This document is part of an archive of postings by John Ray on Dissecting Leftism, a blog hosted by Blogspot who are in turn owned by Google. The index to the archive is available here or here. Indexes to my other blogs can be located here or here. Archives do accompany my original postings but, given the animus towards conservative writing on Google and other internet institutions, their permanence is uncertain. These alternative archives help ensure a more permanent record of what I have written.
This is a backup copy of the original blog
Below is the backup of this blog for October, 2023. To access the backups in earlier years, click here
31 October, 2023
Covid Inquiry An Embarrassment To The English Legal System
Its exorbitant costs already cannot be justified, and there is only worse to come. It should be abandoned
Of all the crass misappropriations of scientific principles during the pandemic, none did more harm than the corruption of the ‘precautionary principle’.
The notion that an action or an intervention is justified only once one is clear that the benefits exceed the harms and that, as one sociologist put it, “you have looked very hard for the harms”.1
That principle came to be almost wholly inverted in the context of the pandemic: an intervention seemingly could be justified on the ‘precautionary’ basis that if it might have any beneficial effect in slowing the course of the pandemic, it would be worthwhile.
This justified indiscriminate measures ranging from universal masking, mass testing (including of young children), 14 day isolated quarantines, and even lockdown itself, for entire healthy populations on the basis that even though the evidence base was often weak or non-existent, the intervention just might achieve something, and opened the door to a slew of harms impacting almost all cohorts of the British population.
It was to be hoped that a core task for the Covid Inquiry in this key Module 2 would have been a dispassionate objective assessment of whether the costs (financial costs, direct harms, probable indirect harms, risk of unquantified future harms) of the Government’s population-wide interventions outweighed possible benefits.
So, it was deeply disappointing last week to see not only key witnesses but the Inquiry Chair herself repeat the same dangerous misconception of the precautionary principle.
In one of the most jaw-dropping interjections of the Inquiry to date, Baroness Hallett appears to have revealed a prejudgment that if masking people could have had even the slightest of benefits, and seemingly without even contemplating that risks and known harms might need to be weighed too, it should have been imposed.
She pressed Sir Peter Horby, an esteemed epidemiologist at Oxford University, who had indicated that he believed universal masking was not a straightforward decision:
“I’m sorry, I’m not following, Sir Peter. If there’s a possible benefit, what’s the downside?”
Coming from the independent Chair of a public inquiry, this is an astonishing comment.
It betrays a presumption, or at the very least a predisposition, to accept that it was better to act than not to act — the reverse of the precautionary principle. When a comment such as this, from the Chair of the Inquiry, goes unchallenged, it risks anchoring the entire frame of reference for the Inquiry’s interrogation of this critical topic.
In our view it was a surprising and serious error of judgment for an experienced Court of Appeal judge.
What made Baroness Hallett feel this to be an appropriate thing to think, let alone say out loud? We suggest the issue may be that the Chair and the official counsel to the Inquiry appear already to have the storyline of the pandemic wrapped up.
The Inquiry’s counsel has been at pains to paint a picture of the country facing an almost existential threat from the virus. From the outset, counsel has framed their questioning on the basis that it was indisputable a “highly dangerous fatal viral outbreak was surely coming”,2 and “… by February this viral, severe pandemic, this viral pathogenic outbreak is coming, and it can’t be stopped…”.3
Even hardened lawyers and epidemiologists, it has seemed, were bunkering down because “the virus was coming, it was a fatal pathogenic disease …”.
And, with the precautionary principle inverted in the collective mind of this Inquiry, almost anything the Government then did against that backdrop was justified.
With Preference…
Worse still, it is now starkly evident that the witnesses whose opinions and perspectives support that proposition are being overtly praised and pedestaled; while those whose opinions and perspectives might cast doubt are treated with prejudice and hostility.
For those witnesses who were part of the ‘home team’ — Government-appointed advisors, and those who have already publicly ascribed to the Inquiry’s apparently favoured storyline — impeccable credentials and impartiality have been assumed.
Sir Jeremy Farrar, for example, former director of the Wellcome Trust, member of SAGE and currently chief scientist at the WHO gave oral evidence to the Inquiry in June. One can almost picture counsel for the Inquiry scattering rose petals as he sums up Farrar’s illustrious credentials:
“You trained, I believe, in medicine, with postgraduate training in London, Chichester, Edinburgh, Melbourne, Oxford and San Francisco.
You have a DPhil PhD from the University of Oxford. You were a director of the Oxford University Clinical Research Institute at the Hospital for Tropical Diseases in Ho Chi Minh City in Vietnam from 1996 to 2013.
From 2013 you were Director of the Wellcome Trust, and from May 2023 have you been the Chief Scientist at the World Health Organisation? Have you throughout your professional career served as a chair on a multitude of advisory bodies, for governments and global organisations?
Have you received a plethora of honours from a number of governments, institutes and entities?”4
Farrar is then treated to counsel’s softest underarm bowls and allowed to give unchallenged testimony in favour of an intervention-heavy approach to pandemic management:
“when you have the countermeasures you’re talking about, diagnostic tests, treatment and vaccines, together they create a Swiss cheese model of what our public health is”.5
Professor Neil Master of Disaster Ferguson of Imperial College London, and chief architect of the dramatic scientific modelling on which the global lockdown response was predicated was warmly welcomed to the witness box by counsel last week “as a world leading specialist in this field”, and was later thanked profusely for his hard work by Baroness Hallett:
“… thank you very much for all the work that you did during the pandemic”.6
Gushing perhaps, but nothing compared to the farewell given to SAGE modeller Professor John Edmunds who had been affirmed up front by counsel as, “a de facto expert in epidemiology”, and one of “a number of brilliant scientists and advisers who assisted the government and the country in the remarkable way that you did”.7
At the end of his evidence, Baroness Hallett delivered the eulogy:
“Thank you very much indeed. If I may say so, Professor, I think you were unduly harsh on yourself this morning.
You had a job, and you described it yourself, your job was to provide expert advice to the policy and decision-makers, and if the system is working properly that advice is relayed to them, then they consider advice coming from other quarters about economics and social consequences and the like.
I’m not sure you could have done more than you did, consistent with your role at the time, but you obviously did as much as you felt was appropriate. So I’m really grateful to you, I’m sure we all are.”8
This is a far departure from the rigorous testing of credentials and potential conflicts that one could expect as an expert witness in any court proceedings under the studious impartiality of the presiding judge.
It is certainly far short of what the public should rightly expect for an exercise set to spend over £55m on lawyers alone.9
None of these witnesses were asked whether their senior positions within organisations that rely on very valuable relationships with global pharmaceutical groups and private pharma-focussed organisations could have had any bearing on their advice at the time or their evidence to the Inquiry now.
Farrar was director of the Wellcome Trust throughout the pandemic. The Wellcome Trust is one of the institutions behind CEPI, a global vaccine development fund created in 2015 which partners with vaccine manufacturers, including Moderna.
During the pandemic Farrar frequently and vocally promoted his view that vaccines would be the means for us to exit the pandemic. He is plainly someone whose professional success and credibility has become indelibly attached to the pharmaceutical industry and in particular the use of pharmaceutical interventions in public health, yet counsel and the Inquiry Chair seemed uninterested in that colouring of Farrar’s evidence.
Likewise, Ferguson, of Imperial College London was not asked a single question about potential conflicts or risk of bias.
Again the Inquiry seemed unaware, or at least uninterested, that a month after Ferguson’s seismic March 2020 paper had concluded that “…epidemic suppression is the only viable strategy at the current time” and that “the major challenge of suppression is that this type of intensive intervention package – or something equivalently effective at reducing transmission – will need to be maintained until a vaccine becomes available…”, it was reported that Imperial College had received £22.5 million in funding from the UK Government for vaccine research and development; and that in that same year, 2020, Imperial received at least US$108 million in funding from the Bill and Melinda Gates Foundation.10
BMGF is a private philanthropic organisation which has been open about its ideological commitment to vaccine-based solutions for global health issues and which itself has very significant financial ties to the pharmaceutical industry.
…And With Prejudice
For witnesses such as Professor Carl Heneghan, Professor of Evidence-Based Medicine at Oxford University, but not a member of SAGE, and (unhelpfully for the Inquiry) not an enthusiastic supporter of lockdowns, the Inquiry appeared to have made somewhat less glowing presumptions:
“You are a professor of evidence-based medicine at Oxford University. Could you explain what that discipline entails?”. Heneghan’s explanation was swiftly followed with a presumptive conclusion as to the strength of his credentials:
“as you know, because I think you have been following the Inquiry, we have heard this week from a series of academics who have spent, in the main, their professional careers researching, analysing the spread of infectious diseases, developing models, to analyse how such diseases are spread and how they can be controlled, and considering large-scale public health issues relating to pandemic preparedness and so on.
You don’t have a comparable type of expertise in this area, do you?”.11
Not satisfied with having attempted his own disparagement of the man, counsel took the opportunity while having Heneghan in the witness box to ask for his perspective on two ‘home team’ scientists having described him in a private discussion as a “fuckwit” (Dame Angela McLean and Professor Edmunds) — to what ends, other than to rattle, rile or embarrass, was not clear.
It was the cheapest shot of the Inquiry so far.
During Heneghan’s evidence session, and having seemingly felt entirely comfortable to rely on the expert opinions of Farrar, Ferguson, Edmunds et al — the ‘good guy’ home team scientists —Baroness Hallett gives short shrift to the notion that Professor Heneghan’s opinion might be relied upon.
When talking about the broad scope of evidence-based medicine Heneghan explains that “even my opinion” amounts to evidence, Baroness Hallett retorted dismissively:
“Not in my world it doesn’t, I’m afraid”.12
The Inquiry is now hopelessly compromised by the seemingly presumptive words of its own Chair and leading lawyers and its failure to ask the right questions.
It is setting us up for a doom-loop of catastrophic errors we cannot afford to repeat.
It has become an embarrassment to the legal profession and is jeopardising the reputation of the English legal system.
Its exorbitant costs already cannot be justified, and there is only worse to come. It should be abandoned.
https://principia-scientific.com/covid-inquiry-an-embarrassment-to-the-english-legal-system/
********************************************************30 October, 2023
Israeli Study: 0.62% of Healthcare Workers Jabbed with Pfizer’s mRNA Vax Show Biomarker for Myocarditis
A clinical trial (NCT05308680) in Israel was conducted by researchers at Shaare Zedek Medical Center to prospectively evaluate the incidence of myocardial injury after the administration of the fourth dose BNT162b2 mRNA vaccine (Pfizer-BioNTech) against COVID-19.
Led by principal investigator Dr. Tal Hasin, Director of the Heart Failure Unit in the Cardiology Department at Shaare Zedek Medical Center, and colleagues, the team sought to prospectively evaluate the incidence of myocardial injury after the administration of the fourth dose BNT162b2 mRNA vaccine (Pfizer-BioNTech) against COVID-19.
The findings of this study have been suppressed not discussed widely, although material. Why? 0.62% of adult healthcare workers evidenced biomarker signals for mild myocarditis. While this may not seem significant, it is. This represents an extraordinarily high percentage of cases, and importantly, the study did not focus on younger males, which are considered higher risk.
The principal investigators are very careful with their language but include subtle messaging to take very seriously. This includes the subtle insertion that the findings have “profound” implications for risk-benefit analyses concerning Pfizer’s mRNA vaccine.
Background
Registered in the American clinical trials registry, this study was based on population-based retrospective studies suggesting an association between BNT162b2 (Pfizer-BioNTech) vaccination against coronavirus disease 2019 (COVID-19) and myocarditis.
The study authors point out the lack of large-scale studies to evaluate the incidence of myocarditis after the administration of the third or fourth vaccine doses, but case reports of myocarditis in recipients of the third dose were described. Although considered to be low, the estimated risk of myocarditis and myocardial injury in vaccine recipients is believed to be underestimated.
The Study
The Israeli investigators estimate the overall incidence of myocarditis at 2.13 per 100,000 persons, the incidence of myocardial injury and subclinical myocarditis may be higher.
In the present study, the team involved adult healthcare workers who received the BNT162b2 (Pfizer-BioNTech) vaccine in two Israeli hospitals (SZMC and Shamir) during the fourth dose campaign; the study participants’ blood samples were taken for high-sensitivity cardiac troponin (hs-cTn) measurement at the time of vaccine administration and after 2-4 days.
Post-vaccine myocardial injury was defined as hs-cTn elevation above the 99th percentile upper reference limit and >50% increase from the first measurement.
Participants with evidence of myocardial injury underwent assessment for possible myocarditis, including electrocardiogram and echocardiography.
What did they find?
With results of this study recently reported in the European Journal of Heart Failure, Dr. Hasin and team reported that out of the study’s 324 participants, 192 (59.2%) were female, and the mean age was 51.8 ± 15.0 years.
Twenty-one (6.5%) participants had prior COVID-19 infection, the mean number of prior vaccine doses was 2.9 ± 0.4, and the median time from the last dose was 147 (142–157) days.
The study authors report, “Vaccine-related myocardial injury was demonstrated in two (0.62%) participants; one had mild symptoms, and one was asymptomatic; both had a normal electrocardiogram and echocardiography.”
In this prospective investigation, an increase in serum troponin levels was documented among 0.62% of healthy healthcare workers receiving the fourth dose BNT162b2 vaccine. The two cases had mild or no symptoms and no clinical sequela. Importantly, this represents a high overall percentage with implications for the hundreds of millions of persons vaccinated with the Pfizer vaccine.
For example, if these figures were extrapolated out to 100 million vaccinations, that would mean 617,284 cases involving an increase in serum troponin levels.
What do the study authors think of this output?
The authors do acknowledge a disturbing signal here, declaring: “Indeed, the current study suggests a higher incidence of myocardial injury during active monitoring for cardiac biomarkers in vaccine recipients with no clinical evidence of myocarditis. Since in our study, the average age was 51 and only 40% were male, with only 8 (2.47%) of them that were 30 years old or younger, it is currently unknown if a prospective evaluation among younger males will yield a higher incidence of myocardial injury.”
The study team further explains “Besides the pathophysiological implications, the clinical significance of the mild injury found in our study may be debated and should be further evaluated in larger studies.”
What’s the mechanism of action?
The mechanism of vaccine-induced myocarditis is unknown but may be related to the active component of the vaccine, the mRNA sequence that codes for the spike protein of SARS-CoV-2, or to an unregulated immune response that follows vaccination in certain individuals with a genetic predisposition.
The authors suggest that in some cases, acute myocardial injury may occur via a similar mechanism without material clinical myocarditis. They write, “Otherwise, a non-immune-mediated initial injury may trigger more significant immune-mediated myocarditis in susceptible individuals, but not in others.”
What are the recommendations given the findings?
Dr. Hasin and colleagues point out that given the potential magnitude of the findings (yet they downplay some more severe implications), they articulate, “A reasonable recommendation may be to withhold strenuous physical activity for a few months. Regarding the recommendation for repeat vaccine doses in the future, there is no consensus. However, given the limited clinical utility reported recently with the fourth dose against Omicron, repeat vaccination of individuals with documented post-vaccine myocardial injury deserves a profound risk–benefit consideration.”
Note, the use of the language—“profound” risk-benefit consideration moving forward!
**********************************************
COVID Hospitalizations Continue to Drop, CDC Data Show
Hospitalizations for COVID-19 have continued to drop, coming after a relatively small increase in cases over the summer, according to data released by the U.S. Centers for Disease Control and Prevention (CDC).
Hospitalizations fell by 5 percent for the week ending Oct. 14, while emergency department visits also dropped by 11.9 percent, and reported case numbers decreased by 0.7 percent. Deaths rose by 4.2 percent, although officials say that deaths generally lag case and hospital numbers.
For the week ending on Oct. 7, hospitalizations were down by 8.2 percent, emergency visits fell 17.7 percent, and reported cases were down by 0.8 percent, while deaths fell 3.8 percent, the data show.
Amid the drop in hospitalizations over consecutive weeks, the CDC sent out a report earlier in October claiming the virus remains a "public health threat" for older Americans, arguing that it's a reason they should take the updated COVID-19 vaccine.
The Food and Drug Administration (FDA) and CDC both signed off last month on the updated shots made by Pfizer, Moderna, and Novavax.
Few Americans Taking Updated Shots
Around the same time, the CDC said officials are expecting a “moderate COVID-19 wave” for the winter months ahead and predicted this year's peak will match last winter’s hospitalization figures. The virus levels, however, could peak earlier this season because of "limited summer activity compared to past years,” the agency said in September.
“This increase could result from the emergence of a new COVID-19 variant with an increased ability to evade the body’s prior immunity, or from a severe influenza season combined with COVID-19 and RSV waves that are similar to last year, or, as we saw last year, an increase in RSV infections,” the CDC stated. “A key factor is the timing of the peak number of hospitalizations associated with each disease and whether those peaks coincide.”
About 3 percent of all Americans who are eligible have received the updated COVID-19 booster shot, nearly two months after it was rolled out, according to officials with the Department of Health and Human Services (HHS). Overall, about 10 million people have taken it, the data show, up from 7 million a week before.
“The administration remains committed to pulling every lever at its disposal during the fall respiratory vaccination campaign, encouraging the American public to stay up to date on their vaccines to keep themselves and their loved ones safe,” an HHS spokesperson told The Epoch Times earlier in October. “As a result of these efforts, around 10 million Americans have been vaccinated since the updated vaccines were authorized and recommended last month.”
The relatively lower pace of vaccinations prompted drug giant Pfizer to revise its revenue guidance for the year, warning that demand for COVID-19 products such as vaccines has plunged.
Pharma Profits Plunge
Pfizer, which has seen its stock drop by about 40 percent for 2023, slashed its outlook by about $9 billion due to the weakened demand, the company said on Oct. 13. It particularly expects sales of its mRNA vaccine to be about $2 billion lower than it previously anticipated.
As for Moderna, the company reiterated earlier this month that its COVID-19 vaccine sales will be between $6 billion and $8 billion. It’s still too early to predict the U.S. vaccination rate, Moderna said this month, coming as the company's stock plunged $7 billion in about a week and as its stock has dropped 83 percent since its peak in August 2021.
Some analysts said that the pharmaceutical companies should be worried about their vaccine sales.
“COVID-19 vaccine revenue concerns should be at an all-time high right now,” Hartaj Singh, an analyst at Oppenheimer, said in a recent Bloomberg report. “A good third-quarter print should allay some of these fears. And good guidance early next year on 2024 potential revenues could get the stock’s mojo back.”
It comes also as multiple U.S. hospitals in recent days have dropped their COVID-19 mask mandates after they reinstated the rule several weeks ago. A handful of hospitals across the United States reimplemented mandates over the summer, although some didn't make masks a requirement for patients or visitors, just staff such as nurses and doctors.
The largest hospital group in New Jersey, Hackensack Meridian Health, reinstated mask mandates last month. However, officials with the company have confirmed it has lifted its mandate for all its hospitals except for Bayshore Medical Center in Holmdel, Old Bridge Medical Center, and Southern Ocean Medical Center in Stafford, local media reported
********************************************************
29 October, 2023
Why COVID sufferers in the US can’t get ensitrelvir, the antiviral drug better than Paxlovid
For people suffering through a bout of COVID-19, the antiviral Paxlovid has been a godsend. The medication emerged as the go-to antiviral treatment during the pandemic after the Food and Drug Administration granted it emergency-use authorization in December 2021.
Now, there’s a new antiviral that’s superior to Paxlovid — but Americans can’t get it, as it’s being held up in the lengthy FDA-approval process.
Ensitrelvir, marketed as Xocova in Japan — the only country where it’s legally available — has several advantages over Paxlovid.
However, experts lament that the newer, better drug probably won’t be available in the US until the end of 2024. The FDA seems to be “slow walking” the approval process for ensitrelvir, infectious disease specialist Dr. David Boulware, a professor medicine at the University of Minnesota, told the Atlantic.
And because the COVID-19 emergency was declared over in May of this year, ensitrelvir probably won’t be granted the same emergency-use authorization that Paxlovid received.
Nonetheless, the FDA has granted the new drug “fast-track” status, meaning its review process will be expedited once the drug’s manufacturer, Shionogi of Osaka, Japan, submits the required documentation.
People who take the drug test negative almost two days sooner than people who take a placebo. Symptoms like fever, congestion, sore throat, cough and fatigue disappear faster among some groups of people than with Paxlovid.
“Rebound” infections, in which symptoms recede and then seem to come back — common among Paxlovid users — have been rare among users of ensitrelvir. In addiction, the taste of ensitrelvir is unremarkable, according to anecdotal reports, whereas patients on Paxlovid have described the aftertaste as “a mouthful of dirty pennies and rotten soy milk.”
And ensitrelvir is easier to take, as it requires just once-a-day dosing, whereas Paxlovid users must take three pills twice daily for five days.
The two drugs have never been compared in head-to-head trials, however, so medical experts are reserving their enthusiasm for ensitrelvir until more data is available.
Loss of smell and taste
Despite this, a new study found that ensitrelvir effectively diminishes one of the most annoying and problematic effects of a COVID infection: loss of smell and taste.
After seven days, the percentage of study participants with smell or taste loss was 39% lower in a group taking ensitrelvir than in a placebo group.
“Most people will eventually recover on their own, but we know that some people have had long-term issues with smell and taste,” Dr. Yohei Doi, an infectious-disease researcher at Fujita Health University in Japan who worked on the ensitrelvir study, told Nature.
“When the omicron variants became dominant, the loss of taste and smell started to become less and less common,” Dr. Amesh Adalja, an infectious-disease specialist at the Johns Hopkins Center for Health Security, explained to Nature.
“But it still occurs, and it is a distressing symptom,” Adalja added. “What we’re trying to do is not just minimize severe disease, hospitalization and death, but also to minimize the disruption that an infection has on people’s activities.”
The drugmaker Shionogi is continuing to conduct clinical trials into the safety and effectiveness of ensitrelvir among different user groups.
*********************************************************
Sore Arm After COVID-19 Vaccine Could Indicate Serious Complication: Doctor
Individuals who experience a sore arm after taking a COVID-19 shot may be at risk of facing cardiac issues, according to cardiologist Peter A. McCullough.
“I always ask patients if they had a sore arm or more severe reaction within the few days of the shot. It may be a harbinger of future cardiovascular serious adverse events, including myocarditis and sudden cardiac death,” Dr. McCullough said in an Oct. 27 Substack post. Myocarditis is an inflammation of a heart muscle called myocardium, which can reduce the heart’s ability to pump blood. Dr. McCullough cited a Sept. 19 study published in the Radiology journal, which states that 458 out of the 700 participants, or 65.4 percent, reported pain in the arm after COVID-19 vaccination.
“The myocardial visual score was higher in patients who reported a sore arm compared with those who did not,” the study said. The participants in the study were “competitive and recreational athletes” from Italy.
The cardiologist pointed to a July 20 study published by Taylor & Francis, which found this specific pain among the majority of participants who took COVID-19 vaccination.
Among the 460 participants in the study, 81.3 percent reported arm pain at the injection site after receiving the first dose of a COVID-19 shot. Following the second dose, 24.9 percent reported arm pain. “Male gender was more likely to present arm pain after the first and the second vaccinations,” it said.
“In our study population, arm pain was inversely associated with SARS-CoV-2 infection before vaccination.” Athletes who were previously infected with COVID-19 were found to be “less likely to present arm pain after the first-dose vaccination.”
CDC Advisers Consider Recommending Mpox Vaccines for Children
Play Video
A November 2022 study cited by Dr. McCullough looked at autopsy data from 25 individuals who had “died unexpectedly” within 20 days after COVID-19 vaccination.
Five individuals in the study received mRNA COVID-19 vaccines and died within a week of taking the shots. Four people died after the first injection, while the fifth died after the second dose.
In 80 percent of mRNA vaccine recipients, the study identified “acute (epi-)myocarditis without detection of another significant disease or health constellation that may have caused an unexpected death.”
The researchers discovered simultaneous vaccine-induced inflammation in the heart muscles and deltoid muscles crowning the shoulder. In the heart, the inflammation was found in the epicardium—the outermost protective layer of the organ located above the myocardium.
Dr. McCullough also highlighted a December 2022 report published at the National Library of Medicine, which brought attention to the issue of rising cardiac arrests among athletes.
During a two-year period “from January 2021 to the time of writing, 1,598 athletes suffered cardiac arrest, 1,101 of which with deadly outcome,” it said, citing a study.
This is a higher rate of death compared to a 38?year timespan between 1966 and 2004 when “1,101 athletes under the age of 35 died (~29/years) due to various heart?related conditions.”
Citing another study on 301 teenagers between the ages of 13 and 18 who received two doses of the Pfizer vaccine, the report said “29.24 percent of participants experienced cardiovascular complications such [as] tachycardia, palpitations, and 2.33 percent suffered myopericarditis.”
“It is noteworthy that no statistically significant increase in the incidence of myocarditis or pericarditis was observed in un?vaccinated subjects after SARS?CoV?2 infection, in a large population study.”
On the basis of these studies, Dr. McCullough determined that a sore arm can be a “harbinger of future cardiovascular serious adverse events.”
The cardiologist said that he was “amazed at how many people have taken one or more of the COVID-19 vaccines are completely free of side effects.” He suggested that many of the vials of the vaccine may have had “little or no viable mRNA.”
A study from Germany published in the British Journal of Pharmacology journal this month found that both Pfizer and Moderna’s mRNA COVID-19 vaccines formed spike proteins in the human heart cells within 48 hours of injection. Both Pfizer and Moderna triggered different cell abnormalities.
Responding to the study, Dr. McCullough suggested that the different responses the cells had to the two mRNA vaccines could point to an mRNA toxicity reaction in these cells.
Despite studies suggesting the risk of medical complications, some experts continue to advise people to get COVID-19 jabs. According to John Hopkins Medicine, both Pfizer and Moderna are “highly effective in preventing serious disease, hospitalization, and death from COVID-19.”
It recommended people to get a COVID-19 shot as “we believe that their benefits outweigh their risks.”
However, Dr. McCullough advises people to avoid it. He wrote in an Oct. 29 Substack post: “I am not recommending COVID-19 XBB.1.5 boosters, influenza, or respiratory syncytial virus vaccines for healthy adults or children. None of these vaccines are compelling and conditions are easily treatable.”
********************************************************
26 October, 2023
Children who get Covid shot are infectious for same amount of time as non-vaccinated, study finds
Children vaccinated against Covid are infectious for the same amount of time as their non-vaccinated peers, a new study out of California has found.
Whether or not students had received their bivalent Covid booster made no difference to the length of time they shed pieces of the virus after testing positive.
Both groups of kids aged seven to 18 were infectious for three days on average, according to the results from April to September 2022.
The study adds more doubt about the importance of giving Covid booster shots to children. Until earlier this year, several states including California and Illinois mandated the vaccines in schools.
Experts from Stanford University and the University of California, Los Angeles, who carried out the study: ‘Return-to-school policies may not need to discriminate by vaccine or booster status.’
Crucially, though, lead author Dr Neeraj Sood said the team did not look at the vaccines' abilities to prevent infection in the first place.
The study also took place before Pfizer's original bivalent booster was approved. That vaccine offered better protection against the Omicron subvariants that were circulating at the time. The youngest children in the study likely did not receive a booster but rather the standard two-dose vaccine course.
Levels of immunity and protection have ebbed and flowed with different vaccines and virus variant combinations.
The report was published in the journal JAMA Pediatrics. The 76 children involved in the study were from the Los Angeles-area included in the study ranged in age children seven to 18 years old.
The goal was to measure the impact of the virus on the children's cells to better understand how it behaves and for how long it is contagious.
The researchers studied their level of viral shedding, the number of virus particles that a child emits through coughing, sneezing, or talking that are then spread throughout the environment.
WHO says healthy kids and teens don't need Covid vaccinations
The World Health Organization (WHO) revised its Covid vaccine recommendations and suggested that healthy children and adolescents may not need a shot.
Every child tested positive for the Covid-19 Omicron variant. Of the 76 children, including 41 seven to 12-year-olds, 52 were vaccinated.
Children who had been vaccinated were infectious for three days, the same duration as children who were not vaccinated.
Researchers did not say whether they were surprised by their results. But what they found was similar to a study in adults with the Omicron variant, which also could not find an association between the length of time that a person is contagious and their vaccination status.
The Centers for Disease Control and Prevention recommends that all children, including babies as young as six months, receive a bivalent booster shot containing components of both the original virus strain as well as the omicron variant.
Yet uptake has remained low. A July 2023 study published in the journal Annals of Medicine reported that just 39 percent of children aged five to 11 and 55 percent of teenagers have gotten a booster dose.
Bivalent boosters have been shown to be highly effective at preventing severe enough cases to land a child in the hospital or at an urgent care clinic, but it is not clear to what extent the shots can prevent infection in the first place.
Covid vaccines are highly effective at preventing severe illness in the elderly, but protection against initial infection tends to be much weaker.
And children do not typically get dangerously sick with Covid, which has led many parents to believe there is not enough benefit to justify the shot.
Pandemic fears prompted many state and local officials to shutter schools in 2020 in order to protect children.
However, children are typically not nearly as vulnerable to severe illness as older adults, especially seniors.
This fact has contributed to an overall lack of enthusiasm among parents for pediatric booster shots, as many parents simply do not believe they are worth getting.
There is a tiny risk of heart inflammation in younger people after being vaccinated with the mRNA vaccines, but the majority of cases are mild and subside on their own.
Still, the tiny risk of a severe Covid infection has left many parents wary.
Widespread school closures have been blamed for fomenting a mental health crisis among school-aged children, as well as causing a downward spiral in academic performance overall.
A Brookings Institution study last year found that average fall 2021 math test scores in grades three to eight were 0.20 to 0.27 standard deviations (SDs) lower relative to same-grade peers in fall 2019.
Standard deviations are used to show how much test scores vary from the overall average, and a decrease of 0.20 to 0.27 SDs suggests a major decline in math performance.
At the same time, reading test scores decreased by 0.09 to 0.18 SDs.
Proponents for keeping schools open, which includes about 60 percent of American parents, have cited plummeting academic achievement as a clear indication that in-person instruction is far superior to consigning children to learn via Zoom at home.
*************************************************
Like Pfizer, the Covid Train May Have Run Out of Track for Moderna
It appears the Covid party for big pharma may finally be coming to an end. Last week, TrialSite reported on the fact that Pfizer will be lucky to generate $13 billion for their Covid product line. With a stagnant to declining stock price, sophisticated investors are concerned. The analysts are still generally upbeat (after all, the company is diversified both in product portfolio and R&D pipeline). But an ominous sense, one based on behavior over the past couple of years, brings dark clouds over the company. Cash flow for the pharmaceutical giant for the twelve months ending June 30, 2023, at $51.168 billion represented a 36.44% decline year-over-year. Pfizer's annual cash flow from operating activities for 2022 was $29.267 billion, a 10.17% decline from 2021. In August of this year, TrialSite speculated Pfizer’s Covid train could be out of track. Now, it looks as if the train has pulled out of another station.
Moderna Loses Value
Moderna became famous during the Covid pandemic because of their mRNA vaccine. The company was named after their innovative shot. But now demand for the jab has waned, and the company appears rudderless. Last week, it was reported Moderna erased $6.8 billion in market value after rival shot maker Pfizer slashed its profit outlook the previous Friday, sounding the alarm on dwindling demand for its Covid shots and pills. Moderna’s stock closed at the lowest since November 2020, when the company was still trying to get its Covid serum authorized for use in the United States.
“Covid-19 vaccine revenue concerns should be at all time high right now,” said Hartaj Singh, an analyst at Oppenheimer. “A good third-quarter print should allay some of these fears. And good guidance early next year in 2024 potential revenues could get the stock’s mojo back.”
Moderna’s stock has dropped about 83% from its August 2021 high when the company’s market capitalization was almost $200 billion. This isn’t good for a company which was once compared with Tesla, but this year, Moderna is one of the worst performing S&P 500 companies.
“Too Early to Predict”
According to Moderna’s management, the company still expects between $6 billion to $8 billion from the Covid shots, while cautioning it is still too early to predict US vaccination rates. Wall Street analysts predict Moderna’s Covid sales will be lower based on an updated guidance range from Pfizer. However, Pfizer has recovered a bit recently, gaining 3.6% as the drug maker’s post-pandemic growth strategy was weighed and investors’ expectations were reset, according to some on Wall Street. Similar to Moderna, Pfizer’s stock has dropped, losing about half its value from its pandemic record high. As with Pfizer, the Covid train tracks appear to have run out for Moderna. They better be ready for the next engine.
*************************************************
Increasing Recognition Of Vaccine Injuries
The push to increase vaccination rates comes amid an increasing recognition of vaccine injuries in Australia and overseas.
In Australia, the government operates a vaccine injury compensation scheme that has paid out over $7.3 million (US$4.87 million) to 137 claimants. It has received 3,501 applications and is progressing with 2,263, according to figures obtained by News.com.au in March this year.
The Department of Social Services has previously estimated the government could be liable for a payout of $77 million (US$49.35 million).
In the UK, the increasing number of vaccine adverse effects had resulted in a lawsuit against vaccine manufacturer AstraZeneca, with families and patients arguing that their loved ones died or suffered severe reactions after taking its vaccine, according to their lawyers.
Meanwhile, multiple doctors and COVID-19 patients have also reported that their discussion of vaccine adverse effects has been labelled as misinformation.
The former president of the peak medical body, the Australian Medical Association, came out in December last year to say that discussion around vaccine injuries is being “censored” despite data confirming COVID-19 vaccines can cause adverse reactions.
Dr. Kerryn Phelps said she herself had suffered from a vaccine injury and that she faced “obstruction and resistance” to openly discuss the issue, according to a submission to the federal Parliament’s inquiry into Long COVID.
She said that while current COVID-19 vaccines may reduce the risk of developing Long COVID by an estimated 15 to 41 percent, recent data shows the risk remains for most people after immunisation, with some adverse events going on to cause “long-term illness and disability.”
Dr. Phelps also revealed in her case, that the vaccine injury resulted in dysautonomia with intermittent fevers and cardiovascular implications including breathlessness, inappropriate sinus tachycardia, and blood pressure fluctuations.
“I have spoken with other doctors who have themselves experienced a serious and persistent adverse event including cardiological, rheumatological, autoimmune reactions and neurological consequences,” she wrote in her submission.
She said while there is higher awareness about the unusual blood clotting from AstraZeneca, “less generally recognised are the reported adverse reactions after mRNA vaccines by Pfizer and Moderna beyond myocarditis and pericarditis.”
********************************************************
24 October, 2023
Skeptical Professor Exonerated After Being Accused of 'Unethical Practices' in Famous COVID Vaccine Study
The vaccine establishment applied irrelevant standards to his work in their zeal to discredit it
A professor from the Michigan State University (MSU) has been exonerated from charges of “unethical practices” related to a study claiming that the COVID-19 vaccines may have resulted in hundreds of thousands of deaths in the United States.
In January, Dr. Mark Skidmore, a professor at the MSU’s Department of Economics with over 90 published papers, published a study in the BMC Infectious Disease, which suggested that the total number of COVID-19 vaccine fatalities in the United States could be “as high as 278,000.”
It soon came under criticism and Dr. Skidmore was accused of using “unethical practices” in the study. Subsequently, the journal retracted the research.
Following a seven-month ethics investigation by the university’s Institutional Review Board (IRB), Dr. Skidmore has now been cleared of any wrongdoing. The board stated that they did not find any “noncompliance” to their protocols by the study, according to an Oct. 17 press release by the Christian ministry Liberty Counsel.
The complaints against Dr. Skidmore alleged he did not follow rigorous oversight procedures that are mandated for clinical studies. If the university were to find him “guilty,” it would have had serious consequences for Dr. Skidmore’s credibility and career.
This is because clinical studies involving human subjects have strict protocols to ensure that no harm comes to the participants. As such, any fault in this regard would be a significant blemish on the reputation of the researchers.
The university’s IRB found that Dr. Skidmore’s study did not involve any clinical work. Instead, it relied only on an online survey, which posed no risk to human participants. The IRB therefore deemed the study to be “exempt” from the protocols of clinical study and cleared it to proceed.
“The allegations against Dr. Mark Skidmore were baseless,” Liberty Counsel Chairman Mat Staver said. “Researchers with integrity like Dr. Skidmore are using rigorous scientific protocols to validate the dangers of the COVID-19 shots.”
“Censoring scientific debate is reprehensible and our researchers need to be free to conduct proper science without fear of later being the subject of an ethics investigation because their findings contradict a certain narrative.”
Top Research Paper
While Dr. Skidmore’s study at the BMC Infectious Disease journal remains retracted, an updated version was recently published in the Science, Public Health Policy & the Law journal.
The study involved an online survey completed by 2,840 participants between Dec. 18 and Dec. 23, 2021, which collected data on COVID-19 health experiences. “The primary aim of this work is to identify factors associated by American citizens with the decision to be vaccinated against COVID-19,” it read.
The survey collected information on why respondents chose to take COVID-19 vaccinations or refused to do so. It also collected details on respondents’ experiences with COVID-19 illnesses and inoculations. With regard to COVID-19 vaccines, the survey found that:
Respondents that knew someone who had experienced a health problem following vaccination were less likely to be vaccinated.
Out of the 2,840 participants, 612 (22 percent) said they knew at least one individual who experienced a health problem after taking a COVID-19 shot.
Dr. Skidmore extrapolated the numbers from the survey to the national level to estimate that COVID-19 vaccine fatalities in America could be as around 289,789. The COVID-19 vaccine fatality number in the revised study published in the Science, Public Health Policy & the Law journal is higher than the original study by 11,789 deaths.
According to the BMC Infectious Diseases journal, Dr. Skidmore’s original study was retracted after “concerns were raised regarding the validity of the conclusions drawn after publication.”
A peer review of the study conducted after publication found that “the methodology was inappropriate as it does not prove causal inference of mortality, and limitations of the study were not adequately described.”
Despite being retracted, the study remains in the top 1 percent of shared research worldwide, according to data science firm Altmetric. The study is ranked number one among all outputs from BMC Infectious Diseases tracked by Altmetric.
In April, Dr. Skidmore claimed that the study at BMC Infectious Diseases journal went viral on social media and reached up to 17 million Twitter users prior to being retracted.
He attributed the vast exposure of the study to two factors. “First, the finding resonated with many who have loved ones who they believe experienced harm from the COVID-19 vaccine. Second, for a variety of reasons, many were angered by the study,” he said.
Other studies have also found links between COVID-19 vaccines and excess deaths. A March report from global macro-investment firm Phinance Technologies calculated that COVID-19 vaccines resulted in around 310,000 excess deaths in the United States.
Some studies have reported otherwise. A study from The Commonwealth Fund estimated that 2 million deaths were prevented in the United States through March 2022 due to COVID-19 vaccination efforts.
Another serious concern regarding the vaccine is the persistence of spike proteins for a prolonged period of time after the vaccination.
Even though the CDC claims that mRNA from COVID-19 vaccines is “broken down within a few days after vaccination and doesn’t last long in the body,” recent research reveals that spike proteins are retained in the biological fluids of people who received an mRNA COVID-19 vaccine six months after vaccination.
**************************************************
More Research Refutes Efficacy of Masks Against COVID-19
As flu—and coronavirus—season approaches, Dr. Anthony Fauci is again saying that wearing face masks protects individuals from spreading the coronavirus.
Some colleges and hospitals are reinstating mask mandates.
Politics and the fear of coronavirus may have held sway the past few years, but common sense and rational science need to prevail now. Masks are ineffective, and mask mandates are unnecessary.
We offer several explanations from our National Association of Scholars report and peer-reviewed study to refute doomsayers’ warnings about the effectiveness of wearing masks.
Viruses Go Around, Through Masks
Coronaviruses are very small, with a size range of 0.06 to 0.16 micron. For perspective, 1,000 microns equals 1 millimeter. Respiratory viruses like the coronavirus are transmitted through secretion fluids during breathing in the form of small aerosols (less than 5 microns in size) or larger droplets (greater than 5 microns in size), rather than isolated viruses.
When viral-infected humans breathe, talk, eat, cough or sneeze, they emit aerosols and droplets containing viruses.
Aerosols emitted from simple breathing are small (size range 0.2 to 0.6 micron), and once emitted can be present in an enclosed setting for several hours. A person showing no symptoms of viral infection does not cough and sneeze, and therefore they do not emit large droplets.
Aerosols less than 0.5 micron are not easily filtered out of air by any physical mechanism. The openings in medical masks range from 0.3 to 10 microns in size. The latter dimension is much larger than small aerosols emitted from an infected person.
Now, there are a couple of ways in which virus-laden aerosols can infect a person wearing a mask when the aerosols are present in their breathing zone. One way is aerosol penetration through the mask during breathing because mask openings are too large.
A second way is breathing air containing aerosols from the side of a mask due to incorrect wear, increased mask resistance, or poor string tension. A mask wearer breathes out moist air, which increases mask resistance by plugging up the openings. Simple breathing has been shown to emit up to 7,200 aerosols per liter of exhaled air. While this can reduce aerosol penetration through a mask, it worsens the problem of inhaling virus-laden aerosols from the side of the mask.
Controlled Trials Show Masks Not Effective
The leading Cochrane Database of Systematic Reviews published a review in 2020 and a reanalysis in 2023 of human controlled trials using masks to slow the spread of respiratory viruses.
Both of these studies concluded that it is uncertain whether wearing masks help to slow the spread of respiratory viruses. Outside of the Cochrane organization’s influence, one of the senior authors of both studies (Jefferson) was more to the point: “There is just no evidence that [masks] make any difference. Full stop.”
Jefferson’s findings are consistent with viral transmission basics. Is he right? To answer this, we independently evaluated his data used in the 2020 review using a novel statistical p-value plot.
A p-value plot is used to visually inspect characteristics of a set of test statistics addressing the same research claim; for example, do masks make any difference? The plot is well-respected, being cited more than 500 times in the literature. The plot examined whether p-values support no association (randomness) or a real association between community mask use and viral infections.
Jefferson’s 2020 review looked at 15 separate community (that is, non-health care worker) controlled trials comparing medical masks to no masks. We took the results from these 15 trials—risk ratios and confidence intervals—and converted them to p-values.
If p-values approximately follow a line with a flat/shallow slope, where most of the p-values are small (less than 0.05), then the set of p-values provides evidence for a real association; that is, masks work.
The p-value plot of the 15 controlled trials clearly shows p-values aligned approximately 45 degrees, indicating randomness. This is consistent with what Jefferson found: Masks don’t work.
A Natural Experiment Shows Ineffectiveness
A final explanation is a natural experiment of World Health Organization-reported daily new COVID-19 deaths in Germany and Sweden during the second wave (October 2020 through July 2021). At the time, Germany had a mask mandate, whereas Sweden did not, as they followed a strategy to let herd immunity develop naturally.
Many factors contribute to mortality risk. Numerous influences may be at play in the airborne respiratory virus-mortality chain across populations; for example, access to health care, health status, lifestyle, standard of living, etc., which complicates efforts to draw conclusions from observational data.
However, Germany and Sweden are members of the European Union with similar national health policies. Both should have had similar capacities to respond to the COVID-19 pandemic. Also, in 2020, Germany and Sweden ranked closely in the top 10 countries of the world with the United Nations Human Development Index: Germany sixth and Sweden seventh. So, comparing the two should control for many factors affecting mortality.
Moreover, mask wearing was very dissimilar in the two countries. Survey data on mask compliance during the pandemic was captured in many countries by the University of Maryland Social Data Science Center and Facebook. Using these data, we observed that monthly average mask compliance in Germany was never less than 80%, whereas in Sweden it was never more than 21%, during the second wave.
Those figures shows that mask use had little or no benefit in preventing COVID-19 deaths in Germany and Sweden during the second wave. Despite similar health care capacities, similar Human Development Index measures, and obvious differences in mask compliance for the two countries, daily COVID-19 deaths per million population were not much different.
Policymakers Should Learn From Experience
It is the obligation of those espousing a theory to provide solid supporting evidence. Undoubtedly, more studies on the medical maskrespiratory virus infection research question, including COVID-19, will be presented in literature in the coming years as those in favor of mask mandates look for empirical support.
However, the evidence to date offers no support for mask mandates.
https://www.dailysignal.com/2023/10/12/evidence-again-shows-masks-dont-stop-viruses/
********************************************************Also see my other blogs. Main ones below:
23 October, 2023
Yet Another Validation of DNA Contaminants in COVID-19 mRNA Vaccines
TrialSite recently covered the unfolding “plasmidgate” controversy involving DNA contamination found in same of COVID-19 mRNA vaccine product. To date, this media reported on four such studies featuring what some experts are declaring are unacceptable amounts of DNA contamination in the mRNA vaccines, with an emphasis on the Pfizer-BioNTech product.
A new study has been uploaded to OSF Preprints, and one of the authors is a regular TrialSite contributor, David Wiseman, Ph.D., but also includes none other than Kevin McKernan of Medicinal Genomics in Beverly, Massachusetts, the investigator leading the first study verifying that DNA contaminants in the mRNA vaccine vials exceeded the European Medicines Agency 330ng/mg requirement and the Food and Drug Administration (FDA) 10g/dose requirements.
The new study is titled “DNA fragments detected in monovalent and bivalent Pfizer/BioNTech and Moderna modRNA COVID-19 vaccines from Ontario, Canada: Exploratory dose response relationship with serious adverse events.” While this study is not yet peer reviewed, meaning as a matter of scientific practice the findings should not be cited as evidence, the combination of seriousness, relevance and timeliness of findings merit high level introductory overview in the TrialSite.
Representing the study as corresponding author is Dr. David J. Speicher, Ph.D., DTM, a molecular virologist and clinical epidemiologist whose Ph.D. thesis in 2012, on the detection and characterization of HHV-8 led to the first HHV-8 quantitative PCR assay in Australia. He currently teaches and does research at University of Guelph.
Other authors involved with this study include Jessica Rose, Ph.D. and Maria Gutschi, a research pharmacist and drug assessor in Canada.
The study team acknowledges in their study paper the recent studies covered by TrialSite pointing to significant levels of plasmid DNA in both mRNA COVID-19 vaccine products (Pfizer-BioNTech and Moderna). But the authors acknowledge that the previous study findings were based on output based on a limited number of lots, as well as questions linked to variance and quality of the underlying samples used in those studies.
The Study
In vitro transcription employed to generate nucleoside RNA (modRNA) for SARS-CoV-2 vaccines to date relies on an RNA polymerase transcribing from a DNA template, meaning DNA is required in the mRNA production process.
In this context, as an example, the manufacture of the modRNA used in the original Pfizer randomized clinical trial was based on such PCR-generated DNA template.
In fact, by generating clones into a bacterial plasmid vector for amplification in Escherichia coli before linearization, part of the second process making up this study, the team can expand the size and complexity of possible residual DNA, while bringing sequences not present in the template mentioned above.
Articulating that Moderna’s vaccine, both clinical trials and post authorization mRNA product, is based on a comparable plasmid-based set of processes, the present authors used quantitative polymerase chain reaction (qPCR) and Qubit® fluorometry as part of a process to test the additional 27 vials of mRNA COVID-19 vaccine product obtained in Canada.
With the samples drawn from 12 unique lots including:
5 lots of Moderna child/adult monovalent
1 lot of Moderna adult bivalent BA.4/5
1 lot of Moderna child/adult bivalent BA.1
1 lot of Moderna XBB.1.5 monovalent
3 lots of Pfizer adult monovalent
1 lot of Pfizer adult bivalent BA.4/5
To better understand safety profile, the authors queried the U.S. Vaccine Adverse Event Reporting System (VAERS) database for the number and categorization of adverse events (AEs) reported for each of the lots tested. Using Oxford Nanopore sequencing, this helped the team investigate the content of one of the previously studied Pfizer COVID-19 vaccine vials as part of the quest in this study to determine the size distribution of DNA fragments.
Speicher and team also used the sample to verify if the “residual DNA is packaged in the lipid nanoparticles (LNPs) and thus resistant to DNaseI or if the DNA resides outside of the LNP and is DNaseI labile.”
Findings
Based on the dose response model established, Speicher and team conducted an exploratory analysis, finding at least early evidence of a dose response relationship of the amount of DNA per dose and the frequency of serious adverse events (SAEs). Could it be that COVID-19 mRNA vaccine safety as reflected in the number of safety incidences could be predicted based on this model?
The study authors report that the Pfizer and Moderna products differed based on size distribution analysis---mean and maximum DNA fragment lengths of 214 base pairs (bp) and 3.5 kb, respectively.
Disturbingly, the study authors write, “The plasmid DNA is likely inside the LNPs and is protected from nucleases.”
Takeaway
Of course, this study output needs to be vetted via peer review, but the authors demonstrate the presence of billions to hundreds of billions of DNA molecules per dose in the studied Pfizer and Moderna mRNA 19 vaccines.
The study team was able to verify using fluorometry that “all vaccines exceed the guidelines for residual DNA set by FDA and WHO of 10 ng/dose by 188 – 509-fold.”
During this study, Speicher et al. point to the need for methodological clarity and consistency when interpreting quantitative guidelines based on observations for instance, that the qPCR residual DNA content in all vaccines were below established guidelines.
They point out, “The preliminary evidence of a dose-response effect of residual DNA measured with qPCR and SAEs warrant confirmation and further investigation.”
Perhaps most importantly is the overall mounting unease about the COVID-19 mRNA vaccines. This concern is expressed by the present authors:
“Our findings extend existing concerns about vaccine safety and call into question the relevance of guidelines conceived before the introduction of efficient transfection.”
***************************************************
Ivermectin/Hydroxychloroquine Lawsuits Continue On
Physicians in Iowa are suing the state’s licensing boards to overturn restrictions associated with repurposed drugs used for COVID-19, including Hydroxychloroquine and Ivermectin. The physician has filed a civil lawsuit seeking a court order to force pharmacies to fill prescriptions for these drugs.
This news was reported by the Des Moines Register and other sources. Why is Iowa doctor David Hartsuch pursuing a lawsuit against the Iowa Board of Medicine and Iowa Board of Pharmacy? He is accusing them of dissuading members against use of hydroxychloroquine and ivermectin as a regimen for COVID-19.
Citing one study published in the Journal of the American Medical Association, the plaintiff points out that despite the fact that the FDA doesn’t authorize the drugs for COVID-19, approximately 1 in 20 U.S. adults are identified as using hydroxychloroquine or ivermectin for COVID-19 treatment.
Briefly authorized as an emergency medicine during COVID-19, Hydroxychloroquine’s status was revoked when ensuing research suggested the potential for harm. Although conflict ensued thereafter over the research, with some studies showing efficacy and others not. Ivermectin was never authorized in the United States although at least a dozen nations, mostly in low-and middle-income countries, authorized ivermectin on an emergency basis against COVID-19.
While some prominent larger studies (TOGETHER, COVID-OUT, ACTIV-6) showed no efficacy, many others have shown promise. For example, a website tracks ongoing studies which now total 99 studies covering 137,255 patients across 28 countries. The takeaway: the drug can statistically lower risk for mortality, ventilation, ICU and other targeted outcomes. But critics in institutions such as the NIH suggest these studies are not trustworthy, with poor design, questionable data, and the like.
Regardless, by 2021, weekly ivermectin prescriptions, according to one study, skyrocketed from 3,000 per week to nearly 90,000 per week!
The FDA joined in on an information war against the drug, labeling it only as an animal drug, when of course hundreds of millions of doses are administered to humans per year.
Iowa Clash
Dr. Hartsuch’s conflict with the Iowa licensing boards emerged in March 2020. While during summer and late 2020 growing ivermectin use across America was generally accommodated, as Biden entered the White House, the conditions changed.
This market demand triggered a massive industry, government and academic medical system response. TrialSite examined how the federal government went after doctors indirectly in December 2021. In “Feds coming after Doctors & Pharmacies that Market Ivermectin as Safe & Effective for COVID-19” for example, the FDA wrote letters to group such as the Federation of State Medical Boards (FSMB) warning state groups to monitor members for espousing misinformation involving ivermectin.
This campaign spooked doctors and pharmacists around the nation. By the fall of 2021, it was becoming harder for doctors such as Hartsuch to prescribe the off-label drug to his patients. Pharmacies were increasingly on alert.
So, a patient of Dr. Hartsuch for example, could not get ivermectin prescriptions filled, which led to investigations by the Board of Medicine into the doctor’s ivermectin prescribing trends.
But the Iowa physician points out in his complaint that warning letters received by the Iowa Board of Medicine were violative of core free speech rights, during his professional brand reputation.
Now seeking the court to expunge the warning letter from his record, he demands an injunction requiring pharmacies to fill prescriptions for the off-label drugs.
The Iowa physician’s point of view: doctors’ rights to consider and prescribe repurposed off-label drugs is a basic physician right, as long as they follow their professional standards (e.g., consent, etc.).
In other states such as Nebraska, the attorney general doesn’t enforce disciplinary measures should physicians prescribe drugs like ivermectin or hydroxychloroquine for COVID-19.
Before COVID-19 physicians routinely would prescribe off label drugs typically with little to no problems.
https://www.trialsitenews.com/a/ivermectinhydroxychloroquine-lawsuits-continue-on-81c1b8ee
********************************************************22 October, 2023
The Decline and Near Fall of the COVID Vaccine Makers
The uptake of the latest version of the COVID vaccines, which underwent almost no testing but were rubber-stamped by regulators anyway, has been far lower than expectations. The CDC is not publishing real-time data but what we know so far suggests that it is in the realm of 2 percent.
This is incredibly low. The most pessimistic prediction I had heard was 5 percent. This is a deep failure by any standard. That is precisely why the numbers are not being advertised. The average person has stopped buying what they are selling.
Initially, the excuse was that drug stores faced logistical problems. Then it was widely suggested that they were too expensive. For a few weeks, such diversions dominated the messaging. But in the end, the reality is here: people just don’t want them.
Now we see why the shot pushers were so intent on mandates wherever and however they could. The makers always claimed that the shots were safe and effective but that bypasses a more fundamental question: were they necessary?
The demographics of risk of COVID have been published and unchanged since February 2020, fully a year before the shots became generally available. By that time, millions were already exposed and gained immunity without the shots.
From the beginning, the claims for what they called a vaccine were wildly exaggerated and obviously so. Vast numbers of people had figured this out by the time they were rolled out.
The Biden administration was advised early on that ending the pandemic required 70 percent uptake, which is consistent with the pharmaceutical target for herd immunity. But that goal presumes an absence of natural immunity, which the crowd in charge at the time pretended did not exist or that there was not enough evidence to rely upon it.
When that number failed to stop the spread, the Biden White House kept expanding the goal, from 70 percent to 85 percent to 90 percent to everyone. Finally, they said that the whole reason COVID still existed was due to the unvaccinated, which most every expert knew was false but the needs of industry at that point overrode all science.
The main competitor to the two mRNA shots of Pfizer and Moderna was Johnson & Johnson, which was a more traditional vaccine and required only one shot. But that was withdrawn briefly for safety concerns by the Food and Drug Administration (FDA) in 2021, which wrecked its market share, leaving only two giants to scoop up the fiduciary rewards of public panic.
Keep in mind that these vaccines were developed by tax dollars. The companies enjoyed patent protection. Briefly, the Biden administration toyed with the idea of giving away the formulas so that anyone could make them but that idea faded quickly following panicked industry protests. Then they relied on mandates, which is a form of conscription. Further, they enjoyed indemnification against harms. Finally, they are publicly listed companies so could reap the whirlwind of profits, and they did.
After three years, where does the stock price of Pfizer and Moderna stand? Moderna has lost 74 percent of value in two years, while Pfizer has lost 46 percent. No question that the time to have sold these stocks was two years ago. The layoffs have already started and their valuation will likely crawl back to what it was two years ago.
There is a temptation to cheer when big shots bite the dust, and I share that sense. And yet, nothing about a fallen stock price undoes the tremendously terrible history of these shots: the expense, the coercion, the harms, and the wealth transfer associated with them.
All of which is to say: they will likely get away with the whole thing.
I often think back to what we knew about coronaviruses from the first days. Such viruses are mostly unstable, prone to constant mutation. They are not candidates for viable vaccines. At best, pharmaceuticals can chase down the last variant and provide some therapeutic benefit. They are completely unlike polio, measles, rubella, or smallpox, which are stable viruses against which there have been sterilizing vaccines for a very long time.
Again, this is not wisdom we recently discovered. It was widely known, and has been for many decades. You could find it in any medical textbook. You could even learn about it in 9th grade biology class a generation or two ago.
For some strange reason, by the time 2020 came around, enough people had forgotten or never learned that bad actors were able to manipulate the public into believing that a magic shot could make a respiratory virus go away. There was never any chance that we could vaccinate our way out of this one. Never.
As for safety and efficacy of the shot, I can only quote Tracy Høeg: “There was thus no informed consent and, as stated, safety and efficacy almost entirely unknown when the vaccine was administered to the public.”
Meanwhile, the FDA had a strong team focused on vaccines, which resigned when they saw what was coming with the first booster and how the manufacturers were essentially buying their way into the approval process. Those who remain, it is widely acknowledged, are entirely in the pay of the industry.
Will they get away with all of this? Certainly the public and the financial markets are now in a punishing mode. It’s about time. As for larger accountability, it’s unclear. We had investigations going and some focus on Capitol Hill but all that might be shelved now in light of the huge attention being paid to war in the Middle East. War tends to do this: put everything else on the back burner.
No question that we urgently need reforms, particularly with the problem of regulatory capture and indemnification against harms. The 1986 act (National Childhood Vaccine Injury Act [NCVIA]) that protects vaccine makers against harms needs an urgent repeal. That will bring an element of reality back to these markets.
And measures need to be taken to restore integrity and science at the FDA. That’s just the beginning.
At the start of this entire mess, thinking and writing not as an expert but as a literate human being, I pretty much assumed that the vaccine would be a great distraction from the need for good protocols for dealing with the sick. It turned out to be far worse than a distraction. Many people have been injured and many have died. The entire fiasco has massively raised public doubt about all vaccines, pharmaceuticals, medical services, and public health generally.
What this means is that even without serious efforts at reform, we could see de facto refusal of the public to go along anymore. Public health in this country and around the world squandered decades of goodwill and built up reputational capital on an unworkable project that was never necessary for the vast majority. Now we are stuck with the consequences.
Given all this, a lowered stock valuation for the main two vaccine distributors is small consolation.
*****************************************************
COVID-19 Vaccines and Reports of Deep Vein Thrombosis (DVT)
Reports of deep vein thrombosis (DVT), the formation of blood clots, as an adverse effect associated with COVID-19 vaccines, are increasing. TrialSite has reported before on the blood clot crisis linked to COVID-19 and its vaccines. A compilation of such hematological case reports has been contributed by Aaron Hertzberg. We will summarize some of them here.
Deep vein thrombosis (DVT) is a medical condition where blood clots form in a deep vein; usually in the lower leg, thigh, or pelvis. However, sometimes they can form in the arm.
Case reports of the adverse events following the COVID-19 vaccine administration are appearing after the massive vaccination campaigns to control the pandemic. Studies have been conducted to investigate the link between these vaccines and blood clot formation. Here we present a summary of case reports of DVT, post-COVID-19 vaccination.
Case 1
The first paper mentioned here entitled “Deep vein thrombosis (DVT) occurring shortly after the second dose of mRNA SARS-CoV-2 vaccine” was published in the Internal and Emergency Medicine journal in 2021.
This case involved a 66-year-old female who received two doses of the Pfizer vaccine. Before vaccination, the woman had been completely healthy and did not smoke or have any allergies. She just had a history of left leg neuropathy (damage to peripheral nerves in the leg) after a trauma. A day after receiving her second dose, she had a persistent fever with chills, fatigue, muscle pain, and discomfort. To control these symptoms, she was administered acetaminophen, a drug used for bringing down fever and easing pain. The fever had not resolved by the next day and the patient had also developed acute pain in her right calf in the absence of any trauma. On the third day post vaccine administration, she could not walk and was admitted for investigations. She had mild swelling in her right calf. A diagnosis of DVT was confirmed through a color-doppler ultrasound scan, a non-invasive method to test for deep vein thrombosis. To treat this condition, she was given 10 mg of apixaban, an anticoagulant, for a week. The dose was later reduced to 5 mg and the symptoms resolved rapidly.
Case 2
The second case study was published in the American Journal of Case Reports in 2021. It is titled “A 59-Year-Old Woman with Extensive Deep Vein Thrombosis and Pulmonary Thromboembolism 7 Days Following a First Dose of the Pfizer-BioNTech BNT162b2 mRNA COVID-19 Vaccine”.
It involved a 59-year-old female who reported to a hospital in Oman after suddenly experiencing pain in her left leg. She had a medical history of type 2 diabetes mellitus (T2DM), a condition in which there is a decrease in the insulin secretion to metabolize glucose in the body, osteoarthritis, a degenerative joint disease, and COVID-19 pneumonia. She had been diagnosed with COVID pneumonia in September 2020 for which she had been hospitalized for a week, but the condition had not been complicated. Seven months later, she received the Pfizer BioNTech vaccine, and seven days after that, she developed leg pain with swelling and tenderness. Acute DVT was diagnosed by performing duplex ultrasonography, a test to visualize how blood travels through arteries and veins. The patient experienced tachycardia for which computed pulmonary tomography angiography (CTPA) was performed to look for blood clots within the arteries of the lungs. The test confirmed the presence of blood clots in her pulmonary arteries. For treatment, she was given enoxaparin, an injectable anticoagulant. This was later switched to rivaroxaban – an oral anticoagulant – due to a positive heparin-induced thrombocytopenia test (HIT).
Case 3
The third case report entitled “An unusual presentation of acute deep vein thrombosis after the Moderna COVID-19 vaccine-a case report” was published in 2021 in the Annals of Translational Medicine journal.
It involved a 27-year-old female who had been completely healthy before receiving the second dose of mRNA-1273 (Moderna) COVID-19 vaccine. She had an unremarkable medical history. On the third day after receiving the dose, she reported to the hospital with swelling, redness, and pain with bruising in her upper right arm. (The first dose of this vaccine had been well-tolerated by her with mild soreness at the injection site which had lasted for a few days.) An acute thrombosis in her subclavian and axillary veins was diagnosed using venous duplex ultrasound. For treatment, she was given a heparin infusion to clear the blood clots. After that, she was given rivaroxaban for three months. Her symptoms significantly improved two weeks after being discharged.
Case 4
The fourth case titled “Deep Vein Thrombosis and Pulmonary Thrombosis After BNT162b2 mRNA SARS-CoV2 Vaccination” was published in Circulation Journal in 2022.
This case involved a 14-year-old male who presented at the clinic with pain in his left lower leg 24 hours after receiving the second dose of the Moderna vaccine. He had no family history of juvenile thrombosis or medical history of thrombosis. A contrast-enhanced computed tomography scan revealed multi-organ thrombosis. The patient was administered heparin initially and then shifted to an oral anticoagulant.
The bottom line
While COVID-19 vaccines have been promoted as safe and effective by the World Health Organization (WHO) and public health organizations like the Centers for Disease Control and Prevention (CDC), several adverse events have been associated with them. These include musculoskeletal events, neurological and cardiovascular events as reported in this article.
While some of these adverse events are manageable, several vaccine-injured individuals are yet to recover completely from the effects of these vaccines. This highlights the need for in-depth investigations into the safety profile of these vaccines, as well as the possible link between adverse effects and the vaccines.
https://www.trialsitenews.com/a/covid-19-vaccines-and-reports-of-deep-vein-thrombosis-dvt-a874d074
********************************************************20 October, 2023
DNA contamination with residual bacterial plasmids and truncated mRNA from the manufacturing process
The more I hear about mRNA vaccines, the more pleased I am that I had only the British AstraZeneca shot, which was a more conventional product. I deliberately chose it because I thought it would be safer. Sadly, it was never approved for use in the USA. I guess I should mention that I had zero after effects from my two injections: Not even a sore arm
We highlight the inherent safety issues associated with a lax regulatory framework for approval of the COVID-19 mRNA vaccines. In this article, we consider how lax regulation is related to DNA and RNA contamination issues.
Summary of Key Facts
Concerns have been raised about DNA contamination in the mRNA COVID-19 vaccines. The specific concern is the presence of higher-than-expected residual DNA plasmids used in the original mRNA production. Independent investigations suggest that the Pfizer mRNA vaccine may have high levels of DNA contamination, potentially exceeding regulatory limits.
There are theoretical risks associated with plasmid DNA expression and migration to the gut, which could affect human health and the microbiome. Concerns have also been raised about the quality control and manufacturing oversight of mRNA vaccines.
The European Medicines Agency (EMA), Europe's drug regulatory authority, noted the presence of truncated and modified RNA as impurities in the mRNA COVID-19 vaccines, raising the need for oversight.
Related to the manufacturing process, a Danish study compared the rate of adverse events to the batch size (number of doses in a batch) and found a correlation.
The Advisory Committee on Immunization Practices met last week to recommend the updated COVID-19 vaccine. However, the manufacturers presented little data from testing in humans. Moderna was the only manufacturer to present safety and antibody response data from experience with 101 individuals. Pfizer presented antibody response data from 20 mice and is currently collecting data from 400 individuals in clinical testing. No data on manufacturing oversight was presented during the meeting.
As part of the safety evaluation of drug approval, the CMC (chemistry, manufacturing, and controls) process becomes critical in identifying and eliminating impurities. It sets strict standards and product specifications to maintain the purity of each batch. Compliance with these standards is essential for obtaining approval from global health authorities.
Imagine you're a coffee drinker, and you decide to buy a bag of premium, freshly ground coffee beans from your favorite store. You expect that each bag contains pure, high-quality coffee grounds to brew that perfect cup of coffee. However, when you open the bag, you discover that it isn't just coffee grounds; it also contains a mixture of sand and other foreign particles. This unexpected impurity completely ruins your experience.
Just as you rely on the purity of your coffee grounds for a great cup of coffee, the pharmaceutical industry, including vaccine production, has regulations in place to ensure good manufacturing practices. Patients and consumers expect that these guidelines mean that drug or vaccine formulations are free from unwanted substances, ensuring their safety and effectiveness.
Controlling impurities in traditional chemical products is a well-established practice, but for biological products such as mRNA-based vaccines, managing impurities presents unique challenges.
mRNA Products Contain 'Gene Factories'
Double-stranded DNA (dsDNA) is used to make the mRNA contained in the COVID-19 vaccines. Tiny dsDNA plasmids are small engineered gene factories (Figure 1). These factories produce the mRNA strands contained in the LNPs. A plasmid appears like a tiny micro-bracelet with different segments representing different pieces of genes.
Regulatory agencies like EMA—Europe's drug regulatory authority—set limits for the number of plasmids in the final lots distributed for injection. New questions have been raised about how much contamination there is, and whether the FDA is monitoring this. It is also unclear whether the plasmids can merge with human genes within the cell or travel to the gut.
The EMA standard for DNA contamination of vials is 0.33 percent (330 pg/mg), or roughly one DNA molecule for every 3,000 mRNA molecules. Although the Moderna mRNA-1273 vaccine meets this standard, the actual volume may be higher due to poor quality control. The DNA must be removed from the final product before distribution, but some residual amount is expected to remain.
Unanswered questions include: How much DNA is in the vials? Is it over the limit? Is the FDA tracking this? And what are the implications, if any, with regard to persistence in the recipient?
There are at least two independent groups of investigators who have conducted lab tests and confirmed the mRNA vaccine of Pfizer has been contaminated by DNA.
One team of scientists, led by microbiologist Kevin McKernan, published a preprint paper showing that the Pfizer/BioNTech BNT162b2 vaccine has DNA “orders of magnitude higher than the EMA’s limit.” His paper has not yet been peer-reviewed. The batches examined, provided by an anonymous source, were unopened, expired vials that were not delivered on dry ice. If these data hold, the actual amount of plasmids was 18 to 70 times higher than the EMA limit. (Table 3, page 12.)
Obviously, future investigations should attempt to establish contamination levels using unexpired doses with an intact cold chain.
Professor Phillip Buckhaults, who holds a doctorate in biochemistry and molecular biology and is considered an expert in cancer genomics research at the University of South Carolina, performed an independent analysis for the presence of DNA in Pfizer batches.
Professor Buckhaults in testimony stated the following:
"The Pfizer vaccine is contaminated with plasmid DNA. It's not just mRNA. It's got bits of DNA in it. This DNA is the DNA vector that was used as the template for the in vitro transcription reaction when they made the mRNA. I know this is true because I sequenced it in my own lab."
We will continue to follow this line of research.
Theoretical Risk of Plasmid DNA Contamination
While having some DNA in a sample is unavoidable and deemed acceptable, some have raised questions about the possibility for genomic integration of the DNA. Our cells use DNA in the nucleus to make protein, so if the plasmid DNA gets into the nucleus, there is a theoretical risk that it can get transcribed and make a protein.
About 5 to 10 percent of our human genome contains ancient retroviral DNA. However, this DNA is mutated to a point that is no longer harmful. Any further research on this topic will therefore need to establish not just the presence of DNA plasmid integration, but also its biological activity.
Professor Buckhaults further commented in his testimony:
"I am kind of alarmed about the possible consequences of this—both in terms of human health and biology—but you should be alarmed about the regulatory process that allowed it to get there."
Concerns About DNA Migration to the Gut
Related to the DNA contamination is the concern about residual expression vectors, or plasmids, in the vials. To make a billion doses of mRNA vaccine, more than a kilogram of DNA is required. Plasmids help produce the DNA by splicing in the desired sequence into a bacterial plasmid (Figure 1).
Then workhorse bacteria, often E. coli, help spin out the DNA for production. These bacteria have an extra burden: They must replicate not only their own genome but also the plasmid DNA inserted within their genome. This takes slightly more time, so the bacteria without the additional DNA will eventually outcompete those with the DNA.
To solve this problem, scientists also splice in an antibiotic resistance gene. The entire pool of bacteria is then treated with an antibiotic to kill the faster-replicating bacteria without the conferred antibiotic resistance. This selective elimination allows the plasmid-carrying antibiotic-resistant bacteria to continue growing. In other words, this antibiotic resistance gene confers an advantage that drives selection pressure to favor the bacteria producing the desired DNA.
However, some scientists are concerned that exceeding EMA standards for DNA plasmid contamination could affect an already growing antibiotic resistance problem. This would be a potential concern only if plasmids containing the antibiotic resistance gene migrate to the gut, integrate with bacterial targets in the gut flora, and disrupt the microbiome of the gut accordingly. Diseases, including obesity, diabetes, cardiovascular disorders, cancer, hypertension, and irritable bowel syndrome have been loosely linked with disturbances of the gut microbiome.
Truncated mRNA Contamination
Nucleic acid contamination with truncated, or shortened, mRNA fragments is something that EMA has been following since February 2021. On page 35 of the EMA assessment report (pdf) on the BNT162b2 mRNA vaccine reviewed in Part 1, the EMA states, "Truncated and modified RNA are present as impurities." The agency noted that the impurities were found at different levels during production. For instance, levels may be higher in smaller test batches than in larger commercial batches.
In fact, Danish scientists, Max Schmeling, Vibeke Manniche, and Peter Riis Hansen linked adverse events with vaccination records and found that smaller batches of the BNT162b2 mRNA vaccine may have a higher rate of adverse events (AEs). While this finding is intriguing, the authors call for more research to see if this is a consistent pattern. We reviewed the raw data provided by the authors and agree that a clustering of AEs seems to be found with batches having fewer than 100,000 doses.
It has already been demonstrated in vitro in a laboratory experiment that mRNA can be reverse-transcribed to DNA within six hours. A remaining question is whether this can happen in a live organism. Thus far, there is no evidence that a reverse-transcribed DNA product can merge with a human cell’s genome. Claims about integration are solely speculative and based upon an evolutionary precedent for such a process.
The EMA asked for additional testing but allowed distribution to go forward. The scientists believed these fragments were unlikely to be intact mRNA fragments. An intact mRNA fragment needs to have a cap and a tail. The cap and tail are needed to tell the cell when to start and stop producing the spike protein.
Nevertheless, the EMA requested additional reports. The agency was concerned that an autoimmune reaction could be triggered if fragments' potentially encoded proteins resemble human proteins. In other words, if the fragments "mimic" human proteins, antibodies could be developed against our own bodies.
"Any homology between translated proteins (other than the intended spike protein) and human proteins that may, due to molecular mimicry, potentially cause an autoimmune process should be evaluated. Due date: July 2021. Interim reports: March 2021, and on a monthly basis," the EMA stated.
It is clear that the mass production of mRNA at an industrial scale carries potential risks. This issue has been raised recently by other researchers pointing out the role of manufacturing quality control. For instance, The Epoch Times has previously investigated the link between quality issues and clotting risk (Part 1, Part 2, and Part 4).
This issue of contamination by DNA and mRNA fragments should also be explored further to understand whether certain lots were affected more than others. We also need to know whether DNA contamination is linked to adverse events. The EMA should strictly follow its monitoring standards.
The issue of having any DNA contamination is biologically unavoidable given that the mRNA is transcribed from DNA vectors. The potential issue here is the unusually high level of DNA contamination involved in the mRNA vaccines.
However, pivoting these RNA therapeutics to a vaccine platform in the context of a lagging regulatory framework has left us with many unanswered questions. Public health officials, nevertheless, were adamant that this new product should be deployed in a one-size-fits-all manner ignoring differential COVID-19 risk profiles across a broad population. This, in turn, we believe, set the stage for policy overreach resulting in unethical and harmful mandates.
********************************************************
19 October, 2023
Rome-Based IRCCS Team Find Distinct Markers Linked to mRNA COVID-19 Vax-Induced Myocarditis
A large team of Italian specialist physician-investigators represented by corresponding author Paolo Palma, affiliated with Rome Italy’s prestigious Instituto di Ricovero e Cura a Carattere Scientifico (IRCCS), the Research Unit of Clinical Immunology and Vaccinology at Bambino Gesu Children’s Hospital, and colleagues conducted a prospective observational study including 15 pediatric patients referred to the hospital’s emergency department for cardiac events (namely suspected acute myocarditis/pericarditis) after receiving a COVID-19 mRNA vaccine.
In this study, all patients were hospitalized and had samples taken on admission or within 48 hours for baseline evaluation, as well as within six months for follow-up evaluation. The study team performed cardiological evaluation with electrocardiogram (ECG) as well as echocardiogram. In this study, the physician-scientists examined the inflammatory features of the Rome children’s hospital pediatric patients developing myocarditis post the mRNA COVID-19 jab. The team combined clinical and routine laboratory data along with high-dimensional proteomic analysis.
Patients meeting the clinical case definition of the CDC (probable myocarditis, confirmed myocarditis, or acute pericarditis) were deemed “c-AEFI patients,” and compared to children with MIS-c and cardiac involvement, SARS-CoV-2 infected children and healthy controls. The Rome-based team was able to confirm a “distinct inflammatory and androgenic profile in patients developing c-AEFI following mRNA vaccination which persists months after the acute event, whereas excluding a pathogenic role of autoantibodies.”
Dr. Palma heads up the pediatric department at the tertiary care academic children’s hospital in Rome that is under extraterritorial jurisdiction of the Holy See—the jurisdiction of the Pope in his role as the bishop of Rome and sovereign of Vatican City.
The study team reports that the subjects represent the clinical and demographic characteristics in line with previously published case series, including class of vaccine product, dose linked to the injury, and the gender ratio.
All the patients in this study developed symptoms following the second or third dose except those who already experienced SARS-CoV-2 infection, who developed symptoms after the first dose. Could this point observed indicate that previous exposure to spike protein may play a role in the pathogenesis of this condition? The study authors believe so.
Study Methods
During this study, the study team investigated the inflammatory features of pediatric patients developing myocarditis following mRNA COVID-19 vaccination, by combining clinical and routine laboratory data along with high-dimensional proteomic analysis.
During the study period the team enrolled 17 patients who met the criteria for the study—CDC work case definitions for myocarditis. These patients all went into observation due to chest pain after COVID-19 mRNA vaccine (BNT162b2 mRNA-Pfizer-BioNTech and the mRNA-1273-Moderna), from August 2021 to February 2022.
The study authors report the exclusion of two patients due to not meeting the study inclusion criteria. The study team used CDC work case definitions to categorize case definitions, fitting as probable myocarditis, confirmed myocarditis or cute pericarditis. All are referred to as c-AEFI.
The Rome-based team was able to use other cohorts for comparison participant data from the CACTUS study—these children were affected by SARS-CoV-2 infection; or had MIS-C with cardiac involvement all before any treatment, as well as healthy children collected in the pre-pandemic period.
Addressing the possibility of confounding factors of age, the team age matched patients, using for comparison of proteomic analysis 21 children with acute COVID-19 infection, 14 children with MISC-C and 31 healthy children. Also, the study team compared androgen levels in children with myopericarditis.
So, what did the Italian researchers find under Dr. Palma and colleagues? TrialSite breakdowns down the outcomes.
Why conduct this study?
Because the risk of acute myocarditis linked to the mRNA vaccines developed in response to COVID-19 attracts lots of attention, and is hotly debated, particularly in the pediatric population. This is a cohort where the risk-benefit of the vaccine must be carefully evaluated. Moreover, the pathogenesis of COVID-19 mRNA vaccine-linked myocarditis remains poorly understood. Several mechanisms are possible.
What are the possible mechanisms involved with COVID-19 mRNA vaccine-induced myocarditis?
The authors suspect one or more of the following:
Immune reactivity
Cross-reacting antibodies to SARS-CoV-2 spike glycoproteins with myocardial contractile proteins
Hormonal differences
So, what were the team’s finding?
Cardiac adverse Events Following COVID-19 Immunization (c-AEFI) have been reported, are a real-world phenomenon, although rare, and were distinctly identified in this study.
Such events not to mention the severe cardiac involvement reported in Multisystem inflammatory syndrome in children (MIS-C) appear more frequent in young adult males. The team here investigates the inflammatory profiles of patients experiencing c-AEFI in comparison with age, pubertal age and gender matched MIS-C with cardiac involvement. Interestingly the study team reports when comparing MIS-C patients to vaccine injured myocarditis patients (c-AEFI), the former possess higher levels of proteins related to systemic inflammation than compared to the latter c-AEFI. But higher levels in proteins related to myocardial injury were found in c-AEFI.
In addition, higher levels of hormones such as DHEAS, DHEA, and cortisone were found in c-AEFI which continued months later during ongoing follow-up. No anti-heart muscle and anti-endothelial cell antibodies have been detected. Overall current comparative data showed a distinct inflammatory and androgens profile in c-AEFI patients which results in being well restricted on heart and to persist months after the acute event.
**************************************************
COVID-19 Vaccines and Reports of Deep Vein Thrombosis (DVT)
Reports of deep vein thrombosis (DVT), the formation of blood clots, as an adverse effect associated with COVID-19 vaccines, are increasing. TrialSite has reported before on the blood clot crisis linked to COVID-19 and its vaccines. A compilation of such hematological case reports has been contributed by Aaron Hertzberg. We will summarize some of them here.
Deep vein thrombosis (DVT) is a medical condition where blood clots form in a deep vein; usually in the lower leg, thigh, or pelvis. However, sometimes they can form in the arm.
Case reports of the adverse events following the COVID-19 vaccine administration are appearing after the massive vaccination campaigns to control the pandemic. Studies have been conducted to investigate the link between these vaccines and blood clot formation. Here we present a summary of case reports of DVT, post-COVID-19 vaccination.
Case 1
The first paper mentioned here entitled “Deep vein thrombosis (DVT) occurring shortly after the second dose of mRNA SARS-CoV-2 vaccine” was published in the Internal and Emergency Medicine journal in 2021.
This case involved a 66-year-old female who received two doses of the Pfizer vaccine. Before vaccination, the woman had been completely healthy and did not smoke or have any allergies. She just had a history of left leg neuropathy (damage to peripheral nerves in the leg) after a trauma. A day after receiving her second dose, she had a persistent fever with chills, fatigue, muscle pain, and discomfort. To control these symptoms, she was administered acetaminophen, a drug used for bringing down fever and easing pain. The fever had not resolved by the next day and the patient had also developed acute pain in her right calf in the absence of any trauma. On the third day post vaccine administration, she could not walk and was admitted for investigations. She had mild swelling in her right calf. A diagnosis of DVT was confirmed through a color-doppler ultrasound scan, a non-invasive method to test for deep vein thrombosis. To treat this condition, she was given 10 mg of apixaban, an anticoagulant, for a week. The dose was later reduced to 5 mg and the symptoms resolved rapidly.
Case 2
The second case study was published in the American Journal of Case Reports in 2021. It is titled “A 59-Year-Old Woman with Extensive Deep Vein Thrombosis and Pulmonary Thromboembolism 7 Days Following a First Dose of the Pfizer-BioNTech BNT162b2 mRNA COVID-19 Vaccine”.
It involved a 59-year-old female who reported to a hospital in Oman after suddenly experiencing pain in her left leg. She had a medical history of type 2 diabetes mellitus (T2DM), a condition in which there is a decrease in the insulin secretion to metabolize glucose in the body, osteoarthritis, a degenerative joint disease, and COVID-19 pneumonia. She had been diagnosed with COVID pneumonia in September 2020 for which she had been hospitalized for a week, but the condition had not been complicated. Seven months later, she received the Pfizer BioNTech vaccine, and seven days after that, she developed leg pain with swelling and tenderness. Acute DVT was diagnosed by performing duplex ultrasonography, a test to visualize how blood travels through arteries and veins. The patient experienced tachycardia for which computed pulmonary tomography angiography (CTPA) was performed to look for blood clots within the arteries of the lungs. The test confirmed the presence of blood clots in her pulmonary arteries. For treatment, she was given enoxaparin, an injectable anticoagulant. This was later switched to rivaroxaban – an oral anticoagulant – due to a positive heparin-induced thrombocytopenia test (HIT).
Case 3
The third case report entitled “An unusual presentation of acute deep vein thrombosis after the Moderna COVID-19 vaccine-a case report” was published in 2021 in the Annals of Translational Medicine journal.
It involved a 27-year-old female who had been completely healthy before receiving the second dose of mRNA-1273 (Moderna) COVID-19 vaccine. She had an unremarkable medical history. On the third day after receiving the dose, she reported to the hospital with swelling, redness, and pain with bruising in her upper right arm. (The first dose of this vaccine had been well-tolerated by her with mild soreness at the injection site which had lasted for a few days.) An acute thrombosis in her subclavian and axillary veins was diagnosed using venous duplex ultrasound. For treatment, she was given a heparin infusion to clear the blood clots. After that, she was given rivaroxaban for three months. Her symptoms significantly improved two weeks after being discharged.
Case 4
The fourth case titled “Deep Vein Thrombosis and Pulmonary Thrombosis After BNT162b2 mRNA SARS-CoV2 Vaccination” was published in Circulation Journal in 2022.
This case involved a 14-year-old male who presented at the clinic with pain in his left lower leg 24 hours after receiving the second dose of the Moderna vaccine. He had no family history of juvenile thrombosis or medical history of thrombosis. A contrast-enhanced computed tomography scan revealed multi-organ thrombosis. The patient was administered heparin initially and then shifted to an oral anticoagulant.
https://www.trialsitenews.com/a/covid-19-vaccines-and-reports-of-deep-vein-thrombosis-dvt-a874d074
********************************************************18 October, 2023
FDA Finds Safety Signal for COVID-19 Vaccination Among Toddlers
A safety signal is a sign that a health condition may be caused by vaccination, but further research is required to verify a link.
A safety signal of seizures for young children following COVID-19 vaccination has been detected by the U.S. Food and Drug Administration (FDA).
Seizures/convulsions "met the statistical threshold for a signal" in children aged 2 to 4 following receipt of a Pfizer COVID-19 vaccine and children aged 2 to 5 following receipt of a Moderna COVID-19 vaccine, researchers with the FDA and three large healthcare companies said in a new preprint study.
A safety signal is a sign that a health condition may be caused by vaccination, but further research is required to verify a link.
The data came from three health claims databases run by Optum, Carelon Research, and CVS Health, supplemented with vaccination information from state and local systems. The health claims databases are part of the FDA's Biologics Effectiveness and Safety System, a drug safety monitoring system.
Researchers looked at 15 health conditions following vaccination entered in the commercial databases and compared rates among children aged 6 months old to 17 years old to background rates from 2019, 2020, or both.
Overall, 72 cases of seizures/convulsions were recorded within seven days of a shot among toddlers and other young children. Most happened within three days of a shot.
When stratifying the data by dose, the researchers found signals for dose one and dose two for Pfizer's shot in two of the three databases in children aged 2 to 4. They also found a signal following dose two of Moderna's shot in children aged two to five.
The signal for seizures/convulsions for the young children "has not been previously reported for this age group in active surveillance studies of mRNA COVID-19 vaccines," the researchers said, referring to the Pfizer and Moderna shots.
There are reports of seizures and convulsions after COVID-19 vaccination among children in the Vaccine Adverse Events Reporting System, the researchers noted. Though anybody can lodge reports with the system, most are made by health care professionals.
Another five convulsions were reported after Pfizer vaccination in Pfizer's clinical trial.
The research did not cover the bivalent COVID-19 vaccines, which were introduced for some populations in 2022 and completely replaced the old vaccines in April, or the newest versions of the vaccines that were rolled out in September.
It's not clear when the signal was first detected. The FDA and Patricia Lloyd, an FDA statistician who is the study's corresponding author, did not respond to requests for comment. Pfizer and Moderna did not return inquiries.
Caution Warranted: Researchers
The researchers said the signal "should be interpreted with caution and further investigated in a more robust epidemiological study."
That's partly because the signal disappeared when changing background rate years. The signal was detected when comparing rates with background rates from 2020. But when using background rates from 2022, which were about 2.3 times higher, a signal was not detected.
The higher number of cases in 2022 may stem from an increased incidence of respiratory infections such as influenza, the researchers posited.
The case count may have also included seizures "unrelated to vaccination," the researchers said.
Similar to previously analyzed data from the same system, the researchers also detected a signal for heart inflammation and a related condition, or myocarditis and pericarditis, for children aged 12 to 17. Because that signal has been known since 2021, researchers did not attempt to further explore it.
No other signals were detected.
Strengths of the study include the population covered by the databases being large and geographically diverse. Limitations include a lack of control of confounding factors.
Stroke Risk in Elderly
The FDA and the U.S. Centers for Disease Control and Prevention in January announced they detected a signal for ischemic stroke for people aged 65 or older following receipt of Pfizer's bivalent vaccine. Ischemic stroke is a type of stroke caused by blood clotting.
In another preprint paper published on Oct. 15, FDA researchers said they analyzed Medicare data to estimate the risk of stroke after bivalent vaccination.
They included Medicare beneficiaries aged 65 or older who received a bivalent shot or an influenza vaccine and suffered stroke, except for stroke cases deemed to have been caused by something other than a COVID-19 shot.
The primary analysis did not identify an increased risk of stroke, but stratifying the population by age showed an increased risk after Pfizer vaccination for people aged 85 or older of non-hemorrhagic stroke and for non-hemorrhagic stroke/transient ischemic attack. An increased risk was also found for Moderna recipients aged 65 to 74 for non-hemorrhagic stroke/transient ischemic attack.
No increased risk was found for hemorrhagic stroke.
For people who received a Pfizer jab with an influenza shot, an elevated risk of non-hemorrhagic stroke was detected. For people who received a Moderna jab with an influenza shot, an elevated risk of transient ischemic attack was detected.
A separate analysis of only influenza vaccination detected an increased risk of non-hemorrhagic stroke following receipt of a high-dose/adjuvanted influenza shot, and signals for different ages upon stratification.
"Our study did identify an elevated risk of stroke when the COVID-19 bivalent vaccines were administered with a concomitant high-dose/adjuvanted influenza vaccine. However, the observed effects were not consistent," the researchers, with the FDA and Acumen, said.
A similar finding was detected in a study of data from the Centers for Disease Control and Prevention's Vaccine Safety Datalink system.
The researchers said that the study's findings suggest the elevated risk of stroke in the group that received influenza and COVID-19 vaccines together "was likely driven by influenza vaccination alone rather than concomitant administration."
******************************************************
Collapsing Demand for Pfizer products leads to price RISES
On Thursday, Oct. 12, the Director of the Centers for Disease Control and Prevention (CDC) perhaps, inadvertently shared the current state of COVID-19 vaccine demand, which appears fairly abysmal. Mandy Cohen mentioned at a mobile clinic situated in an elderly community center in California late last week in California that to date, since the vaccine was recommended Sept. 12 by her agency, 7 million doses of the monovalent COVID-19 booster targeting XBB.1.5 have been administered. This represents 2.1% of the total population. For comparison purposes, ultimately about 56.4 million people across the USA opted for the bivalent booster made available last September, representing about 17% of the nation’s population. Pfizer recently predicted the rate of vaccination with the new monovalent vaccine would hit 24%. Director Cohen’s reference to the total number vaccinated was first picked up by the San Jose Mercury News, then later other media such as Reuters and CNN.
Various news agencies attempted to spin the weak turnout for the inoculation noted by some of the right-leaning media such as The Blaze, Glen Beck’s media outlet. For example, CNN positioned the vaccinated figure in a positive light given the “rocky rollout.” COVID-19 has surged somewhat, and based on CDC data, by Sept. 30, approximately 11% of all COVID-19 tests making their way to the national public health agency evidenced a positive for the virus. In this latest surge, 1.6% of all emergency department visits are associated with COVID-19.
Not surprisingly, the weak demand impacts the COVID-19 vaccine manufacturers’ revenue and profit forecasts. With a deceptively innocuous title, Pfizer issued somewhat of a bombshell report on Friday, October 13, titled “Pfizer Amends U.S. Government Paxlovid Supply Agreement and Updates Full-Year 2023 Guidance.”
Among other things, Albert Bourla disclosed in a video the updated Pfizer—U.S. government arrangement. By January 2024, Paxlovid will be available via commercial payers, not just the U.S. government via the emergency use authorization. In what clearly hints at mounting pressure on the Pfizer chief, he noted the parties agreed to a Paxlovid stockpile for the U.S. government until 2028, “at no cost to the taxpayer.” This stockpile will include 1 million courses.
The dropping demand for COVID-19-related products impacts the company’s full 2023 guidance. Some key notable points:
Paxlovid revenues are estimated to decline by approximately $7 billion ($4.2 billion of this part of the non-cash revenue revealed for the return of the approximately 7.9 million treatment courses of EUA labeled U.S. government inventor)
COVID-19 vaccine Comirnaty revenues decline by $2 billion
A $5.5 billion non-cash charge in 2023 in Q3 due to inventory write-offs caused by lower-than-expected demand for the company’s COVID-19 products.
While Pfizer’s other pharmaceutical products appear to likely meet full-year expectations (6% to 8% growth), the company is cutting $3.5 billion, including $1 billion this year and $2.5 billion in 2024. The company holds its analyst and investor call today at 8 AM EDT.
How will Pfizer attempt to overcome this COVID crisis? Much like the large pharmaceutical companies did during the last couple of decades, by raising vaccine prices. In fact, TrialSite reported in March 2021, at the height of the pandemic that Pfizer informed investors the company would find ways to monetize the pandemic products---meaning extract as much money out of them as possible.
At the time Frank D’Amelio, Pfizer’s Chief Financial Officer called pricing at $19.50 “pandemic pricing.” He shared candidly with investors, “[There’s] significant opportunity for those margins to improve once we get beyond the pandemic environment that we’re in.”
That’s happening now as the company’s Comirnaty list price skyrocketed to $120 to $130 per dose covered last month by AP. While mainstream media avoids coverage of the price surge in any material way, that’s likely due to the reality that pharmaceutical advertising represents a sizable portion of overall ad revenue for media companies.
But some media have become more critical, such as the Washington Post. In a piece authored by Jenna Portnoy, a chief operating officer at a Maryland-based hospital shared that the price of the jab has risen to $150 in some cases. Jenna Vallejo told the reporter, “That’s ridiculous.” Meanwhile, the company is pricing what the market will bear, and even though technically under federal law the jabs should still be covered by public or private payers, the company and its fulfillment chain will likely try to squeeze as much out of consumers as possible.
What did Pfizer’s disclosure do to the stock price? At 3:30 PM on Thursday, Oct. 12, the company’s stock price equaled $33.10. While Pfizer is a huge company with blockbuster and innovative niche medicine, the company’s stock is in trouble. And as the reality of how the company behaved during the pandemic comes to light, likely investors may see more troubles with this stock.
To put it all in perspective, the company’s stock was priced at 59.48, an all-time high on December 13, 2021, at the height of the pandemic. But aside from the temporary surge, Pfizer equity has been on a cascading slide downward since then. It’s the artificial nature of the pandemic surge in revenues that likely helped spook investors, along with other disturbing behavior such as how the company abused its position in contracting during the crisis. As of today, Oct. 16, 2023, Pfizer’s price is $32.11.
TrialSite reported that Pfizer recently sought out unorthodox financing, inking a deal with Blackstone, a private equity group investing in drug development.
Meanwhile, TrialSite has predicted that Moderna faces real trouble when the market rejects their Spikevax COVID-19 vaccine—the only revenue-generating product.
Presently priced at $98.30 per share, Moderna’s slide throughout 2023 is apparent upon instant gaze of their chart. By Sept. 6, 2021, again right in the middle of the pandemic, Moderna’s stock hit an all-time high of $449.38. It’s been all downhill since then, currently priced at 98.30.
********************************************************
17 October, 2023
Australian Medical Society Investigating Excess Deaths—Suspects the Population Faces a doctor-caused Crisis
The Australian Medical Professionals Society (AMPS) recently launched an inquiry into Australia’s excess mortality: Unveiling an overlooked crisis. Throughout the medical system, the political system and the media, the fact that there are too many Australian people dying is being ignored. And the group of providers seeks to change that. The group has commissioned studies and expressed concern that mass COVID-19 countermeasures have led to excess mortality.
Recently, the society was in touch with TrialSite, sharing updates on imminent activity and events involving the controversial, but important topic.
This Wednesday, October 18, in Parliament House, Canberra, the AMPS holds an inquiry, addressing the alarming rise in excess mortality in Australia since 2021. This timing is of deep concern given the mass vaccination scheme occurred right at this time.
This inquiry aims to uncover the most pressing question: What is causing Australians to die at unprecedented rates? Why has the death rate rocketed? In response to the Senate's extraordinary decision on 23 March 2023, against investigating this sudden excess mortality, a committed group of Australians, in collaboration with international colleagues, has undertaken the investigation that, unfortunately, Australian political and medical authorities thus far have refused to pursue.
Delving deeper into the regulatory failures hindering the proper analysis of preclinical data concerning experimental COVID-19 vaccines, the Australian Medical Society reports serious shortcomings, potential data discrepancies, and alarming signals of harm being overlooked.
It is hoped that this investigation will in fact shed light on the inadequacies within the Therapeutic Goods Administration's (TGA) pharmacovigilance systems. The TGA regulates drugs and vaccines in Australia.
The analysis conducted by AMPS indicates that Australia is facing an iatrogenic crisis – one that has resulted from policies based on insufficient evidence. A bombshell of an allegation, AMPS alleges that the COVID-19 mass countermeasure response is likely linked to the death signals.
Conclusions from AMPS are documented in a book due for release titled, Too Many Dead – An Inquiry into Australia’s Excess Mortality. In collaboration with peers around the world, the group calls for an immediate suspension of the vaccination rollout, pending a full and transparent investigation.
Invitations have been issued to hundreds of politicians especially ministers; and to health authorities, medical colleges and associations Australia-wide including all members of ATAGI, the TGA, and academics in the health fields.
As a society committed to the well-being of all Australians, AMPS shares its commitment to ensuring accountability, transparency and justice, even when the facts may be unpalatable.
******************************************************
Yale Medicine Refers to the ‘Tripledemic’ That Never Was
Major academic medical institutions such as Yale Medicine go on record that the United States already experienced a “Tripledemic.” That’s the implication of a headliner accompanying the recent piece by Kathy Katella writing for Yale Medicine, implying that the presence of influenza, respiratory syncytial virus (RSV), and COVID-19 over the past few years led to such an event.
Well, another fact check is in order: one covering one of the most elite of medical institutions. Yes, there was a COVID-19 pandemic, but never a “tripledemic.” But it’s true that all three viral infections can raise the risk of morbidity and mortality in vulnerable individuals, typically the elderly and individuals with comorbidities but also in some cases children.
Katella, a senior clinical writer for Yale Medicine, follows her hyperbolic headline with a report that this year, for the first time vaccines are available that help to “prevent these diseases, including an updated COVID vaccine, as well as vaccines and a monoclonal antibody injection for those most vulnerable to RSV.”
The Yale article borders on misinformation right at the onset with the title: “Can RSV and COVID Vaccines Prevent Another Tripledemic?”
First, it should be noted that there was never a tripledemic over the past “several” years as Katella states. So why refer to “another tripledemic” unless the author purposely seeks attention for this headline? Disingenuous, we expect a lot more from a prestigious place like Yale.
Does the piece fall under the category of misinformation or disinformation? Very possibly. Importantly, the distinction is that the former is false or inaccurate information—getting the facts wrong, while the latter represents false information which is deliberately intended to mislead—intentionally misstating the facts. Based on these definitions including a clearly inaccurate headline likely means the whole piece falls in the latter category, unfortunately.
The writer turns to be honest when addressing actually how helpful would the three vaccines be for individuals this winter, especially vulnerable persons to these viruses, stating it “is still difficult to say.”
But how to know how these vaccines can help? We cannot know for sure, more honestly, thus academia’s penchant for models. The Yale writer refers to the positive prospects of the use of “predictive models” citing a quote from infectious disease specialist Shana Gleeson, M.D.. Honesty again prevails, as the Yale doc states, “But we can’t say for sure how it’s all going to play out.”
Have any formal clinical trials testing approved COVID-19, influenza and RSV vaccines ever been undertaken and completed? Not at all, but you won’t get that information from Yale. What about the fact that Moderna is currently testing its mRNA vaccine with influenza vaccine for safety? Not a peep. But at TrialSite, you can learn more about these unfolding activities. See TrialSite in “Is it Safe to Receive both Moderna mRNA COVID-19 Vaccine Influenza Vaccine—Clinical Trial Designed to Find Out.” Why Yale doesn’t take the time for basic research 101 we cannot say, other than it’s following some top-down approach to research and health communications.
Meanwhile, the influenza jab vaccine effectiveness was an abysmal 16% effective in the 2021-22 season. This is NOT to discourage those in high-risk cohorts from getting that vaccine. But for a healthy young person, we should ensure to understand a rational risk-benefit analysis and understand with such low effectiveness many of the vaccinated will still pass on the virus. So like COVID-19, the only reason to get vaccinated at this point is if one falls at risk for more severe flu, or for that matter, if one’s preference is to bolster their protective probabilities, even if it’s more psychological than scientific, for some.
The public health tools definitely help, but they are not the panacea promoted by the government, academic medicine and industry. And there are externalities involved, especially for the COVID-19 mRNA products. During emergency times the math of acceptance was more liberal, than today.
COVID-19 vaccines in the age of Omicron involve many breakthrough infections, meaning vaccinated persons can and do carry and spread the disease. With the COVID-19 vaccines, TrialSite started reporting on this scientific understanding by spring of 2021.
Yet Dr. Gleeson assumes all three of these vaccines are essentially sterilizing, in that they will stop viral transmission in all three viruses. She exhibits this bias upon addressing factors as to their effectiveness and impact. Dr. Gleeson states that one potential factor is how many people get the new shots. She implies the more people that get the shots, the more people will avoid infection, and consequently not spread the disease to others.
But given we don’t know the true effectiveness rates yet, and that these are not necessarily sterilizing vaccines, how can she be certain the volume of shots will make a difference at all? The truth is that she cannot. True, she can look back at epidemiological data and find some correlations, but this does not mean causation.
Other factors according to Gleeson such as masking, and the assumption that fewer people will take their masks off in the forthcoming season, along with crowding and get-togethers in enclosed places (think Holiday Season) all spell potential trouble for the “tripledemic.”
More here:
https://www.trialsitenews.com/a/yale-medicine-refers-to-the-tripledemic-that-never-was-6b0fbe6a
********************************************************16 October, 2023
UK: Vaccine injury scheme ramps up staff as claims over Covid jabs keep growing
Increasing demand for Covid vaccine injury payments has seen the number of staff processing claims increase 20-fold, figures show.
The Vaccine Damage Payment Scheme (VDPS) has scaled up operations and boosted its administrative staff from four to 80 to handle the claims.
A project is also under way to digitalise the application process to make it simpler and quicker for claimants.
But MPs, campaigners and families have called for the process to be reformed, arguing that the payment cap of £120,000 is too low, too slow and bureaucratic, and the eligibility criteria is too strict.
If a person is left severely disabled as a result of receiving certain vaccines they could be entitled to the one-off payment from the Government.
Families can also apply for the payment if a loved one died as a result of a vaccination.
It is not treated as compensation, meaning claimants can still seek damages in court.
“Inadequate funds to families’
A group of patients and families are now taking legal action against AstraZeneca after they suffered injury or bereavement as a result of complications from the Covid vaccine.
The Hausfeld Claimant group, which includes 13 bereaved families and 28 survivors, says the VDPS offers “inadequate funds to families”.
Sarah Moore, leading the litigation, said: “No amount of compensation will bring back loved ones or restore those injured to health but it can make life a little bit easier for the mothers, fathers, children, parents and partners who are now reshaping their lives.”
Figures released under a Freedom of Information (FOI) request in March show more than 4,000 claims related to a Covid-19 vaccine have been submitted since Nov 1 2021.
The payment scheme was taken over by the NHS Business Services Authority in November 2021, after previously being handled by the Department for Work and Pensions.
Of the 4,017 claims made, 334 relate to a claimant who has died.
Some 48 claims have been approved so far, Maria Caulfield, a health minister, told MPs in February.
A separate FOI document published in February revealed 3,842 claims had been received, meaning the number submitted has increased by almost 200 in one month alone. Of those, 814 claims were unsuccessful and a further 37 did not meet the eligibility criteria.
Under the VDPS, severe disablement means a patient must be at least 60 per cent disabled to qualify, based on the Social Security (General Benefit) Regulations 1982.
‘Balance of probabilities’
A patient’s medical records along with “all scientific evidence” will be considered in the application by an independent medical assessor.
They will decide if the person is due a payment based on whether “on the balance of probabilities” the vaccine caused the disability, and if the level of disability is 60 per cent.
Many claimants have been diagnosed with vaccine-induced thrombocytopenia and thrombosis, a rare condition linked to the Covid-19 jab.
The number of people who experienced life-changing adverse reactions to coronavirus vaccines is tiny compared to the millions who received the jab.
Data from the Medicines and Healthcare products Regulatory Agency, up to Nov 23 2022, show 445 cases of major thromboembolic events (blood clots) with concurrent thrombocytopenia (low platelet counts) in the UK following an AstraZeneca jab. The overall case fatality rate was 18 per cent with 81 deaths.
The Government says it can take “at least six months” to process a VDPS claim, but a claim about a Covid-19 vaccine “will take longer”.
Jeremy Wright, Conservative MP for Kenilworth and Southam, raised the issue in the Commons this week and called on the Prime Minister to revamp the scheme.
He told The Telegraph: “It's good news if they're improving the resources to handle claims. There are a lot of claims and it's taking a very long time to process them.”
He added there were still “structural problems” with the scheme, including the low cap and 60 per cent disablement cut off.
Rishi Sunak said on Wednesday: “We are taking steps to reform vaccine damage payments schemes by modernising the operations and providing more timely outcomes, but of course I'd be happy to talk to the honourable gentleman further about it.”
The Telegraph has spoken to families who have waited more than a year for the payment.
Sheila Ward, whose husband Stephen, 57, died after having the Covid vaccine, said the compensation scheme was “not fit for purpose”.
Her husband, who was retired, had the Oxford AZ jab in March 2021. Mr Ward had no pre-existing conditions but after a few days developed a headache and had to stay in bed.
“We just thought he had been doing too much,” said Mrs Ward, 55, who lives in Newcastle.
When she went upstairs to check on him she found him unable to speak. He was taken to hospital where he was treated for a stroke. The doctors found bleeds and clots on his brain.
Compensation took a year
Later Mrs Ward was told by doctors that her husband had suffered seizures. He died before he could receive an operation.
A coroner’s certificate listed the vaccine as one of the causes of death but obtaining compensation took a year.
“The whole process was very slow and they never gave me updates unless I chased them,” said Mrs Ward, whose claim was finalised in June 2022.
“Personally, I don't think the compensation families receive is enough. I'm in a fortunate position that my husband had a pension, so my income has been subsidised that way.
“For anyone who has been left with a lifelong disability or young children, it simply wouldn’t be enough to replace somebody's income.”
Mrs Ward said the Government should consider raising the cap but also make the process faster. “It is not fit for purpose,” she said. “I’ve heard of cases where it takes 20 months for a decision. That is far too long”.
Vikki Spit, 40, lost her partner Zion of 21 years in May 2021 after he suffered a blood clot linked to the AZ vaccine. It took more than a year for Ms Spit, who campaigns for Vaccine Injured Bereaved UK, to receive the VDPS.
“The [60 per cent disabled] criteria is a really big [issue], because there are so many people just left with nothing after being severely injured, and have life-changing disabilities, and they’re just told ‘well you’re not interested enough’,” she said.
****************************************************
Immune Tolerance and the COVID-19 Vaccines
Turbo-cancers, which are very aggressive cancers characterized by 1) rapid progression and 2) diagnosis at a late stage, have been increasing significantly in the last couple of years. One of the major factors that may be contributing to this increase is the COVID-19 vaccine, especially those vaccines operating on the mRNA platform. In particular, one of the major mechanisms associated with the modus operandi of these mRNA vaccines is the class-switch from IgG3 to IgG4, and the subsequent reversal in the phenomenon known as Immune Tolerance.
Immune Tolerance can be defined as 1) “the process by which immune cells are made unresponsive to self-antigens to prevent damage to healthy tissues. It prevents an immune response to antigens produced by the body itself or recognized from a prior encounter.”, or 2) “the state of an active, highly regulated unresponsiveness of the immune system to self-antigens or against a particular antigen that can induce an immune response in the body.”, or 3) “prevention of an immune response against a particular antigen. For instance, the immune system is generally tolerant of self-antigens, so it does not usually attack the body's own cells, tissues, and organs. However, when tolerance is reduced substantially, disorders like autoimmune disease or food allergy may occur.” Immune tolerance is analogous to a military operation defending one’s homeland against invasion from without and within, where it is desired to do maximum damage to the invaders and minimum damage to the homeland and its residents (also see the following references for more comprehensive analyses of Immune Tolerance (link#1; link#2; link#3; link#4; link#5; link#6).
Immune Tolerance is important for analyzing biological mechanisms, and for examining the onset and progression of many diseases. A more comprehensive view of Immune Tolerance would be useful for understanding its mechanisms and impacts. This Op-ed provides an overview of Immune Tolerance, based on the contents of the premier biomedical literature (Medline). The main output of this study is a hierarchical taxonomy of the Immune Tolerance biomedical literature, where the taxonomy is generated using a text-clustering approach. This Op-ed will show how the immune system uses Immune Tolerance to destroy foreign invaders or endogenous dysfunctional processes like rapid cancer cell multiplication without destroying the host in the process, or, conversely, how the immune system allows mild foreign invaders, such as allergens, to co-exist within the host with minimal damage to the host. It will also show how factors that adversely impact the immune system can distort the function of Immune Tolerance, and allow foreign invaders or endogenous dysfunctional processes to exert massive damage on the host.
METHODOLOGY
A query was developed to retrieve articles from Pubmed that focused on Immune Tolerance, and was entered into the Pubmed search engine on 25 September 2023. It retrieved 23,049 articles (with Abstracts only) for the period 1 January 1993-31 December 2023. The records retrieved were imported into the CLUTO text-clustering software, 64 leaf clusters were selected, and a hierarchical taxonomy was generated by the algorithm. Each leaf cluster was analyzed by visual inspection, and aggregate categories consisting of related leaf clusters were constructed.
The Immune Tolerance phenomena related to COVID-19 vaccine effects were identified from the records retrieved by the Pubmed query (as well as records related to the records retrieved by the query). and discussed.
The Pubmed query used is: "Immune Tolerance" [Majr] OR "immune tolerance" [tiab] OR “immune system tolerance" [tiab] OR “immunological tolerance" [tiab], where Majr is major MeSH theme and tiab is title and abstract.....
Some of the more egregious contributors to immune system dysfunction and, in some sense, promoters of unwanted Immune Tolerance to both micro-organisms and cancer cells are the present bioweapon injections masquerading as COVID-19 vaccines. The immune system consequences of these injections are highlighted here because of the large number of people who received them. Our studies have shown that the fundamental modus operandi of these injections is destruction of the immune system, where the level of immune system destruction increases with each injection. This immune system destruction can potentially lead to i) increased numbers of, and more aggressive, cancers, ii) reactivation of dormant viruses, and iii) increases in autoimmune diseases. The Immune Tolerance that accompanies this immune system destruction plays a strong role in each of the three adverse effects mentioned above.
Specific mechanisms of both the SARS-CoV-2 virus and the COVID-19 (mainly) mRNA vaccines that could induce unwanted Immune Tolerance were presented in the text, but only those arising from the COVID-19 vaccines will be presented here. They include: Class switching to increased IgG4; Incorporation of pseudouridine into mRNA; Multiple mRNA injections; Degradation and suppression of the immune system potentially leading to cancer (Suppression of Toll-Like Receptors, Impact on Tumor Suppressor Protein p53 and Genomic Transposable Element LINE-1, Spike Protein Interference with DNA Repair Mechanisms, Vaccines contaminated with Plasmid DNA containing SARS-CoV-2 spike protein, Simian virus 40 (SV40) in DNA discovered in Pfizer mRNA vaccine vials, Enhanced expression of PD-L1, Induction of pseudo-autoimmunity (more focused on autoimmunity rather than cancer)). Additionally, excerpts from critical papers show some of the synergies among these mechanisms acting in concert.
https://www.trialsitenews.com/a/immune-tolerance-and-the-covid-19-vaccines-27e6426a
********************************************************Also see my other blogs. Main ones below:
http://edwatch.blogspot.com (EDUCATION WATCH)
http://antigreen.blogspot.com (GREENIE WATCH)
http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)
http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com (TONGUE-TIED)
https://immigwatch.blogspot.com (IMMIGRATION WATCH)
https://awesternheart.blogspot.com (THE PSYCHOLOGIST)
http://jonjayray.com/blogall.html More blogs
***************************************************
15 October, 2023
New York State Supreme Court Issues Final Blow to Vaccine Mandate for Healthcare Workers
The pandemic is over. The Biden administration was forced to end the COVID-19 public health emergency declaration in May. Most people threw out their masks, embraced large indoor gatherings once again, and stores finally ditched those obnoxious and ineffective Plexiglass dividers. But even in this post-pandemic era, there are still legal battles playing out across the country over vaccine mandates.
In January, New York's Supreme Court struck down the state's vaccine mandate for healthcare workers but, of course, the Empire State didn't want to let go without a fight.
Last week, however, the Supreme Court Appellate Division, Fourth Department, dismissed the state's appeal.
"The mandate is over and declared unconstitutional," Sujata Gibson, attorney for the plaintiffs, said on X.
"This was an important victory. While it does not make healthcare workers whole, it does protect us from future overreach by the executive branch," she noted, according to Children's Health Defense.
The state Supreme Court on Jan. 13 declared New York’s COVID-19 vaccine mandate for healthcare workers “null, void, and of no effect,” and ruled that the New York State Department of Health (NYSDOH) lacked the authority to impose the mandate.
The ruling pertained to a lawsuit filed on Oct. 20, 2022, against the NYSDOH, Gov. Kathleen C. Hochul and health commissioner Mary T. Bassett, by Medical Professionals for Informed Consent — a group of medical practitioners impacted by the mandate — and additional plaintiffs, including two doctors, a nurse, a radiologic technologist and a medical laboratory specialist. Children’s Health Defense (CHD) funded the lawsuit.
On Jan. 24, the state appealed the Supreme Court’s ruling that overturned the mandate. However, before the appeals court ruled, Jonathan Hitsous, attorney for the New York State Attorney General’s office, announced unexpectedly during a May hearing that the state planned to rescind the mandate.
Hitsous argued that the repeal would render the original lawsuit “moot” — meaning the rights and interests of the parties involved would no longer be at stake — and he requested that the lower court’s Jan. 13 decision striking down the mandate be vacated.
CHD and Gibson opposed the move in a joint statement, arguing that vacating the lower court’s decision would “leave open the very real possibility that this constitutional violation could happen again and ruin many more lives.”
“The law does not allow an agency to voluntarily stop an illegal activity and then claim they shouldn’t be held legally accountable,” Gibson told CHD.TV at the time.
Since then, New York formally repealed the mandate through the administrative process. In its ruling issued last week, the court held that the repeal “moots” the state’s appeal, but it declined to vacate the lower court’s decision or to take any position on it.
The vaccine mandate for healthcare workers went into effect in September 2021, which led to about 34,000 medical professionals to quit or be terminated.
Margaret Florini, a spokesperson for Medical Professionals for Informed Consent, told The Defender, "This is just the beginning."
"I think we will see many new lawsuits come about because of this historic win," Florini said. "There is still plenty of work to be done. We lost so much, not just money but relationships, marriages, friends, and homes. We cannot forget what was done to us and we must continue to shed light on it and make impactful changes that will truly prevent this from happening again."
******************************************************
Beware the COVID Cranks
Dr. Anthony Fauci is back in the news as the media hype a resurgence of COVID-19 cases. Asked earlier last month by CNN’s Michael Smerconish if people should begin wearing masks again, he said, "I hope they would abide by the recommendation and take into account the risks to themselves and to their families. We are not talking about forcing anybody to do anything." Fauci, of course, backed a national mask mandate in 2020.
But that’s the least of the COVID contradictions from Fauci and others. Put aside the obfuscations of the origin of the virus (smearing proponents of the Wuhan “lab-leak” as conspiracy theorists.) Our public health bureaucracy has made so many misleading and confusing pronouncements, and FGI has uncovered such inconvenient facts through FOIA requests, that the public should take any new dictates with a truckload of salt.
Prior to COVID, the only randomized control trial (RCT) of cloth mask efficacy was performed in the context of SARS virus. Considered to be the “gold standard” for drawing scientific conclusions, the RCT study found that cloth mask “filtration was extremely poor (almost 0%).” So, when COVID hit, the information with the highest integrity indicated cloth masks were virtually useless as a filter for airborne SARS virus. Perhaps Fauci was thinking of this study when he initially said there was no need for masks.
By October 2020, Fauci was a mask-believer, and working on a paper for the Journal of the American Medical Association (JAMA) that praised mask efficacy when The Federalist published an article that cited the findings of a CDC study completed the month before. Masks and face coverings, the CDC concluded, were ineffective in preventing the spread of COVID-19.
The records obtained by FGI showed that Fauci was aware of both the article and the CDC study while working on his JAMA paper, as a co-author sent them to him the day the article was published. Fauci’s response: “Not good for our paper.”
In another email she stated, “I would not tell people that the cloth masks we are all wearing provide PERSONAL PROTECTION against acquisition of the virus-they may to some degree, but I have never seen convincing data on this.”
Shortly thereafter, Fauci’s JAMA paper was published without reference to the inconvenient studies, instead relying on an already discredited mask study. When another scientist pointed out the blunder, Fauci told his assistant to make a note of it but not to take any action to correct it.
It wasn’t just Fauci. Early in the pandemic, the CDC and the Infectious Diseases Society of America (IDSA) created the COVID-19 Real-Time Learning Network website purporting to share “accurate, timely information about COVID-19.” In November 2021, Dr. Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, penned an official letter with several colleagues to the medical editor of the website, pointing out that both the site and the CDC’s guidance on masks currently contained incorrect, harmful advice for the American public.
Osterholm warned that the flawed information would “not only damage the credibility of science and endanger public trust by misrepresenting the evidence, but also provide false expectations in terms of respiratory protection to the public.” Officials should “reconsider [their] statements about the efficacy of masks and face coverings for preventing transmission of SARS-CoV-2.” Osterholm identified a pattern of cherry-picking studies based on their alignment with the administration’s policy agenda, saying, “Studies that do not support its perspective are similarly downplayed.”
Osterholm was ignored and CDC doubled down on claims that “any mask is better than no mask.”
Unfortunately, the dysfunction doesn’t end with masks. In November 2022, Vice President Kamala Harris tweeted, “One shot, once a year—that’s all most people will need to stay protected from COVID year-long.” The next day, HHS Secretary Becerra tweeted, “An updated COVID vaccine can help protect you from the worst outcomes of COVID. If it’s been over 2 months since your last dose, make a plan to get one now.” Becerra repeated his two-month recommendation the following day in another tweet.
Upon seeing the tweets, FGI made a FOIA request for documentation of the scientific reasoning supporting Becerra’s prescription for COVID-19 vaccine booster shots every two months. By law, the government is given 20 business days to respond to a FOIA, yet it took eight months and a lawsuit for the HHS to confirm that there was no medical evidence for six shots per year nor were there any documents or communications explaining the origin of the Secretary’s public health pronouncement.
We can hope COVID-19 as a public health issue and the government dysfunction that came with it will continue to fade into memory. Our public health bureaucracy didn’t exactly cover itself in glory while it was trying to cover our faces – and its posterior.
https://townhall.com/columnists/petemcginnis/2023/10/10/beware-the-covid-cranks-n2629584
*******************************************************Italian Study Claims Neanderthal Genes Are Linked to Long Covid
The cause of Long Covid has been the source of ongoing speculation. Studies have pointed to a dysfunction in the immune system and another points Covid-19 latching onto the ACE2 (angiotensin-converting enzyme 2) receptor, which acts as the doorway through which the virus infects cells. The depletion of ACE2 is central to the neuromuscular complications experienced by a significant percentage of Covid-19 patients. There may be at least 6 million people worldwide suffering from Long Covid and the prolonged disease also has advocacy groups. Now, a recent study out of Italy indicates the reason some people are infected with Long Covid is because of ancient genes.
Neanderthal Genes
A recent study from Milan, Italy and carried out in the Northern Italian city of Bergamo, suggests genes inherited from Neanderthals, extinct cousins of modern humans, could help explain why some people developed life-threatening forms of Long Covid while others didn’t. The Northern Italian city was hit very hard by the Covid pandemic, and Bergarmo suffered one of the highest death rates of the pandemic. The high number of infections provided scientists with data for the study, though the research doesn’t address why so many people died there compared with other parts of Italy or Europe.
The researchers were led by Giuseppe Remuzi. They found genes passed down from Neanderthals may confer higher risk from Covid-19. Remuzi is with the Mario Negri Institute for Pharmacological Research in Milan. This research was done on behalf of WHO’s ORIGIN study group.
The study was a genome wide associate study (GWAS). The researchers studied a sample of nearly 10,000 people in the Bergamo area, identified several genes associated with the development of severe respiratory illness. Three of those genes belonged to a group of variations in DNA, or haplotype, inherited from Neanderthals. The study found that people who carry the Neanderthal haplotype were twice as likely to develop severe pneumonia from a Covid infection than those who didn’t, and three times as likely to be hospitalized in intensive care units and put on ventilators.
What is not known is whether the haplotype is more common in the Bergamo region than in other Italian or European regions. Epidemiologists still don’t know why parts of northern Italy suffered such high death tolls, especially early in the pandemic. Scientists have suggested factors could have included age, air pollution and that the virus hit the region early in the pandemic and spread undetected.
Study Shows Risk for Some
“This study shows there is a particular section of the human genome that is significantly associated with the risk of getting Covid-19 and of developing a severe form of it,” says Remuzzi. “That section is more important than any others to explain why some fall seriously ill.” Remuzzi added in Bergamo 33% of those who developed life-threatening forms of Covid had the Neanderthal haplotype.
About 2% of the genomes of people of European or Asian ancestry is inherited from Neanderthals, and they have been linked to modern humans’ susceptibility to a variety of diseases. The study adds to a growing body of research which indicates that a cluster of Neanderthal genes increases the likelihood of developing severe forms of Covid-19. Bergamo was an early epicenter of the pandemic. As pointed out, a notable feature of Bergamo is that its population is relatively homogeneous. Perhaps this study provides the answer as to why Covid was so prevalent in the Northern Italian city.
********************************************************
15 October, 2023
New York State Supreme Court Issues Final Blow to Vaccine Mandate for Healthcare Workers
The pandemic is over. The Biden administration was forced to end the COVID-19 public health emergency declaration in May. Most people threw out their masks, embraced large indoor gatherings once again, and stores finally ditched those obnoxious and ineffective Plexiglass dividers. But even in this post-pandemic era, there are still legal battles playing out across the country over vaccine mandates.
In January, New York's Supreme Court struck down the state's vaccine mandate for healthcare workers but, of course, the Empire State didn't want to let go without a fight.
Last week, however, the Supreme Court Appellate Division, Fourth Department, dismissed the state's appeal.
"The mandate is over and declared unconstitutional," Sujata Gibson, attorney for the plaintiffs, said on X.
"This was an important victory. While it does not make healthcare workers whole, it does protect us from future overreach by the executive branch," she noted, according to Children's Health Defense.
The state Supreme Court on Jan. 13 declared New York’s COVID-19 vaccine mandate for healthcare workers “null, void, and of no effect,” and ruled that the New York State Department of Health (NYSDOH) lacked the authority to impose the mandate.
The ruling pertained to a lawsuit filed on Oct. 20, 2022, against the NYSDOH, Gov. Kathleen C. Hochul and health commissioner Mary T. Bassett, by Medical Professionals for Informed Consent — a group of medical practitioners impacted by the mandate — and additional plaintiffs, including two doctors, a nurse, a radiologic technologist and a medical laboratory specialist. Children’s Health Defense (CHD) funded the lawsuit.
On Jan. 24, the state appealed the Supreme Court’s ruling that overturned the mandate. However, before the appeals court ruled, Jonathan Hitsous, attorney for the New York State Attorney General’s office, announced unexpectedly during a May hearing that the state planned to rescind the mandate.
Hitsous argued that the repeal would render the original lawsuit “moot” — meaning the rights and interests of the parties involved would no longer be at stake — and he requested that the lower court’s Jan. 13 decision striking down the mandate be vacated.
CHD and Gibson opposed the move in a joint statement, arguing that vacating the lower court’s decision would “leave open the very real possibility that this constitutional violation could happen again and ruin many more lives.”
“The law does not allow an agency to voluntarily stop an illegal activity and then claim they shouldn’t be held legally accountable,” Gibson told CHD.TV at the time.
Since then, New York formally repealed the mandate through the administrative process. In its ruling issued last week, the court held that the repeal “moots” the state’s appeal, but it declined to vacate the lower court’s decision or to take any position on it.
The vaccine mandate for healthcare workers went into effect in September 2021, which led to about 34,000 medical professionals to quit or be terminated.
Margaret Florini, a spokesperson for Medical Professionals for Informed Consent, told The Defender, "This is just the beginning."
"I think we will see many new lawsuits come about because of this historic win," Florini said. "There is still plenty of work to be done. We lost so much, not just money but relationships, marriages, friends, and homes. We cannot forget what was done to us and we must continue to shed light on it and make impactful changes that will truly prevent this from happening again."
******************************************************
Beware the COVID Cranks
Dr. Anthony Fauci is back in the news as the media hype a resurgence of COVID-19 cases. Asked earlier last month by CNN’s Michael Smerconish if people should begin wearing masks again, he said, "I hope they would abide by the recommendation and take into account the risks to themselves and to their families. We are not talking about forcing anybody to do anything." Fauci, of course, backed a national mask mandate in 2020.
But that’s the least of the COVID contradictions from Fauci and others. Put aside the obfuscations of the origin of the virus (smearing proponents of the Wuhan “lab-leak” as conspiracy theorists.) Our public health bureaucracy has made so many misleading and confusing pronouncements, and FGI has uncovered such inconvenient facts through FOIA requests, that the public should take any new dictates with a truckload of salt.
Prior to COVID, the only randomized control trial (RCT) of cloth mask efficacy was performed in the context of SARS virus. Considered to be the “gold standard” for drawing scientific conclusions, the RCT study found that cloth mask “filtration was extremely poor (almost 0%).” So, when COVID hit, the information with the highest integrity indicated cloth masks were virtually useless as a filter for airborne SARS virus. Perhaps Fauci was thinking of this study when he initially said there was no need for masks.
By October 2020, Fauci was a mask-believer, and working on a paper for the Journal of the American Medical Association (JAMA) that praised mask efficacy when The Federalist published an article that cited the findings of a CDC study completed the month before. Masks and face coverings, the CDC concluded, were ineffective in preventing the spread of COVID-19.
The records obtained by FGI showed that Fauci was aware of both the article and the CDC study while working on his JAMA paper, as a co-author sent them to him the day the article was published. Fauci’s response: “Not good for our paper.”
In another email she stated, “I would not tell people that the cloth masks we are all wearing provide PERSONAL PROTECTION against acquisition of the virus-they may to some degree, but I have never seen convincing data on this.”
Shortly thereafter, Fauci’s JAMA paper was published without reference to the inconvenient studies, instead relying on an already discredited mask study. When another scientist pointed out the blunder, Fauci told his assistant to make a note of it but not to take any action to correct it.
It wasn’t just Fauci. Early in the pandemic, the CDC and the Infectious Diseases Society of America (IDSA) created the COVID-19 Real-Time Learning Network website purporting to share “accurate, timely information about COVID-19.” In November 2021, Dr. Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, penned an official letter with several colleagues to the medical editor of the website, pointing out that both the site and the CDC’s guidance on masks currently contained incorrect, harmful advice for the American public.
Osterholm warned that the flawed information would “not only damage the credibility of science and endanger public trust by misrepresenting the evidence, but also provide false expectations in terms of respiratory protection to the public.” Officials should “reconsider [their] statements about the efficacy of masks and face coverings for preventing transmission of SARS-CoV-2.” Osterholm identified a pattern of cherry-picking studies based on their alignment with the administration’s policy agenda, saying, “Studies that do not support its perspective are similarly downplayed.”
Osterholm was ignored and CDC doubled down on claims that “any mask is better than no mask.”
Unfortunately, the dysfunction doesn’t end with masks. In November 2022, Vice President Kamala Harris tweeted, “One shot, once a year—that’s all most people will need to stay protected from COVID year-long.” The next day, HHS Secretary Becerra tweeted, “An updated COVID vaccine can help protect you from the worst outcomes of COVID. If it’s been over 2 months since your last dose, make a plan to get one now.” Becerra repeated his two-month recommendation the following day in another tweet.
Upon seeing the tweets, FGI made a FOIA request for documentation of the scientific reasoning supporting Becerra’s prescription for COVID-19 vaccine booster shots every two months. By law, the government is given 20 business days to respond to a FOIA, yet it took eight months and a lawsuit for the HHS to confirm that there was no medical evidence for six shots per year nor were there any documents or communications explaining the origin of the Secretary’s public health pronouncement.
We can hope COVID-19 as a public health issue and the government dysfunction that came with it will continue to fade into memory. Our public health bureaucracy didn’t exactly cover itself in glory while it was trying to cover our faces – and its posterior.
https://townhall.com/columnists/petemcginnis/2023/10/10/beware-the-covid-cranks-n2629584
*******************************************************Italian Study Claims Neanderthal Genes Are Linked to Long Covid
The cause of Long Covid has been the source of ongoing speculation. Studies have pointed to a dysfunction in the immune system and another points Covid-19 latching onto the ACE2 (angiotensin-converting enzyme 2) receptor, which acts as the doorway through which the virus infects cells. The depletion of ACE2 is central to the neuromuscular complications experienced by a significant percentage of Covid-19 patients. There may be at least 6 million people worldwide suffering from Long Covid and the prolonged disease also has advocacy groups. Now, a recent study out of Italy indicates the reason some people are infected with Long Covid is because of ancient genes.
Neanderthal Genes
A recent study from Milan, Italy and carried out in the Northern Italian city of Bergamo, suggests genes inherited from Neanderthals, extinct cousins of modern humans, could help explain why some people developed life-threatening forms of Long Covid while others didn’t. The Northern Italian city was hit very hard by the Covid pandemic, and Bergarmo suffered one of the highest death rates of the pandemic. The high number of infections provided scientists with data for the study, though the research doesn’t address why so many people died there compared with other parts of Italy or Europe.
The researchers were led by Giuseppe Remuzi. They found genes passed down from Neanderthals may confer higher risk from Covid-19. Remuzi is with the Mario Negri Institute for Pharmacological Research in Milan. This research was done on behalf of WHO’s ORIGIN study group.
The study was a genome wide associate study (GWAS). The researchers studied a sample of nearly 10,000 people in the Bergamo area, identified several genes associated with the development of severe respiratory illness. Three of those genes belonged to a group of variations in DNA, or haplotype, inherited from Neanderthals. The study found that people who carry the Neanderthal haplotype were twice as likely to develop severe pneumonia from a Covid infection than those who didn’t, and three times as likely to be hospitalized in intensive care units and put on ventilators.
What is not known is whether the haplotype is more common in the Bergamo region than in other Italian or European regions. Epidemiologists still don’t know why parts of northern Italy suffered such high death tolls, especially early in the pandemic. Scientists have suggested factors could have included age, air pollution and that the virus hit the region early in the pandemic and spread undetected.
Study Shows Risk for Some
“This study shows there is a particular section of the human genome that is significantly associated with the risk of getting Covid-19 and of developing a severe form of it,” says Remuzzi. “That section is more important than any others to explain why some fall seriously ill.” Remuzzi added in Bergamo 33% of those who developed life-threatening forms of Covid had the Neanderthal haplotype.
About 2% of the genomes of people of European or Asian ancestry is inherited from Neanderthals, and they have been linked to modern humans’ susceptibility to a variety of diseases. The study adds to a growing body of research which indicates that a cluster of Neanderthal genes increases the likelihood of developing severe forms of Covid-19. Bergamo was an early epicenter of the pandemic. As pointed out, a notable feature of Bergamo is that its population is relatively homogeneous. Perhaps this study provides the answer as to why Covid was so prevalent in the Northern Italian city.
13 October, 2023
CDC Data Reveals Status of COVID-19 Hospitalizations Across US
The U.S. Centers for Disease Control and Prevention (CDC) posted updated data showing that COVID-19 hospital admissions are continuing to decline across the United States after it showed an uptick in cases over the summer.
As of the week ending Sept. 30, hospitalizations are down by 6 percent, emergency department visits are down by 14.5 percent, and cases are down by 1.2 percent, according to the CDC. Deaths are up by 3.8 percent, but health officials have long said that deaths usually lag behind hospitalizations and case numbers.
For several weeks now, hospital admissions have been declining on a weekly basis. In July, COVID-19 hospitalizations, however, had been on the rise—although CDC historical data suggest that they were relatively low compared with previous years.
The EG.5 variant, which has been dubbed Eris, has accounted for about 24.5 percent of all COVID-19 cases, according to the federal health agency's variant tracker. FL.1.5.1, known as Fornax, is estimated to be responsible for about 13.7 percent of infections, the CDC figures show.
During the late summer and during a rise in hospitalizations, some health officials suggested that it doesn’t appear to be as bad as previous increases of the virus.
“Looking at that graph [of] hospitalizations, even though it’s on an upward trend, that’s still lower than it was last year at this time,” Dr. John Segreti, an epidemiologist and the medical director of infection control and prevention at Chicago's Rush University Medical Center, told ABC News at the time. “The fact that the numbers are going up fairly slowly, I think is a good sign.”
Dr. Shira Doron, chief infection control officer for Tufts Medicine, said that the recent “upswing is not a surge; it’s not even a wave.” The doctor added: “What we’re seeing is a very gradual and small upward trajectory of cases and hospitalizations, without deaths really going along, which is great news."
'Public Health Threat'
Despite the drop in hospitalizations over multiple consecutive weeks, the CDC issued a report on Oct. 6 saying that COVID-19 remains a "public health threat" for older Americans and called on people again to get the updated COVID-19 booster vaccine. Older adults, it said, make up the majority of hospitalizations across the United States in recent days, although that has been consistent with historical trends.
In mid-July, around seven out of every 100,000 people aged 65 and older were hospitalized with COVID-19, said the CDC. But by mid-August, according to the agency, 16.4 per 100,000 adults aged 65 and older were hospitalized with the viral infection.
Overall, from January to August 2023, adults aged 65 years and older "accounted for 62.9 percent of all COVID-19–associated hospitalizations," it said before suggesting that older people get the "recommended COVID-19 bivalent vaccine."
Other than getting the vaccine, they should also adopt "measures to reduce risk for contracting COVID-19" and receive "prompt outpatient antiviral treatment after a positive SARS-CoV-2 test result," it added.
The second highest hospitalization rate was among individuals aged 50 to 64 at around one out of 100,000, it said.
Since the original COVID-19 vaccines were rolled out several years ago, uptake of the booster shots has consistently dropped. After the CDC and U.S. Food and Drug Administration (FDA) signed off on the latest vaccines, data from the Department of Health and Human Services show that just 1 percent of all Americans opted to get the shot in September.
However, six medical journals rejected a key paper on COVID-19 vaccines and heart inflammation, a condition the vaccines cause, according to documents reviewed by The Epoch Times. The CDC's journal, the Morbidity and Mortality Weekly Report, was among those that rejected the paper, which estimated that COVID-19 hospitalizations would be prevented than cases of heart inflammation, or myocarditis, caused.
Another report from The Epoch Times, published Wednesday, revealed the FDA received results from two studies of subclinical heart inflammation following Moderna COVID-19 vaccination, but won't release them to the public—for now.
Some hospitals since August have started implementing mask mandates—at least for staff—claiming a rise in COVID-19 and other respiratory infections like RSV or influenza.
Notably, several Northern California counties issued a rule mandating masks be worn by all health care staff starting Nov. 1 and lasting until April 30, 2024. Contra Costa, Sonoma, Alameda, and San Mateo counties in September mandated masking regardless of vaccination status for hospitals and other care facilities, starting Nov. 1 and ending April 30, 2024.
California's San Luis Obispo County issued a similar mandate several days ago, requiring staffers to either wear a mask or get the vaccine.
Several hospitals in upstate New York, Massachusetts, and California also implemented a mandate in recent weeks, while at least one school in Maryland made masks mandatory for one kindergarten class. As for vaccine mandates, several dozen U.S. universities and colleges still have them intact, according to a recent report.
****************************************************
The VA Is Rejecting Disability Claims for COVID Vaccine Injuries and Senators Want to Know Why
After forcing U.S. service members to receive the COVID-19 vaccine or be released from the military, the Biden administration is refusing to provide disability status for soldiers injured by the jab. A number of Republican Senators are demanding to know why.
"We write for clarification on the U.S. Department of Veterans Affairs (VA) policy for veterans who have injuries resulting from receiving the COVID-19 vaccine while in service. As you are aware, the U.S. Department of Defense (DoD) required all service members to be vaccinated against COVID-19. Many service members, despite hesitations against receiving the vaccine, chose to be vaccinated to continue their service to our country," Senators Marco Rubio, Mike Braun, Tom Cotton, Rick Scott, Ted Cruz, and Steve Daines wrote in a letter to Department of Veterans Affairs Secretary Denis McDonough.
"Thousands of service members were discharged from service as a result of refusing to receive the COVID-19 vaccine. Yet, some U.S. service members received the vaccine to maintain their service and have since experienced lasting health impacts as a result," they continued. "If our government is asking service members to receive a vaccine, we must be cognizant that there will be unintended side effects that may cause lifelong impacts on their health. We must keep our promise to support our service members, including ensuring those who come to the VA for help with COVID-19 vaccine injuries are justly compensated and receive the care that they deserve."
The Senators also pointed out that the department has provided disability for injuries from vaccines for years but isn't doing so for the COVID-19 shot.
"For years, the VA has evaluated the health effects of certain vaccinations that veterans received during their service, and have expressed concern with certain health impacts arising from these vaccinations," they wrote. "The agency has also provided several resources to veterans seeking the COVID-19 vaccination, but no clear information about how to support members who are injured as a result of the vaccine. Given the high rate of service members who have been vaccinated against COVID-19 under DoD’s mandate, we request information as to how the VA is considering vaccine-related injuries in determining VA benefits and disability claims."
The Senators are seeking information from McDonough about how the department is handling claims.
********************************************************
13 October, 2023
CDC Data Reveals Status of COVID-19 Hospitalizations Across US
The U.S. Centers for Disease Control and Prevention (CDC) posted updated data showing that COVID-19 hospital admissions are continuing to decline across the United States after it showed an uptick in cases over the summer.
As of the week ending Sept. 30, hospitalizations are down by 6 percent, emergency department visits are down by 14.5 percent, and cases are down by 1.2 percent, according to the CDC. Deaths are up by 3.8 percent, but health officials have long said that deaths usually lag behind hospitalizations and case numbers.
For several weeks now, hospital admissions have been declining on a weekly basis. In July, COVID-19 hospitalizations, however, had been on the rise—although CDC historical data suggest that they were relatively low compared with previous years.
The EG.5 variant, which has been dubbed Eris, has accounted for about 24.5 percent of all COVID-19 cases, according to the federal health agency's variant tracker. FL.1.5.1, known as Fornax, is estimated to be responsible for about 13.7 percent of infections, the CDC figures show.
During the late summer and during a rise in hospitalizations, some health officials suggested that it doesn’t appear to be as bad as previous increases of the virus.
“Looking at that graph [of] hospitalizations, even though it’s on an upward trend, that’s still lower than it was last year at this time,” Dr. John Segreti, an epidemiologist and the medical director of infection control and prevention at Chicago's Rush University Medical Center, told ABC News at the time. “The fact that the numbers are going up fairly slowly, I think is a good sign.”
Dr. Shira Doron, chief infection control officer for Tufts Medicine, said that the recent “upswing is not a surge; it’s not even a wave.” The doctor added: “What we’re seeing is a very gradual and small upward trajectory of cases and hospitalizations, without deaths really going along, which is great news."
'Public Health Threat'
Despite the drop in hospitalizations over multiple consecutive weeks, the CDC issued a report on Oct. 6 saying that COVID-19 remains a "public health threat" for older Americans and called on people again to get the updated COVID-19 booster vaccine. Older adults, it said, make up the majority of hospitalizations across the United States in recent days, although that has been consistent with historical trends.
In mid-July, around seven out of every 100,000 people aged 65 and older were hospitalized with COVID-19, said the CDC. But by mid-August, according to the agency, 16.4 per 100,000 adults aged 65 and older were hospitalized with the viral infection.
Overall, from January to August 2023, adults aged 65 years and older "accounted for 62.9 percent of all COVID-19–associated hospitalizations," it said before suggesting that older people get the "recommended COVID-19 bivalent vaccine."
Other than getting the vaccine, they should also adopt "measures to reduce risk for contracting COVID-19" and receive "prompt outpatient antiviral treatment after a positive SARS-CoV-2 test result," it added.
The second highest hospitalization rate was among individuals aged 50 to 64 at around one out of 100,000, it said.
Since the original COVID-19 vaccines were rolled out several years ago, uptake of the booster shots has consistently dropped. After the CDC and U.S. Food and Drug Administration (FDA) signed off on the latest vaccines, data from the Department of Health and Human Services show that just 1 percent of all Americans opted to get the shot in September.
However, six medical journals rejected a key paper on COVID-19 vaccines and heart inflammation, a condition the vaccines cause, according to documents reviewed by The Epoch Times. The CDC's journal, the Morbidity and Mortality Weekly Report, was among those that rejected the paper, which estimated that COVID-19 hospitalizations would be prevented than cases of heart inflammation, or myocarditis, caused.
Another report from The Epoch Times, published Wednesday, revealed the FDA received results from two studies of subclinical heart inflammation following Moderna COVID-19 vaccination, but won't release them to the public—for now.
Some hospitals since August have started implementing mask mandates—at least for staff—claiming a rise in COVID-19 and other respiratory infections like RSV or influenza.
Notably, several Northern California counties issued a rule mandating masks be worn by all health care staff starting Nov. 1 and lasting until April 30, 2024. Contra Costa, Sonoma, Alameda, and San Mateo counties in September mandated masking regardless of vaccination status for hospitals and other care facilities, starting Nov. 1 and ending April 30, 2024.
California's San Luis Obispo County issued a similar mandate several days ago, requiring staffers to either wear a mask or get the vaccine.
Several hospitals in upstate New York, Massachusetts, and California also implemented a mandate in recent weeks, while at least one school in Maryland made masks mandatory for one kindergarten class. As for vaccine mandates, several dozen U.S. universities and colleges still have them intact, according to a recent report.
****************************************************
The VA Is Rejecting Disability Claims for COVID Vaccine Injuries and Senators Want to Know Why
After forcing U.S. service members to receive the COVID-19 vaccine or be released from the military, the Biden administration is refusing to provide disability status for soldiers injured by the jab. A number of Republican Senators are demanding to know why.
"We write for clarification on the U.S. Department of Veterans Affairs (VA) policy for veterans who have injuries resulting from receiving the COVID-19 vaccine while in service. As you are aware, the U.S. Department of Defense (DoD) required all service members to be vaccinated against COVID-19. Many service members, despite hesitations against receiving the vaccine, chose to be vaccinated to continue their service to our country," Senators Marco Rubio, Mike Braun, Tom Cotton, Rick Scott, Ted Cruz, and Steve Daines wrote in a letter to Department of Veterans Affairs Secretary Denis McDonough.
"Thousands of service members were discharged from service as a result of refusing to receive the COVID-19 vaccine. Yet, some U.S. service members received the vaccine to maintain their service and have since experienced lasting health impacts as a result," they continued. "If our government is asking service members to receive a vaccine, we must be cognizant that there will be unintended side effects that may cause lifelong impacts on their health. We must keep our promise to support our service members, including ensuring those who come to the VA for help with COVID-19 vaccine injuries are justly compensated and receive the care that they deserve."
The Senators also pointed out that the department has provided disability for injuries from vaccines for years but isn't doing so for the COVID-19 shot.
"For years, the VA has evaluated the health effects of certain vaccinations that veterans received during their service, and have expressed concern with certain health impacts arising from these vaccinations," they wrote. "The agency has also provided several resources to veterans seeking the COVID-19 vaccination, but no clear information about how to support members who are injured as a result of the vaccine. Given the high rate of service members who have been vaccinated against COVID-19 under DoD’s mandate, we request information as to how the VA is considering vaccine-related injuries in determining VA benefits and disability claims."
The Senators are seeking information from McDonough about how the department is handling claims.
********************************************************
12 October, 2023
‘We Can't Force the Human Body to Accept Foreign Genetic Code': Dr. McCullough on mRNA Technology
Cardiologist Dr. Peter McCullough warned that messenger RNA (mRNA) vaccines inject “foreign genetic code” into human beings, which the body fails to break down or expel for a prolonged period of time.
Research on mRNA “has been going on for decades,” Dr. McCullough said during an Oct. 5 interview. The 2023 Nobel Prize for medicine was awarded to two scientists for making “messenger RNA long-lasting in the human body,” he said. “I mean, it has been tested in multiple applications … It's an absolute bust. It was just the worst idea ever to install the genetic code for a lethal protein without being able to shut it off. It wasn't the fact that it was rushed; it's just ill-conceived from the very beginning.”
“We can't force the human body to accept foreign genetic code and produce a foreign protein … Messenger RNA for vaccines is a completely failed concept. It’s a dangerous concept, and the U.S. government wasn't honest. They should have been honest. Trump should have come out and said, ‘Listen, it's on our website; our military's been working on this since 2012.’”
During a testimony at the European Parliament last month, Dr. McCullough said, “There's not a single study showing that the messenger RNA is broken down” in the human body once it is injected. “There's not a study showing it leaves the body.” Since the vaccines are “made synthetically, they cannot be broken down.”
He added that the lethal protein from the [COVID-19] vaccines found in the human body after vaccination was found to be circulating “at least for six months, if not longer.”
In the case of seasonal jabs, that is, taking an injection or booster at the end of six months as recommended by the authorities, “there's another installation in more circulating potentially lethal protein.”
Scientist Drew Weissman, who won the 2023 Nobel Prize in Medicine for his role in developing mRNA technology, warned in a 2018 paper that not only did clinical trials of mRNA vaccines produce “more modest [results] in humans than was expected based on animal models,” but that the “side effects were not trivial.”
Dr. Mccullough’s comments come as the Gates Foundation is spending $40 million on countries in Africa and other economically backward nations to produce new mRNA vaccines in efforts to prevent diseases like tuberculosis and malaria.
Concealing a ‘Global Security Threat’
In the Steve Deace interview, Dr. McCullough said that the ineffectiveness of the technology was not unknown to the government since they’ve been testing it for nearly 40 years.
He referred to a February 2023 paper published in the British Medical Journal (BMJ), which cited that the U.S. government has been investing billions of dollars in developing messenger RNA technology since 1985.
The Defense Advanced Research Projects Agency (DARPA) began investing in mRNA tech in 2011. DARPA then launched the Pandemic Prevention Platform (P3) program in 2016 that sought to produce “relevant numbers of doses” against infections within 60 days of identifying them.
The ADEPT P3 was a program by the U.S. military “to end pandemics in 60 days.” There is no other technology “that our government has invested more in,” Dr. McCullough said.
Dr. McCullough cited another paper that stated there were “over 9,000 patents on messenger RNA. And all the patent assignees are big entities. At the top is Sanofi, then Cervavac, BioNTech, Moderna, and the U.S. government. No single person invented messenger RNA. Someone who comes up in 2021 and says, ‘You know I invented it’. That's impossible. This has been going on for decades.”
Dr. McCullough pointed out that the United States and China have been in “collaboration for years” in their research on infectious and lethal coronavirus.
However, officials like Anthony Fauci, the former head of the National Institutes of Allergy and Infectious Diseases (NIAID), Francis Collins, the former head of the National Institutes of Health (NIH), and “a whole cadre of scientists, they collaborated to conceal this global security threat.”
“They actually intentionally lied to the world and said the virus came out of nature. They knew it came out of the Wuhan lab,” he said, citing a research paper by Ralph Baric and Dr. Zhengli-Li Shi that was published in the Nature journal in 2015.
Dr. Zhengli-Li Shi is affiliated with the Wuhan Institute of Virology, while Mr. Baric is from the Department of Epidemiology, University of North Carolina at Chapel Hill.
“They said they created SARS-CoV-2 virus. They called it the Wuhan Institute of Virology 1 virus. That was the prototype SARS-CoV-2. So, that's in 2015. Instead of bringing Ralph Baric out [and asking] ‘Dr. Baric, how do we get ourselves out of this disaster,’ you masterminded this virus funded by the US.”
‘Pull All COVID-19 Vaccines Off the Market’
In his interview, Dr. McCullough made three recommendations. “I say number one, I've called in the US Senate [and] now the European Parliament [to] pull all COVID-19 vaccines off the market before anyone else is harmed.”
“Number two, US, EU and all westernized Nations [should] pull out of the WHO. They're not trustable. And number three, I'm following the World Council for Health. I am recommending a halt on all childhood vaccines, the entire vaccine schedule until this is clarified since messenger RNA is now on the schedule without any concerns for safety.
While some studies related to the safety of COVID-19 vaccines have shown the jabs to be safe, others have raised concerns about the safety of the shots.
A December 2022 study analyzed trials comparing vaccine recipients with individuals who did not receive a vaccine or were given a placebo.
It concluded that “compared to placebo, most vaccines reduce, or likely reduce, the proportion of participants with confirmed symptomatic COVID-19, and for some, there is high-certainty evidence that they reduce severe or critical disease.”
However, a June 2022 study that looked at mRNA vaccinations found that “Pfizer and Moderna mRNA COVID-19 vaccines were associated with an increased risk of serious adverse events of special interest (AESI).”
“The excess risk of serious adverse events of special interest surpassed the risk reduction for COVID-19 hospitalization relative to the placebo group in both Pfizer and Moderna trials.”
‘Shedding’ the Infection
During the interview, Mr. Deace asked about hearing issues that he and his colleague suffered and whether they had any ties with the vaccines. While he did not take a COVID-19 shot, the colleague was vaccinated. Mr. Deace asked if this was “further proof that basically the last few years Peter everybody was a lab rat whether you took the vaccine or not.”
“It's true, nearly all of us have been exposed to the Wuhan spike protein,” Dr. McCullough replied. “When I see patients in the office, we check antibodies against the spike protein. Invariably, they're elevated. Rarely, I'll find somebody who hasn't been exposed.”
Dr. McCullough pointed out that there are “clear-cut papers” showing individuals suffering hearing loss after taking COVID-19 jabs. “It's all related to the spike protein,” he said. mRNA vaccines work by instructing cells in the body to produce the spike protein found on the surface of the COVID-19 virus.
Once vaccinated, an individual’s muscle cells begin producing spike protein pieces, displaying them on cell surfaces, which end up triggering the immune system to create antibodies. When such an individual gets infected with the COVID-19 virus, these antibodies will then fight the virus.
Dr. McCullough warned that even people who have not received mRNA COVID-19 vaccines can eventually get affected by messenger RNA through a vaccinated individual via “shedding.”
“Shedding means that one has been exposed to the spike protein or to the messenger RNA from close contact with another individual. We know both of them can travel via exosomes which are small phospholipid packets that can be exhaled [via] breath, through sweat, [and] various forms of body fluid, typically you know very close contact.”
“There was a big project called the Eva project in the UK showing 78 percent of women who take a vaccine—they actually have menstrual abnormalities. And those who even didn't take a vaccine, they end up having menstrual abnormalities. There's been plenty of these reports that have occurred.”
Dr. McCullough cited an interview he did with scientist Helene Banoun, an expert on shedding, who believes such things “clearly happens, for sure, in people who've taken the vaccine within 30 days, close contact.”
“Now, two studies—one in the United States, one in Japan—[show] the messenger RNA comes through breast milk. The spike protein may be shedded potentially for a much longer duration of time. It's been shown in the human body now for months, maybe even years afterward. And that's the rationale for what our recent proposal to actually undergo spike protein detoxification.”
The cardiologist pointed out that “every signal” related to cardiovascular disease, neurologic disease, blood clots, immune disease, and cancer “is up.”
“There can be debates on why all these chronic diseases are up, all-cause mortality up in every single area of the world,” he said. “The two big exposures we've had are COVID-19 infection and now COVID-19 vaccines, and I think both mechanisms have led to this wave of disease.”
“I think more powerfully with the vaccines since the vaccines are largely genetic, they're given every six months, and they install the genetic code for the disease-promoting and lethal Wuhan spike protein.”
******************************************************
FDA Has Results of Subclinical Myocarditis Studies, but Won't Release Them Yet
The U.S. Food and Drug Administration (FDA) has received results from two studies of subclinical heart inflammation following Moderna COVID-19 vaccination, but is refusing to release them to the public—at least for now.
FDA officials in January 2022 directed Moderna to run three prospective studies on subclinical myocarditis, or heart inflammation without symptoms, after COVID-19 booster vaccination. One study, mRNA-1273-P204, would examine the incidence of subclinical myocarditis in children aged 6 months through 11 years. Another, mRNA-1273-P203, would examine the incidence in adolescents aged 12 years through 17 years. The third, mRNA-1273-P301, would examine the incidence in adults.
Moderna has shared the results of the P203 study with the FDA, an FDA spokeswoman told The Epoch Times in an email. But she declined to provide them. To obtain the results, she said, The Epoch Times would need to request them under the Freedom of Information Act (FOIA).
"The FDA doesn’t post PMR/PMC study reports," she said, using acronyms for postmarketing requirements and postmarketing commitments, or requirements and commitments pharmaceutical companies make when receiving FDA clearance for their products. "They may be requested under FOIA."
The spokeswoman did not disclose why the FDA doesn't release the results absent a FOIA request.
********************************************************
11 October, 2023
SSRN and medRxiv Censor Counter-Narrative Science
Huge blockages to getting skeptical science about Covid published
Jay Bhattacharya1 and Steve H. Hanke
Chapter XI of Friedrich Hayek’s The Road to Serfdom is titled “The End of Truth.” Hayek develops the idea that to function and maintain power, totalitarian regimes must use propaganda to establish an official doctrine:
The need for such official doctrines as an instrument of directing and rallying the efforts of the people has been clearly foreseen by the various theoreticians of the totalitarian system. Plato’s “noble lies” and Sorel’s “myths” serve the same purpose as the racial doctrine of the Nazis or the theory of the cooperative state of Mussolini. They are all necessarily based on particular views about facts which are then elaborated into scientific theories in order to justify a preconceived opinion. (Hayek 1965, 157)
To be effective, propaganda must exhibit monopoly power, with no dissent allowed and “all information that might cause doubt or hesitation…withheld” (Hayek 1965, 160). Hayek grew up in Vienna and lived there until 1931. He had first-hand experience with totalitarianism and studied its operations. He dedicated much of his professional life to understanding the causes of bad government and combatting its brutalities.
So, we may ask: has covid brought an end to truth? We answer by accounting our covid research experiences, as well as those of others. Before doing so, we reflect on how matters of public health, such as covid, fit into Hayek’s “The End of Truth.”
There is perhaps nothing that opens the door to censorship wider than the fear of disease and the prospect of an early death. Indeed, there is nothing that matches a looming pandemic to generate fear. And there is nothing like fear to grease the skids of censorship.
In the present article, we use the word censorship in the sense of the first definition of the transitive verb censor given at Wiktionary (link): “To review for, and if necessary to remove or suppress, content from books, films, correspondence, and other media which is regarded as objectionable (for example, obscene, likely to incite violence, or sensitive).”
This definition does not confine censorship to activity undertaken by governmental players. We believe that a line that is connoted by censorship, a line that distinguishes censorship from plain and honest content curation, has been crossed by SSRN and medRxiv. That line has to do with violating terms and conditions, even if those are only tacitly understood and are derived from established convention, and with the violations deriving from motives like those that drive government censorship. Indeed, we would not rule out the possibility governmental pressures are playing a role in the censorship perpetrated by SSRN and medRxiv.
So, how does covid fit into this picture? A signal event in the timeline of Western covid lockdowns occurred on March 16, 2020, with the publication of the Imperial College London covid report (Ferguson et al. 2020). Its frightening predictions sent shock waves around the world. The next day, the government threw the United Kingdom into lockdown.
The impact of the report was amplified by the United Kingdom’s soft-power machine, the BBC. Its reach has no equal: broadcasting in 42 languages, reaching 468 million people worldwide each week, and efficiently disseminating its message (Barber 2022). With the BBC in full cry and the public genuinely alarmed, there was little room or tolerance for dissent. In the United Kingdom, the government put its recently established Counter Disinformation Unit on full covid alert, to stamp out dissent (Investigations Team 2023).
A copycat cascade then took hold, with the United States and other countries embracing the UK government’s messaging and policies. The result was a policy based on a defective model (see Herby et al. 2023a, 28–29) that originated at Imperial College London under the leadership of Professor Neil Ferguson, who is the director of Imperial College’s School of Public Health.
UK policymakers should have been aware that Professor Ferguson’s Imperial College team had a history of defective modeling and a track record littered with what are little more than fantasy numbers. To put the blunders of the Imperial College London’s epidemiological fear machine into context, consider the numbers generated by the modelers in 2005, when Professor Ferguson suggested that “up to around 200 million” could die from bird flu globally. He justified this claim by comparing the lethality of bird flu to that of the 1918 Spanish flu outbreak, which killed 40 million (Sturcke 2005). By 2021, bird flu had only killed 456 people worldwide (WHO 2021). And, there were other huge misses by the Imperial College London’s modelers: foot and mouth in 2001, mad cow in 2002, and swine flu in 2009 (Hanke and Dowd 2022).
SSRN censors Herby, Jonung, and Hanke
The Social Science Research Network (SSRN), operated by Netherlandsbased publishing house Elsevier, is an enormous platform in academia. SSRN is extremely important to professors for disseminating their research results and for advancing within the academic community. Indeed, as of September 25, 2023, the SSRN provided 1,271,271 research papers from 1,381,280 researchers in 70 disciplines, per its homepage (link). SSRN is the leading site for academic working papers. It platforms research irrespective of whether the research has been submitted, accepted, or published in journals. Such platforming of research is vital for giving space to all voices, to make scholarship contestable and challengeable, and without delay or stonewalling.
The gatekeeping role of the journals is also a vital facet of the common enterprise of scholarship—but it is separate from the realm of the working paper, and it should continue to be kept separate. If SSRN wishes to play the role of scholarly gatekeeper, it is obliged to assume that role responsibly, which includes clarifying its gatekeeping procedures and living up to the procedures it purports to follow, avoiding double-standards.
Here is what SSRN says (as of September 25, 2023) about its policies regarding “Contributed Content” (link):
Contributed content should be relevant to the subject scope of SSRN. Content may not be illegal, obscene, defamatory, threatening, infringing of intellectual property rights, invasive of privacy or otherwise injurious or objectionable. Elsevier does not pre-screen or regularly review any contributed content, but Elsevier has the right (though not the obligation) to monitor submissions to determine compliance with these Terms and any operating rules to satisfy any law, regulation, or authorized government request.
Needless to say, none of the SSRN-censored research products mentioned in the present article runs afoul of the guidelines against material that is “illegal, obscene, defamatory, threatening, infringing of intellectual property rights,” or “invasive of privacy.” As for “otherwise injurious or objectionable,” if that is the grounds for SSRN’s censorship, it is something they should declare and defend. Thus far, SSRN has failed to do so.
More here:
https://econjwatch.org/File+download/1276/BhattacharyaHankeSept2023.pdf
************************************************Hydroxychloroquine Reduces COVID-19 Mortality, Study Finds
People who took hydroxychloroquine in combination with another drug while hospitalized with COVID-19 were less likely to die than those who didn't, according to a new study.
Hydroxychloroquine, which is widely used against malaria and arthritis, was given to hundreds of patients hospitalized with COVID-19 in Belgium. Thousands of others didn't receive the drug.
Researchers examined records from 352 adults hospitalized in AZ Groeninge Hospital in Kortrijk, Belgium. All patients tested positive for COVID-19 or had results from CT scans that suggested COVID-19 was present. Patients received hydroxychloroquine alone or with azithromycin, an antibiotic. They were scanned before and after treatment.
Researchers compared the results of the record analysis with a control group of 3,533 people hospitalized across Belgium with COVID-19 from March 14, 2020, to May 24, 2020. The people didn't receive hydroxychloroquine but did receive standard of care.
Twenty-eight days following the diagnosis of COVID-19, 59 people treated with hydroxychloroquine had died. The mortality percentage, or 16.7 percent, was lower than the 25.9 percentage in the control group.
Researchers found patients who received hydroxychloroquine were more likely to survive even after adjusting for age and other factors.
"Our study suggests that, despite the controversy surrounding its use, treatment with hydroxychloroquine and azithromycin remains a viable option," Dr. Gert Meeus, a nephrologist with AZ Groeninge Hospital, and other researchers wrote.
The study was published by the journal New Microbes and New Infections. Limitations include the retrospective nature of the study and differences between the treatment and control groups, including the former being younger on average. Authors declared no conflicts of interest or funding.
The research adds to a mixed dataset on hydroxychloroquine against COVID-19.
Some other studies have found that hydroxychloroquine recipients were less likely to die, including a study that analyzed records from a health system in Michigan. Many of the positive findings concerned hydroxychloroquine in combination with azithromycin.
Others have found little or no evidence that hydroxychloroquine affects COVID-19, including a U.S.-government funded study across 34 hospitals.
Multiple studies on hydroxychloroquine and COVID-19 have been retracted.
Hydroxychloroquine is approved by the U.S. Food and Drug Administration but the agency has warned since mid-2020 against using it for COVID-19. Belgian regulators rescinded authorization for hydroxychloroquine for COVID-19 in June 2020.
Dosage Issue?
Hydroxychloroquine proponents say that the amount of the drug, and when it's given, is key to properly studying how it affects COVID-19.
Dr. Meeus and the other Belgian researchers acknowledged clinical trials that did not find a benefit for hydroxychloroquine, as well as some observational studies. Other observational papers have suggested hydroxychloroquine is effective.
"A potential explanation for the discrepancy between the results in the observational trials and the large randomized trials may be the use of a different dose of hydroxychloroquine," they said.
The researchers started with 400 milligrams, two times a day, on day one. That was followed by 200 milligrams a day for five days, in line with national guidelines.
In the clinical trials that found no benefit, patients received four times as much hydroxychloroquine.
"Our treatment was lower and also used the antibiotic azithromycin. This double treatment is a possible explanation for why we found positive effects, but other studies did not," Dr. Meeus told Doorbraak.
Peter Horby, a spokesman for one of the trials, told The Epoch Times previously that the dosage amounts were "carefully selected" and "designed to achieve the concentrations needed to inhibit the virus as quickly and safely as possible."
Dr. Meeus told Doorbraak that further research needs to be done on the drug, or HCQ, but that it very well could be beneficial.
"HCQ is not a panacea, and of course, further research needs to be done. After all, you can't just conclude from an observational study like ours whether something works or not," he said. "But look, we have followed the protocol as it was originally prescribed in Belgium. A study ... also showed in early 2020 that HCQ did lead to lower mortality. If the results of our study confirm this again, we think it is very plausible that the drug has helped quite a few patients."
********************************************************
10 October, 2023
You’re Getting The COVID19 Vaccine – Whether You Want It Or Not
At this point, everyone knows: the health perils of the COVID-19 vaccines are huge. According to our own government’s data reported in the CDC’s “V-Safe” vaccine safety reporting system:
Out of the approximately 10 million v-safe users, 782,913 individuals, or over 7.7% of v-safe users, had a health event requiring medical attention, emergency room intervention, and/or hospitalization. Another 25% of V-safe users had an event that required them to miss school or work and/or prevent normal activities.
In fact, this data was so bad, that the CDC shut down the V-safe website on June 30, 2023, with no explanation. Dr. Peter McCullough, COVID-19 expert and Chief Scientific Officer at The Wellness Company, expresses his dismay on his Substack:
“...my interpretation is that the CDC has now openly turned a blind eye to vaccine safety. The public should be outraged in this overt US government capitulation indicating it simply does not care what happens to people as they take more novel shots.”
A Shocking Next Chapter in COVID-19 Vaccine Development
Despite the overwhelming safety issues, The National Institute of Health (NIH) continues to fund programs seeking to develop novel ways to deliver mRNA vaccines. Science Translational Medicine recently published an NIH study celebrating the accomplishment of effectively delivering the SARS-CoV-2 vaccine in an inhalable vapor form. From the authors:
“An inhalable platform for messenger RNA (mRNA) therapeutics would enable minimally invasive and lung-targeted delivery for a host of pulmonary diseases... Here, we report an inhalable polymer-based vehicle for delivery of therapeutic mRNAs to the lung. We optimized biodegradable poly(amine-co-ester) (PACE) polyplexes for mRNA delivery... We applied this technology to develop a mucosal vaccine for severe acute respiratory syndrome coronavirus 2 and found that intranasal vaccination with spike protein–encoding mRNA polyplexes induced potent cellular and humoral adaptive immunity and protected susceptible mice from lethal viral challenge...”
The government and Big Pharma are showing their hand.
“The ability to efficiently deliver mRNA to the lung would have applications for vaccine development, gene therapy, and more,” casually remarks the editor of Science.
Chief of Epidemiology at The Wellness Company and vaccine critic Dr. Harvey Risch recently warned in an interview with The Epoch Times:
“We know that the COVID vaccines have done various degrees of damage to the immune system in a fraction of people who’ve taken them. And that damage could be anywhere from getting COVID more often, getting other infectious diseases, and perhaps it may also be cancer in the longer term.”
*************************************************
COVID Vaccine Mandates Begin in Red State
The implementation of vaccine mandates at one of the largest institutions in the red state of Texas has raised concerns over the diminishing state of health freedom while a law that would provide Texans with vaccine choice remains stalled by lawmakers.
The Baylor College of Medicine (BCM), a medical school and research center in Houston, Texas, announced last week that it will mandate the latest COVID booster shot for its students, faculty, and employees.
“An updated Covid vaccine has been approved by the FDA and is now available," the Sept. 28 statement from the school reads. "A single dose is recommended for individuals 6 months and older. Because protection from prior vaccination fades over time and this updated vaccine better matches the currently circulating strains the updated dose is recommended. Baylor faculty, staff, and students must get the COVID vaccine, or request a medical, religious, or personal exemption by Nov. 30.”
“Because of the concern in case numbers, some entities have reinstated mask mandates. BCM does not have a mask mandate, but if you are at high risk you may consider making a personal choice to wear a mask in enclosed indoor areas,” the statement adds.
In 2022, the number of employees listed at BCM was 11,288. The institution is within the Texas Medical Center, the world's largest medical center.
Texas Gov. Greg Abbott has publicly declared that his state “should be leading the fight against the COVID tyranny.” However, large publicly funded institutions are still allowed to impose vaccine mandates.
In September Mr. Abbott signed into law Senate Bill 29, which prohibits local governments from requiring COVID-related masks, vaccines, or business shutdowns. However, a separate bill, “The Texas COVID-19 Vaccine Freedom Act,” intended to block any Texas entity, including hospitals and private businesses, from mandating COVID vaccines for employees, remains stalled.
Texas State Rep. Brian Harrison, who has pushed for a statewide ban on vaccine mandates, told The Epoch Times that he is calling for Mr. Abbott to convene a special session of the legislature to protect patient rights.
“This is Texas. We should not tolerate this here,” said Rep. Harrison. “The governor should demand we pass the Covid Vaccine Freedom Act in a special session. This makes no sense that people aren’t protected. The Senate has passed it, the governor has called for it, and members of the House overwhelmingly support it. Now we need to do it.”
Despite support for the bill, it has been blocked from getting to the floor by Rep. Dustin Burrows, a Republican member of the Texas House of Representatives, who is in charge of the Calendar Committee, according to Mr. Harrison.
“The chairman waited until the very last day when a bill could be heard then he put it on page nine or 10 knowing that mathematically there would be no chance for the bill to be heard in time,” said Mr. Harrison.
“If not for his act, 30 million Texans would have freedom from COVID vaccine mandates and because of his actions Texans still have to choose between their health and their livelihood,” he added.
Mr. Burrows didn’t respond to a request for comment.
Dr. Mary Talley Bowden, a practitioner in Texas and founder of Coalition of Health Freedom, told The Epoch Times that the return of mandates, especially in red state Texas, is catching a lot of people off-guard.
“Too many people have fallen into this mindset that COVID is behind us and that we don’t have to worry about mandates anymore,” said Dr. Bowden. “Well, COVID mandates are alive and well in Texas and this could just be the beginning.”
“Texas is not as red as many people would think,” she added.
Dr. Bowden noted that controversial vaccine advocate Dr. Peter Jay Hotez works at the BCM where he is the founding dean of the National School of Tropical Medicine. Dr. Hotez has made statements comparing those hesitant to take vaccines to “the anti-intellectualism promoted during the Nazi and Stalin periods of the 20th century.”
Dr. Bowden says that lawmakers in Texas who are looking to reform the current system are up against a powerful and well-funded machine in the medical industry, but that the stakes are too high to back down.
“Unfortunately, a lot of Texan politicians who people believe are on their side have been captured by the medical establishment,” said Dr. Bowden. “We need to keep the pressure on because if they can mandate their shot at Baylor College of Medicine, and get away with it, it will embolden others. The question Texans should be asking themselves now is, what are they going to mandate next?”
Mr. Harrison, who represents Ellis County, Texas—which in September became the first Texas city to ban all COVID vaccine mandates—called the move to block patient protections “disgusting.”
“Texas should be leading the fight against COVID tyranny. Instead what we are experiencing is shameful and a disgrace.”
*************************************************
Taiwan VICP Awards Another 12 COVID-19 Vax Injured—Including $93.1K to Young Man Permanently Injured by AstraZeneca Vax
A 20-something-year-old man from Kaohsiung in the southern coastal area of the disputed island nation will receive NT$3 million (US$93,147) due to the severe disabilities he has struggled with after receiving the AstraZeneca COVID-19 vaccine.
The recent information about the award to the man identified as Lin, was released by the Taiwan Vaccine Injury Compensation Program (VICP). It turns out that Lin, after getting jabbed with the vaccine, experienced a case of immune thrombocytopenia purpura and became severely disabled two weeks after receiving a shot of the AstraZeneca vaccine, Centers for Disease Control (CDC) Deputy Director-General Tseng Shu-huai.
The mainstream Taipei Times covered this vaccine injury award. TrialSite has found that Taiwan, an independent nation that was established in 1949, during the revolution in China, mainstream media reports more transparently on COVID-19 vaccine injuries than in the West.
The VICP decided to compensate Lin even though he is a young man. This decision was based on the fact that his condition proved incurable even after he sought treatment several times and was hospitalized for two months.
The decision to award NT$3 million was reached during a VICP meeting on Sept. 7, which examined reports about health problems recorded after people received COVID-19 vaccines.
The Last VICP Meeting’s Metrics
The Taipei Times reports that during the last VICP meeting, 151 vaccine injury cases were discussed, with compensation of NT$5,000 to NT$3 million eventually awarded to 12 people.
Importantly, unlike the compensation schemes in the UK or America, Taiwan’s VICP meetings are conducted as part of a process to evaluate if individuals should receive compensation for serious side effects associated with vaccines, including COVID-19 shots. This is the case even if no direct link can be conclusively established.
********************************************************
9 October, 2023
Four Million People Have Received One of the New COVID-19 Vaccines: CDC
Some four million Americans have received one of the new COVID-19 vaccines, U.S. officials say.
"Already four million Americans have rolled up their sleeves," Dr. Mandy Cohen, director of the U.S. Centers for Disease Control and Prevention (CDC), told reporters during a briefing this week.
More than 10 million vaccines from Pfizer and Moderna have been shipped to various locations, including pharmacies, according to CDC officials.
About 56.5 million people, or 17 percent of the population, received one of the bivalent vaccines, which were available from the fall of 2022 until recently, according to CDC data. The shots mostly went to people aged 65 and older.
Some people have reported struggling to find doses of the new vaccines at their local pharmacies and doctors.
Jen Kates, a senior vice president at KFF, said on X in late September that her vaccine appointment was canceled because the pharmacy at which it was scheduled did not have enough vaccines.
Others were able to find a shot but were charged more than $100. Insurers and government insurance were supposed to cover shots for the insured, while people without insurance can still receive one without paying under the CDC's Bridge Access Program.
"The Biden-Harris Administration, through HHS, has been working directly with manufacturers and distributors to ensure that the vaccines are getting to pharmacies, hospitals, clinics, and other vaccination sites, including long-term care facilities as quickly as possible," a spokesperson for the U.S. Department of Health and Human Services (HHS), which includes the CDC, told Reuters.
Dr. Nirav Shah, the CDC's deputy director, said the agency is aware that people have gone to receive a vaccine, or taken their child to receive one, and that there were not any available.
"My message for folks who have had that experience is twofold. The first is, please don't give up on the vaccine. Please know that vaccine is available," he said. "And ... more and more vaccine is getting out there every single day, every single week. And so please check back in with your provider with your pharmacist, because it's likely if they didn't have vaccine two weeks ago, they will have it."
CDC officials said they tried to cut down on barriers in the supply chain to quicken the delivery of doses. Distribution has shifted to businesses instead of the government, which helmed the network for prior versions of the vaccines.
Recommendations
The CDC recommends at least one dose of the new vaccines, which were authorized and approved on Sept. 11 by the U.S. Food and Drug Administration with virtually no clinical trial data, for Americans 6 months of age and older regardless of prior vaccination or infection.
The widespread recommendations are in contrast to many other countries and Florida, which has advised against vaccinating many younger, healthy people due to how many have previously been vaccinated, contracted COVID-19, or both.
Observational data for the bivalent vaccines, or the previous versions, found weak initial effectiveness that quickly waned.
CDC officials made unsupported claims during the briefing, part of a trend for the agency. "These vaccines will prevent severe disease for COVID-19," Dr. Demetre Daskalakis, director of the CDC's National Center for Immunization and Respiratory Disease, told reporters. There's no evidence that's true.
The only clinical study data for the new shots is from a study Moderna ran that included injecting 50 humans with the company's updated formation. The result was a higher level of neutralizing antibodies. Officials believe antibodies protect against COVID-19.
Moderna did not provide any clinical efficacy estimates for infection, severe disease, or death.
Pfizer said it was running a trial but has not reported any results.
Novavax's vaccine was authorized later without any new trial data. CDC officials said the agency also recommends that shot.
"This is a great vaccine for anybody, but particularly for individuals who didn't want to take one of the mRNA vaccines," Dr. Shah said.
Cost
Manufacturers are charging the federal government more than ever for the new vaccines. Pfizer and Moderna charged around $20 per dose for the original vaccines. They are charging around $85 per dose for the new vaccines for people aged 12 and older, and up to $97 for the new vaccines for younger children.
The companies were charging the private sector up to $128 a dose. Pfizer's shot was lower priced for adults, while Moderna's came in higher for most children.
Novavax charged $16 for its initial vaccine but is now charging the government $58 a dose for adults and children.
Novavax is charging the private sector $130 a dose.
"You don't have to pay out of pocket for your vaccine, but it is not cost free. There are costs to making a vaccine available," Health Secretary Xavier Becerra said while getting a shot in Washington in September.
Officials have said they expect the vaccines to be updated annually, similar to the framework for influenza vaccines. There's also some work on so-called next-generation vaccines or shots that work better. That includes a trivalent vaccine that targets measles, mumps, and COVID-19.
****************************************************
California scraps 2022 law punishing doctors who dissent from COVID consensus
California quietly repealed a law making a doctor spreading state-determined COVID-19 misinformation guilty of unprofessional conduct that could cost a doctor his or her medical license.
AB 2098, signed into law in 2022, allows the Medical Board of California to revoke the license of doctors who share any information with a patient that is contrary to the state-defined “contemporary scientific consensus” on COVID-19. The law focused on "false or misleading information regarding the nature and risks of the virus, its prevention and treatment; and the development, safety, and effectiveness of COVID-19 vaccines."
AB 2098 remains into effect until January 1, 2024, when a new law, SB 815, signed by Gov. Gavin Newsom, invalidates action against doctors for sharing COVID-19 information.
The Liberty Justice Center, which engaged in litigation to prevent the law from taking effect, claimed that the organization's oral arguments drove the state legislature to amend SB 815, an existing bill reauthorizing the Medical Board of California, and argued that AB 2098 violated the First Amendment.
In oral arguments in the United States Court of Appeals for the Ninth Circuit, attorney Jacob Huebert, president of the Liberty Justice Center, made the case that AB 2098 would harm patients, doctors and free speech alike.
"A medical professional can have a good faith disagreement with the government about appropriate medical treatments. It's very dangerous for the government to prescribe one appropriate view, and particularly for the government to do so in the name of regulating conduct," Huebert said. "AB 2098 imposes strict liability for speech and punishes advice even if the patient doesn't follow the advice, or follows the advice and has a good result."
An injunction was granted in January of 2023, when AB 2098 took effect, to block punishment under the law until a trial could be held. Even the American Civil Liberties Union filed an amicus brief against the law, calling it a “blunt instrument.”
“It took a federal lawsuit for California legislators to reverse course and repeal an unconstitutional attack on free speech and the doctor-patient relationship,” said plaintiff Dr. Mark McDonald in Liberty Justice Center’s case against California, in a public statement celebrating the measure’s repeal. “We need real accountability, or this will happen again.”
********************************************************
8 October, 2023
A mistaken Nobel
This week, Katalin Karikó and Drew Weissman won the Nobel Prize in Physiology or Medicine ‘for their discoveries… that enabled the development of effective mRNA vaccines against COVID-19’. The ‘efficacy’ of their vaccines was illustrated by a photograph of the pair at a prize-giving event wearing large face masks, a medieval method of reducing viral transmission in the absence of any protection from their award-winning vaccine.
The Nobel Foundation wrote that ‘The laureates contributed to the unprecedented rate of vaccine development during one of the greatest threats to human health in modern times.’
This is false on two counts. First, a vaccine was developed in the US in only four months in response to the 1957 Asian flu whereas the mRNA vaccines took almost a year. Second, the notion that Covid poses one of the greatest threats to human health in modern times is absurd. The virus poses a threat to the elderly and the ill and the vaccines have done little to mitigate that reality. Sweden, home of the Nobel, had no lockdowns in 2020 and didn’t use repurposed drugs to treat Covid yet still had only half the excess mortality (7.7 per cent) of fully vaccinated Australia in 2022 (15.3 per cent).
The Nobel comes with prize money of more than a million dollars but Karikó at least shouldn’t be hard up since she was senior vice-president until 2022 at BioNTech which generated 36 billion euros in vaccine sales in 2022 and 2021. The timing of her departure was fortuitous. Demand for vaccines is down and BioNTech faces hundreds of claims for compensation for vaccine injuries in its home country, Germany.
The long-term safety of the vaccines was raised at the announcement by a Chinese journalist. The committee members looked gob-smacked but they shouldn’t have been. BioNTech’s Chinese partner was never allowed to sell the Pfizer vaccine in China presumably due to safety concerns.Professor Richard Sandberg said 13 billion people had got the virus before correcting himself and saying the vaccine. It was not so much a Freudian slip as a statement of fact since virtually everyone who has got the vaccine has got the virus. He then said there had been very few adverse events so he didn’t think safety was a major concern. In reality, there have been more serious adverse events and deaths reported after mRNA COVID-19 vaccines than for all non-Covid vaccines combined.
Professor Olle Kampe followed Sandberg saying the mRNA ‘can’t be integrated into the nucleus, into the DNA, and that’s a safety precaution’. Worryingly, this may not to be true.
Thanks to Kevin McKernan, who previously worked on the Human Genome Project at MIT, we know that the Pfizer and Moderna vaccines are both contaminated with DNA plasmids, tiny fragments of DNA that were produced as part of manufacturing process. Six independent laboratories around the world have confirmed this.
The DNA may be transported, along with the vaccine, into any cell in a vaccinated person. From there, at least five features of Covid mRNA vaccines may facilitate the transport of the DNA into the nucleus of the cell and its integration into a vaccinated person’s DNA. (An excellent substack by the pseudonymous Dr Ah Kahn Syed titled ‘5 ways to skin a (genetically modified) cat’ sets out the details.)
DNA contamination is very serious. It may be responsible for a range of serious adverse events including death as well as potentially harming the descendants of vaccinated people.
Professor Philip Buckhaults, a cancer geneticist who was one of those who independently confirmed the presence of the DNA, has called for vaccinations to stop until the DNA has been removed.
Others, such as Dr Janci Lindsay, a toxicologist who, together with Buckhaults, testified in a South Carolina Senate hearing on the vaccines, have joined McKernan and a throng of doctors and scientists calling for the complete withdrawal of the Covid vaccines while a full safety audit is conducted.
But it gets worse. Professor Retsef Levi of MIT Sloan and Dr Josh Guetzkow of the Hebrew University wrote to the British Medical Journal in May warning that the vaccine used in the Pfizer clinical trials was not the same as the vaccine given to the public. The DNA contamination was introduced in the process of mass production and only 252 people in the trial were injected with the mass-produced version of the vaccine. Pfizer has so far not released any details about the adverse events in people who received the mass-produced vaccine but the adverse event rate for those in the placebo group, who were vaccinated after the trial ended, was 2.5 times higher than for the rest of the trial participants. Did they get the mass-produced vaccine?
In a final response to the Chinese journalist about long-term safety, Professor Kampe said that adverse events are ‘mostly myocarditis and pericarditis, mainly affecting young males, but that normally resolves without any long-term effects’.
This is an outrageous claim because it is impossible to know the long-term effects of mRNA vaccine-induced myocarditis after only 2.5 years but there is no reason to think there will be no long-term effects. A Danish study published in 2021 found that even in younger healthy patients who were free of adverse events and medication one year after discharge, myocarditis was associated with a long-term excess risk of heart failure, hospitalisation, and death.
A paper published in Nature on 27 September shows that SARS-CoV-2 mRNA spike protein routinely persists up to 30 days after vaccination. In autopsies of people who died after mRNA vaccination, the mRNA-generated spike proteins are present in the heart surrounded by immune cells trying vainly to kill them. Commenting on the recent revelations, Dr Bluemke Professor of Radiology at the University of Wisconsin School of Medicine said they show that ‘mild asymptomatic myocardial inflammation could be more common than we ever expected’ and patients who present with myocarditis may have more severe systemic inflammation related to mRNA vaccination.
None of this should be a surprise. In a 2018 paper, Drew Weissman warned that mRNA vaccines could provoke autoimmunity, blood coagulation, and pathological thrombus formation.
This year’s Nobel for Medicine isn’t the only one riven with controversy. In 1949, António Egas Moniz won the Nobel for inventing the lobotomy. The butchery of the prefrontal cortex was intended to treat mental illness but as Soviet psychiatrist Vasily Gilyarovsky said it simply turned the insane into idiots. To his credit he got the procedure banned in the Soviet Union in 1950. In the West, however, the Nobel added cachet and thousands of lobotomies were performed, particularly on women, gay men, even on children, despite side effects which included severe brain damage, seizures, suicide, and death. Lobotomies eventually fell out of favour in the West but the Nobel Foundation still defends the award.
The scientist who invented mRNA vaccine technology (and holds the patents, with others) is Dr Robert Malone. He was asked this week if he should also have been given the Nobel. His reply? ‘Probably not because the technology has not been proven safe’.
https://www.spectator.com.au/2023/10/not-nobel/
******************************************************Would Australians have consented to vaccinations if they knew the potential risks?
Julie Sladden
The bombshell discovery of DNA contamination in mRNA Covid shots has shocked and alarmed scientists around the globe. They are calling on regulators to urgently stop the injections and conduct a full safety evaluation.
Following Kevin McKernan’s initial discovery earlier in 2023, his findings have been independently verified by several internationally recognised labs around the world including Dr Philip Buckhaults and Dr Sin Lee. These results were again confirmed most recently in Germany when biologist Dr Jurgen Kirchner tested various batches of the Pfizer product (Comirnaty) at his laboratory in Magdeburg and discovered DNA contamination that he claims exceeds regulatory levels by a factor of 200-350. Dr Kirchner followed up with a letter to Health Minister Karl Lauterbach on 20 August 2023, attaching the results of the findings. The official reply from the ministerial office was unimpressive, to say the least:
’(…) the Federal Ministry of Health has no evidence of possible DNA contamination in the Covid-19 vaccine Comirnaty (BioNTech/Pfizer) that has been marketed in Europe and Germany (…) From a local perspective, there is therefore no need for further action.’
This lack of alarm has frustrated members of the scientific community who ask, ‘Under what regulatory system doesn’t this lead to immediate withdrawal from market?’
In the US, testimonies from Dr McKernan to the FDA, Dr Phillip Buckhaults, and Dr Janci Lindsay to the South Carolina Senate seem to raise alarm from all except the therapeutic regulator, the FDA.
You might think ‘well this is all overseas’ and therefore not relevant to Australia. Well, dear reader, you may change your mind when you learn that the Covid mRNA injections are manufactured in just a handful of facilities around the world, and none of them in Australia. This concerns us too.
Many worry that DNA contamination in the mRNA vaccines could bring with it a truckload of serious risks and potential adverse outcomes, including the possibility of genomic integration. That is, the DNA in the injection becomes a part of the DNA of a person’s cells.
The repeated and verified finding of DNA contamination has alarmed scientists from different disciplines and, as McKernan notes, ‘It is important for readers to see where various divergent voices agree.’ Despite being a proponent for the mRNA platform, Buckhaults describes his alarm at the finding, ‘…and the possible consequences of this both in terms of human health and biology.’ In testifying to the Senate he adds, ‘But you should be alarmed at the regulatory process that allowed it to get there.’
World-renowned Professor Wafik El-Deiry, Director of the Cancer Centre at Brown University and known for his work in identifying genes associated with cancer, added his voice to the conversation stating Buckhaults’ testimony was ‘good science raising concerns about contamination of Covid mRNA vaccines with DNA’. He adds:
‘[Buckhaults] explains how pieces of naked DNA allowed in protein vaccines at a certain threshold was not so problematic in a different era but that with encapsulation in liposomes they can now easily get into cells. If they get into cells they can integrate into the genome which is permanent, heritable, and has a theoretical risk of causing cancer depending on where in the genome they integrate. There is a need for more research into what happens in stem cells and I would add germ-line, heart, (and) brain. I am also concerned about prolonged production of spike for months with the pseudouridine in the more stable RNA.’
‘Blood clots, myocarditis, cardiac arrests, and other adverse effects are documented,’ adds El-Deiry. Many believe there’s an urgent need to quantify this problem as DNA is itself prothrombotic and could be the cause of some of the rare but serious side effects like sudden death from cardiac arrest.
Dr Janci Lindsay, a biochemist and molecular biologist, agrees with these concerns and has spent months calling for the shots to be suspended. Alongside the identified risks of genomic integration, autoimmunity, and cancer, Lindsay says other possibilities include gut bacteria (E. coli) taking up DNA plasmids and becoming ‘perpetual spike factories’ or incorporating the antibiotic resistance gene. There is another potential issue Lindsay highlights, ‘If there’s that much (DNA) plasmid in the shots, there’s a very good chance that there’s bacterial endotoxin in the shots… bacterial proteins which can cause anaphylaxis and even death.’
You may wonder, how the DNA and other potential contaminants got into some of these products. Well, it all comes down to the manufacturing process, as discussed in a recent BMJ article. The clinical trials involving around 40,000 people were conducted using injections manufactured via ‘Process 1’ which involved in vitro transcription of synthetic DNA. This is essentially a ‘clean’ process. However, this process is not viable for mass production, so the manufacturers switched to ‘Process 2’ which involves using E. coli bacteria to replicate the plasmids. Getting the plasmids out of the E. coli. can be challenging and may result in residual plasmids, and possibly bacterial endotoxin, in the vaccines. Australian Professor Geoff Pain provides extensive details on these endotoxins.
With the highest rates of adverse events and injuries we’ve ever seen for a ’provisionally approved’ product, you would think any regulator worth their salt would be jumping in to ensure that what has been discovered overseas isn’t so in Australia. But it seems the burden of proof is falling on everyone but the regulator.
From the very start, countless medical and legal professionals have called out the ethical disaster of ‘un-informed’ consent and these experimental injections. Informed consent requires a full discussion of the known and potentially unknown risks of any medication or treatment. This, and the coercion, manipulation, and mandates applied to the Australian people, made informed consent impossible.
How many Australians, I wonder, would have agreed to receive an injection that potentially contained DNA with all the inherent risks described?
None, is my guess.
https://www.spectator.com.au/2023/10/what-the-shot/
********************************************************5 October, 2023
Covid guru Sir Patrick Vallance claims experts were used as 'human shields' for British Government and officials 'cherry-picked' science to justify decisions
Experts were used as 'human shields' for the Government, whose officials 'cherry-picked' science to justify Covid decision-making, Sir Patrick Vallance's pandemic diaries claimed.
The Chief Scientific Adviser, who regularly addressed the nation alongside ministers during press conferences, wrote that Downing Street sought to justify its actions by claiming they were 'following the science'.
And he accused an unnamed official of 'completely rewriting' scientific advice on social distancing, the Covid-19 Inquiry in London heard today.
Sir Patrick's previously undisclosed contemporaneous notes described the intervention as 'extraordinary'.
And he described No 10 as being 'at war with itself', leaving then-Prime Minister Boris Johnson 'caught in the middle'.
Others accused Mr Johnson, who was admitted to intensive care after falling ill with Covid in April 2020, of 'flip-flopping', and of poor and delayed decision-making.
Meanwhile Dominic Cummings, the former Downing Street senior adviser, is said to sent a message to one colleague saying the Cabinet Office was 'terrifyingly shit' as the Government pondered introducing the first, unprecedented lockdown measures in March 2020.
Hugo Keith KC, lead counsel to the Inquiry, told the first day of the probe's second module into Government action that 'the WhatsApp messages between ... Johnson, Cummings and others betray a depressing picture of a toxic atmosphere, factional infighting and internecine attacks on colleagues'.
And he said Mr Cummings claimed Cabinet was 'not the place for serious discussion or decisions'.
Mr Keith said: 'It was a rubber stamp, the main function of which was to function as political theatre.
'Perhaps more importantly, he says Cabinet committees were scripted – ministers were given scripts to read out, and conclusions were drafted in advance, so problems were simply not grappled with.'
Mr Keith suggested Mr Cummings, who left No 10 in November 2020 after a series of internal rows, was 'himself a source of instability'.
Mr Keith also referred to several entries in Sir Patrick's daily notebooks, revealing frictions at the heart of Government.
In one, Sir Patrick said: 'Morning PM meeting, (Mr Johnson) wants everything normal by September... he is now completely bullish.'
In another, from May 2020, he wrote: 'Ministers tried to make the science give the answers, rather than them making decisions.'
Sir Patrick, a member of Sage (the Scientific Advisory Group for Emergencies), added: 'I am worried that a "Sage is trouble" vibe is appearing in Number 10.
'There is a paper from No 10 Cabinet Office for one metre, two metre review (into Government's social distancing measures).
'Some person has completely rewritten the science advice as though it's the definitive version. They've just cherry picked – quite extraordinary.'
Mr Keith said the diaries 'speak of Sage, of the CMO (Chief Medical Officer Professor Sir Chris Whitty) and the CSA being positioned as human shields'.
He added: 'Sage was a scientific advisory body, it produced the science.
'It couldn't integrate economic and societal considerations. So who did? The Government of course.'
And he said then-Chancellor Rishi Sunak's 'eat out to help out' scheme designed to support the hospitality sector went ahead without the approval of the most senior scientific advisers, nor was it informed by evidence on the impact it would be likely to have on infection transmission.
Mr Keith said inquiry chairman Baroness Heather Hallett would have to determine the extent to which the Government may have dawdled while Covid cases began ramping up internationally in the start of 2020.
He said: 'Some argue that had the Government reacted with greater urgency and to greater effect in January and February, it might not have been forced into making the extraordinary, far-reaching decisions that it later found itself obliged to take.'
He said: 'Never again can a virus be allowed to lead to so many deaths and so much suffering.'
The hearing opened with a 20-minute film featuring testimonies from those bereaved and affected by Covid.
One widower, Alan Handley, whose wife Susan died with Covid, hit out at government officials for flouting restrictions on the day less than a dozen people were permitted to gather for her funeral.
He said: 'To compound the grief of my wife's passing, on the day of her funeral — only eight people were allowed to attend — and then to find out the day of my wife's funeral, under those draconian restrictions, that government officials were holding parties on the very same day... My wife deserved better.'
Baroness Hallett appeared moved by the footage, and said she needed to reach conclusions and make recommendations to reduce suffering in the future 'when the next pandemic hits the UK is pressing'.
She said: 'I say "when" the next pandemic hits the UK because the evidence in module one suggested it is not if another pandemic will hit us but when.'
More than 230,000 people have died with Covid-19 in the UK.
The inquiry, which has already cost in excess of £40million, is set to conclude in 2026.
***************************************************
Facing the Highly Mutated Variant BA.2.86
Vaccinations may not help
Following EG.5, the latest highly mutated COVID-19 variant, BA.2.86 (also known as Pirola), is spreading in multiple countries. BA.2.86 is a subvariant of omicron, with over 35 genetic mutations on its spike protein, making it more capable of immune escape. Medical experts recommend increasing the intake of vitamins, minerals, and phytonutrients to boost immunity.
BA.2.86 was first discovered in Denmark in July, and it has since been detected in human or wastewater samples from the United States, Canada, Denmark, the United Kingdom, South Africa, Sweden, Norway, Switzerland, and Thailand.
According to data from the U.S. Centers for Disease Control and Prevention (CDC) updated at the end of August, approximately 97 percent of Americans have developed SARS-CoV-2 antibodies due to prior infection, vaccination, or a combination. However, the significant number of mutations in BA.2.86 raises concerns about whether the immunity acquired from vaccines and previous infections is adequate to combat it.
According to the CDC, it is currently unclear whether the BA.2.86 variant will lead to more severe illness, but these highly diverged lineages may arise in immunocompromised individuals with prolonged infections.
Since the outbreak of COVID-19, the world has experienced multiple waves of pandemic peaks caused by virus strains like alpha, delta, and omicron. The various variants of the SARS-CoV-2 virus that have evolved continue to alter the virus' transmissibility and pathogenicity, presenting challenges to medical treatment and prevention measures.
In August, the CDC stated that the existing tests used for COVID-19 detection and the medications used to treat the disease appear effective against BA.2.86. Updated COVID-19 vaccines are set to be released before the end of September, with the expectation of significantly reducing the risk of severe illness and hospitalization.
However, will that be the case? A recent study analyzed the impact of vaccination and natural immunity on COVID-19 infection rates. The research team conducted this study with 96,201 male inmates across 33 California state prisons, analyzing their data from January to July 2023.
The research findings showed that the infection rate in the bivalent-vaccinated group was 3.24 percent, whereas the infection rate in the entirely unvaccinated group was 2.72 percent. When the data were filtered for individuals aged 50 and above, infection rates were 4.07 and 3.1 percent, respectively. Among individuals aged 65 and above, the bivalent-vaccinated group had an infection rate of 6.45 percent, higher than the 4.5 percent rate observed in the entirely unvaccinated group.
********************************************************
4 October, 2023
Australian Medical Doctors May Need to Arm Themselves with a Law Degree
Australian doctors have expressed displeasure with medical regulatory bodies like Ahpra and the TGA, stating that doctors with different views are being targeted and suspended. TrialSite interviewed some doctors who served in the system and who were suspended unfairly for expressing differing opinions. They emphasized that to be fully protected in the Australian health system, doctors may need to be well-versed in the law before they start practicing.
The Australian Health Practitioner Regulation Agency (Ahpra) regulates medical practice in Australia. Some doctors fear that people anonymously use Ahpra as a weapon against them. There are also concerns that external bodies in the United States like the Federation of State Medical Board (FSMB) may influence the International Association of Medical Regulatory Authorities (IAMRA). The IAMRA is responsible for effective medical regulation worldwide. They achieve this by providing guidance to the medical profession and bolstering scientific, educational and collaborative activities in the field.
What does the FSMB do?
Founded in 1912, the FSMB is a body or association representing state medical licensing in the U.S. Its CEO, Dr. Humayun Chaudhry, is regarded as one of the most influential physicians in the U.S. He released healthcare policies that were approved by the American Medical Association and authored research papers on how to boost vaccine usage. In April 2022, the FSMB adopted a misinformation policy and released a manifesto to be heavy-handed with doctors spreading misinformation. This raised suspicions, especially among vaccine-hesitant doctors, as there appeared to be a seeming connection between Dr. Chaudhry's effort to influence the vaccine-hesitant and “boost vaccine usage” and his strict approach towards doctors expressing hesitancy or spreading opposing information about the vaccines.
Pressured by regulatory bodies
Interestingly, medical authorities from different countries, including Australia, formed an international arm in September 2000, IAMRA. The IAMRA– a non-profit–supports medical regulatory bodies globally. In June 2004, the IAMRA said that it was separate from the FSMB. However, Chaudhry was IAMRA secretary and FSMB CEO at the same time in 2020.
Before the FSMB's adoption of the misinformation policy, the IAMRA had hosted webinars in 2020, to address ethical concerns among doctors and educate them on ways to combat COVID-19 misinformation. An Australian doctor, who would prefer to stay anonymous, said, "... in 2021, as I said, their agenda was to be heavy-handed with all doctors who spread misinformation."
Ahpra wields a strong authority in Australia. As such, a few doctors were concerned that the FSMB may have influenced decisions at Ahpra because its current CEO, Martin Fletcher, was a director at the IAMRA until the end of 2022. He was one of the panelists in a global webinar educating regulators on how to respond to the challenge of vaccine-hesitant doctors.
Were these concerns justified?
The Therapeutic Goods Association (TGA) and Ahpra are at the forefront of fighting COVID-19 misinformation, and they continually advocate for the dissemination of the right information on vaccine safety.
In 2023, Ahpra released a 2021 survey result reflecting the distrust among doctors of its regulatory services. Doctors in Australia had the most negative views compared with other health practitioners, and only 35% of doctors had positive reviews of Ahpra.
Part of the result said, "Distrust was undercut by practitioners’ personal views of how the COVID-19 pandemic was handled, but also related to perceived unfairness and injustice of Ahpra and the Boards’ processes."
In October 2021, the TGA suspended a medical doctor for using ivermectin on a patient with severe COVID-19 symptoms. The patient had initially sought treatment at another hospital but had only been told to wear a mask and isolate, without receiving any early treatment. As the patient’s condition had worsened after returning home, they had sought treatment from the doctor instead of going back home due to concerns about being unable to say goodbye to their family if they were to pass away.
A junior doctor in that hospital then made a complaint, stating that there was a case of polypharmacy and encephalopathy.
Speaking with TrialSite, she said, "I wanted to find out what happened to my patient, so I called this doctor up… She basically said to me that she didn't know why she made a complaint against me and that her boss was the one who actually told her to make the complaint."
The junior doctor’s supervisor was Associate Professor Naren Gunja, a toxicologist at the Westmead Hospital. She mentioned that she’d tried speaking to him, but he didn’t listen to her.
"So, I did a bit of research and discovered that he actually went to the media and spoke about a case of ivermectin overdose in a patient that he had treated at casualty," she continued.
“I couldn’t understand why Dr. Gunja, a toxicologist, chose to warn the public about the risk of ivermectin. It is well known that taking ivermectin in combination with other medications can effectively treat COVID-19, and the occurrence of ivermectin overdose is rare.”
The ivermectin overdose case went viral from September 1 to September 3, 2021, after Gunja had spoken to the media, advising the public to ignore online claims that ivermectin was a cure for COVID-19. And on September 10, 2021, the TGA banned ivermectin as an off-label treatment for COVID-19.
According to our source, a second complaint came from an anonymous source with the pseudonym – John Smith. Eventually, the evidence presented in the complaint was traced back to Ahpra. All these contributed to her suspension in October 2021.
Additionally, in February 2021, the COVID Medical Network came under intense scrutiny from the TGA for endorsing the off-label use of hydroxychloroquine in treating COVID-19 infection.
The COVID Medical Network (CMN) is a group of doctors in Australia who have reservations about COVID-19 vaccines and have voiced their dissatisfaction with the government's pandemic response. Instead of recommending vaccines, they prescribe alternative medications like ivermectin and hydroxychloroquine to address and curb the effects of COVID-19 infection.
This may explain why a doctor had to publicly renounce and dis-endorse the group within seven days to regain medical registration after being urgently suspended for having a link on her website to the CMN website.
A case of corruption among regulatory bodies
In October 2022, the Australian government made over 30 changes to the national law guiding the regulation and registration of doctors. This also included disciplinary action against doctors who had broken the law. It was called the Health Practitioner Regulation National Law and Other Legislation Amendment Act 2022.
This law gave Ahpra the power to release a public statement regarding a practitioner who is under assessment or investigation if there was a "reasonable belief" that the practitioner's behavior, performance or health could seriously endanger public safety. Some doctors fear that Ahpra or the TGA could use this law as a means of bullying.
According to our first anonymous source, Ahpra weaponized the reasonable belief concept to take down medical doctors with different beliefs.
She implied that Ahpra could influence the subjective state of mind of the medical board by making statements about a doctor with no medical basis. "It has so much power. They can target any doctor they like. All it needs to do is to have an anonymous complaint against a particular doctor, and that doctor could be urgently suspended without verification of the facts."
People have complained that Ahpra bullies and has numerous scandals. After three Senate, a state inquiry into Ahpra’s conduct and according to recent polls, many doctors, the Royal Australian College of General Practitioners (RACGP) and the Australian Medical Association (AMA) remain unhappy with Ahpra’s framework. Ahpra is an agency with a five-year contract with the National Board to carry out administrative duties like notifications and collection of subscriptions.
The regulatory power lies with the Board, not Ahpra, and one anonymous doctor said that the Board was negligent in renewing its contract with Ahpra, knowing the level of incompetence of Ahpra officials. She added that perhaps the Board liked this arrangement, as most complaints are deflected away from the Board and directed against Ahpra.
The TGA was also accused of hiding vaccine side effects like myocarditis from the public, making people doubt its authenticity. They also allegedly concealed the death of several previously healthy children from vaccine side effects, as they were afraid it would promote vaccine hesitancy.
To curb corruption among regulatory bodies like the TGA, the Australian government introduced the National Anti-corruption Commission (NACC) in July 2023. Ahpra and the Medical Board are not answerable to either the state, federal parliament or the NACC. Many doctors believe they should be accountable.
Do doctors need a law degree for protection?
During TrialSite's conversation with the sources, they hinted that the insurance company lawyers meant to protect doctors were actually supporting the medical council and Ahpra. If this is true, doctors may need to become experts in law to make the right choices when getting advice from lawyers, especially if they end up in such a situation.
When TrialSite inquired if the medical board's actions would make doctors anxious about reporting adverse effects and other related matters, they firmly responded that the board's actions had caused underreporting. Apparently, doctors were afraid of saying or doing anything that would earn them a suspension.
Even so, some doctors have challenged the system and are legally smart about it. An example is Dr. William Bay, an Australian doctor in Queensland and the leader of the Queensland People’s Protest (QPP). TrialSite has previously reported on Dr. Bay's protests against the COVID-19 vaccines in Australia. He had previously received a suspension for disrupting an Australian Medical Association conference. He then took legal action against the medical board and Ahpra, aiming to have the suspension revoked. At the time of authoring this article, Dr. Bay was still waiting for the final verdict from the Court.
Dr. Gary Fettke, an orthopedic surgeon, also faced a four-and-a-half-year legal case initiated by Ahpra starting in 2014 for giving nutritional and weight loss advice to his patients. The case was challenged along legal and procedural grounds, and then, using the National Health Practitioner Ombudsman’s Intervention (NHPO), was reviewed independently.
Speaking to TrialSite, Fettke said, “Nonetheless, we had to become 'expert' in the National Law, as the Indemnifiers are not supportive of preserving your practicing rights, nor reputation.” Additionally, he added that because these insurance company lawyers were mainly responsible for financial liability, they found it safer and cheaper to side with Ahpra.
These are examples of people who may have understood their legal rights as doctors.
Final thoughts
To treat patients in the best way possible, doctors in Australia may need to learn to navigate the legal system strategically. While this may not apply universally, Ahpra's survey indicates decreased confidence in the system among practitioners. So, beyond relying solely on medical defense insurance providers in Australia, doctors may require additional safeguards to function effectively within the healthcare system. Of course, from another perspective—the top down, government and medical establishment’s point of view doctors should simply line up and follow the guidance.
********************************************************
3 October, 2023
Do COVID-19 Vaccines Link to Cancer? 3/4 Reviewers Accept but Frontiers in Oncology Reject Manuscript
A recent paper uploaded to the Authorea preprint server, involves the possibility that COVID-19 mRNA vaccines could trigger changes leading to oncogenesis. Led by Rachel Valdes Angues, a senior researcher and Post Doc at Oregon Health and Science University (OHSU), and researcher Yolanda Perea Bustos, the pair point to a hypothesis for COVID-19 vaccines and oncogenesis, also known as tumorigenesis or carcinogenesis, a phenomenon referring to the process by which normal cells are transformed into cancer cells. This process represents one that is complex, and multistep, one that involves various genetic, epigenetic, and environmental factors. Overall, oncogenesis leads to the development and progression of cancer. The pair express a disturbing hypothesis, one that’s based on reviews of the medical literature: that COVID-19 vaccines may predispose some cancer patients to cancer progression, recurrence, and/or metastasis.
The recent paper was submitted to Frontiers in Oncology. Interestingly, three of the reviewers endorsed the paper's publication yet the paper was rejected on “editorial grounds.” Does the topic raise an inconvenient topic? This manuscript has not been peer-reviewed and should not be cited as evidence. But TrialSite calls attention to the disturbing premise, one that should be further vetted.
What’s this hypothesis based on? According to the two authors whose paper was rejected for “editorial” reasons, they argue, “One that raises alarm of “biological plausibility (i.e., induction of lymphopenia and inflammation; downregulation of ACE2 expression; activation of oncogenic cascades; sequestration of tumor suppressor proteins; dysregulation of the G4-RNA-protein binding system and type I IFN responses; unsilencing of LINE-1 retrotransposons) together with growing anecdotal evidence and reports filed to Vaccine Adverse Effects Report System (VAERS) suggesting that some cancer patients experienced disease exacerbation or recurrence following COVID-19 vaccination. In light of the above, and because some of these concerns also apply to cancer patients infected with SARS-CoV-2, we encourage the scientific and medical community to urgently evaluate the impact of both COVID-19 and COVID-19 vaccination on cancer biology, adjusting public health recommendations accordingly.”
What is this hypothesis?
The pair hypothesize that “COVID-19 and/or certain COVID-19 vaccines generate a pro-tumorigenic milieu that predisposes some (stable) cancer patients and survivors to disease progression and/or (metastatic) recurrence.” Importantly, the vaccines covered in this hypothesis include those that “promote the endogenous production of SARS-CoV-2 spike (S) glycoprotein” including the two mRNA COVID-19 vaccines (Pfizer-BioNTech and Moderna) and the adenovirus-vectored vaccines (Johnson & Johnson and Oxford/AstraZeneca).
Limitations of this hypothesis
The authors to their credit acknowledge that studying the matter of COVID-19 and cancer, using VAERS and other sources remains a tricky research affair. It’s likely difficult to truly prove that COVID-19 vaccines induce cancer because of the “other clinical and social factors resulting from the 111 pandemic, such as adverse effects related to SARS-CoV-2 infection (29,30); steep declines in cancer 112 screening, diagnosis and treatment (31); adoption of unhealthy behaviors (i.e., increased alcohol 113 consumption, reduced physical activity) during long pandemic lockdowns (32); stress induced by the 114 COVID-19 crisis (33); and the assumption that millions of adults will remain unemployed and without health insurance; will independently contribute to cancer mortality in the months and years to come.”
Evidentiary Summary
The pair articulate that COVID-19 vaccine-based “SARS-CoV-2 spike glycoprotein-based vaccines, and particularly mRNA vaccines, can possibly initiate a set of biological mechanisms that could, in theory, “collectively generate a (transient) pro-tumorigenic environment favorable to cancer progression and/or reactivation of dormant cancer cells (DCCs).”
Such tragic adverse events would be “attributed to the pro-inflammatory action of the lipid nanoparticles (LNPs); the impaired type I interferon (IFN) response and/or translational dysregulation of cellular microRNAs triggered by structurally modified mRNA (mRNA vaccines); as well as to the unique nature, expression pattern, binding profile, and proinflammatory and tumorigenic effects of the produced antigens, namely the SARS-CoV-2 spike protein and/or its subunits S1 and S2 (mRNA and adenovirus-vectorized 127 vaccines).”
Biodistribution evidence points to the possibility at least in rare occasions of substantial levels of soluble spike and/or its subunits and peptide fragments in the circulation of vaccinees, possibly persisting for weeks, or even months.
Could it be the case that sustained and systemic distribution of spike within the human body promote a range of unforeseen interactions with angiotensin-converting enzyme 2 (ACE2), the entry receptor for SARS132 CoV-2, either in its soluble circulating form or expressed in cells from various tissues and organs? As part of this hypothesis, the authors point out that in most cases, the spike protein associated with the SARS-CoV-2 virus itself usually only impacts respiratory tract tissues and organs.
********************************************
Children’s Health Defense Australia: saving our kids after Covid lockdowns
Julie Sladden
Few would disagree that the health of the children today foreshadows the health of the population tomorrow. With that in mind, the past three years of pandemic fear and dystopia have upset any preconceived ideas that the health of the people is on solid ground. In a worldwide response that saw nations lockdown, mask up, and mass vaccinate – ‘to protect grandma’ – it seems scant regard was paid to the cost incurred on the future generation.
Australia was ground zero for many of the more tyrannical restrictions of freedom and it didn’t go unnoticed. ‘The whole world is alarmed by what’s happening in Australia,’ said Robert F. Kennedy Jnr., founder of Children’s Health Defense US. With many states enforcing closed schools, masking of children, social distancing, and mandates, it will be years before the full impact of these actions is known.
As early data emerges on the impact on education, health, and social development it seems those who might pay the greatest price are the next generation. It is timely then that the Australian Chapter of the Children’s Health Defense was officially launched on August 26 this year.
With a board packed with expertise – Professor Robyn Cosford, Emeritus Professor Ramesh Thakur, lawyers Julian Gillespie and Peter Fam, Dr Astrid Lefringhausen, AMPS secretary and registered nurse Kara Thomas, and medical freedom advocate Cloi Geddes – Children’s Health Defense (CHD) Australia is well placed to bring light to, and stand against, the incursions on children’s health over the Covid years. But the story doesn’t begin there. The Covid response may simply be the catalyst, in Australia at least, for a light to be shone on the deterioration in the health of children over recent decades.
‘What we’re seeing in our children now … is an epidemic of chronic disease,’ explains Professor Cosford. ‘The sorts of things that we used to be seeing in older adults, in our grandparents, and our great aunts and uncles. We don’t expect to be seeing them in our children. We’re seeing an epidemic of immunological disorders where nearly half of the children have some kind of allergic-type disease, and we have autoimmune diseases occurring in our children which never have been seen before… We have an epidemic of mental health … (with) some 40 per cent (suffering) with depression, anxiety, OCD, panic disorders, and so on.’
‘And then there’s a big epidemic we’re seeing of neurodevelopmental disorders … one in ten diagnosed with ADHD, one in five with learning disorders, (and) one in 36 with autism. These (figures) have increased dramatically over the last 20-30 years and were unheard of before now.’
With a mission to ‘end childhood health epidemics’ the road ahead looks long. These alarming trends in the health of our children have been brewing for years and now may well have been exacerbated by the additional insult inflicted by the Covid response.
‘I ask as a grandparent: Why did we use children and adolescents as human shields to protect the supposed grown-ups and elderly?’ asks Ramesh Thakur, in his presentation titled Our Enemy the Government. ‘A major study recently concluded that lockdown harmed the emotional development of almost half of all British children.’ With lockdowns, closing of schools, restricted socialising, and masking it seems the price was paid by the young, who were least at risk, ‘…for a few more months of existing without living by the elderly most at risk,’ concludes Thakur.
More concerning and down-right disturbing, information is delivered during the launch by fellow presenters including the adverse effects of the Covid injections, censorship of free speech in science and medicine, DNA contamination in the Pfizer Covid injections, and legal cases in process which aim to protect our future generations.
Julian Gillespie described the heartache of ‘being belted by a judiciary that’s not acting like a judiciary’ in the recent AVN Babies case. Despite this, an unexpected benefit was the growth in support as the story spread around the nation.
‘Even though we didn’t get the correct and proper decision from the High Court, there was a massive outpouring of donors who told their friends who watched our videos with Maria Z, or Graham Hood, Health Alliance Australia, and AMPS. Parents would (start to) question (as) those videos… were pushed out across the country.’
Speaking to supporters Gillespie is clear, ‘It is correct to feel good that you participated. It did make a difference. You’ve enabled us to get the message out which is just the most important thing to allow the court of public opinion to make its mind up. (And) there are millions of us who can share the information and (help) save lives.’
********************************************************
2 October, 2023
Doctor Peter McCullough: Stop all COVID-19 Vaccination Now
As TrialSite has reported, on September 13, Dr. Peter McCullough spoke at an event hosted at the European Parliament, and he called for an immediate end to use of any existing COVID-19 vaccines. The prominent cardiologist, clinical investigator and public health scientist, often outspoken in his challenging of the U.S. government’s strategy to combat COVID-19, shared at the hearing that the pandemic included two separate waves of crisis or injury: SARS-CoV-2 and the mRNA vaccines.
The Dallas area-based physician that’s become a regular on various media—usually conservative leaning-- argues that a pharmaceutical syndicate led by the WHO, Bill Gates, GAVI, the EMA, and the US’s CDC, NIH, and FDA usurped the practice of medicine, away from the front-line doctors that placed patient health first and foremost priority. This group of organizations, he says, are operating as a carefully coordinated unit. This has been a problem, as an example this syndicate covered up the origins of SARS-CoV-2. Dr. Anthony Fauci and other leaders conspired to hide the fact that this virus was created by a US-funded lab in Wuhan, China.
“Environment of therapeutic nihilism”
And the WHO did not help doctors in their efforts to treat folks with COVID-19, creating an “environment of therapeutic nihilism” in which it was advised that people in an early stage of the disease not receive treatment. TrialSite reported on all sorts of examples which in some ways, support the claims of the much-criticized physician.
For example, early on during the pandemic, a pharmacist in a Florida -based health system developed the ICAM protocol which reportedly was saving hundreds of lives. TrialSite learned after the pharmacist got herself in trouble after our report, that the CEO cut the protocol which included blood thinners and other FDA approved drugs, as their contracts with Pfizer during the pandemic precluded them from actually doing anything to treat COVID-19 patients off label.
Early on during the pandemic, TrialSite chronicled front line doctors around the world and their use of different combinations of off label drugs such as ivermectin, a drug used by hundreds of millions in the tropics as an anti-parasite regimen. Studies in the U.S. such as the ICON study, published in the journal Chest, showed off-label early treatment may help at least mild to moderate COVID-19 patients. Later, NIH supported studies pointed to no effectiveness. Yet McCullough, a frequent contributor of opinion pieces to TrialSite, at the onset of the pandemic experimented with various combinations, even publishing an analysis of the COVID-19 disease lifecycle, and appropriate off label combinations to treat patients.
McCullough says that there are two things that prevent hospitalization or death: early intervention and natural immunity. To this day, WHO is not embracing early treatment. He also argues that the majority of bad COVID-19 outcomes could have been prevented with treatment.
Does mRNA ever leave?
Moving on to crisis number two, according to McCullough, contrasting to most medical establishment reports saying the contrary, since 2021 vaccines have “ravaged” the world’s population. When 75% of people in the US got a COVID-19 vaccine, McCullough was publicly calling out that this was a major mistake. He says that our vaccines “code for the worst part of the virus” and that our approach was the “worst possible.” There have been no studies showing that mRNA ever leaves the body, and so far, research has found spike proteins up to six months after vaccination. While there are plenty of data points that mRNA leaves the body via the lymphatic system, the outspoken doctor is correct that at least in some rare cases, the mRNA’s spike protein may circulate in the human body for up to a couple years. TrialSite has reported on nearly a dozen studies that in the aggregate lead to serious evidence for the unfolding science to not be what the government presents.
Three false narratives
Based on about 3,500+ studies, categories of harm from these vaccines include cardiovascular, such as mass cardiac deaths in young athletes with myocarditis from the vaccine; neurological; clotting “like never seen before” with spikes found within clots which are larger and more resistant to medication than pre-vaccine norms and immunological.
McCullough is the senior author of the largest study of post-vaccination autopsies. He reported to the European MPs that he and colleagues found that 73% of deaths that occurred after vaccination were due to the vaccine. He shared that the world faces three false narratives: 1) the initial fear and lockdowns; 2) the safety and efficacy of the vaccines; and 3) the claim that the surge in heart problems is caused by COVID-19 itself.
15% adverse event rate?
Per the doctor, the technical criteria for causality in medicine are met, so it is clear that the vaccine is causing the medical complications. And there are issues with varying adverse event rates among different batches of the same vaccine. In a study in Denmark with three batches, one of them was related to the prevalence of sudden death. Analysis shows that in Europe 4.2% of batches are “bad.”
He cites another CDC database of 10 million self-reports showing that 7.7% of that cohort after vaccination needed to go see a doctor in a clinic or hospital. According to a Zogby poll, 15% of vaccinated folks had an adverse event. While TrialSite’s far more conservative estimate of between about 0.2% to 0.8% of those vaccinated face life-altering injuries. Even in the conservative estimation of TrialSite that leaves anywhere from just under half-a-million to over 2 million people in need of care.
“No one should ever take another one of these shots,” states McCullough to the European MPs. According to the cardiologist, the World Council for Health looked at 30 “safety databases” and opined that the COVID-19 vaccines should be taken off the market forthwith.
Is McCullough right or not? Or perhaps, some core truth lies somewhere in between what the good Dallas, Texas doctor opines, and the government’s ongoing position that the products are fully safe and effective?
https://www.trialsitenews.com/a/doctor-peter-mccullough-stop-all-covid-19-vaccination-now-9c304cab
************************************************UK Qualitative Study: Long COVID’s Adverse Impacts on Children’s Health, Education, Overall Quality of Life
Children are significantly impacted by long COVID, both direct health and school experience according to the results of a recent study published BMJ Open. Led by the Nuffield Department of Primary Care Health Sciences at the University of Oxford in England, the pioneering qualitative study investigated the impact of Long Covid on children and young people’s experiences of school. In addition to the University of Oxford, the universities of Stirling and Aberdeen helped conduct the study.
Key researchers include Dr Alice MacLean, lead author and researcher based within the Institute for Social Marketing and Health, University of Stirling, Sue Ziebland, Principle Investigator for the study and Professor of Medical Sociology based within Nuffield Department of Primary Care Health Sciences, University of Oxford and Dr Cervantée Wild, co-author and researcher based within Nuffield Department of Primary Care Health Sciences, University of Oxford.
The University of Oxford included a quote from a study subject, 11-year-old Mae who had long COVID for eight months to convey the essence of findings:
'I have really bad meltdowns where I just want to be back to normal [...] I do half days at school [...] go in at like 11am, and I come home and I just, I’m crying [and] ‘I just want to be normal again.”
The Study
The researchers carried out narrative interviews over video calls or telephone between October 2021 and July 2022. They engaged with 22 children and young people (aged 10-18) and 15 parents and caregivers of those aged 5-18 years, all dealing with the persistent aftermath of Covid-19 infection – Long Covid.
Participants were recruited through routes including social media, Long Covid support groups, clinicians, and community groups to capture a varied spectrum of experiences. The researchers particularly focused on what interviewees said about the impact of Long Covid on schooling and education.
Troubled Conditions
As reported by University of Oxford the study findings point to the vital role school plays in children’s return to a ‘normal life’ after enduring COVID-19.
Yet, life has changed for good since COVID-19. That’s because returning to school was often a false hope, rather than a genuine return to normality. Why? The study team found that extreme fatigue meant full school attendance was often a quick route back into illness.
As one 13-year-old boy described: 'I couldn't really do anything [with friends] at break. I was just resting. I struggled going up the stairs. I can’t do PE. Yeah, I just feel tired after every lesson.’
For those managing to attend school part-time, juggling studies and social activities with enough rest to avoid making symptoms worse was a big challenge. The University of Oxford shared a 16-year-old’s explanation:
‘The hardest part is not being able to go to school or like see people my age, socialise and everything. It’s all like online for me now over like social media or messages [...] seeing other people [...] my age that are going out in school or doing all their exams [and] doing lots of things throughout the summer that I would like to be able to do, but I just can’t. I think that’s quite hard.’
‘Cut off’ & Falling Behind
Young people valued education highly but felt cut off from friends and stressed about falling behind due to frequent absences. Parents told of difficulties liaising with schools, particularly around getting validation about legitimate illness from already overburdened healthcare. School support varied drastically, spanning from skepticism to empathy and tailored adjustment.
PI POV
According to lead author Dr. Maclean, “This research clearly shows that absence from school due to Long Covid has a stressful and isolating impact on children and young people. The findings highlight the need for greater awareness and understanding of Long Covid in schools, and for tailored support to enable those affected to engage with school in a way that is manageable and not detrimental to their physical or mental health.”
According to Sue Ziebland:
“Our study provides practical recommendations for how healthcare and education professionals can better support children and young people in managing their Long Covid symptoms alongside school demands. These have the potential to improve experiences for young people with Long Covid and reduce pressures on their caregivers. Listening to and validating the experiences of children and young people with Long Covid is vital.”
********************************************************
1 October, 2023
During the pandemic, the U.S. government violated my free speech rights and those of my scientist colleagues for questioning the federal government’s COVID-19 policies
Jay Bhattacharya
American government officials, working in concert with Big Tech companies, defamed and suppressed me and my colleagues for criticizing official pandemic policies—criticism that has been proven prescient. While this may sound like a conspiracy theory, it is a documented fact, and one recently confirmed by a federal circuit court.
In August 2022, the Missouri and Louisiana attorneys general asked me to join as a plaintiff in a lawsuit, represented by the New Civil Liberties Alliance, against the Biden administration. The suit aims to end the government’s role in this censorship and restore the free speech rights of all Americans in the digital town square.
Lawyers in the Missouri v. Biden case took sworn depositions from many federal officials involved in the censorship efforts, including Anthony Fauci. During the hourslong deposition, Fauci showed a striking inability to answer basic questions about his pandemic management, replying “I don’t recall” over 170 times.
Legal discovery unearthed email exchanges between the government and social media companies showing an administration willing to threaten the use of its regulatory power to harm social media companies that did not comply with censorship demands.
The case revealed that a dozen federal agencies pressured social media companies Google, Facebook, and Twitter to censor and suppress speech contradicting federal pandemic priorities.
In the name of slowing the spread of harmful misinformation, the administration forced the censorship of scientific facts that didn’t fit its narrative de jour. This included facts relating to the evidence for immunity after COVID-19 recovery, the inefficacy of mask mandates, and the inability of the vaccine to stop disease transmission. True or false, if speech interfered with the government’s priorities, it had to go.
On July 4, U.S. Federal District Court Judge Terry Doughty issued a preliminary injunction in the case, ordering the government to immediately stop coercing social media companies to censor protected free speech. In his decision, Doughty called the administration’s censorship infrastructure an Orwellian “Ministry of Truth.”
In my November 2021 testimony in the House of Representatives, I used this exact phrase to describe the government’s censorship efforts. For this heresy, I faced slanderous accusations by Rep. Jamie Raskin, who accused me of wanting to let the virus “rip.” Raskin was joined by fellow Democrat Rep. Raja Krishnamoorthi, who tried to smear my reputation on the grounds that I spoke with a Chinese journalist in April 2020.
Judge Doughty’s ruling decried the vast federal censorship enterprise dictating to social media companies who and what to censor, and ordered it to end. But the Biden administration immediately appealed the decision, claiming that it needed to be able to censor scientists or else public health would be endangered and people would die. The U.S. 5th Circuit Court of Appeals granted it an administrative stay that lasted until mid-September, permitting the Biden administration to continue violating the First Amendment.
After a long month, the 5th Circuit Court of Appeals ruled that that pandemic policy critics were not imagining these violations. The Biden administration did indeed strong-arm social media companies into doing its bidding.
The court found that the Biden White House, the Centers for Disease Control and Prevention, the U.S. Surgeon General’s Office, and the FBI have “engaged in a years-long pressure campaign [on social media outlets] designed to ensure that the censorship aligned with the government’s preferred viewpoints.”
The appellate judges described a pattern of government officials making “threats of ‘fundamental reforms’ like regulatory changes and increased enforcement actions that would ensure the platforms were ‘held accountable.’”
But, beyond express threats, there was always an “unspoken ‘or else.’” The implication was clear. If social media companies did not comply, the administration would work to harm the economic interests of the companies. Paraphrasing Al Capone, “Well that’s a nice company you have there. Shame if something were to happen to it,” the government insinuated.
“The officials’ campaign succeeded. The platforms, in capitulation to state-sponsored pressure, changed their moderation policies,” the 5th Circuit judges wrote, and they renewed the injunction against the government’s violation of free speech rights. Here is the full order, filled with many glorious adverbs:
Defendants, and their employees and agents, shall take no actions, formal or informal, directly or indirectly, to coerce or significantly encourage social-media companies to remove, delete, suppress, or reduce, including through altering their algorithms, posted social-media content containing protected free speech. That includes, but is not limited to, compelling the platforms to act, such as by intimating that some form of punishment will follow a failure to comply with any request, or supervising, directing, or otherwise meaningfully controlling the social media companies’ decision-making processes.
The federal government can no longer threaten social media companies with destruction if they don’t censor scientists on behalf of the government. The ruling is a victory for every American since it is a victory for free speech rights.
Although I am thrilled by it, the decision isn’t perfect. Some entities at the heart of the government’s censorship enterprise can still organize to suppress speech.
For instance, the Cybersecurity and Infrastructure Security Agency within the Department of Homeland Security can still work with academics to develop a hit list for government censorship. And the National Institutes of Health, Fauci’s old organization, can still coordinate devastating takedowns of outside scientists critical of government policy.
So, what did the government want censored?
The trouble began on Oct. 4, 2020, when my colleagues and I—Dr. Martin Kulldorff, a professor of medicine at Harvard University, and Dr. Sunetra Gupta, an epidemiologist at the University of Oxford—published the Great Barrington Declaration. It called for an end to economic lockdowns, school shutdowns, and similar restrictive policies because they disproportionately harm the young and economically disadvantaged while conferring limited benefits.
The declaration endorsed a “focused protection” approach that called for strong measures to protect high-risk populations while allowing lower-risk individuals to return to normal life with reasonable precautions. Tens of thousands of doctors and public health scientists signed on to our statement.
With hindsight, it is clear that this strategy was the right one. Sweden, which in large part eschewed lockdown and, after early problems, embraced focused protection of older populations, had among the lowest age-adjusted all-cause excess deaths of nearly every other country in Europe and suffered none of the learning loss for its elementary school children. Similarly, Florida has lower cumulative age-adjusted all-cause excess deaths than lockdown-crazy California since the start of the pandemic.
In the poorest parts of the world, the lockdowns were an even greater disaster. By spring 2020, the United Nations was already warning that the economic disruptions caused by the lockdowns would lead to 130 million or more people starving. The World Bank warned the lockdowns would throw 100 million people into dire poverty.
Some version of those predictions came true—millions of the world’s poorest suffered from the West’s lockdowns. Over the past 40 years, the world’s economies globalized, becoming more interdependent. At a stroke, the lockdowns broke the promise the world’s rich nations had implicitly made to poor nations. The rich nations had told the poor: Reorganize your economies, connect yourself to the world, and you will become more prosperous. This worked, with 1 billion people lifted out of dire poverty over the last half-century.
But the lockdowns violated that promise. The supply chain disruptions that predictably followed them meant millions of poor people in sub-Saharan Africa, Bangladesh, and elsewhere lost their jobs and could no longer feed their families.
In California, where I live, the government closed public schools and disrupted our children’s education for two straight academic years. The educational disruption was very unevenly distributed, with the poorest students and minority students suffering the greatest educational losses. By contrast, Sweden kept its schools open for students under 16 throughout the pandemic. The Swedes let their children live near-normal lives with no masks, no social distancing, and no forced isolation. As a result, Swedish kids suffered no educational loss.
The lockdowns, then, were a form of trickle-down epidemiology. The idea seemed to be that we should protect the well-to-do from the virus and that protection would somehow trickle down to protect the poor and the vulnerable. The strategy failed, as a large fraction of the deaths attributable to COVID-19 hit the vulnerable elderly.
The government wanted to suppress the fact that there were prominent scientists who opposed the lockdowns and had alternate ideas—like the Great Barrington Declaration—that might have worked better. They wanted to maintain an illusion of total consensus in favor of Fauci’s ideas, as if he were indeed the high pope of science. When he told an interviewer, “Everyone knows I represent science. If you criticize me, you are not simply criticizing a man, you are criticizing science itself,” he meant it unironically.
Federal officials immediately targeted the Great Barrington Declaration for suppression. Four days after the declaration’s publication, National Institutes of Health Director Francis Collins emailed Fauci to organize a “devastating takedown” of the document. Almost immediately, social media companies such as Google/YouTube, Reddit, and Facebook censored mentions of the declaration.
In 2021, Twitter blacklisted me for posting a link to the Great Barrington Declaration. YouTube censored a video of a public policy roundtable of me with Florida Gov. Ron DeSantis for the “crime” of telling him the scientific evidence for masking children is weak.
At the height of the pandemic, I found myself smeared for my supposed political views, and my views about COVID-19 policy and epidemiology were removed from the public square on all manner of social networks.
It is impossible for me not to speculate about what might have happened had our proposal been met with a more typical scientific spirit rather than censorship and vitriol.
For anyone with an open mind, the Great Barrington Declaration represented a return to the old pandemic management strategy that had served the world well for a century—identify and protect the vulnerable, develop treatments and countermeasures as rapidly as possible, and disrupt the lives of the rest of society as little as possible since such disruption is likely to cause more harm than good.
Without censorship, we might have won that debate, and if so, the world could have moved along a different and better path in the last three and a half years, with less death and less suffering.
Since I started with a story about how dissidents skirted the Soviet censorship regime, I will close with a story about Trofim Lysenko, the famous Russian biologist.
Josef Stalin’s favorite scientist was a biologist who did not believe in Mendelian genetics—one of the most important ideas in biology. He thought it was all hokum, inconsistent with communist ideology, which emphasized the importance of nurture over nature. Lysenko developed a theory that if you expose seeds to cold before you plant them, they will be more resistant to cold, and thereby, crop output could be increased dramatically.
I hope it is not a surprise to readers to learn that Lysenko was wrong about the science. Nevertheless, Lysenko convinced Stalin that his ideas were right, and Stalin rewarded him by making him the director of the USSR’s Institute for Genetics for more than 20 years. Stalin gave him the Order of Lenin eight times.
Lysenko used his power to destroy any biologist who disagreed with him. He smeared and demoted the reputations of rival scientists who thought Mendelian genetics was true. Stalin sent some of these disfavored scientists to Siberia, where they died. Lysenko censored the scientific discussion in the Soviet Union so no one dared question his theories.
The result was mass starvation. Soviet agriculture stalled, and millions died in famines caused by Lysenko’s ideas put into practice. Some sources say that Ukraine and China under Mao Zedong also followed Lysenko’s ideas, causing millions more to starve there.
Censorship is the death of science and inevitably leads to the death of people. America should be a bulwark against it, but it was not during the pandemic. Though the tide is turning with the Missouri v. Biden case, we must reform our scientific institutions so what happened during the pandemic never happens again.
https://www.dailysignal.com/2023/09/22/american-pandemic-samizdat/
********************************************************Also see my other blogs. Main ones below:
http://edwatch.blogspot.com (EDUCATION WATCH)
http://antigreen.blogspot.com (GREENIE WATCH)
http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)
http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com (TONGUE-TIED)
https://immigwatch.blogspot.com (IMMIGRATION WATCH)
https://awesternheart.blogspot.com (THE PSYCHOLOGIST)
http://jonjayray.com/blogall.html More blogs
***************************************************