
Researchers speculated that the difference stemmed from more immune-evasive virus variants becoming dominant in the United States by the time children received a third dose.
“Updated vaccines will likely be needed to maintain protection against contemporary Omicron strains in young children,” they wrote.
The study was published by the Journal of the American Medical Association.
Sara Tartof, the study’s corresponding author and an employee of Kaiser Permanente Southern California, did not answer questions, including why researchers included those with two doses but not those with one dose.
Pfizer did not return a request for comment. A child receives a dose of the Pfizer-BioNTech COVID-19 vaccine at the Fairfax County Government Center in Annandale, Va., on Nov. 4, 2021. (Chip Somodevilla/Getty Images) Key Problems
FDA Detects Serious Safety Signal for Covid Vaccine Among Kids
Among the key problems with the research were only including children who were diagnosed with acute respiratory infection (ARI), Dr. Robert Malone, who was not involved in the research, said.
That “may predispose to young children that lack a primary care physician/pediatrician,” Dr. Malone, who helped invent the mRNA technology Pfizer’s vaccine utilizes, told The Epoch Times via email.
“Likewise, the control group of non-vaccinated with ARI will also have selection bias. These intrinsic study biases make the relevance of the measured outcome to the general population quite problematic.”
Another issue is using positive results on polymerase chain reaction testing as the metric for having COVID-19, given the false positives the testing brings, Dr. Malone said. Some patients who tested positive may actually have another virus, such as influenza, he said. Need a TrialPfizer’s vaccine was authorized for children despite unreliable efficacy estimates against infection, and no efficacy estimates against severe disease.
The newly reported results are based on a test-negative design, which is inappropriate for measuring effectiveness, said Dr. Jay Bhattacharya, professor of health policy at Stanford University.
“The design starts with children who are already seeing a doctor and then makes strong and unsupportable statistical assumptions to derive the probability of seeing a doctor for vaccinated and unvaccinated children,” Dr. Bhattacharya, who was not involved in the research, told The Epoch Times via email.
“What is needed to answer this question without bias is a randomized control trial. I am shocked that the FDA has not asked Pfizer and Moderna to conduct such a study,” he added.
The U.S. Food and Drug Administration (FDA) cleared Pfizer’s shot on the basis of immunobridging, or comparing antibody levels in children after vaccination with levels in adults after vaccination.
Antibodies are believed to protect people against COVID-19.
The authorization has been the subject of protests, including a complaint that said the FDA violated its own standards with the clearance.
The FDA this month cleared new vaccines from Pfizer and Moderna for children. The only trial data was from 50 people aged 12 or older who received Moderna’s shot. The U.S. Centers for Disease Control and Prevention (CDC) recommended the shots to all people aged 6 months and older. CDC DataCDC data presented on Sept. 12 showed that both the Pfizer and Moderna vaccines failed to provide much protection to young children.
One dose of Pfizer’s vaccine provided just 8 percent protection against emergency room and urgent care visits beyond 13 days, while two doses provided a peak of 44 percent protection, according to the data (pdf).
A third dose provided 71 percent protection between 14 and 59 days, but the shielding plunged to 16 percent after two months.
A two-shot primary series of Moderna’s shot initially provided 46 percent protection. That shielding dropped even lower, to 24 percent, beyond 60 days.
The World Health Organization considers 50 percent as adequate effectiveness for vaccines.
A single dose of a bivalent shot, introduced in the fall of 2022, boosted protection to 61 percent, but no estimates were available over time and the estimate was based on just eight vaccinated patients who tested positive.
“This imprecision indicates that the actual [effectiveness] could be substantially different,” the CDC said.
Zachary Stieber
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FDA, CDC Hid Data on Spike in COVID Cases Among the Vaccinated: DocumentsBy Zachary Stieber
COVID-19 cases among vaccinated seniors soared in 2021, according to newly disclosed data that was acquired by U.S. health agencies but not presented to the public.
Humetrix Cloud Services was contracted by the U.S. military to analyze vaccine data. The company performed a fresh analysis as authorities considered in 2021 whether COVID-19 vaccine boosters were necessary amid studies finding waning vaccine effectiveness.
Humetrix researchers found that the proportion of total COVID-19 cases among the seniors was increasingly comprised of vaccinated people, according to the newly disclosed documents.
For the week ending on July 31, 2021, post-vaccination COVID-19 cases represented 73 percent of the cases among people 65 and older, the company found. The elderly were 80 percent fully vaccinated at the time.
Breakthrough infection rates were higher among those who were vaccinated early, the researchers found. They estimated that the rates were twice as high in those who had been vaccinated five to six months prior, when compared to people vaccinated three to four months before.
The breakthrough cases started in January 2021, according to the data.
Protection against hospitalization was also fading, researchers discovered. In the week ending on July 31, 2021, 63 percent of the COVID-19 hospitalizations in seniors were among the fully vaccinated, according to the documents. The same pattern of weaker protection among people who were vaccinated early was found.
It’s Really Happening: Vaccine and Mask Mandates, Contact-Tracing RETURN
Researchers calculated that the vaccine effectiveness (VE) against infection was just 33 percent while the effectiveness against hospitalization had dropped to 57 percent.
Seniors who previously had COVID-19 and recovered were more likely to avoid hospitalization, the researchers also found. Risk factors included serious underlying conditions such as obesity and being in the oldest age group, or older than 85.
The cohort analysis was completed on 20 million Medicare beneficiaries, including 5.6 million seniors who received a primary series of a COVID-19 vaccine.
“Our observational study VE findings show a very significant decrease in VE against infection and hospitalization in the Delta phase of the pandemic for individuals vaccinated with either the Pfizer or Moderna vaccine for those 5–6 months post vaccination vs. those 3–4 months post vaccination,” Dr. Bettina Experton, Humetrix’s president and CEO, said in a Sept. 15, 2021, email to top U.S. Food and Drug Administration (FDA) officials.
Humetrix also found that among the beneficiaries, there had been 133,000 cases, 27,000 hospitalizations, and 8,300 intensive care admissions among the fully vaccinated since the start of the COVID-19 pandemic.
Dr. Experton disclosed that Humetrix shared the data with the U.S. Centers for Disease Control and Prevention (CDC) in August 2021.
“It would have been nice to know [the military] was conducting this prior to now. Also might have been nice for CDC to share the data,” Dr. Peter Marks, one of the FDA officials, told colleagues in response.
“This is more worrisome than the other data we have in my opinion,” Dr. Janet Woodcock, the FDA’s acting commissioner at the time, said in reply.
The presentation and emails were obtained by the Informed Consent Action Network, a nonprofit that seeks to provide transparency around medical issues, through the Freedom of Information Act (FOIA).
“It is hard to see this as anything other than a failure of our health authorities to assess, share, make public, and act upon valuable, real-world data in the midst of a so-called pandemic,” Del Bigtree, founder of the network, told The Epoch Times via email. “And without FOIA, the public likely would never be made aware of these failures which, of course, allows them to be perpetrated again and again.”
The FDA and CDC declined to comment. Dr. Francis Collins, the director of the U.S. National Institutes of Health at the time, wrote in a separate email obtained through FOIA that the results of the study provided “pretty compelling evidence that VE is falling 5–6 months post vaccination for both infection and hospitalization for those over 65.”
He added, “Even for those 3–4 months out there is a trend toward worsening VE.” The CDC, FDA, and National Institutes of Health did not share the data with the public as they considered whether to clear and recommend COVID-19 vaccine boosters.
The CDC held a meeting with its vaccine advisers on Aug. 30, 2021. During the meeting, CDC officials went over emerging data on waning vaccine effectiveness. But the military study was not included.
The FDA held a similar meeting on Sept. 17, 2021. The CDC participated. The Humetrix analysis was also not presented during that meeting.
Both agencies have aggressively promoted COVID-19 vaccines throughout the pandemic, including hyping them as strongly protective against severe disease even after their own data have suggested that is not the case.
The CDC did present (pdf) data from COVID-NET, one of its systems, that showed effectiveness against COVID-19-associated hospitalization was falling among the elderly since the emergence of the Delta variant but that data still showed 80 percent effectiveness.
The presentation also included data from outside researchers and Israel that estimated the protection during the Delta era against infection ranged from 39 percent to 84 percent and that the effectiveness against hospitalization ranged from 75 to 95 percent.
The FDA ended up clearing a Pfizer booster for many Americans. The CDC advised most people to receive it. The agencies later expanded booster clearance and recommendations to virtually all Americans aged 5 and older, with Moderna’s shot as another option. Authorities have since replaced the old shots due to their lack of durability, and are preparing to roll out another slate of shots this fall.
Zachary Stieber Zachary Stieber is a senior reporter for The Epoch Times based in Maryland. He covers U.S. and world news. |
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Forensic Analysis of Deaths in Pfizer’s Early mRNA Vaccine Trial Found Significant InconsistenciesResearchers are calling into question Pfizer’s early trial data on its original COVID-19 vaccine after a forensic analysis revealed significant problems.By Megan Redshaw
A group of researchers are calling into question Pfizer’s and BioNTech’s early trial data on its original COVID-19 vaccine after a forensic analysis revealed significant inconsistencies between data in the companies’ six-month interim report and publications authored by Pfizer/BioNTech trial site administrators.
The preprint, published on Sept. 4, showed trial subjects vaccinated with Pfizer’s COVID-19 vaccine experienced a 3.7 times increase in cardiovascular deaths compared to placebo controls—a “significant adverse event signal” not disclosed by Pfizer when the vaccine was authorized for emergency use. In addition, the analysis found numerous instances where Pfizer/BioNTech attributed potential vaccine-associated deaths to other causes and undermined vaccine safety data. Clinical Trial ‘Cause of Death’ Unsupported by DocumentationResearchers from the DailyClout Pfizer/BioNTech Documents Investigations Team assessed data from Pfizer’s original phase two/three clinical trial involving 44,060 subjects equally divided into two groups. One group received a dose of Pfizer’s COVID-19 vaccine, and the other received a placebo. As part of their analysis, researchers reviewed the cause of death forms (CRFs) of 38 trial subjects who died during the study period from July 27, 2020, to March 13, 2021, the end date of the clinical trial.
They found that 14 of the 38 deaths—more than one-third of deaths—resulted from cardiovascular events, accounting for the difference between the 21 deaths in the vaccination arm compared to the 17 deaths in the placebo arm. In numerous cases, researchers found that documentation did not support the cause of death diagnosis or allow one to rule out the possibility of a cardiovascular event with an autopsy.
“In general, our review of the CRFs found them to be lacking in detail and extremely difficult to interpret and develop a good timeline of events,” researchers wrote. “Often, a subject’s pre-trial clinical history was absent. Absent also were results of the extensive array of medical testing carried out at the pre-trial screening and at other regularly scheduled visits.”
Absent test results included complete blood counts, metabolic tests, pregnancy tests, COVID-19 tests, a comprehensive list of active medications, and other tests that would have provided clarity on a subject’s overall health. Although more detailed clinical data on the trial subjects exists, the researchers said it is being withheld. Given the limitations of what Pfizer provided, the researchers said the information in the CRFs was often insufficient to support the investigator’s conclusions regarding the cause of death.
The researchers also noted frequent communications between Pfizer/BioNTech physicians and trial site medical staff about the CRFs, some of which were over 400 to 900 pages. Pfizer Used Earlier Data Cutoff and Unblinded Control GroupAccording to the analysis, Pfizer excluded the 38 deaths from information provided to the U.S. Food and Drug Administration (FDA) during its December 2020 meeting where its vaccine advisory panel was considering whether to authorize the Pfizer/BioNTech vaccine for emergency use.
When Pfizer/BioNTech submitted its application for Emergency Use Authorization (EUA) on Nov. 20, 2020, to the FDA, the application described clinical trial results using a cutoff date of November 14, 2020, even though the end date of the trial was March 13, 2021. Researchers said the earlier cutoff date concealed mortality data from the clinical trial.
“Both Pfizer presenters and the FDA committee failed to ask for and review deaths that occurred in the clinical trial participants after the data cutoff. As a result, they missed a more than three-fold increased risk of cardiovascular death with the Pfizer-BioNTech COVID-19 vaccine,” cardiologist Dr. Peter McCullough told The Epoch Times in an email.
“If the FDA presentation with core slides had been presented with accurate, updated data, the Pfizer COVID-19 vaccine should not have been approved because of safety concerns,” he added.
Twenty weeks into the clinical trial on Dec. 11, 2020, Pfizer’s COVID-19 vaccine received EUA from the FDA, and the agency allowed Pfizer to unblind its control group. Unblinding occurs when study participants are told whether they received a vaccine or a placebo, and placebo subjects are permitted to get vaccinated. All but a few chose to receive the vaccine.
All subjects continued to be followed for 24 months and deaths were reported to Pfizer/BioNTech. Pfizer called the period from Dec. 11, 2020, to Jan. 24, 2021, the “open-label follow-up period” without explanation, and the period from Jan. 25, 2021, to the end date of the trial, March 13, 2021, as the cutoff date for the six-month interim report. According to the analysis, this made it easier to conceal deaths potentially linked to the vaccine.
A comparison of the number of deaths during the 33-week study period found no considerable difference between the deaths in the vaccinated versus the placebo groups for the first 20 weeks. After week 20, when participants in the placebo group were unblinded and vaccinated, deaths among the remaining unvaccinated cohort of this group slowed and then plateaued, while deaths in vaccinated subjects continued at the same rate. These inconsistencies were not explained by Pfizer/BioNTech or reported to the FDA, according to the analysis. Vaccinated Placebo Group Death Cases Used to Obscure Trial DataDocuments obtained through the Freedom of Information Act (FOIA) show that 462 subjects (pdf) in the placebo group received a dose of Moderna’s COVID-19 vaccine, with deaths reported attributed to the unvaccinated control group, and the analysis identified numerous instances where Pfizer/BioNTech undermined potential vaccine-related deaths or used complex terms to obscure trial data.
For example, a 65-year-old male with a medical history of pulmonary fibrosis and hypertension was in the trial’s placebo arm. He received doses 1 and 2 of the placebo on Sept. 30, 2020, and Oct. 21, 2020, respectively. After Pfizer/BioNTech unblinded the trial, he received his first dose of Moderna’s COVID-19 vaccine on Dec. 23, 2020. Five days later, on Dec. 31, 2021, he reported symptoms of COVID-19 and was admitted to the hospital.
While hospitalized, he became hypoxic and was intubated. Efforts to treat him failed, and he died on Jan. 11, 2021. Pfizer’s six-month interim report lists the subject as a “discontinued subject” and classified the death as a placebo death with COVID-19 as the secondary cause of death. The researchers said the subject should have been discontinued from the clinical trial entirely because he received a “non-study COVID-19 vaccine.”
Another trial subject, a 53-year-old male with a history of chronic obstructive pulmonary disease and “stress-related myocardial infarction,” died suddenly from “cardiopulmonary arrest” less than two months after receiving his second dose of Pfizer’s COVID-19 vaccine. According to the analysis, the trial site’s medical monitor listed the cause of death as “cardiopulmonary arrest related to myocardial infarction.” Days later, Pfizer/BioNTech told the trial site that multiple causes of death could not be entered on the CRF and requested that “related to myocardial infarction” be deleted.
When the medical monitor wouldn’t alter the entry’s wording, Pfizer/BioNTech overrode the trial site and changed the cause of death to “cardiopulmonary arrest,” omitting “myocardial infarction” as a secondary cause of death. Pfizer/BioNTech did not explain why a specific diagnosis of a serious adverse event was later changed to something undefined.
Another vaccine subject died within three days of receiving his first Pfizer vaccine dose. The medical examiner attributed the death to the progression of atherosclerotic disease, and Pfizer listed the cause of death in its six-month interim report as “atherosclerosis.”
However, atherosclerosis was not documented in the subject’s CRF as a comorbidity of the patient, nor did the subject’s CRF include the pre-screening portion of comorbidities that would have shown whether the subject had a history of atherosclerosis. Furthermore, an autopsy would have confirmed whether the subject died from atherosclerosis, but autopsy results were unavailable. The subject’s death was attributed to an underlying disease, yet the researchers said there is “no basis for ascribing the subject’s death to advanced atherosclerosis or concluding that the death was unrelated to the vaccine” when the subject died “within a day or two” of vaccination.
Another subject died 76 days after receiving the first placebo dose. The primary cause of death was first listed as diabetes mellitus based on the subject’s medical history. Yet the diagnosis was revised several times, despite the “presence of very high blood glucose levels,” until COVID-19 pneumonia was listed as the secondary cause of death. In addition, the subject was HIV positive with an HIV RNA load over the acceptable limit for inclusion in the trial.
“The FDA should review these data immediately in addition to the mounting safety data and peer-reviewed manuscripts on vaccine injuries, disabilities, and deaths and move swiftly to remove all COVID-19 vaccines from the market,” Dr. McCullough said. FDA and Pfizer Attempted to Hide Health Outcomes of Trial Participants: Preprint ResearchersWhen Pfizer/BioNTech filed its EUA in November 2020, the FDA didn’t make the application containing clinical data available on its website for the general public or the medical community to evaluate until Dec. 11, 2020. Although an article was published on Dec. 10, 2020, in The New England Journal of Medicine disclosing the interim results of the trial, it was authored by the trial site administrators who were “intimately aware of the trial’s findings,” researchers said.
The following year, in September 2021—after the Pfizer/BioNTech vaccine had received EUA—the same trial site administrators published another paper in The New England Journal of Medicine on the safety and efficacy of Pfizer’s COVID-19 vaccine through six months.
With the “knowledge and approval” of the FDA, the preprint researchers said Pfizer and the FDA had no plans to disclose the clinical trial data that formed the basis of EUA for the Pfizer/BioNTech vaccine for 75 years, including the health outcomes of the 44,060 subjects who participated in the original trial. It wasn’t until the Public Health and Medical Professionals for Transparency filed a FOIA lawsuit to obtain the original clinical trial data involved in the licensing of Pfizer/BioNTech’s Comirnaty vaccine that data was made available and the problems with the initial clinical trial were revealed.
Release of the data to the Public Health and Medical Professionals for Transparency site began early in June 2022 and was projected to take eight months to complete. They have taken much longer than estimated and documents continue to be downloaded.
“Had it not been for the successful court case brought by the Public Health and Medical Professionals for Transparency, no one outside of the Pfizer and BioNTech corporations would have had the opportunity to investigate the original data generated by this clinical trial and none of the discrepancies reported here would have been revealed,” they added.
The researchers said their analysis provides evidence the decision to authorize the Pfizer COVID-19 vaccine as a safe and effective means of controlling the pandemic was not an “informed decision based on an unbiased, thorough, and transparent evaluation of the evidence.”
Despite early warning signals and other reported adverse events in the post-marketing of mRNA vaccines, the Pfizer vaccine has not been removed from the market and has been approved for the nation’s youngest children. At the very least, the researchers said they hope their analysis will inform physicians and other medical professionals of the dangers of the mRNA vaccines so that they can better advise their patients on the personal risks compared with the benefits of getting vaccinated. “This would return healthcare decisions back to individuals and their medical providers where it belongs.”
The Epoch Times has contacted both Pfizer and the FDA for comment and has not yet received a response. Author (J.D.) Megan Redshaw is an attorney and investigative journalist with a background in political science. She is also a traditional naturopath with additional certifications in nutrition and exercise science. |
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Israeli Ministry of Health Mask Fear Porn PropagandaJerusalemCats Comments: This is the only mask you need.  Friday the 13th Horror Movie, Jason Yoorhees  Friday the 13th Horror Movie, Jason Yoorhees From the propaganda site called Arutz 7
Is COVID coming back? Health Ministry recommends masksMinistry of Health recommends that people at high-risk use a mask in closed places to minimize the risk of infection.Israel National News
The Ministry of Health said on Tuesday evening that there is a moderate increase in the number of people hospitalized from coronavirus in Israel.
“The ministry constantly monitors the morbidity trends and variants of the coronavirus and, as of this moment, a moderate increase in the number of hospitalized patients is evident in Israel. Both in Israel and in the world, there are a number of variants that cause morbidity,” it said.
Ahead of the holidays and as a result of the increase in morbidity, the Ministry of Health recommends that if a person is in a high-risk group or wishes to reduce the risk of infection, use of a mask in closed places with many people is advised. It is also recommended that a mask be used when meeting with people who are in high-risk groups. The Ministry of Health stated that it is important for a patient with symptoms to remain in isolation until the symptoms pass, and added that if a sick person needs to go outside, it is recommended that he wear a mask.
It was also noted that “it is important to maintain awareness and be tested at home for early detection when there is a suspicion of illness. The ministry is preparing to provide dedicated vaccines against the new subvariants in the near future.”
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Dear fully vaccinated: The newly approved COVID shot is NOT a booster – it is literally a new (untested) vaccine15September2023 // Ethan Huff // https://www.naturalnews.com/2023-09-15-new-covid-shot-not-booster-kathy-hochul.html
If you already previously got “vaccinated” and “boosted” for the Wuhan coronavirus (COVID-19), congratulations: you accomplished absolutely nothing except for the destruction of your immune system because the latest circulating COVID “variants” are no match for anything other than the newest COVID jabs to be approved by the U.S. Food and Drug Administration (FDA).
This is basically what New York Gov. Kathy Hochul told her constituents this week following the FDA’s decision to approve and emergency use authorize (EUA) the “updated” COVID jabs from Pfizer and Moderna.
According to Hochul, all previous COVID injections are ineffective against newer variants like Omicron XBB.1.5. As such, the fully vaccinated will need to head on down to the clinic once again to take these latest Big Pharma shots if they hope to stay protected this fall and winter.
“It is literally a new vaccine,” Hochul said, delivering that line in her best “valley girl” voice. “It is not a booster shot. It is not an enhancer. It is a new vaccine designed to attack the new variants.”
Put another way, Hochul is basically saying that Operation Warp Speed did nothing, and that now everyone must get jabbed once again if they wish to survive COVID 2.0.
(Related: Did you know that Kathy Hochul wants to ban gas stoves in the state of New York because of “global warming?”)
Hochul: Refusing to take newest COVID jabs means you’re selfishIf that message alone is not enough, Hochul went on to state that this is all no big deal because Americans have already been getting jabbed again and again since the beginning.
“We’ve done this since March 2020 – no reason to stop now,” Hochul said, trying to be funny. “Don’t think about just yourself.”
“Tell everybody: Don’t rely on the fact that you had a vaccine in the past – it will not help you this time around,” she further emphasized. “Even for healthy adults, COVID is serious – you don’t want to get it.”
In other words, do not be upset that you already took two, three, four, or even more COVID jabs because the government promised you would be protected, only to have that protection disappear in an instant because oopsie. No, you should instead just shut up, stop being selfish and just get jabbed again, according to Hochul.
Playing the part of bureaucrat doctor, even though she is barely qualified to run a hot dog cart, Hochul promised New Yorkers that if they will just agree to take this new shot, then that will be the end of getting COVID jabbed – for now, anyway.
“I will be getting my vaccine very soon,” Hochul promised unconvincingly. “This news is coming at a perfect time. My team just got off a call with the FDA confirming the COVID vaccine is on its way to New York.
“The updated vaccine guards against the newer COVID strains because it was built off the Omicron … variant – that’s what we’re calling it. It’s really a customized vaccine … We’re waiting to find out what age groups the FDA and CDC are recommending should get the shot … You only need one, no more double doses, and again, this will be starting here in New York on Friday.”
Hochul would end her propaganda speech by reiterating the same tired lie that “the vaccine has always been the best way to protect yourself and your community against COVID-19,” even though she said earlier in the speech that “the vaccine,” referring to the old vaccines, have failed.
Want to keep up with the latest news about what becomes of folks who take the newly approved COVID jabs from Pfizer and Moderna? You can do so at Vaccines.news.
Sources for this article include:
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