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 May, 2023. To access the backups in earlier years, click here
31 May, 2023
Retracted COVID-19 Papers Cited an Average of 53 Times per Paper
An investigation into COVID-19 research found that among the more than 270,000 papers that have been published since the start of the pandemic, 212 retracted papers were cited 2,697 times, with a median of seven times and an average of 53 times per paper.
A retracted study linking the antimalarial drug Hydroxychloroquine to an increased risk of mortality and heart arrhythmia was the most cited paper with 1,360 citations at the time of data extraction.
Publishing processes were often compromised with COVID-19, according to the co-author of the investigation and director of Cochrane Australia Steve McDonald.
“We saw this push to get information out quickly, and with many more people doing and rapidly publishing COVID research, there’s been a spike in retractions,” senior research fellow McDonald said.
Eighteen percent of citations from retracted papers were critical and “may have directly impacted patient care,” the authors wrote in their paper (pdf).
Despite the retractions, the damage has been done as the research has already been cited by other researchers in the field, spawning more citations.
It had also been reported on in the media, changing the direction of policymaking, including social distancing measures, travel restrictions, and infection control measures which introduced a myriad of disruptions.
Retractions safeguard against error and misconduct, stopping research from impacting scientific ideas and clinical practice, and are crucial to preserving scientific integrity.
However, even high-profile medical journals became vulnerable to haste during the COVID-19 pandemic, the report found.
This comes after hundreds of COVID-19 papers have been removed due to compromising ethical standards, such as using fake or suspect patient data, and were either withdrawn by the prominent medical journals that published them or removed altogether.
Evidence of research papers changing the trajectory of governmental decision-making can be found in the case of monoclonal antibodies, which triggered controversy after several scientists said certain brands of the key COVID-19 treatment would not work for the Omicron variant.
A few months after preprints written by those scientists were published, the monoclonal antibody “sotrovimab” lost Emergency Use Authorisation, causing policymakers to move on to COVID-19 drugs like remdesivir.
The U.S. Food and Drug Administration (FDA) later expanded remdesivir’s authorisation to outpatient treatment and pediatric patients.
Eventually, pandemic response critics put monoclonal antibodies into the alternative treatment group, a place where critics say is automatically stifled or publicly scrutinised as unsafe or ineffective.
Another significant example of governments and the World Health Organisation acting on suspected fraudulent and unverifiable data is the hydroxychloroquine study.
Published in the Lancet on May 2020, the study concluded that the drugs hydroxychloroquine and chloroquine increased the chances of death from COVID-19 at a time when the drug was largely untested.
The authors of the study claimed to obtain medical records of nearly 100,000 patients from hundreds of hospitals on six continents, but more than 100 scientists analysed the findings and found major issues, including inadequate adjustment for variables, a lack of ethics review, and numbers that don’t appear to add up regarding patients in Australia and Africa.
The paper was retracted after two weeks, but it had already shaken the scientific world, prompting the World Health Organization and French authorities to suspend clinical trials testing hydroxychloroquine against COVID-19.
While some studies have shown patients experiencing heart problems when taking hydroxychloroquine or chloroquine, the drugs were approved decades ago and have been used historically by people against malaria and other ailments with little concern.
Why Did This Happen?
McDonald said that preprints—which allow authors to publish early versions of research papers before peer review or journal publications—resulted in dubious COVID-19 science, for academics were able to exploit loopholes in the process.
Further, retracted studies weren’t treated with due severity, McDonald said.
“In theory, when people cite retracted studies, they should be citing them in a critical way, alluding to the fact that these papers have been retracted because the research is unreliable,” he said.
“But what we found was that actually in a lot of these cases, even if the author team who cites the retracted paper were doing so long after the paper had been retracted, they weren’t citing it as a retraction.
“They were using it as evidence that ‘this particular intervention is effective’, or ‘there’s nothing wrong with that research’. So they were uncritically citing retracted papers.”
COVID-19 Research Volume Dwarf Other Pandemics
Different sources have stated that some 90,000 to 450,000 COVID-19 papers have been lodged online since the start of the pandemic, outstripping that of other pandemics “by orders of magnitude.”
One source said nearly 28,000 COVID-19 research papers were published in 2020, rising to nearly 68,000 in both 2021 and 2022, whereas another study quotes 404,541 papers from 2020 to 2022.
The Institute for Scientific Information examined the evolution of research across five pandemics—SARS, MERS, H1N1, Zika virus, and COVID-19.
They found that only H1N1 came close to COVID-19 in numbers, peaking at about 1,300 papers in 2011.
McDonald said the pandemic has exposed frailties in scientific publishing that should serve as a warning to the medical science community.
“Blindly citing papers—irrespective of where they’re published—without first assessing their reliability or retraction status can falsely elevate poor and possibly fraudulent research, potentially harming the very people the research should be helping,” he said.
https://www.theepochtimes.com/retracted-covid-19-papers-cited-7-times-per-paper_5296963.html
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The German-based Investigational Heart Drug That Just Might Effectively Treat Long COVID
In July 2021, the University Hospital Erlangen, situated just north of Nuremberg, Germany came through with a significant discovery involving an investigational heart drug called BC007. The intellectual property went to an academic medical center spin-off called Berlin Cures. The hospital-based team of clinicians-scientists found that BC007 helped a long COVID patient to become symptom free. What’s the status of this drug? Why have so few in North America heard of the drug?
Recently, a TrialSite community member requested a review of BC007, an asset in the Berlin Cures’ pipeline. The biotech declares via its website that it was the first to pursue scientific findings involving a number of diseases associated with pathological functional autoantibodies targeting G protein-couple’s receptors. The company reports that both heart failure and long COVID fall into this category of disease. According to the company, BC007 “can neutralize these autoantibodies, and this is why Berlin Cures has developed a product based on scientific knowledge that may help many suffering patients.”
What follows is a TrialSite breakdown and update on the product’s clinical development.
What is BC007?
BC007 is a DNA aptamer-based compound bound to and eliminated pathogenic autoantibodies directed against the beta-1 adrenoceptor, a receptor that regulates the heart’s rate and contraction strength. Heart cells are harmed by autoantibodies that chronically bind to this receptor in a process that has been found to lead to heart cell death and organ failure in 80 percent of dilated cardiomyopathy patients.
Berlin Cures' flagship product platform, BC007—a novel drug which the company claims shows “potential to revolutionize the treatment of a number of incurable diseases” associated with pathogenic functional autoantibodies (fAABs).
What’s the company’s operating vision?
The company declares that they seek to lead the market for the neutralization of pathogenic functional autoantibodies—their research to date points to the ability of BC007 to “significantly mitigate or even cure a set of diseases associated with autoantibodies, ranging from Long Covid Syndrome (LCS), Chronic Fatigue Syndrome (ME/CFS), heart failure, and several more.”
What’s the pressing need?
Long COVID may afflict up to 20% of persons infected with SARS-CoV-2—meaning potentially, hundreds of millions worldwide at one point or another during the pandemic may have experienced this condition.
Berlin Cures articulates that BC007 may be “the only drug worldwide that may cure long COVID Syndrome (LCS) at the moment.”
Did BC007 start out as an investigational therapy targeting heart disease?
Yes. The company gave a report via an oral presentation at the March 11 American College of Cardiology’s 2018 annual scientific session in Orlando, Florida. Representatives from the company stated that BC007 was the first drug designed to eliminate autoantibodies that are a major cause of heart failure and to treat heart failure symptoms was effective and well tolerated in a Phase 1 clinical study.
What were the study details?
In the Phase 1 study reported in 2018, the sponsor enrolled 68 subjects and determined that a single dose of intravenous infusion of BC007 was able to eliminate autoantibodies targeting the beta-1 adrenoceptor completely and sustainably. They further reported the investigational product was well tolerated, not provoking any clinically relevant side effects. See the company’s press release.
What about any long COVID evidence?
In July 2021, the period of when Delta was in circulation, media source Archyde, as well as Berlin Cures reported on use of the experimental drug with long COVID.
A group of doctors at the Eye Clinic at the Erlangen University Hospital succeeded for the first time as part of an individual healing attempt involving a 59-year-old man with long COVID Syndrome (long COVID)—he became symptom free thanks to the off label treatment with the experimental drug.
Dr. Christian Mardin, the senior physician running the eye clinic reported, “At the moment, unfortunately, we can no longer treat people with the drug because it has not yet passed all approval studies.”
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30 May, 2023
How the COVID-19 Pandemic Caused Massive Mental Illness on the Left
We’ve all noticed it; there has been a distinct rise in online vitriol and mental illness from the left over the last few years, not just online but also making headlines for outrageous behavior in public and in their daily lives. Studies have shown that the COVID-19 lockdowns caused a sharp increase in mental health problems, and since the left locked down the hardest, it makes sense it affected them the worst.
Even for those on the left who didn’t live in heavily locked down areas, their paranoia made them take their own steps to isolate themselves from society. We all know the families who disappeared; they stopped going to church, the gym, and other social activities, refused to let their children participate in sports or hang out with other children due to the brainwashing, which caused a disturbingly sad increase in mental illness among children.
A 2022 study from the National Institutes for Health (NIH) examined the partisan difference in mental health problems caused by the pandemic, and found “a clear partisan distress gap, with Democrats consistently reporting worse mental health than Republicans.” The study observed “Democrats experiencing more disruption of routine and social isolation to reduce the risk of physical illness and Republicans risking physical health to maintain normalcy and sustain social connections.”
The World Health Organization reported that the pandemic triggered a 25% increase in depression and anxiety worldwide. The NIH published a study which found that suicide rates increased by as much as 145%.
Due to excessive paranoia about COVID-19, the left was more likely to find ways to work in social isolation — if they worked at all; many took advantage of the left’s generous expansion of unemployment benefits during the pandemic. A significant negative about working from home is higher stress, since “being ‘always on’ and accessible by technology while working remotely leads to the blurring of work and non-work boundaries,” the World Economic Forum (WEF) reported. The WEF cited a study from the United Nations which found that 41% of remote workers reported high stress levels, compared to just 25% of office workers.
No doubt some of those on the left who have been the hardest hit are paid trolls working from home, who encounter little real social interaction, so most of their days consist of posting vile things on social media towards the right. This is horrible for their mental health, since an NIH study found that “workplace incivility” is correlated “with a host of negative outcomes, including increased burnout, turnover intentions, and physical symptoms.”
Ever since Elon Musk bought Twitter last year, halting the banning of conservatives merely for engaging in healthy debate, the left has gone all out against them with hate. Instead of following through and leaving the platform as the left initially threatened, the paid left-wing trolls have stuck around and multiplied, spewing out hate at an alarming level.
An NIH study of mask wearing among older people found that 25% of them “experienced depressive symptoms.” A study in Hong Kong from Frontiers of Psychiatry which found that psychiatric morbidities including depression increased due to the pandemic, revealed that those who were more educated about COVID-19 were less likely to suffer depression due to masks.
The study said, “[P]articipants who had better knowledge of the disease pandemic and higher perceived self-efficacy to wear masks properly were less likely to report depressive symptoms.”
It found that those who “perceived high severity of the disease outbreak were most likely to report probable depression.” In other words, the fear that leftist government officials and their comrades in the mainstream media put into people about COVID-19, instead of educating them, contributed to mental illness.
Hostility on social media continues to increase, with Pew finding that about 40% of Americans have experienced online harassment, and half of those state it was over politics. Democrats are more likely to get stressed out over talking politics with those on the other side than Republicans. A study in 2021 found that Democrats are now twice as likely as Republicans to end a friendship over politics.
Violent threats from the left regarding politics are becoming more commonplace. This month, after receiving a backlash for putting on a prominent display of radical LGBTQ and Satanist merchandise, Target minimized the display. In response, an LGBTQ supporter sent the corporation an email stating that bombs had been placed in five Target stores.
Unfortunately, it’s difficult to track this rise in hate on the left because most of the research out there is from the left and focuses on making the left victims instead of accurately reporting the data. There are myriads of victim groups on the left like the Anti-Defamation League and Human Rights Watch which appear to exist solely to create the illusion that the right is responsible for all the threats and violence.
We know the hate isn’t increasing on the right, for the simple fact that because other than on Twitter, the right is massively censored by big tech. Those engaging in hate on Facebook, YouTube, Instagram, Google, etc. have either been banned, suspended or threatened with bans so much they no longer post as much offensive content. In contrast, the left has free reign on those platforms to bash the right.
The mainstream media won’t cover the increase in hate coming from the left. They publish long, sympathetic articles about left-leaning political figures who have been harassed by the right — some which aren’t even true — while ignoring those of us on the right who are seeing a steady increase in the most vile attacks including death threats.
And perhaps even more alarming, the left already had worse levels of mental illness than the right. The NIH study which found more mental illness among Democrats than Republicans also stated, “This gap did not simply emerge as a result of the pandemic, but rather reflects a pre-existing partisan distress gap.”
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Early Use of Molnupiravir antiviral Associated with Reduced Hospitalization and Death Among US Veterans
When both Paxlovid and Molnupiravir were rolled out as EUA oral drugs to treat COVID-19, I accepted them clinically and placed them as antiviral options in the McCullough Protocol.
One of the reasons for my early adoption was that I knew any novel drug advanced by Operation Warp Speed and endorsed by the CDC, FDA and NIH would engage doctors who wanted to treat patients but were fearful of prescribing hydroxychloroquine or ivermectin outside of a clinical trial.
In the McCullough Protocol, no drug is necessary or sufficient, thus any oral antiviral in combination with other medications would comprise a lifesaving “early treatment regimen” as compared to patients who received no medications at all.
Xie et al. reported from the Veterans Administration automated database and found that among US veterans of whom were 92% men aged 70 years, 46% former smokers, 63% vaxxed and boosted, that early use of the SARS-CoV-2 polymerase inhibitor, molnupiravir, especially if started on Day 1, was associated with reduced risk of post-acute sequalae, hospitalization and death after acute COVID-19.
Of note, slightly more patients who received molnupiravir had natural immunity (18%) and more received concurrent corticosteroids (14%). The authors did not account for other ambulatory drugs in the McCullough Protocol, but I anticipate that molnupiravir was associated with more extensive use of multidrug therapy shown to reduce hospitalization and death.
In summary, we use non-randomized analyses such as this not to make therapeutic claims on a specific drug, but to analyze overall patterns of care and in this case, be reassured that early molnupiravir as part of a multidrug regimen was associated with achieving the over-arching goal of reducing hospitalization and death. The only shortcoming is that not all high-risk patients were given a chance with home therapy to survive free of these two outcomes.
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Ron DeSantis Running for President on his Covid Record
Given the current political climate and the fact the Covid pandemic has turned into a dividing line between Republicans and Democrats, DeSantis seems to be seeking a way to bolster his conservative credentials, with an anti-vaxx slant. The Florida governor is also looking for a way to distinguish himself from both Donald Trump and Joe Biden. DeSantis’ Covid policies appear to be the way for him to separate from the pack. Afterall his state was the state of freedom during the pandemic, right?
DeSantis critical of both Trump and Biden
This past weekend DeSantis criticized Donald Trump for his Operation Warp Speed imperative during the onset of the Covid pandemic, also going after Joe Biden for his support of vaccine mandates. The Florida Governor declared “The way they weaponized these Covid vaxes was a massive incursion into our freedoms,” the governor said. “They wanted to deny people the right to put food on their table if they didn’t bend the knee and get a Covid shot that they may not have wanted and that many of them did not need.” In reference to Trump, DeSantis added, “We can never allow ‘Warp Speed’ to trump informed consent in this country ever again.” This was regarding Trump’s push to develop the Covid vaccine in conjunction with Big Pharma.
DeSantis: anti-mask, anti-vax, anti-lockdown
DeSantis is “escalating” his campaign, in conjunction with his presidential bid, to discredit the Covid-19 vaccines and the companies that produced them. Indirectly this means he must attack Trump, given the vaccines were his program.
This will draw a sharp distinction between the governor and Biden who worked hand in hand with Big Pharma on pushing the Covid vaccines. Under the DeSantis administration Florida came out against mandatory vaccination, mask wearing and lockdowns. And his surgeon general also came out against vaccination. DeSantis touted Florida as an “oasis of freedom.” He even hosted a 90-minute discussion on the safety and efficacy of the Covid vaccines.
Covid policies could be centerpiece of campaign
DeSantis could make his Covid policies the immediate focus of his campaign as a way of distancing himself from Donald Trump. Even though, reportedly, the governor did receive a Johnson and Johnson jab.
This was at the beginning of the pandemic but DeSantis has evaded questions as to whether or not he received a booster. He has a point: it’s his own personal business.
Even though DeSantis wanted Trump’s approval in the past and the governor likely can’t win the White House without Trump’s base, DeSantis may use his Covid policies to bolster his conservative, differentiating views. “They didn’t want to have any criticism of their lockdown policies,” DeSantis said. “If you can’t defend the policy, then maybe you should be looking in the mirror. But that’s not what these elites wanted to do.”
DeSantis distrust of the vaccines spread in Florida and only 11.8% of Florida children five and older are fully vaccinated and boosted with the Covid-19 jab. The nationwide average is 17.4% according to the Centers for Disease Control (CDC). And Publix, the Florida drug store chain, decided not to offer the Covid shot to children under five years old. Even though Covid may be fading as a health issue, Ron DeSantis appears to be using it as a political issue.
https://www.trialsitenews.com/a/ron-desantis-running-for-president-on-his-covid-record-ec9928b2
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29 May, 2023
Long Covid causes erectile dysfunction and hair loss
Hair loss and erectile dysfunction have joined the list of long Covid symptoms, according to new research.
The study found that while the most common symptoms include loss of smell, shortness of breath and chest pain, others include amnesia, erectile dysfunction, hallucinations, an inability to perform familiar movements or commands, bowel incontinence and limb swelling.
Patterns of symptoms tended to be grouped into respiratory symptoms, mental health and cognitive problems, and then a broader range of symptoms.
As well as spotting a wider set of symptoms, researchers also identified key groups and behaviour that put people at increased risk of developing long Covid.
As reported last month, a record 2 million people in the UK are estimated to be suffering from long Covid, according to the Office for National Statistics (ONS).
Around 3.1 per cent of the British population are suffering symptoms that persist for more than four weeks after catching Covid. Some 376,000 people who first caught Covid around the start of the pandemic have reported symptoms lasting at least two years.
The study suggests that females, younger people, and those belonging to a Black, mixed-race or other ethnic group are at greater risk of developing long Covid.
Additionally, those from a poorer background, smokers, and people who are overweight or obese, as well as those with any of a wide range of health conditions, were more likely to report persistent symptoms.
Senior author Dr Shamil Haroon is an associate clinical professor in public health at the University of Birmingham.
He said: “This research validates what patients have been telling clinicians and policymakers throughout the pandemic – that the symptoms of long Covid are extremely broad and cannot be fully accounted for by other factors, such as lifestyle risk factors or chronic health conditions.
“The symptoms we identified should help clinicians and clinical guideline developers to improve the assessment of patients with long-term effects from Covid-19, and to subsequently consider how this symptom burden can be best managed.”
People who tested positive for the virus reported 62 symptoms much more frequently 12 weeks after initial infection than those who had not contracted the virus, the study found.
The NHS list of common Covid symptoms includes fatigue, shortness of breath, chest pain or tightness, and “brain fog”.
Researchers from the University of Birmingham analysed the anonymised electronic health records of 2.4 million people in the UK alongside a team of clinicians and researchers across England.
The data obtained between January 2020 and April 2021 comprised the records of 486,149 people with prior infection, and 1.9 million people with no indication of coronavirus infection after matching for other clinical diagnoses.
Using data from patients who had not been admitted to hospital, the team of researchers was able to identify the three distinct categories of symptoms.
Anuradhaa Subramanian, research fellow at the Institute of Applied Health Research at the University of Birmingham and lead author on the paper, said: “Our data analyses of risk factors are of particular interest because it helps us to consider what could potentially be causing or contributing to long Covid.”
She added: “Women are, for example, more likely to experience autoimmune diseases. Seeing the increased likelihood of women having long Covid in our study increases our interest in investigating whether autoimmunity or other causes may explain the increased risk in women.
“These observations will help to further narrow the focus on factors to investigate what may be causing these persistent symptoms after an infection, and how we can help patients who are experiencing them.”
The findings are published in Nature Medicine.
https://www.independent.co.uk/news/health/long-covid-symptoms-treatment-hair-b2160752.html
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New York, in Sudden Reversal, to Drop COVID-19 Vaccine Mandate for Health Care Workers
New York officials are rescinding a COVID-19 vaccine mandate for health care workers that led to thousands being fired.
Lawyers for the state announced the sudden move during a hearing on May 24 in a case brought by doctors who faced termination for not getting vaccinated.
“Due to the changing landscape of the COVID-19 pandemic and evolving vaccine recommendations, the New York State Department of Health has begun the process of repealing the COVID-19 vaccine requirement for workers at regulated health care facilities,” the state health department stated.
“This is a big win,” Sujata Gibson, a lawyer representing the plaintiffs in the case, told The Epoch Times in an email. “I cannot underscore enough how significant this is, not only for the 34,000 doctors, nurses, and other health care workers who have been unable to work in this state since 2021, but also for the millions of New Yorkers who have been impacted by the dangerous and crippling staffing crisis that resulted from their forced exodus from the field.”
Some 34,000 workers lost or left their jobs over the mandate, which was imposed in 2021. That reduced the health care workforce in the state by 3.5 percent.
Nurses and others had warned that the mandate would contribute to staffing shortages that were already plaguing some facilities.
No new punitive actions will be undertaken as the mandate’s repeal is being considered by the Public Health and Health Planning Council, the department stated in a letter to providers. But sanctions over previously cited violations may still be sought.
Plaintiffs in the state case said officials violated the New York Constitution when they made the mandate permanent in 2022, bypassing the Legislature. Mary Bassett, the health commissioner at the time, also ignored data that showed that vaccinated people could be infected with and transmit COVID-19, the petition stated.
State officials during the pandemic claimed that the mandate would help to fight the spread of COVID-19 and protect staff members and patients. They also said they followed the law in promulgating the mandate.
New York Supreme Court Judge Gerard Neri sided with the plaintiffs in January, ruling that the government was “clearly prohibited from mandating any vaccination outside of those specifically authorized by the legislature” and that the Department of Health “blatantly violated the boundaries of its authority” in issuing the mandate despite the fact that the vaccines do not prevent transmission.
The ruling barred enforcement of the mandate but was stayed after New York Gov. Kathy Hochul’s administration filed an appeal.
Hearing
Plaintiffs had expected state lawyers to argue in court for the January ruling to be overturned. They were surprised when lawyers first announced that the mandate would be dropped.
“The State Health Department has just informed me that they intend to repeal the regulation that is being challenged here,” Jonathan Hitsous, one of the lawyers, told the court.
“Because there’s no longer a regulation to enforce, we argue that this case has now gone moot,” he added.
Hitsous then urged the court to still overturn Neri’s ruling, claiming that if left in place, it would cast doubt on the regulation and other immunization requirements.
Gibson objected.
“It’s taken years of litigation to get here, and if they can keep doing this every time there’s a new flu vaccine mandate they want to pass or if they want to put in another COVID vaccine mandate, or if they want to do the next pandemic, the next vaccine, this will happen again, and these people … their lives have been ruined,” she said. “They have lost everything, and we just want to prevent that from happening again.”
The court adjourned without issuing a ruling.
“Our fight is not over. In a blatant show of gamesmanship, the state had the gall to ask the Court not only to drop the appeal, but to also vacate … the decision below, without reviewing it on the merits,” Gibson told The Epoch Times.
“Courts cannot allow defendants to get out of legal consequences of a final ruling by simply stopping the unlawful conduct mid-appeal. New Yorkers must be able to use the lower court’s ruling as precedent so that this never happens again.”
The New York State Department of Health and Hochul’s office didn’t respond by press time to requests by The Epoch Times for comment.
Under state rules, the Public Health and Health Planning Council must vote to repeal certain regulations. The body is composed of Dr. James McDonald, the acting commissioner of health, and a number of other doctors and health officials. It isn’t clear yet when the council will take up the matter.
Individual providers, meanwhile, should “individually consider how to implement their own internal policies regarding COVID-19 vaccination while remaining in compliance with applicable state and federal laws,” Dr. Eugene Heslin, a state health official, said in the letter to providers.
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28 May, 2023
Over 300 COVID-19 Papers Withdrawn for Not Meeting Standards of Scientific Soundness
Including the "Lancet" study that condemned hydroxychloroquine
Research journals have withdrawn well over 300 articles on COVID-19 due to compromised ethical standards and concerns about the publications’ scientific validity.
Retraction Watch has provided a running list of withdrawn papers on COVID-19 ranging from “Acute kidney injury associated with COVID-19” to “Can Your AI Differentiate Cats from COVID-19?”
A total of 330 research papers have currently been retracted.
During the pandemic, researchers have compromised on ethical standards and tried to either get more publications approved or to take shortcuts around ethics, senior researcher Gunnveig Grødeland at the Institute of Immunology at the University of Oslo says, after going through the list of articles that have been withdrawn, and the reasons for some of them.
While it is quite natural for some articles to be updated or changed to be published in a different form, some have been retracted because the researchers did not obtain informed consent during the research.
“It will, of course, be withdrawn when it is found that ethical guidelines have been breached,” Grødeland told Khrono, a Norwegian higher education and research newspaper.
She pointed out that other articles have been withdrawn after the editors noticed that the strategies the papers mentioned were giving the wrong impression in the media of being recommended as actual treatment or prevention of COVID-19.
She said these sorts of articles had to be withdrawn as they claimed things that neither the authors of the articles nor their institutions could vouch for.
In addition, some studies did not include a large enough sample size. When more subjects were included, the researchers could no longer maintain the same conclusions they made earlier about the effect of the drugs.
Grødeland said that part of the reason this happened during the pandemic was that relatively more people suddenly started conducting research on a topic they really knew relatively little about.
Even prestigious journals such as the Lancet were publishing those articles. One of Lancet’s studies even caused both the World Health Organization (WHO) and the national government to stop the comprehensive testing of hydroxychloroquine’s effectiveness against COVID-19.
The extensive Lancet study, allegedly based on research fraud, said that the drug increased the risk of heart arrhythmia and mortality for COVID-19 patients.
However, most of the retracted papers were published in smaller journals, the vaccine researcher points out.
“When you look at the articles that have been retracted, the vast majority were published in the less interesting journals. It is they who are mainly affected by withdrawals,” Grødeland said.
But there were a number of environments that do not normally carry out research, which suddenly started producing research after receiving funding from local hospitals. “It may have caused things to get a little out of hand in some places,” she said.
Hearing Loss?
A recent case from the University of Manchester backtracked on an earlier study that said that COVID-19 was associated with hearing loss, tinnitus (ringing in the ears), and vertigo.
Published in 2021, the researchers said they had identified about 60 studies that report audio-vestibular problems in people with confirmed COVID-19.
“Our analysis of the pooled data, published in the International Journal of Audiology, reveals that seven to 15 percent of adults diagnosed with COVID-19 report audio-vestibular symptoms,” audiology professor at the University of Manchester Kevin Munro said.
“The most common symptom is tinnitus followed by hearing difficulties and vertigo.”
Two years later, after the virus has been blamed for a range of health problems, including auditory disorders, the same university published a new study concluding that hearing loss is unlikely to be caused by COVID-19.
Lead author and audiologist Anisa Visram explained their reasoning. “We know that viruses such as measles, mumps, and meningitis can damage the auditory system,” Visram said in a release.
“It is also well known that COVID-19 can affect our sense of smell and taste, so it was reasonable to assume it might also affect our sense of hearing.”
Visram assured that their current study is well designed and executed and is the most thorough assessment of hearing conducted in people with COVID-19.
Munro also acknowledged that their earlier work may have been rushed. “There was an urgent need for this carefully conducted clinical and diagnostic study to investigate the long-term effects of COVID-19 on the auditory system,” he said.
“Many previous studies were published rapidly during the pandemic but lacked good scientific rigour.”
“It hasn’t been clear if these are incidental findings or if COVID-19 is damaging the hearing system,” Professor Richard Ramsden, Trustee at the Dowager Countess Eleanor Peel Trust, added.
“While the study cannot rule out infrequent hearing loss as a result of COVID-19, we now know that for most people, there is nothing to be concerned about.”
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FDA Detects Serious Safety Signal for COVID-19 Vaccination Among Children
Children of certain ages who received Pfizer’s COVID-19 vaccine face an elevated risk of heart inflammation, according to a new federally funded study.
Vaccinated children aged 12 to 17 face a heightened risk of myocarditis, a form of heart inflammation, and a related condition called pericarditis, U.S. Food and Drug Administration (FDA) researchers found.
The number of myocarditis and pericarditis events in that age group met the threshold for a safety signal, the researchers reported in the Journal of the American Medical Association on May 22.
The elevated risk was present within seven days of vaccination, according to the data.
Researchers identified 89 cases among 12- to 15-year-olds and 64 cases among 16- and 17-year-olds after reviewing records from commercial databases run by CVS Health, HealthCore, and Optum.
The claims were made between Dec. 11, 2020, when Pfizer’s vaccine was cleared by the FDA, and mid-2022.
Researchers looked at data to determine whether any of the 20 health problems were experienced at higher rates by the vaccinated. The problems included myocarditis or pericarditis, Bell’s palsy, appendicitis, and stroke.
Only myocarditis or pericarditis met the criteria for a safety signal, which may be related to vaccination.
U.S. officials have already concluded that the conditions are caused by the Pfizer and Moderna COVID-19 vaccines, although the vaccines didn’t carry a warning for months after authorization. One possible mechanism is excessive immune responses triggered by lipid nanoparticles. Novavax’s vaccine, authorized in 2022, can also cause the heart conditions, authorities say.
More on Study
Researchers looked at health plan members who received a Pfizer vaccination, excluding those who lost their insurance during a certain window of time, which was 365 days for most outcomes.
Researchers then examined the number of each outcome in a different window of time, referred to as a risk window, which varied from a single day to as long as 42 days after vaccination.
The study then took the rates of problems from each database and compared them with expected rates, which are based on pre-pandemic numbers.
Out of 3 million children who received at least one vaccine dose, 153 cases of myocarditis or pericarditis were identified in the 12- to 17-year-old age group. More cases were identified among children aged 5 to 11, but not enough to trigger a signal.
A medical record review of the 37 cases for which records were obtainable confirmed 27 cases as true myocarditis or pericarditis.
None of the other 19 outcomes examined met the signal criteria, according to researchers.
“These results provide additional evidence for the safety of the COVID-19 vaccines in the pediatric population,” the researchers said.
Dr. Peter McCullough, a cardiologist, disagreed.
“My concern is that these data represent a gross under-reporting of the frequency and severity of COVID-19 vaccine-induced myocarditis,” McCullough, who has called for the withdrawal of the Pfizer vaccine, told The Epoch Times via email.
Since the FDA and the U.S. Centers for Disease Control and Prevention acknowledged in mid-2021 concerns that the vaccines might cause heart inflammation, “there have been [more than] 200 papers in the peer-reviewed literature and over 100 fatal documented cases largely among young men, peak ages 18–24 years, some with autopsy proven COVID-19 vaccine heart inflammation resulting in death,” according to McCullough.
That includes five people who suddenly died in Germany and six people who perished in the Nordic countries.
A request for comment sent to Steven Anderson, the FDA official listed as the study’s corresponding author, sparked a response by an FDA spokesperson, who declined to provide additional citations for the safety claim.
Anderson’s co-authors included researchers with Acumen, Optum, HealthCore, CVS, and IQVIA, with multiple members reporting connections with Pfizer. The time period included when the old Pfizer vaccine, which is no longer available in the United States, was used.
‘Pretty Ludicrous’
Norman Fenton, emeritus professor of risk at the Queen Mary University of London, said the researchers’ safety claim doesn’t hold up in light of the facts that the study shows a signal for myocarditis and pericarditis and that children are unlikely to benefit from the COVID-19 vaccines.
“The conclusion that ‘these results provide additional evidence that COVID-19 vaccines are safe in children’ is pretty ludicrous,” Fenton told The Epoch Times in an email.
The researchers also failed to take into account what’s known as the healthy vaccine bias; previous research has found that people who decide to get vaccinated tend to be healthier than those who don’t.
“They are comparing a highly select group of child and adolescent insured vaccine recipients to a historical baseline population consisting of everyone in the relevant age group who were insured,” Hebrew University lecturer Josh Guetzkow said.
Experts also said the risk windows appeared short, as post-vaccination conditions can sometimes crop up months afterward, and noted that the signal criteria were structured so that some outcomes would need to happen at more than double the rate among the vaccinated to meet them.
The shortest risk window was just one day, for anaphylaxis, or severe allergic shock. Some others were just one week. The rest were 28 days or 42 days.
In their protocol (pdf) for conducting the research, FDA officials said they chose risk windows based on pre-pandemic studies, including one from 2007.
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25 May, 2023
Breakthrough: Hong Kong Study Demonstrates SIM01 Treats Long COVID Symptoms
The Chinese University of Hong Kong (CUHK) reports that 70% of patients in the Hong Kong Special Administrative Region of the People’s Republic of China who have recovered from COVID-19 continue to suffer from at least one long COVID symptom by month six after onset of SARS-CoV-2 infection. With no proven therapeutic regimen to address long COVID, CUHK is quickly becoming a microbiome (gut health) research hub. They conducted a triple-blind, randomized, placebo-controlled clinical trial revealing that modulation of the gut microbiome using oral microencapsulated live bacteria (SIM01) developed at CUHK led to marked improvement in long COVID symptoms.
Notable news, this was not broadcast widely in the West. The findings were presented recently at the late breaking abstract plenary session at Digestive Disease Week 2023 in Chicago. Once these results are scrutinized by the broader scientific community along with advancement of human research could lead to a compelling therapeutic answer to long COVID.
Gut microbiome research watchers: CUHK increasingly becomes a leading hub for this pioneering research, discovering an intricate, intertwined connection between internal bacteria and the condition afflicting possibly hundreds of millions of people worldwide. With an urgent need to identify effective therapeutic interventions for long COVID symptoms, particularly when debilitating, breakthroughs in Hong Kong may point to therapeutic pathways. Biotech’s in the USA, Europe and elsewhere should look into SIM01.
Who is behind this latest CUHK research?
Professor Martin Wong, Professor from the Jockey Club School of Public Health and Primary Care as well as Francis KL Chan, Dean and Director of the Centre for Gut Microbiota Research, CU Medicine and Professor Siew Ng, CU Medicine’s Croucher Professor in Medical Sciences and Director of Microbiota I-Center (MagIC).
What does the research show so far?
In the CUHK announcement, the Hong Kong-based academic research center’s Professor Martin Wong Chi-sang first defined long COVID and explained that the contagion affects various organs in the body, with potentially debilitating impacts.
Previous studies by CU Medicine, again, arguably the leading academic research center in the world when it comes to the intersection of the gut microbiome and long COVID, demonstrate that patients with long COVID symptoms were linked to altered gut microbial signatures.
Last year, the Hong Kong team reported results from an open?label, proof?of?concept study published in the Journal of Gastroenterology and Hepatology showing that the use of SIM01 hastened antibody formation against SARS?CoV?2, reduced nasopharyngeal viral load, reduced pro?inflammatory immune markers and restored gut dysbiosis in hospitalized COVID?19 patients. TrialSite has actively chronicled the CHUK team. This finding suggests that modulation of the gut microbiota represents a potentially useful intervention.
Now, with a bigger triple-blind, randomized, placebo-controlled trial (the RECOVERY study) points to the efficacy of SIM01--improving long COVID symptoms across multiple systems and organs.
What is SIM01?
CU Medicine researchers invented SIM01using big data and machine-learning technologies as part of the discovery process. Developed based on a microbiome formula, the team developed the experimental regimen containing Bifidobacteria strains, galactooligosaccharides, xylooligosaccharide and resistant dextrin into an oral formula using microencapsulation, an advanced food processing technology using which any compound can be encapsulated into a specified material, making a tiny sphere of diameter ranging from 1 ?m to several ?m.
The study results
From 2021 to 2022, a total of 463 recovered patients with at least one long COVID symptom joined the RECOVERY study. Their mean age was 49 years old, and 65.4% were female. Nearly 70% of participants were suspected to have been infected with the Omicron variant. All subjects were randomly assigned to receive SIM01 or a placebo containing low dose Vitamin C for six months.
CUHK investigators report on compelling results, finding that significantly more patients who received SIM01 than those who had placebo evidenced improvement in digestive problems, fatigue, difficulty in concentrating, memory loss and general unwellness at six months follow-up.
Additional metagenomic analysis of study participant stool samples revealed that SIM01 resulted in increased bacteria diversity, increased abundance of “favorable” bacteria and reduced abundance of “unfavorable” bacteria in the gut, highlighting the effectiveness of SIM01 in restoring gut dysbiosis.
Professor Siew Ng, CU Medicine’s Croucher Professor of Medical Sciences and Director of Microbiota I-Center (MagIC), commented, “To our knowledge, this is the first clinical trial to show that modulation of the gut microbiome can improve long COVID symptoms including memory and concentration problems. These data support the importance of the gut-brain axis. Restoring a healthy gut microbiota is a novel approach to improve neurological symptoms via the production of beneficial metabolites from gut bacteria that circulate to the brain to improve brain function.
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Cardiovascular Disease Death Soars Worldwide-- particularly in poor countries
A new study released by the World Heart Federation reveals a truly global cardiovascular disease crisis unfolding over the last few decades, particularly intensifying in low-and middle-income countries (LMICs). The World Heart Report launched at the 2023 World Heart Summit, offers a detailed breakdown of cardiovascular disease risk and mortality data across the globe, combined with the group’s reviews of country-to-country health policy initiatives to mitigate this scourge. Deaths linked to cardiovascular disease increased from 12.1 million in 1990, to 20.5 million in 2021, making this therapeutic contagion the biggest killer worldwide. While it’s assumed by many that the rich, developed world represents the highest burden of cardiovascular deaths, the opposite is true: four in five cardiovascular disease death occur in LMICs.
The report was made possible by the Novartis Foundation, the philanthropic arm of the multinational Switzerland-based pharmaceutical company Novartis.
A non-governmental organization (NGO), the World Heart Federation sponsored the report. The World Heart Federation was formed in 1978 by the coming together of the International Society of Cardiology and the International Cardiology Federation first under the name “the International Society and Federation of Cardiology.” By 1998, they changed their name to the current one. Representing over 200 organizations across 100 countries, the World Heart Federation champions global cardiovascular health pursuing the organization's mission to provide information about heart-related research, care and treatments. The organization declares on its website that it’s the only cardiovascular-focused organization “in official relations with the World Health Organization.”
The study authors report the highest concentration of cardiovascular disease deaths occurred in the Central Europe, Eastern Europe and Central Asia region. Importantly, over the past three decades, total cardiovascular disease deaths increased mostly due to ageing and a growing population. But actual cardiovascular disease death rates declined from 345.5 deaths per 100,000 people in 1990 to 239.9 deaths per 100,000 people in 2019. The declining rates are enjoyed more by rich developed countries than LMICs.
The study’s authors are listed below. One co-author, Professor Fausto Pinto, a former World Heart Federation President went on the record:
“The data doesn’t lie. This report confirms the serious threat that cardiovascular disease poses all over the world, particularly in low-and middle-income countries. Up to 80 percent of premature heart attacks and strokes can be prevented. It’s vital that countries prioritize rolling out tools and policies to protect people from CVD.”
A confluence of factors contributes to the growing deaths including high blood pressure, air pollution, tobacco use and elevated LDL cholesterol. Overall, a key finding is that risk factors vary across regions, making it vital that countries be aware of their risk profile. It also found that countries that invest more in healthcare as a percentage of gross domestic product (GDP) have lower CVD death rates, while CVD death rates are higher in countries where people pay more out-of-pocket for healthcare.
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24 May, 2023
Myocarditis with Ventricular Tachycardia Following Bivalent COVID-19 mRNA Vaccination
In the elderly with baseline heart disease, any degree of cardiovascular injury could be disastrous as published by Yamamoto et al., a case report involving the death of an 81-year-old man after his fifth mRNA shot.
The authors report this man decompensated within a day of his fifth shot and required defibrillation, mechanical ventilation and full life support measures for myocarditis which precipitated the cardiac arrest, conduction defects and heart failure. He stayed in the hospital for over a month.
Yamamoto et al., Myocarditis with ventricular tachycardia following bivalent COVID-19 mRNA vaccination, 2023.
The authors summarize the recent growing literature on COVID-19 vaccine induced myocarditis: “This report indicates the need to suspect myocarditis based on clinical presentation and the importance of multimodality diagnosis using electrocardiography, echocardiography, laboratory testing, myocardial scintigraphy, and CMR. In our case, CMR showed LGE in the inferolateral segments of the epicardial to mid layers, which has been reported to be a characteristic finding in patient with mRNA vaccine-associated myocarditis. Endocardial biopsy is the gold standard for detecting myocarditis but is invasive and thought to have less sensitivity in disorders resulting from epicardial and patchy diseases such as myocarditis.
On the other hand, CMR is considered to be the cornerstone for diagnosis of vaccine-associated myocarditis due to its high diagnostic performance, with a reported sensitivity of 88% and specificity of 96% in community-acquired myocarditis. The COVID-19 vaccine is thought to cause myocarditis via direct damage by free spike protein and induction of inflammatory cytokines (e.g., IL-1? and IL-6) by the lipid nanoparticles covering the mRNA. Expression of free spike protein may increase after the initial bivalent vaccination because antibodies against the spike protein of the BA.4-5 variant are yet to be generated.
In autopsy cases, histology has shown patchy interstitial myocardial T-lymphocytic infiltration (T-cell dominant; CD4>>CD8) associated with damage to myocytes.6 Molecular mimicry between myocyte tissue and the SARS-COV2 spike protein may also produce an anti-myocytic immune response.6 Therefore, T lymphocyte-mediated cell injury and heart-specific autoimmunity have been suggested as mechanisms of post-vaccine myocarditis.”6
I wonder how many elderly patients have died within a few days of the COVID-19 vaccine, unrecognized and not reported by families, doctors or others. Only all-cause mortality data published in the coming months to years will give us a clue. In the meantime, all seniors should understand that even if prior shots were tolerated, the next one could be fatal.
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Conspiracy-Driven Osteopath Dies at 57--Didn’t Believe in COVID-19 Narrative but Lacked Proof for His Claims
What happened to Dr. Rashid Buttar? Known for outlandish claims about the COVID-19 pandemic, at least, according to the mainstream media—he was even part of a group tagged the “Disinformation dozen”—he died suddenly May 18, at the age of 57. He was able to get on CNN where he was alleged to have made exaggerated claims and later told people he had been poisoned. Was there a connection?
British-born but raised in the U.S. Midwest, Buttar was a licensed osteopath doctor based in Charlotte, North Carolina. He had a long history of run-ins with the medical establishment and was labeled a quack and an “anti-vaxxer” by the mainstream media and medical establishment. See evidence of a 2008 encounter via Quack Watch.
Buttar, undoubtedly troubled by growing confluence of industry and medicine, increasingly embraced alternative medicines and approaches, contrary to mainstream acceptance. For example his views, deemed controversial, for the use of chelation therapy for a number of conditions, this type of claim is frowned upon as there is no Food and Drug Administration (FDA) authorized procedure associated with such claims. The FDA issued a warning on chelation claims back in 2016.
He was reprimanded on two occasions by the North Carolina Board of Medical Examiners for unprofessional conduct plus once cited by the FDA for illegal marketing of unapproved and adulterated drugs.
His videos were available via the Next News Network.
Buttar was branded a conspiracy theory for making claims that among other things, Dr. Anthony Fauci, the former head of the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), was at least, partially behind the creation of the SARS-CoV-2 pathogen.
Yet TrialSite has chronicled how the mainstream media and medical establishment ridiculed discussion of a lab leak theory after Dr. Anthony Fauci seemingly suppressed any critical vetting of the lab leak hypothesis early on in the pandemic. Such government-related suppression will make folks paranoid, as they will wonder “What is he trying to cover up?” Transparency and accessibility to data and government activity is important for a free and open democratic market economy and society.
And to this day the origins of SARS-CoV-2 hasn’t been proven yet, but a growing momentum suspects a lab leak origin, including contingents in the U.S. government and in intelligence agencies.
There is considerable evidence that Fauci’s NIAID had outsourced coronavirus research to Wuhan Institute of Virology via the EcoHealth Alliance nonprofit group.
While there could be something to the claim that NIAID and EcoHealth were outsourcing coronavirus research to Wuhan (maybe even gain-of-function activity) Buttar pushed the envelope with ever more outlandish declarations such as that “everyone who has had the vaccine would be dead by 2025.”
While there is a cult-like group continuously declaring that the COVID-19 mRNA vaccines are bioweapons meant to kill people, TrialSite has extensively reviewed contracts involved with the federal government’s procurement (including Department of Defense-related entities) and all of them point to contractual call for a safe and effective vaccine.
Most likely coronavirus research, including some joint NIAID and DoD dual use R&D activity goes back at least a few decades. It’s how a post-World War II American system gained geopolitical and socio-economic superiority. But contradictory forces now threaten the unraveling of that post World War II order.
Think about the internet—it wasn’t Al Gore that invented the amazing network making the world a much smaller place. It actually started in the 1960s as a way for government researchers to share information and collaborate. Back then computers were not only huge, but also immobile, and to share data in one computer meant traveling to the site of that computer, or alternatively go through the process of having magnetic computer tapes sent via snail mail. But this network of computers, first funded by government and defense interests, further developed in universities and companies in the private sector, leading to a revolution in how we live and work---and of course paving the way for fortunes to be made—the ultimate point.
Ditto for life sciences which undergoes a trajectory that includes lots of private sector but also public and government and defense R&D. Myriad aims involved, ultimately in America profit seeking motives transcend the social, political and cultural milieu.
So just because the DoD is involved with the triggering of a national emergency due to the deadliest pandemic since the Spanish American flu doesn’t mean that the resulting countermeasures are meant for warfare, even if at some point along the historical R&D trajectory defense research was a factor.
TrialSite has received significant hate mail when using logical, reasoning and contractual evidence to critically question the sensationalistic claims from individuals claiming to know definitively that the vaccines are designed with nefarious intent.
During his CNN interview, Buttar made a few claims all of which we believe are sensationalized, including 1) more people are dying from the COVID-19 vaccines than from COVID-19 itself 2) the Red Cross won’t accept blood from COVID-19 vaccinated people 3) most people who took COVID-19 vaccines will be dead by 2025 and 4) definitely declare COVID-19 a staged, planned operation politically motivated as part of a secret global plot to depopulate the earth.
In the interview with Drew Griffin, Buttar backs off a claim comparing Fauci directly to Hitler, which is often the case with COVID-19 criticism making exaggeration declarations online, often for clicks, dollars and recognition. TrialSite has observed a whole COVID-19 counter industry form often driven ultimately by monetization via various channels.
What’s the reference to poisoning?
Recently Buttar was interviewed by CNN and claimed that he had been given poison “200 times of what was in the vaccine” reports.
Now deceased with no cause of death disclosed, it’s not known what happened and why he was recently in intensive care. In an interview with Laura-Lynn Tyler Thompson earlier in the month, the skinny Buttar told her, “I went through a very difficult personal health challenge a few months ago.”
Full court press
Mainstream media has been tough on Buttar, referring him to an “Antivax crank” and touting that if he would have received the mRNA vax, they would have cited that as the cause of his demise. Some activists actually blame “vaccine shedding” or alleging poisoning for his death. Vaccine proponents have pointed the finger that Buttar’s anti-Covid vaccine conspiracy rhetoric broadcast to millions via social media caused the loss of life during the pandemic.
Confirmed death?
A friend of Buttar, Sayer Ji founder of GreenMedInfo.com and co-founder of Stand for Health Freedom confirmed the doctor’s death via a tweet declaring “In loving memory of Dr. Rashid Buttar, 1966-2023 It is with sadness, yet great appreciation, that we pay tribute to my friend and colleague Dr. Rashid Buttar, who passed away on May 18th.”
The GreenMedInfo blog owner Sayer Ji confirmed that just weeks earlier he was in the ICU for 6 days purportedly with both a stroke and diagnosis. Ji shared that the doctor allegedly told him he had biomarkers consistent with adverse events from mRNA vaccination, which of course never happened with him. Ji notes, “As you will see in the video, he believed that he was experiencing the result of shedding…from the transgenic mRNA jabs.”
Some in the medical freedom movement believe that the COVID-19 response is a part of a broader initiative to usher in totalitarian controls over Western society.
Yet this media suspects SARS-CoV-2, if made in a lab, was more than likely an accidental event and that government responses were defensive but coordinated to some extent with World Health Organization involvement. Although it could be the case that if the pandemic did start with a leak there has been a considerable cover up. But this doesn’t mean an all-encompassing plot by say, the Word Economic Forum, to impose global domination. Life’s far more complex than that, or at least that is the general consensus of ours.
While conspiracy theorists rage, often important unfolding events and manifestations represent the evolving, often historically rooted, dynamic results of interest seeking behavior involving conflicting spheres of influential, social, economic and political life. In a hybrid capitalist market and administrative State-entangled system such as ours the march to continuously capture ever more value, often through disruptive, or destructive, leads to an observation that nearly everything could be deemed an orchestrated series of actions—a possible foundation for a conspiracy. While simultaneously, one could come to the complete opposite conclusion, that human systems such as ours face the ongoing menace of completely unraveling, into a far darker, more perilous abyss.
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23 May, 2023
Lax Indian sterility precautions for eye drops cause 4 Deaths + 4 Lose Eyeballs: Drugs Linked to Rare Bacteria
After previous episodes of laxity, I have personally long maintained a blanket policy of never using pharmaceuticals from India
The U.S. Centers for Disease Control and Prevention now collaborate with the Food and Drug Administration (FDA) as well as state and local health department investigating 81 people who have succumbed to a rare bacterial strain linked to recalled eye drop products produced by Global Pharma Chennai, India ( EzriCare Artificial Tears, Delsam Pharma Artificial Tears and Delsam Pharma Artificial Ointment) which were recalled a few months ago in February of this year.
Fourteen people have suffered vision loss, and four people have had to have their eyeballs removed, and another four people have died. This outbreak is concerning as the bacteria behind the infections and deaths, known as Pseudomonas aeruginosa, is resistant to standard antibiotics. Based on US health agency’s flagging, Indian inspectors visited a plant near Chennai, India, that produced the eyedrops which led to the identification of how the products were produced, exposing inadequate sterility controls and measures.
Now cases have spread across 18 states, including California, Colorado, Connecticut, Delaware, Florida, Illinois, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, South Dakota, Texas, Utah, Washington, and Wisconsin.
In a case that generated little U.S. media notice acting on a U.S. concern, Tamil Nadu’s Drug Controller and members of the Indian Central Drug Control Authority paid a surprise visit to inspect Global Pharma facility at 2 AM in early February, as reported by Indian press.
TrialSite breaks down this crisis.
How many people have the CDC identified so far in the U.S. affected? 81, 4 deaths, 4 people have lost their eyeballs, 14 people have lost their eyesight.
What’s causing the outbreak?
A drug-resistant strain of Pseudomonas aeruginosa. The outbreak strain, carbapenem-resistant Pseudomonas aeruginosa with Verona integron-mediated metallo-?-lactamase and Guiana extended-spectrum-?-lactamase (VIM-GES-CRPA), had never been reported in the United States prior to this outbreak.
What types of infections is the outbreak associated with?
The outbreak is associated with multiple types of infections, including eye infections.
What are the culpable products?
The investigation has identified EzriCare artificial tears as a common exposure for many patients. CDC and FDA recommend clinicians and patients stop using and discard EzriCare Artificial Tears and two additional products made by the same manufacturer, Delsam Pharma’s Artificial Tears, and Delsam Pharma’s Artificial Ointment.
What’s the CDC’s current update?
As of May 15, 2023, CDC, in partnership with state and local health departments, identified 81 patients in 18 states (CA, CO, CT, DE, FL, IL, NC, NJ, NM, NV, NY, OH, PA, SD, TX, UT, WA, WI) with VIM-GES-CRPA, a rare strain of extensively drug-resistant P. aeruginosa. This represents an increase of 13 patients since the last update. Among these 13 patients, 6 (46%) had specimens collected prior to the February 2, 2023, manufacturer recall of products associated with this outbreak. These cases were confirmed after the recall date due to the time it takes for testing to confirm the outbreak strain and because of retrospective reporting of infections. Of the 7 patients who had specimens collected after the recall, most either resided in long-term care facilities with other known cases or reported use of a recalled brand of artificial tears.
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Net Zero politicians: liars, scoundrels, and morons
The lies told by politicians usually have no consequences. Their intellectual dishonesty, as a species, is such that citizens go to the polls assuming election promises have an expiry date similar to nine-day-old milk.
If the lie is a promise to ‘lower taxes’, the inevitable raising of taxes several months later is met with a groan in the same way that the purchaser of a used car sees an oil stain develop on the garage floor. There’s a sense of resignation rather than rage. After all, you’re the one that shook hands with a shonky dealer.
Fast-forward three years, and that same politician is likely to be re-elected on a follow-up promise to subsidise mechanics working on repairs for all leaking and broken used cars – provided they become members of a union.
Do you see how this works?
Even though people were ripped off by failed election promises the first time, they are motivated to vote for the same bunch of scoundrels in the hope they’ll fix the problem their policies caused. Then we have a whole new group of mechanics tempted by government-contracted work which they can only secure if they make a permanent commitment to an institution aligned with that political party.
Is this kind of governance good for society? No. It encourages the sale of crap cars and a generation of mechanics who earn their living from failed government policy. The only clever thing it does is create a cycle of dependence where each broken election promise serves as a platform for the next campaign. Solving problems is a thankless task, but creating them … well, that’s genius.
Remember the Covid era? Governments in every state employed hundreds of thousands of ‘health’ workers to man vaccine booths, check vaccine certificates, work in quarantine centres, clean public spaces, and police the behaviour of citizens. It was a Goliath, publicly-funded industry that encouraged all of those people to vote for politicians who promised to protect Covid jobs. Is it good for society to remain in a permanent pandemic state? No. But it’s good for those workers, operating at the expense of an ever-diminishing pool of genuine private wealth creators. Eventually people turn around and wonder where this economic disaster came from. Never mind, surely the government will fix it…
The are no consequences for political parties that operate in this fashion. They remain in power, gaining bewildering majorities, until society falls to bits and the ruling party has no choice but to donate the mess to the opposition with little more than a box of band-aids in the Treasury.
This is the standard Labor model for government. Barter. Break. Bleed. Bail.
Unfortunately, the other half of this equation is an opposition that is prepared to forgo political glory and instead clean up the mess created by its rivals. For the first time in Australian history, the Liberal Party has decided to dismiss its historical duty and ‘get in on the game’, leaving the country with no one to stop the economy from crossing the red line.
If this nauseous feeling seems familiar, it’s because this is the cycle adopted by major parties across the world for Net Zero. We have to give them credit for a Bond-level deceit after bureaucracies, such as the United Nations, got bored with ‘world peace’ and decided to invent an existential problem which they used to con nations into spending trillions every year to ‘fix’ – even though you cannot fix something that isn’t real. It’s the same scam run by tribal wizards extorting favours in exchange for ‘weather dances’. While they might not be saving the planet, the United Nations did give themselves a new purpose. Maybe it’s for the best, given how terrible the whole ‘world peace’ initiative is looking.
In summary, the global leadership line goes: ‘There’s an apocalypse coming, but vote for us and we can save you!’
This comes with a range of feel-good slogans like, ‘clean, cheap, reliable energy’ and, ‘be a good global citizen’, but the underlying policy is the same: ‘your taxes can change the weather’. It’s the fashionably acceptable version of the white saviour syndrome where the same people that used to take gap years in Africa now stick a banner on their social media profile, shrug off rising prices, and delude themselves into thinking that makes them a good person.
Humans have been paying for their sins and silencing their existential fears this way for a long time. Politicians prey on this kind of thinking. What’s not to love about Net Zero? You get to be a good citizen, businesses compete on slogans instead of product quality, and the government ends up rich. Everybody wins! Well, not exactly. There are plenty of problems with Net Zero – power bills for one, and the blackouts for another. Pretty soon we’re going to hear from disgruntled landowners as the government reclaims their properties to build transmissions lines, and if Chris Bowen gets his way regarding offshore wind farms – the entire East Coast of Australia is going to march on Canberra. That’s before we get to the mounting pile of renewables corpses to contend with and society’s blind eye to real pollution which sits unattended in our waterways.
‘But don’t worry! Vote for us again and this time we’ll give you a discount on your power bills!’ Woe be to the idiots that fall for that one.
There’s now an entire class of workers with no ideological investment in the spiritual cause of Net Zero. Their lack of faith is irrelevant, because Net Zero policies mean they’re struggling to keep their businesses going. Instead of punishing politicians for endangering their livelihoods, humans do a very strange thing: they vote for the same guys on the promise of it being ‘fixed’.
This is how Net Zero manages to wreck the economy and increase its popularity. It’ll happen again and again and again until those businesses shut down and the population ends up on welfare. Then they want more welfare. Then taxes are raised to pay for it. Then they want more… Those voters have to vote for the government, or their welfare cycle vanishes.
Australia will die long before the lights go out. These are not the politicians of Australia’s infancy. They are not going to have a common sense epiphany and do the right thing for the survival of the nation. Hard choices and self sacrifice are not phrases found in the language of career politicians and factional seat warmers. The rats that scurry around in Canberra have their eye on lucrative international positions and corporate jobs. They’ll move on to bigger salaries. No consequences, remember?
The next slogan is already being promoted: ‘Vote for us and we’ll give some of you a government handout for your power bills! (And raise taxes on the rest of you suckers.)’
What was that last bit?
Maybe we’ll get lucky next time if we vote for them again. That’s what people think as they are reminded by wall-to-wall state-funded media that the apocalypse is on its way.
I’m not sure how to make this any clearer: stop voting for liars, scoundrels, and morons.
https://www.spectator.com.au/2023/05/net-zero-politicians-liars-scoundrels-and-morons
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22 May, 2023
Justice Gorsuch Slams COVID Emergency Powers: ‘Greatest Intrusions on Civil Liberties’ in ‘Peacetime History’
Supreme Court Justice Neil Gorsuch on Thursday lamented what he calls an intrusion into civil liberties by pandemic emergency decrees since the start of COVID-19 as the high court dismissed a suit on Title 42 as moot.
“Since March 2020, we may have experienced the greatest intrusions on civil liberties in the peacetime history of this country,” Gorsuch, one of six conservative-leaning Supreme Court justices, said in an opinion accompanying the court’s decision (pdf) published on Thursday.
Gorsuch wrote that emergency decrees ordering vaccine mandates and lockdowns issued by federal and state executive agencies resulted in an accumulation of power in those agencies and accompanied this loss of liberties during the pandemic.
“The concentration of power in the hands of so few may be efficient and sometimes popular. But it does not tend toward sound government,” the justice wrote. “However wise one person or his advisors may be, that is no substitute for the wisdom of the whole of the American people that can be tapped in the legislative process.”
This view, some experts say, shines a light on the high court’s vision of restoring a balance of power in the federal government to that more aligned with America’s founders.
“My first reaction to reading Justice Gorsuch’s comments was that the Constitution is waking up,” attorney Jeff Childers told The Epoch Times in an interview on Friday. Childers fought—and won—against local governments in a mask mandate and another vaccine mandate case in Florida.
Gorsuch’s warning came as the Supreme Court dismissed a case brought by Republican attorney generals to keep in place Title 42, the emergency measure that the Trump administration implemented in March 2020 as a reaction to the COVID-19 pandemic. Both Trump and Biden administrations used Title 42 to expel illegal immigrants.
While the state’s case hinges on the more technical question of whether they can intervene in a case in another state to keep Title 42 in place, Gorsuch’s opinion indicated that the high court believed this question is no longer relevant as the public health emergency—to which Title 42 was designed as a reaction—ended in April.
Technicalities aside, Gorsuch took the opportunity to reflect on the bigger picture: namely, what he sees as a threat to civil liberties during the COVID pandemic when “executive officials across the country issued emergency decrees on a breathtaking scale.”
Loss of Civil Liberties
The Title 42 case brought by the states illustrates this threat to civil liberties, Gorsuch, a Trump appointee, wrote in his Thursday opinion.
He acknowledged that the surging illegal immigration across the border is a “crisis,” and so was COVID. But he warned that “the current border crisis is not a COVID crisis,” and the fact that the executive branch used the pandemic as the pretext to deal with another crisis at the border is emblematic of the broader, fear-driven response from U.S. institutions that may have led to “the loss of many cherished civil liberties” during COVID.
“Executive officials across the country issued emergency decrees on a breathtaking scale. Governors and local leaders imposed lockdown orders forcing people to remain in their homes. They shuttered businesses and schools, public and private. They closed churches even as they allowed casinos and other favored businesses to carry on,” the justice said, adding that violators were threatened with criminal sanctions and federal officials pressured social media companies into suppressing views they disagree with.
“They used a workplace-safety agency to issue a vaccination mandate for most working Americans. They threatened to fire noncompliant employees and warned that service members who refused to vaccinate might face dishonorable discharge and confinement,” he wrote.
Gorsuch also noted the apparent inaction of the legislative branch—state legislatures and Congress—in response to these executive decrees and how the judicial branch, which was “bound to protect our liberties addressed a few—but hardly all—of the intrusions upon them.”
“In some cases, like this one, courts even allowed themselves to be used to perpetuate emergency public-health decrees for collateral purposes, itself a form of emergency-lawmaking-by-litigation,” Gorsuch added, referring to the effort by Republican states to keep Title 42. Collateral purposes refer to purposes other than those originally intended by the decree or law.
The conservative justice warned that an important lesson from the pandemic is that “fear and the desire for safety are powerful forces,” and, citing Aristotle, noted that “even the ancients warned that democracies can degenerate toward autocracy in the face of fear.”
“Make no mistake—decisive executive action is sometimes necessary and appropriate,” he added. “But if emergency decrees promise to solve some problems, they threaten to generate others.
“And rule by indefinite emergency edict risks leaving all of us with a shell of a democracy and civil liberties just as hollow.”
A Need for Reflection
H. Jefferson Powell, a prominent constitutional scholar who teaches law at Duke Law School, echoed Gorsuch’s view that the country should reflect on what the government did in response to Covid via emergency powers.
He quoted an opinion of Supreme Court Justice Robert Jackson in the landmark Steel Seizure Case, that the founders “suspected that emergency powers would tend to kindle emergencies.”
“My only disagreement with the assertion is that I see no reason to qualify it with ‘may’ – I do not think there is any question that the intrusions imposed because of the Covid virus on the civil liberties that Americans ordinarily exercise were the greatest in our peacetime history,” Powell, who served as the Deputy Assistant Attorney General in the Clinton administration, wrote to The Epoch Times in an emailed statement.
“This is, simply put, a historical fact, which Justice Gorsuch chose (understandably) to present in non-dogmatic terms,” Powell wrote.
John Malcolm, vice president of the Institute for Constitutional Government at the Heritage Foundation, a conservative think tank, said that Gorsuch’s Thursday opinion reflected a “course correction” on the Supreme Court’s view of executive overreach that has been taking place since Justice Amy Coney Barrett, a Trump appointee, started her tenure in 2020.
A prime example of that correction, Malcolm said, was when the court ruled (pdf) in a 5-4 vote in favor of a group of religious adherents in New York who sued the state to remove COVID restrictions imposed on worship activities via emergency decrees.
The New York case, with Barrett on the bench, was similar in facts to two earlier cases in Nevada and California, but its ruling ran counter to the two earlier rulings that were made when the late Ruth Bader Ginsburg was part of the Supreme Court.
“The Supreme Court said enough—this goes too far, and [the state executive branch] is impinging on the free exercise rights of these religious adherents,” Malcolm said.
Looking at the more distant past, Malcolm noted that out of about 80 national emergencies declared from the beginning of the 20th century to today, 41 are still in effect—not including the COVID public health emergency, which ended in April.
Each one of these emergency declarations, he said, “gives the president and executive branch agencies extraordinary powers,” or power that goes beyond what the law normally prescribes.
“Now there’s something wrong with that.”
He observed that Gorsuch was making an “incredibly powerful statement” calling Americans to “not to step back and defer, but to step up and debate” during these emergencies: “Is this an emergency? Or are we going to let it curtail our civil liberties? If so, how? And in what ways? And for how long?”
Agreeing with Gorsuch’s view that these extraordinary authorities need to be seriously examined, Malcolm suggested: “What [Congress] probably needs to do is have a sunset provision that says, you can declare an emergency, but unless we reauthorize it, that emergency officially ends after six months, a year, two years, some reasonable time period.”
A Consequential Ruling to Come
According to Zack Smith, Manager of the Supreme Court and Appellate Advocacy Program in Heritage’s Meese Center, a future case in the Supreme Court may curb the power of executive agencies by subjecting their actions to a higher degree of scrutiny from the courts.
That case involves a dispute between fishing companies and the Biden administration, in which attorneys for the fishing companies asked the Supreme Court to overturn the Chevron doctrine, a Supreme Court precedent set in 1984.
The Chevron doctrine has led to the “exponential growth of the Code of Federal Regulations and overregulation by unaccountable agencies,” the attorneys for the fishing companies wrote to the Supreme Court in a filing (pdf).
Under this doctrine, Smith explained, courts must give way to executive agencies (such as the Environmental Protection Agency) in interpreting certain ambiguous laws—provided their interpretation is reasonable.
The consequence, Smith indicated, is that courts are sometimes barred from ruling against these agencies, even when these agencies interpret the law differently than the court would have.
“And that’s not really the way our system of government is supposed to work,” Smith said. “It’s not the duty of the courts to defer generally to executive branch officials. It’s their duty to interpret the law and say what the law is.”
Reflecting on Gorsuch’s comments on Thursday, Smith criticized the current “bureaucratic morass” in the executive branch: “You essentially have an executive branch agency making their own rules, prosecuting violations of those rules, and then adjudicating prosecutions—that’s a concentration of power.”
“So, if Chevron is overturned, that would be a very big decision—and we go a long way, I think, to restoring the proper balance of power between our different branches of government,” Smith said.
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Rebel doctors speak
From the Australian Medical Professionals Society
We have seen censorship unparalleled in the scope of its reach in human history, especially in the treatment of Covid. Doctors who have dissented from official state-sanctioned treatment diktats have been and continue to be sanctioned by the medical regulator, and egregiously unfairly fired from their positions.
The restrictions on prescribing ivermectin have recently been dropped by the TGA. The provisionally approved Covid vaccines have been associated with unprecedented harm and demonstrated negative efficacy; alarmingly, there are still official recommendations for their continued usage.
The unprecedented squashing of scientific debate by the regulatory authorities enabled by MainStream Media and social media censorship, which continues to this day, is a major block to the advancement of healthcare in this country and around the world. This is highly destructive to the foundations of an open and free democracy. If the medical profession is happy to unquestioningly accept the dictates of health bureaucrats instead of scientific debate, this is to the detriment of patients’ health.
The doctors at the Australian Medical Professionals Society have invited the doctors of the Australian Medical Association to a public debate on the government’s response to Covid with a particular focus on the safety and efficacy of the provisionally approved Covid vaccines. Health Professionals must be free to publicly debate public policy using the most up to date scientific evidence and their clinical judgment, unhindered by government regulatory censorship. We would also like to debate the ethical egresses forced on the medical profession and the public by the imposition of mandates.
In modern medicine, our symbol is that of a Physician’s staff with an Asclepiusian snake wrapped around it. Asclepius was the Greek God of healing, and Hippocrates was a student of his. Asclepius made use of a magic potion, which when drawn from the right side of the Gorgon would kill, and from the left side could cure. It speaks to the duality as our role as healers, we seek to heal, but we also have the capacity to harm. The way we minimise harm to our patients is to always allow open discourse, and courteous dialogue amongst health professionals so that the best ideas can prevail.
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21 May, 2023
‘Millions of Lives Lost’ in Pandemic Mainly From Pharma-Government Nexus, Says Critical Care Expert
Dr. Pierre Kory, a pulmonary and critical care medicine specialist, is blaming the nexus between the pharma industry and the government along with corrupt medical journals for deceiving the public about COVID-19 and vaccines, which resulted in “millions of lives lost.”
“I always knew pharma was bad. I didn’t understand that they are literally a criminal syndicate, who have been committing crimes for decades. They pay fines, then move on and continue their standard operating business,” Kory said in an April 28 interview with EpochTV’s “American Thought Leaders” program. “When it came to government, I wasn’t aware of how corporations have literally taken over almost all the agencies of government. The response to COVID was controlled and conducted by the pharmaceutical industry, with probably even bigger powers behind them.”
To understand how the pharma industry’s propaganda works, Kory claims to have looked at three years of every policy issued by government agencies.
“All you had to ask yourself was, ‘What would a pharmaceutical company want?’ Voila, there was your policy. Every single policy was in line with serving the interests of a pharmaceutical company,” he said.
“Guess what that brought us? It brought us multiple humanitarian catastrophes, millions of lives lost from the suppression of early treatment, millions of people dead around the world from the vaccines, and now epidemics of vaccine injury and long COVID with very little treatment.
“Ultimately, it was a war of information. All of the destruction was about information and how it was controlled. I was already transformed before the Twitter Files. The Twitter Files are just absolutely astonishing. Government intelligence agencies and health agencies were literally controlling Twitter, and what was showing up on Twitter,” he said.
In a March 17 exposé, investigative journalist Matt Taibbi revealed the alleged collusion between Stanford University’s Virality Project (VP) and Twitter to censor what they deemed to be misinformation about COVID-19 vaccines. VP is also said to have colluded with the American government.
“Though the Virality Project reviewed content on a mass scale for Twitter, Google/YouTube, Facebook/Instagram, Medium, TikTok, and Pinterest, it knowingly targeted true material and legitimate political opinion, while often being factually wrong itself,” Taibbi said on Twitter.
The initiative “accelerated the evolution of digital censorship, moving it from judging truth/untruth to a new, scarier model, openly focused on political narrative at the expense of fact.”
Compromised Media and Medical Journals
According to Kory, corporations are funding media agencies to promote vaccine campaigns and censor any information that would raise the levels of vaccine hesitancy among people. “It’s almost like you’re watching a military operation, and they’re using all of the institutions of society.
“I saw a global propaganda and censorship campaign which made the world go mad,” he said. “I saw them do things with this blanket of propaganda and censorship, like mandating these vaccines for young children, who had basically zero risk of anything serious happening to them from COVID.
“They mandated these vaccines and people lost their jobs. They were victimized and vilified for being unvaccinated, along with those who were adjacent to them. If you were anywhere near an unvaccinated person, you still got attacked. The most absurd thing was the people who got vaccinated and then got injured.”
Another tactic the media used was fearmongering. “The fear and dangers of COVID were constantly propagated,” Kory said.
“It was a war where the voices of truth and sanity were getting drowned out by lies that were told for different objectives. The CEO of Moderna has $4 billion [in] wealth. The pharmaceutical companies made tens to hundreds of billions with this massive transfer of wealth. It has been a really difficult three years.”
Kory also highlighted the role played by medical journals during the pandemic. “The high-impact medical journals played a massive role in the human toll of COVID by censoring positive studies of repurposed drugs like hydroxychloroquine and ivermectin,” he noted.
“They published clearly fraudulent trials that were designed to fail; to show that ivermectin didn’t work, and to show that hydroxychloroquine didn’t work.
“They also manipulated trials showing the safety and efficacy of the vaccines. Remember 95 percent effective, then to 70, 50, 30 percent? Then, they said, ‘Okay. It doesn’t work for transmission, but it still protects against hospitalization and death.’ The reality is that nothing was ever true, and they were just shifting their stories.”
According to Kory, the propaganda and censorship carried out by high-impact medical journals have been so massive that he is unable to trust them.
“When I read a study, the first thing I read now is about the conflicts of interest. That’s all you have to read. Once you read a study and you see that they have numerous conflicts of interest with the actual molecule or compound or medicine that’s being studied, you cannot trust that paper,” Kory said.
“It may be true. It may not be true. But I refuse to act on a paper whose conclusions were reached by investigators who have direct conflicts of interest with their findings. There’s no more objectivity.”
War on Repurposed Drugs
Kory also insists that there is a “war” against repurposed drugs. He pointed out that when the National Institutes of Health (NIG) finally decided to conduct a large randomized controlled trial on ivermectin, the individual they chose as its principal investigator was a “woman from Duke who they gave a $140 million grant to, who has stock in a competitor to ivermectin.
“She has conflicts of interest with Gilead Sciences, who manufactures remdesivir. She’s got a long rap sheet of pharmaceutical industry influences, as does almost every other investigator on that trial.
“What are they studying? They’re studying a drug that would decimate the COVID market for every single one of those pharmaceutical companies. Can anyone actually believe they’re going to lead to anything but a predetermined result?”
Kory claims to have a collection of a large number of rejection letters from medical journals that were sent to investigators who had conducted “good randomized controlled trials, showing phenomenal benefits of ivermectin.
“The rejection letters were all the same, ‘I’m sorry, this topic is not of sufficient interest to our readers at this time,’” Kory said. “You either want to laugh at that or cry, because in the middle of a global pandemic with people dying across the world, they said that a positive trial of ivermectin was not of sufficient interest to their readership. This is how it’s done.”
Kory talked about reading an article sent by one of his colleagues that finally made him understand how the pharma industry and propaganda worked to manipulate the world.
“It’s a short and very powerful article, and they outlined each tactic. I said, ‘Wait. I’ve seen this. I’ve seen that. They did this yesterday. They did that to me two days ago. This is what they’re doing to the FLCCC [Front Line COVID-19 Critical Care Alliance].’
“It was almost like getting the teacher’s edition to the world. Suddenly, it was like a light went on. I said, ‘That’s what is happening. The FLCCC and I have launched ourselves into the middle of a decades-long war on repurposed drugs. This is not about ivermectin, and it’s not about hydroxychloroquine,” he said. “The disinformation has been going on for a long time.”
Multiple studies have been done on ivermectin’s impact on COVID-19. A study from 2020 led by the Monash Biomedicine Discovery Institute had shown that a single dose of ivermectin could stop the COVID-19 virus from growing in cell culture.
“Even a single dose could essentially remove all viral RNA (effectively removed all genetic material of the virus) by 48 hours and that even at 24 hours there was a really significant reduction in it,” Monash Biomedicine Discovery Institute’s Dr. Kylie Wagstaff said at the time.
In 2021, government from the Indian state of Uttar Pradesh claimed that the use of ivermectin allowed them to maintain a lower fatality as well as positivity rate amid the COVID-19 pandemic.
Global Coverup Exposed, Pharma-Military Links
“The scale helped expose it,” Kory said while talking about the global COVID-19 propaganda, “but also the fact that it failed.
“You could see that it failed early on, and how much they had to do to hide that. If it had been a success, it would not have exposed anything. In fact, it would’ve entrenched it even more.
“You saw a failed medical experiment being covered up on a global scale. It was the cover-up. There is the old adage, ‘It’s not the crime that gets you in trouble, it’s the cover-up’. It was the fact that they had to cover up a global catastrophe, and there’s no way to do that.
“The truth is starting to come out now. You’re starting to see more and more investigations. I wouldn’t call them tribunals, but some of the state legislators are starting to look harder.”
Kory also highlighted the links between the American military and COVID-19 vaccines. “Pharma was working for the military to make these vaccines,” he said.
“The contracts were all from the Department of Defense. That was a Department of Defense contract. The Department of Defense did not do their due diligence in ensuring safety. The manufacturing of these products violated every CGMP [Current Good Manufacturing Practice] standard, which is an FDA regulation.”
“There’s never been a product, even a baby seat, a car seat, a car, a can of peaches, nothing has had this level of adverse events reported, including deaths and the variation between lots. It was a manufacturing catastrophe.
“If the pharmaceutical industry was working correctly, those things would’ve been stopped and taken off the market immediately,” Kory stated. “But it was just an unrelenting push through the media, even the government and the Department of Defense.”
Kory compared the COVID-19 policies implemented in the country to some sort of military exercise. “Let’s say it (COVID-19) was an accident and our government had been preparing for this massive countermeasure, and it really was the military that was employing a military countermeasure.
“That actually makes some sense, because when you see all of the medical ethics that were violated, that’s telling you it’s not health care. We still have a sense of ethics, and they forgot it overnight. It sounded like a military exercise, where you have to sacrifice 100 people to take that hill.
“The VAERS [Vaccine Adverse Event Reporting System] exploded, and with the amount of deaths that were reported within the first weeks, nobody looked at it. It was nothing but attacking VAERS as a source of data, ‘Nothing to see here.’ It was like the military seeing the battlefield strewn with soldiers and just moving ahead, ‘You have to get your objective.’”
“The corporations benefited and profited greatly, but the conduct was like nothing we’ve ever seen before.”
VAERS Deaths And Adverse Events
According to a Dec. 22 analysis published by The Epoch Times, a total of 909,868 adverse events were reported in the VAERS system related to all six COVID-19 vaccines in the United States as of Dec. 9. This included 96,140 serious adverse events and 15,733 deaths.
In contrast, total adverse events for major vaccines related to other diseases like seasonal flu, hepatitis B, HPV, measles, and polio only came to 380,490. There were 28,058 serious adverse events and 3,185 reported deaths.
Documents disclosed in March showed that the number of vaccine injury reports that popped up after COVID-19 vaccination began exceeding the expectations of officials.
The contractor hired to process reports to the VAERS system had only estimated a maximum of 1,000 reports per day as the “worst-case scenario.”
However, this limit was broken in December 2020, less than three weeks after regulators greenlit COVID-19 vaccines from Pfizer and Moderna. By Jan. 10, 2021, the number of daily reports exceeded 4,500.
In February this year, Florida Surgeon General Joseph Ladapo claimed that there was a 4,400 percent jump in life-threatening conditions reported in the state with VAERS since the COVID-19 vaccine rollout.
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18 May, 2023
New COVID Origin Report Includes Some of the Most Chilling Revelations We've Heard to Date
On Wednesday morning, Sen. Marco Rubio (R-FL)'s office released a chilling 328-page report about the origins of COVID-19. While a press release from March highlights how the report is "[b]ased on vast troves of previously undisclosed documents and fresh analysis of previously known but inadequately scrutinized information," much of what is included serves to bolster what many already feared about the virus, and about China and the Chinese Communist Party (CCP).
The release back in March noted that the report is based on almost 18 months worth of investigations, and that it "uncovered and will reveal evidence that was either previously unknown or otherwise ignored by the U.S. government." The senator referred to it as "a groundbreaking look at what was happening in China during the years and months leading up to the known outbreak of the pandemic."
It took even longer to put together the final product.
"After years of censorship, there is growing evidence that some type of lab accident is responsible for the Covid-19 pandemic. This report, which took two years to compile, edit, and refine, is a groundbreaking look at what was happening in China during the years and months leading up to the known outbreak of the pandemic," Rubio said in a statement about the report's release. "I am grateful to the staff, fellows, and outside experts who worked to connect the dots. Their work helps fill in some critical blanks and has already contributed to other reports, hearings, and investigations. The implications are impossible to ignore: Beijing hid the truth. This report reinforces the need to hold the Chinese Communist Party accountable."
An executive summary and a short documentary were also released.
The documentary features a narrator walking viewers through documentation and footage to do with lab technicians in China working on gain-of-function. The senator himself is also featured, as he delves into such information. At one point, he provides perhaps the best explanation of gain-of-function research you'll hear, as well as a warning about its dangers.
"What that basically means is that you take a naturally occurring virus that you would find in nature, and you reverse it, you engineer it, you mess with it, and you make it contagious in humans, so there might be a virus in an animal and it may not be infectious in humans," Rubio explains about gain-of-function. He also warns "but you change it in the laboratory. You make it infectious in humans. And the reason why you do that is because you try to predict how a virus that today's only found in animals could evolve into one that would be dangerous in humans. You try to predict it, you try to invent it yourself. And once you've invented it, then you try to find a cure for it. And the problem is, once you invent it someone might get infected with it."
The virus became known in late 2019, closer to 2020. The "CDC Museum COVID-19 Timeline" from the Centers for Disease Control's (CDC) begins on January 1, 2020.
The World Health Organization (WHO) officially declared it to be a pandemic in March 2020, and the United States following suit shortly after when it comes to declaring a public health emergency. Both ended just recently. As the report's findings detail, however, it was really in the middle of 2019 where events worth paying attention to took place, leading up to "a serious biosafety incident" that occurred later that year.
Early warning signs appeared when the head of the Chinese Academy of Sciences (CAS) inspected the state-run Wuhan Institute of Virology (WIV) in April of 2019 and warned of a need for upgrades. The WIV went on to pursue costly projects, but it ended up not being enough, because in July 2019 the CCP secretary of the WIV still spoke of "current shortcomings and foundational problems in the construction, operation, and maintenance" of the lab complex, with the director of the WIV calling on staff to "prioritize solving the urgent problems we are currently facing."
What happened next took place in a timeline sooner and with more chilling urgency that the CCP sought to cover up than the rest of the world knew about at the time.
For it was on September 12, 2019 when the WIV shut down its online database in the middle of the night. On September 18, the WIV advised the airport of a drill for the outbreak of a "novel coronavius." Mere days later, on September 21, a resident known as Su died from what may have been COVID-19. Several more cases were documented in November 2019, but were kept hidden. Eventually, a Chinese official traveled from Beijing to the WIV to deliver "important oral and written instructions."
The CCP was not prepared or well-equipped. In October 2019, the Chinese legislature reviewed a draft biosecurity law and noted that "currently the biosecurity situation in our country is grim" and listed "laboratories that leak biological agents" as one of several threats about the "the complex and grave situation currently facing safety work."
CCP officials at the WIV published a report that gave arguably the most chilling but also accurate descriptions of the virus, and from those that would know. "Once you have opened the stores test tubes, it is just as if having opened Pandora’s Box. These viruses come without a shadow and leave without a trace," the report said.
What else happened in 2019? Chinese scientists were working on a vaccine, with their own research methodology indicating they began working on it no later than November 2019, almost two months before the virus' existence was even disclosed by Beijing.
From December 2019-October 2021, WIV researchers also filed patents for inventions meant to address the lab's differential air pressure system, biocontainment equipment, and waste handling process. "Any one of these problems could have allowed a pathogen to escape the lab complex. WIV researchers confirmed this by explaining that their inventions were designed to prevent precisely such a scenario," the executive summary mentions.
"As the disease spread, it was only a matter of time before the news of the outbreak came out. The moment came on December 30, when rebellious Chinese doctors blew the whistle on their own government," the documentary's narrator also explains. "Shortly after the CCP finally admitted to the truth, but only part of the truth. Two years later, China still refuses to review what really happened."
While some admissions came in December, with the official timeline saying the first cases occurred that month, Rubio points out in the documentary that they were already closing schools by November 2019. "So something's already happening. Well, we don't know exactly that at that point. They began to see evidence of it spread or that they knew they had a lab leak and they were taking proactive measures, but they start closing schools in November of 2019 when they claimed that the first known cases worn until late December of 2019," he explains.
In February 2020, still before the rest of the world was so deeply impacted, a campaign was launched to strengthen biosafety through inspections, stricter regulations, and the elimination of unauthorized research. "Just as Beijing was denying the possibility that COVID-19 came from a lab on the world stage, it was warning its own officials of such risks and rolling out new measures to prevent lab accidents," the executive summary aptly points out.
In case you needed any more evidence to believe that the theory about this virus originating from the Wuhan wet market is bogus, Chinese scientists determined as early as January 2020 that the wet market was likely not the origin of the virus. It's also still the official position of the Chinese CDC.
On Tuesday night, the eve of the report's release, Rubio appeared on Fox News' "Hannity" where he teased the report, explaining that it includes "previously unknown information that builds on an investigation that happened last year." Such insight "was not included as part of it, so we want to make sure the public sees it," Rubio told host Sean Hannity about the new information.
"You start to see all sorts of internal communications within the Chinese government and researchers about the urgent need for biosecurity measures at both the Wuhan Institute of Virology and the Wuhan Institute of Health. You begin to add a mountain of circumstantial evidence. No single piece by itself is determinative. But you put it all together," Rubio explained about connecting the dots.
In the documentary, Rubio acknowledges that "I'm not sure we'll ever know the entire story," though he does offer "I think now we have enough pieces put together to really change the entire narrative." He goes on to share that "I think this additional circumstantial evidence that's been gathered which is pretty compelling and which was never been seen before will weigh heavily towards those odds towards something bad happened in one of these laboratories and infected someone, they took it out into the general population, and they changed the course of history."
Regardless of how, exactly, we got the COVID-19 virus and what we may never truly be sure of, one major takeaway that cannot be denied is that the dangerous ambitions of the CCP is something to be feared and acted upon. In addition to being someone who uses his position of power to get to the bottom of the virus' origins, Rubio has been a leading figure in warning about the dangers posed by China. Perhaps this is his greatest piece of evidence yet.
"The world deserves to know the real origin of the disease that has caused so much suffering. The Chinese Communist Party must be held accountable for his lies. And we must never stop trying to uncover the truth," Rubio says to conclude the documentary.
https://townhall.com/tipsheet/rebeccadowns/2023/05/17/covid-origins-report-n2623351
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Tory MP Faces Political Exile for COVD-19 Vaccine Skepticism & Reference to Holocaust
As reported last month by The Guardian, Most of the political establishment in the United Kingdom has shunned Tory (Conservative Party) MP Andrew Bridgen. A few months prior, as reported by TrialSite, he had been removed from his whip position for comparing the COVID-19 vaccine programs as the worst human event after the Holocaust. Then in April, he was permanently expelled from the Conservative Party.
Bridgen has been in Parliament since 2010, and he has been acting as an independent since his original comments. The North-West Leicestershire MP had tweeted a ZeroHedge article, “which purported to show the health risks from Covid vaccines.” Bridgen also tweeted: “As one consultant cardiologist said to me, this is the biggest crime against humanity since the Holocaust.” This came after weeks of “increasingly anti-vaccine social media posts, as well as messages to journalists, many of which openly backed conspiracy theories.” One Conservative spokesperson stated that, “Mr. Bridgen was expelled from the Conservative party on April 12, following the recommendation of a disciplinary panel. He has 28 days from this date to appeal.”
The MP “should not be countenanced”
The under-fire MP argued that the fact that he was kicked out the Conservative Party, “only confirms the culture of corruption, collusion and cover-ups which plagues our political system----I have been a vocal critic of the vaccine rollout and the party have been sure to make an example of me. I am grateful for my newfound freedom and will continue to fight for justice for all those harmed, injured and bereaved due to governmental incompetence.”
The largest Jewish communal organization in the UK approved of the expulsion, noting that: “Suggesting that Covid vaccines are the biggest crime against humanity since the Holocaust is not an opinion which should be countenanced in any serious political party.”
Bridgen joins Reclaim Party as its first MP
In a May 9 follow-up article, The National reported that Bridgen was joining the nascent Reclaim Party after being booted from the Tories. Bridgen has officially announced he will make this move. He is now the first MP ever from the Reclaim Party. The MP said that “There is a huge chasm now between our Parliament and what goes on in Westminster and the people.” He offered that he was joining Reclaim, “because they respect free speech as the basis for every aspect of our democracy and our society.”
In an interview on Rumble, the dissident MP said that he decided that he had to speak out when vaccines were approved for 6-month-old; this policy was then changed. He believes that his discipline was designed to set an example for MP’s: if you step out of line, you're out. And the MP finds it suspicious that the ideas of the World Economic Forum’s Klaus Schwab was implemented in lockstep around the western world. As an example, the vague “Build Back Better” was promoted in some ways everywhere and all at once.
The Reclaim Party Manifesto
While The Reclaim Party has embraced the medical freedom surge, the byproduct of government emergency responses to COVID-19, the party was launched in 2020 by Lawrence Fox, a British actor and right wing populist activist thanks to funding from Jeremy Hosking, the British businessman and political donor purportedly worth about £375 million. Part of a movement of nationalist-populist tendencies emerging in the developed world over the past several years, that movement may merge with groups challenging the official COVID-19 narratives in the developed world.
The new party has an uphill battle to take on the three dominant parties in the UK: The Conservative Party, Labor Group and the Liberal Democrats.
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17 May, 2023
Leaked Pentagon Report Forensically Dismantled Fauci-Led Natural Origin Study
Researchers at the Department of Defense wrote a devastating takedown of the Proximal Origin study, which was used by Dr. Anthony Fauci as proof that the COVID-19 virus had come from nature.
The takedown, dated May 26, 2020, was written in the form of a working paper called “Critical analysis of Andersen et al. The proximal origin of SARS-CoV-2.” It was authored by Commander Jean-Paul Chretien, a Navy doctor working at the Defense Advanced Research Projects Agency, and Dr. Robert Cutlip, a research scientist at the Defense Intelligence Agency. The paper came to light on May 15, when it was leaked to the public via virus origins search group DRASTIC (Decentralized Radical Autonomous Search Team Investigating COVID-19).
The working paper forensically dismantles the natural origin case made in Proximal Origin and concludes, “The arguments that Andersen et al. use to support a natural-origin scenario for SARS-CoV-2 are based not on scientific analysis, but on unwarranted assumptions.”
The existence of this internal Pentagon paper is crucial, as it proves that government officials were well aware in the early months of the pandemic that there was no evidence in support of a natural origin of the COVID-19 virus. Additionally, given the crushing discrediting of Proximal Origin, Pentagon officials would also have been aware of Fauci’s efforts to seed a false narrative about the origin of COVID-19.
Proximal Origin was initially conceived by Fauci during a secret teleconference held on Feb. 1, 2020. The ostensible purpose of the teleconference was to deflect attention from a possible lab origin of COVID-19 and to shift the focus to a natural origin theory. Fauci directed a number of scientists, led by Kristian Andersen of Scripps Research and Robert Garry of Tulane Medical School, to pen a study that could be used to discredit the lab leak theory. Despite being directly involved in the inception of the paper, as well as in shaping its arguments, Fauci’s role was concealed from the public. Fauci later bestowed Andersen and Garry with lavish taxpayer-funded grants.
The defects in Proximal Origin were immediately noticed by reviewers at science journal Nature. This fact only became known late last year from emails obtained via the Freedom of Information Act by independent journalist Jimmy Tobias. However, with the help of Jeremy Farrar, who now is the chief scientist of the World Health Organization and who had helped Fauci shape the natural origin narrative, Proximal Origin was accepted for publication in Nature Medicine on March 17, 2020. It boldly concluded that no “laboratory-based scenario is plausible.”
On April 17, 2020, President Donald Trump confirmed that the COVID-19 pandemic likely started in a Wuhan laboratory in China. On the same day, while attending a White House press conference, Fauci categorically dismissed the possibility of a lab origin of COVID-19, citing Proximal Origin as corroboration. Fauci feigned independence, telling reporters that he could not recall the names of the authors. What was not known at the time was that Fauci not only knew the authors well, but had personally led the effort to have Proximal Origin written.
Proximal Origin became the media’s go-to natural origin authority, repeating Fauci’s claim that the paper provided dispositive proof that COVID-19 had come out of nature. It also became the most-read article on COVID-19 and one of the most cited academic papers of all time.
Yet, while the public was being told by Fauci and the media that Proximal Origin had settled the origin debate, Pentagon researchers came to a very different conclusion.
Epoch Times Photo
National Institute of Allergy and Infectious Diseases Director Anthony Fauci waits for the beginning of a hearing before the Subcommittee on Labor, Health and Human Services, and Education, and Related Agencies of Senate Appropriations Committee at Dirksen Senate Office Building on Capitol Hill in Washington on May 17, 2022. (Alex Wong/Getty Images)
Chretien and Cutlip found that COVID-19’s features, which Proximal Origin ascribed to natural evolution, were actually “consistent with another scenario: that SARS-CoV-2 was developed in a laboratory, by methods that leading coronavirus researchers commonly use to investigate how the viruses infect cells and cause disease, assess the potential for animal coronaviruses to jump to humans, and develop drugs and vaccines.”
One of those features is COVID-19’s furin cleavage site, which makes the virus particularly infectious in humans. This feature has never been observed in any naturally occurring betacoronaviruses. Proximal Origin claimed that since this feature was not part of any known laboratory-generated virus, it had to have arisen through a “natural evolutionary process.” As Chretien and Cutlip point out, this argument is “not based on scientific analysis but on an assumption that the prior work would have been published if it had been done.”
According to the Pentagon report, a similar argument made in Proximal Origin about COVID-19’s receptor binding domain, the part of a virus that allows it to dock to cells in humans or animals, was “not a scientific argument but rather an assumption of intent and methodology for a hypothesized scientist.”
The Pentagon report also highlights a major logical flaw in Proximal Origin in that it relies on a lack of publications about particular aspects of coronavirus engineering as a reason to conclude that such engineering did not take place. For instance, Proximal Origin claims that “the genetic data irrefutably show that SARS-CoV-2 is not derived from any previously used virus backbone.” As Chretien and Cutlip point out, “The absence of a publication does not mean that the research was not done.”
In what is perhaps the most notable portion of the Chretien and Cutlip paper, the authors note the collaboration between Ralph Baric of the University of North Carolina, a pioneer of gain-of-function experiments, and Shi Zhengli, the director of the Wuhan Institute of Virology. As Chretien and Cutlip point out, Baric and Shi carried out an experiment in 2015 that mirrored how the COVID-19 virus would have been engineered in a laboratory. The direct link between the Wuhan Institute of Virology and the know-how needed to make COVID-19 was not mentioned in Proximal Origin.
While Chretien and Cutlip did not offer a definitive answer on the origin of COVID-19, they concluded that none of the arguments in Proximal Origin lessened the plausibility of a laboratory origin. Proximal Origin claimed to have done the exact opposite.
Given the sweeping nature of the takedown of Proximal Origin, the question is why the public was not told about the Pentagon’s paper, which was fully paid for by taxpayers?
Instead, the Pentagon, which was led at the time by Trump appointee Mark Esper, allowed Fauci’s false origin narrative to fester. One of the two authors, Cutlip, left the Department of Defense in 2021. The circumstances of his departure are not known. Cutlip’s bio states that he is currently a visiting professor at Fairmont State University in West Virginia. The bio also states that Cutlip was part of “the Corona Virus Task Force, providing intelligence to the President of the United States.” It is not known whether Cutlip shared his insights with either Trump or President Joe Biden.
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Feds Fall Woefully Short with COVID-19 Vax Injury Compensation: CICP Director: No Computer Systems!
With almost 12,000 people having filed claims with the Countermeasures Injury Compensation Program (CICP), the vaccine injury compensation scheme established with the national public health emergency, just a few of these injured persons have secured any payment, and those compensated are done so on average at $1,500 per claimant. Mainstream media inches its way into coverage, discussion and commentary.
It is a tragic situation for those injured by vaccines that were often mandated to take. The government, while overreaching in many respects during the pandemic, did little to nothing to anticipate the tens of thousands that would claim injuries. The program is understaffed, and now, a director from the Countermeasure Injury Compensation Program (CICP) told a Georgia-based Congressperson that they had no technology to support the scale up of the program. Also, the CICP program is severely understaffed. Who in the federal government is responsible for this reality?
Most recently, WXIA-TV (11Alive) television station in Atlanta, Georgia, United States, affiliated with NBC covered this disturbing problem. Owned by Tegna Inc. alongside MyNetworkTV affiliate WAT, the piece reveals that only 706 claims have been processed to date, with the vast majority denied.
Enter one case study on the waiting game: Allen Storey. Still recovering after receiving the COVID-19 vaccine two years ago, bills have mounted. Waiting in limbo, 11Alive investigated, discovering that Mike Collins, representing the 10th District of Georgia, demanded to discuss the growing crisis with CICP leadership.
The CICP’s leadership now claims that technology is the core of the problem, writes Rebecca Lindstrom for 11Alive. For example, Collins reports the CICP director program laments the lack of technology to support the scale out of the program:
“They did not even have a computer system in place, a software system to handle people making requests or even inquiring about what their status was, which was what you were talking about in y'all's reporting.”
Although CICP recently launched a claims portal to track claims, they are purportedly requesting $15 million from Congress to “enhance communication” as well as “substantially increase its capacity to review at least 2,000 claims.”
Crisis scenario
This is clearly not enough. While CICP hopes to access technology that can help the federal group scale up to 2,000 claims, this is nowhere near enough. At the current case load rate of claimed COVID-19 vaccine-related injuries, the CICP director informed Congressman Collins that it would take five years to get to them.
In addition to the lack of technology which represents a complete lack of planning on the part of the federal government, Collins reports to 11Alive that “a third of the federal employees have been working from home. And that just doesn't work very well.”
Last year, the CICP funded only 34 positions to deal with over 11,000 claims and now the federal group proposes a budget for an additional 42 full-time employees. But will this be enough?
“You're asking the same questions that we ask,” Collins said. “They don't know how many people they employ; the federal government, these departments, they don't know. And so that's one of the big issues that we have. You're right. Do you have enough people who are inefficient, or do you not have enough people?”
COVID-19 vaccine injured struggling
The plight of the Storey family was featured in this latest piece from 11Alive. With an average payout to date of $1,500 (and just a few persons compensated), Allen Storey’s bills accumulate to what will likely be in the tens of thousands.
What are people injured by the COVID-19 vaccines supposed to do? In many cases they were mandated to get the shots, and that same government compelling the procedure waived all liability of the vaccine manufacturers.
Groups such as React19 have been launched in the private sector to support persons injured by the COVID-19 vaccines. While that nonprofit has recruited a network of now over 20,000 vaccine injured people and over 200 doctors supporting this class of care, this is nowhere near enough to deal with the accumulating demand.
Rebecca Lindstrom reports that likely, most persons injured by the COVID-19 vaccines are not even aware of the CICP program. According to Allen Storey, “I don’t think most people know this program exists. You can probably walk down and 10 out of 10 people don’t know about it. I don’t know how they would find out about it if they weren’t specifically looking for this program. Most doctors don’t even know about it.”
This lack of awareness also represents a problem for persons injured by the vaccines seeking help from the private sector. React19 has often been censored by Facebook, traditionally, the number one social network for patient groups. Why the censorship? A confluence of government, media and social tech companies have collaborated during the pandemic to censor key information including stories about COVID-19 vaccine injuries, even if the information is truthful.
Clearly, the federal government has on the one hand, completely overstepped its boundaries during the pandemic while at the same time, when it comes to caring for the nation’s population damaged by the mass vaccination program they stepped back, doing not nearly enough.
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16 May, 2023
All of a sudden, ivermectin is safe again
Dr. Julie Sladden is writing from Australia:
Has anyone else noticed a pattern around the Covid-related restrictions of the past three years?
Each infringement felt like a wave crashing on the shore of Australian freedoms, which, after a while, would quietly recede into the background with little fanfare, media, or attention. So it was with the introduction of lockdowns, masks, and mandates.
No wonder we’ve all felt ‘at sea’.
On May 3, 2023, the TGA quietly announced it was removing the prescribing restrictions on ivermectin. These restrictions were imposed on September 10, 2021 in an effort to stop doctors prescribing the drug to treat Covid.
These original restrictions were described as an ‘extraordinary intervention’.
Ivermectin is an (actual) ‘safe and effective’ medication with decades of safety data and known side effects. Heck, it’s even on the World Health Organisation’s list of essential medications. At the time, ivermectin was being used by several countries around the world to treat Covid and several studies were in process of being conducted.
But why would the TGA restrict ivermectin? Good question. The reasons given for the amendment to the Poisons Standard include:
A rise in the number of off-label prescriptions of ivermectin.
A significant increase in personal importation of ivermectin into Australia.
Concern that people who had been prescribed ivermectin might believe themselves to be protected and therefore not get vaccinated.
Concern that ivermectin would come into short supply in Australia.
Ivermectin also has the potential to cause severe adverse events, particularly when taken in high doses; though oral ivermectin is generally well-tolerated at recommended doses.
Nowhere, back in September 2021, did the TGA say there had been a rise in serious adverse events associated with ivermectin. The closest the regulator came was stating a ‘potential’ to cause severe adverse events.
Hmm… So, if a therapeutic agent is restricted for ‘potentially’ causing serious adverse events, what happens when a therapeutic agent actually causes serious adverse events?
Let’s move on.
The concern that ivermectin would come into short supply is perplexing. As an ‘off-patent’ drug, ivermectin is incredibly cheap to make (around 55 US cents per course of treatment) and widely available. As one commentator ponders, ‘If the TGA foresaw a potential shortage, why did no one in the Australian government think to phone an order through to Indiamart?’ Another good question.
In light of the above, the rise in number of off-label prescriptions of ivermectin and increase in personal importation is no reason to restrict a medication. These signals should be taken as an indication to investigate (why is it being used and what is the ‘front-line’ experience) and educate (regarding potential side effects). According to Dr Peter McCullough, ‘About two dozen countries have ivermectin as a first-line treatment for Covid in their government guidelines.’ They can’t all be wrong.
Furthermore, the increased prescription and importation heralds another consideration, something prohibition taught our friends across the Pacific: when you prohibit something the people want, you just drive it underground.
The reason that incited me most back in September 2021 was the ‘concern that people who had been prescribed ivermectin might … not get vaccinated’.
So, as the government funneled the Australian people down the ‘vaccine or bust’ pathway with mass coercion, an essentially safe and potentially significant therapeutic option was removed. This was done not because it was causing harm, but because it might stop people from getting the ‘experimental’ injection.
I find this outrageous.
Why? Because in a time of ‘unknowns’, the TGA put its weight behind an injection with minimal safety data over a medication with a known safety and therapeutic profile.
So, in what seems like a miracle, ivermectin is now deemed ‘safe’ again.
‘How can ivermectin go from being a toxic horse de-wormer in 2021 and then be declared to have a low safety risk in 2023?’ asks Pharmacologist and Drug Regulatory Affairs consultant Dr Philip Altman. Yet another good question.
In my opinion, the only reason a therapeutic agent like ivermectin, with a proven track record, should be restricted is a demonstrated safety signal that truly indicates the health of Australians is at risk. To do otherwise makes no sense to me.
Dr Philip Altman takes it further, ‘If the Australian TGA cannot tell the difference between a toxic horse deworming medicine and a potentially life-saving, widely used, essential safe medicine – they should not exist.’
https://www.spectator.com.au/2023/05/all-of-a-sudden-ivermectin-is-safe-again/
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Fired Teachers Who Refused COVID Vaccine to Get Full Reinstatement and Back Pay
Three Rhode Island teachers who were fired for refusing the COVID-19 vaccine have been offered their jobs back with full back pay after reaching a settlement with the school district.
Teachers Stephanie Hines, Brittany DiOrio, and Kerri Thurber were terminated from their positions in Barrington Public Schools after they had requested a religious exemption after the school mandated employees get the vaccine.
Last week, their attorney, Greg Piccirilli, and the school district said they had reached a settlement, allowing the teachers to return to their jobs. They are also each entitled to $33,333 in damages along with their back pay. DiOrio will get $150,000, Thurber will get $128,000, and Hines will receive $65,000 under the agreement.
“The three teachers have the opportunity to return to teaching positions within the Barrington School District should they choose to do so, at the steps they would have been at had they worked continuously,” the Barrington Public Schools district said in a statement on May 11.
In a statement to the Boston Globe, Piccirilli said that his clients are “extremely gratified that they’ve been vindicated in their position,” adding that he will get $50,000 in attorneys fees as part of the settlement. “A lot of people were dismissive and skeptical of their claims at the time,” he told the Boston Globe. “They went through a lot of personal trauma dealing with this. Their faith has gotten them through this.”
Meanwhile, Barrington Public Schools told the Providence Journal that it reached the settlement because the litigation would likely put a drag on the school’s resources and funding. It attempted to distance itself from its own vaccine mandate by claiming that it was dealing with the spread of COVID-19, although there is a growing body of evidence that shows the vaccines do not prevent the spread of the virus.
“Our district was navigating an unprecedented health pandemic and leaned on the important recommendations by the CDC and the Rhode Island Department of Health to ensure the safety of our students and school community,” the Barrington School Committee said Thursday, according to the outlet. “Our then-policy helped combat the pressing public health crisis of the time, while keeping schools open, and [was] one that nearly all faculty and staff adhered to.”
It added that “we determined this ongoing, expensive litigation” would likely continue for a lengthy period of time, and a resolution should be reached because the “administration’s time, and our district’s financial resources, should be spent on the daily work and mission of Barrington Public Schools … our School Committee looks forward to continuing to support this important work.”
Details
The three were first placed on unpaid leave in late 2021 before they were fired in January 2022, according to statements made by the district and the teachers. During a hearing in Barrington in October 2021, DiOrio said that she “did nothing wrong.”
“I have done nothing wrong. This is destroying my future ability to earn a living,” she said of the mandate. “What makes me more of a threat now? Is this how a highly-rated school department treats its people?”
At the time, Sara Rapport, a lawyer representing the School Committee, said that the teachers were violating the school policy for not complying, adding that committees have the plenary authority over school interests. She said that the teachers’ decision not to get vaccinated pose a greater risk to students.
“Teachers have a right not to be vaccinated,” she said in late 2021. “But every decision has consequences. Religious beliefs do not override the health and safety of the community.”
It’s not clear if Thurber, Hines, or DiOrio will return to their previous teaching positions. During an interview with Legal Insurrection, Piccirilli said that the settlement should be seen as a victory for others who were fired because they refused to take COVID-19 vaccines.
“They’ve shown amazing resilience to stick by their faith. A lot of other people with similar situations have gone through this. And hopefully [this resolution] will serve as an example of how others should be vindicated the same way, for sticking up for what they believe in,” he said.
Last year, a Rhode Island Superior Court judge issued a ruling in favor of the three teachers who were fired, saying the district violated the state’s Open Meetings Act laws over their mandating the vaccine. The Barrington School Committee said after the ruling that officials disagree with the judge’s opinion.
“This case is not about whether mandating vaccinations is appropriate. Regardless of the significant political stance which the public may take for or against that issue, the issue here is whether the Barrington School Committee provided sufficient notice before enacting the Emergency Policy on COVID-19 Related Issues in August and September 2021. This Court finds that violations occurred,” Judge Jeffrey Lanphear wrote at the time.
Piccirilli, meanwhile, has said that the school committee did not possess the legal authority to implement a vaccine mandate and asserted it didn’t follow proper procedures in carrying it out. For example, he said that the district didn’t advertise it correctly.
“It’s shocking to me that the rule of law seems to have gone out the window in a lot of these situations,” Piccirilli said in 2021, reported the Globe. “There’s supposed to be a process.”
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15 May, 2023
Officials Neglect Covid Vaccines’ Side Effects
Brianne Dressen was an energetic mom, an avid hiker and a preschool teacher—until she got a Covid vaccine.
Ms. Dressen, 42, was among the first Americans to be vaccinated. She volunteered to participate in AstraZeneca’s trial, and she received her first dose on Nov. 4, 2020, at a clinic in West Jordan, Utah. “I am pro-science and pro-vaccine,” Ms. Dressen says. “I was more than glad to participate in the scientific process.”
But even highly beneficial vaccines can have rare serious side effects. Minutes after the shot, Ms. Dressen’s arm began to tingle, her vision grew blurry, and sounds became muffled. The clinic suggested she see a neurologist, who directed her to the emergency room. The ER couldn’t figure out what was wrong and sent her home.
Her condition steadily deteriorated over the next 2½ weeks. She experienced extreme nausea, diarrhea, dizziness, painful vibrating sensations, pins and needles in her arms and face, numbness, tremors, brain fog, heart palpitations and fever. Physicians were mystified. They diagnosed her with a “silent migraine” and “anxiety due to the Covid vaccine” after a hospital stay. She was provided occupational and physical therapy but spent weeks in bed, unable to tolerate sound, light or even her children’s touch.
In the ensuing months, she faced not only debilitating symptoms but also bureaucratic indifference—though government officials tried to be helpful at first. On Jan. 11, 2021, her husband, Brian, a U.S. Army chemist, contacted Avindra Nath, intramural clinical director of the National Institute of Neurological Disorders and Stroke. Dr. Nath responded immediately that he would discuss her condition with other National Institutes of Health neurologists. He asked for blood and spinal-fluid samples for analysis, and he ominously mentioned that “the current political climate is another aspect that we need to keep an eye on.”
Dr. Nath didn’t elaborate, but by now the politics of the Covid vaccines are familiar. Bitter disputes over mandates fed skepticism of the shots and claims, often false and outlandish, about their dangers. At the same time, public-health authorities, anxious to promote vaccination, played down risks that were real if rare, leaving patients like Ms. Dressen in limbo.
After failed attempts to work remotely with Ms. Dressen’s home medical team, Dr. Nath invited her to an NIH facility in Bethesda, Md., for examination. Physicians there diagnosed her with postvaccine neuropathy and severe postural orthostatic tachycardia syndrome, or POTS, which causes rapid heartbeat on standing up. She was treated with intravenous immune globulin, an infusion of antibodies from healthy donors that can modulate an overactive immune response.
The treatment helped, but symptoms persisted and would wax and wane. She learned that many others were experiencing similar symptoms after getting vaccinated. She organized online support groups, but Facebook shut them down under its “misinformation” policy, which bans information that is “likely to directly contribute to the risk of imminent physical harm, including by contributing to the risk of individuals getting or spreading a harmful disease or refusing an associated vaccine.” This includes “claims about the safety or serious side effects of COVID-19 vaccines”—even, it appears, when such claims are truthful.
The Facebook censorship and government inaction spurred her to launch React19, a “science-based nonprofit offering financial, physical, and emotional support” for people who suffered severe reactions after Covid vaccines. React19 has more than 21,000 members in the U.S. and another 20,000 in 24 international partner organizations. It also has a Facebook page.
“We are not antivax and are neutral on the Covid vaccines,” Ms. Dressen says. “But doctors need to be aware of what’s going on so they can treat patients.” Ms. Dressen and others have pressed the NIH, the Centers for Disease Control and Prevention and the Food and Drug Administration to acknowledge their symptoms so patients don’t feel shunned and can obtain the medical care they need.
Interviews with React19 members and emails they shared with me show that public-health authorities haven’t been transparent about these adverse events. Officials privately expressed concern to patients but kept mum about the issue in public and failed to keep promises to investigate the side effects thoroughly. With the Covid public-health emergency over at last, perhaps they will get the attention they deserve.
Ms. Dressen says NIH officials were initially solicitous. They brought at least a dozen patients like Ms. Dressen to their facilities for tests and treatment as part of an informal study. “Good that you are getting the word out,” Dr. Nath wrote her on June 27, 2021. “Maybe the issue has not received the deserved attention, but there [sic] now an increasing number of publications in the literature documenting the complications. Considering over a billion doses administered, the complications are still rare. From my stand point the important message to get out is that they are treatable, so should treat early or do it in the context of a clinical trial. Keep me posted.”
But the NIH didn’t get the word out. Ms. Dressen kept updating Dr. Nath and his assistant clinical investigator, Farinaz Safavi, about her symptoms. She complained about the cost of her intravenous immune globulin treatments—$2,200 a month out of pocket. She told Dr. Nath that she had communicated with FDA officials, including Peter Marks, head of the Center for Biologics Evaluation and Research, which oversees vaccines.
FDA officials, she told him, were passing the buck to the NIH. “You and I both know that it isn’t fair to your small team there to take on all of these people,” she wrote on Sept. 16, 2021, referring to other patients with postvaccine neurological conditions. “Is there something I am missing with this? Or someone I should be appealing to there at the NIH to encourage further research? Funding for care?”
“Ordinarily when any drug is released it is the manufacturers responsibility to investigate and treat the side effects,” Dr. Nath replied. “Where are the vaccine manufacturers in all of this? Have you tried to contacting [sic] them? It cannot be the government’s responsibility to pick up after them. They are a profit company and they should be the ones taking change [sic]. Don’t you think?”
Ms. Dressen says AstraZeneca offered her $1,243.30 if she agreed to waive “any additional claims.” She turned it down. AstraZeneca says the offer was a reimbursement for medical expenses and tests rather than a legal settlement, and its independent experts determined the injury wasn’t vaccine-related. AstraZeneca’s vaccine was never authorized in the U.S. (It has been in Canada, Europe and the U.K. and is widely used in poor countries.)
Other React19 members I spoke with said they didn’t receive responses from Pfizer or Moderna about adverse-event reports they filed with the companies. A Pfizer spokesperson said its “medical team thoroughly assesses and reviews medical documentation to further understand the event,” and “reports are shared regularly with federal and global regulatory and health authorities for further review.” Moderna didn’t respond to requests for comment.
The U.S. Countermeasure Injury Compensation Program, which covers vaccines and treatments used during public-health emergencies, has received 11,686 Covid-related claims, only 23 of which have been ruled eligible for compensation. React19 members say their claims are under review or have been rejected.
In the fall of 2021, as some Americans resisted vaccination, the Biden administration mandated vaccines for healthcare workers and employees of large corporations. Although it was becoming clear that vaccines didn’t prevent infection, officials claimed mandates were necessary to ensure “employee safety and health.”
At the same time, FDA and NIH officials received a growing number of reports of severe side effects—including from medical professionals who had been among the first to get vaccinated. One was Danice Hertz, a 66-year-old now-retired gastroenterologist in Santa Monica, Calif.
Dr. Hertz received her first Pfizer dose on Dec. 23, 2020. Within 30 minutes, her face began to burn and tingle, her vision grew blurred, and she became lightheaded. She took Benadryl and prednisone at her home to no effect. Over the next 24 hours, she developed intense burning in her face, numbness in her mouth and scalp, chest pain, dizziness, twitching and a feeling that her whole body was vibrating. “I had pain to the degree of screaming out loud.”
She contacted a neurologist at a local hospital, who was flummoxed. “I was in bed for several weeks and barely able to emerge,” she says. After consulting two dozen doctors around the country, she was diagnosed with small-fiber neuropathy, tinnitus, dysautonomia, POTS and mast cell activation syndrome, a condition that causes severe allergic symptoms affecting multiple parts of the body.
Dr. Hertz spent her days in bed searching the internet for a medical explanation: “I was desperately ill. I was unable to get medical care. I was suicidal at times. A lot of others went through this. I wrote goodbye letters to my family. It was too miserable to live with this.”
On Feb. 4, 2021, she stumbled on an article from Neurology Today in which Anthony Fauci sought to correct his earlier recommendation that people with a history of Guillain-Barré syndrome, a rare disorder in which the immune system attacks the nervous system, shouldn’t get vaccinated because it might trigger a recurrence. After drawing pushback from the medical community, Dr. Fauci retracted his statement because it clashed with the CDC. “As soon as the CDC recommendations came out, I began advising people according to the recommendations. I do stand corrected,” he told Neurology Today.
Dr. Hertz posted in the comments section on the article that she developed severe parathesias—pins and needles, a classic symptom of Guillain-Barré and other neurological disorders—30 minutes after vaccination. “Despite my multiple reports to Pfizer, the CDC and FDA, no one has recognized my complication or reported it,” she wrote. “I wonder how many other cases there are like mine.” The FDA has reported a link between Johnson & Johnson’s vaccine and Guillain-Barré syndrome.
She says she filed nine reports with the Vaccine Adverse Event Reporting System, or Vaers, the government surveillance system that is supposed to track possible side effects, and “nobody has ever contacted me.” She also filed reports with Pfizer, which she says didn’t respond.
But two weeks after posting her comment on the journal article, she received an email from Sheryl Ruettgers, who had experienced similar symptoms. Ms. Ruettgers said she also filed a Vaers report and had contacted Dr. Marks of the FDA’s Biologics Center.
“I read a transcript from a web-lecture you gave on 1/29/2021 highlighting your commitment to medical safety as it relates to the vaccine,” Ms. Ruettgers wrote to Dr. Marks on Feb. 21. “I have been unable to find answers and have been frustrated by the lack of transparency as it relates to adverse reactions.” She didn’t receive a response.
Dr. Hertz soon received more emails, including one from Ms. Dressen. They organized an email list and later a Facebook group. In March Dr. Hertz also contacted Dr. Nath and sent her lab work to the NIH for analysis. Dr. Safavi noted in an email to her that more than 1,000 neurological side effects had been reported in Vaers, “but in order to present it to scientific community we have to gather as much information as we can before sending it out.”
“We need to be patient and scientifically follow the appropriate path to br [sic] able to push this work forward,” Dr. Safavi wrote on April 17, 2021. Over subsequent months, Dr. Hertz and Ms. Dressen referred members of their group to the NIH, whose neurologists reviewed patient medical records and helped them obtain treatment.
While NIH scientists were privately validating their vaccine-related injuries, FDA officials had yet to acknowledge them. On May 24, 2021, Ms. Dressen emailed Janet Woodcock, then acting FDA commissioner, attaching letters from 17 other patients detailing their postvaccine nervous-system problems.
Dr. Woodcock replied solicitously: “We take your experiences seriously and are evaluating all reports of adverse events associated with vaccination. I will follow up with individuals who do research into these types of conditions.” She added: “I hear you and understand that you are asking that more attention be directed to what you are experiencing. I will see if more studies can be undertaken. It is not really possible to provide good medical care without understanding what is going on with the patients.”
The correspondence between FDA officials and React19 members continued. Dr. Woodcock responded to each of Ms. Dressen’s emails with compassion and promises to investigate. “I need to get with people who are studying this issue,” she wrote on July 22, 2021. “I know I need to make progress on this and I have been working with the Biologics Center on this issue.”
Dr. Marks also repeatedly assured Ms. Dressen that the agency was investigating and that its reporting systems would identify “safety signals.” “We have a staff of epidemiologists at FDA involved in safety surveillance activities, and these individuals are looking into this,” Dr. Marks wrote on Nov. 12, 2021. “Though I am unable to give you a definitive time when they will be done with their analyses, I will certainly let you know when I hear anything.”
Tired of waiting, React19 began doing its own research. On Jan. 9, 2022, Ms. Dressen sent FDA officials an email with 850 case reports and medical-journal articles related to severe adverse vaccine reactions. She noted that the European agency responsible for regulating vaccines in October identified parathesias as a potential Pfizer vaccine side effect.
“Thanks so much for all of this information,” Dr. Marks replied. “We really appreciate this and will start working through the papers and contacting investigators to better understand things.”
Ms. Dressen kept sending Dr. Marks published research on neurological adverse events, and Dr. Marks kept assuring her the FDA was investigating. FDA leaders regularly met with React19 members. “We were getting lip service over and over again,” Dr. Hertz says.
A senior FDA official told me the agency has strong surveillance systems in place to identify adverse events, including for small-fiber neuropathy, but that it hasn’t detected an increase in neurological cases among Pfizer and Moderna recipients. “For those individuals affected, we can’t confirm or deny. We will continue to work and be receptive,” the official said.
“FDA likes to say there’s no safety signal in Vaers data, but the problem is that it’s not complete,” says Joel Wallskog, a React19 member who practiced orthopedic surgery in Wisconsin before he had a neurological reaction after a Moderna shot.
Because Vaers relies on self-reporting, it is both under- and overinclusive. Some people don’t report adverse reactions that are likely caused by vaccines, while others report events that probably aren’t. Dr. Wallskog says healthcare providers should be mandated to report potential adverse effects to Vaers whether or not they think the vaccine was the cause.
Patients may also report their diffuse neurological symptoms under different headings, making it harder for public-health officials to detect links. Some reports that patients claim to have filed also don’t appear in the public database. A React19 review found that 12% of Vaers reports filed by members had been deleted and 22% lacked a permanent identification number so they weren’t publicly visible.
A CDC spokesperson says that “all reports to Vaers are publicly available and can be examined,” but “due to privacy and confidentiality, CDC cannot confirm which reports have been reviewed and what the review revealed.” For reports classified as serious, CDC says, it requests and reviews all available medical records.
“Serious” is defined as death, life-threatening illness, hospitalization or prolongation of hospitalization, permanent disability, congenital anomalies, or birth defects. A CDC presentation on Jan. 26, 2023, showed that 883 Vaers reports of “pain in extremity” following Moderna and Pfizer bivalent boosters were categorized as nonserious.
“Vaers is not designed to determine if the vaccine caused the reported adverse event,” the CDC spokesperson says. “The determination of the cause of serious adverse events is done by healthcare providers.” But React19 members say the CDC didn’t follow up on their complaints.
Doctors are typically reluctant to ascribe a rare adverse event to a vaccine unless the FDA and CDC validate the association. Postvaccine neurological symptoms are relatively rare, and it is nearly impossible to conclude whether they were caused by the vaccines. Some patients who get infected with Covid also report developing neurological disorders after their illness. It’s unclear if these symptoms are more common after vaccination or infection, or if they have become more common during the pandemic than before.
More than 600 million doses of Pfizer and Moderna vaccines have been given in the U.S., so even a 1-in-100,000 adverse effect would result in 6,000 cases. Postvaccine neurological conditions appear most common in young and middle-aged women, the demographic most prone to autoimmune diseases.
It’s possible vaccines are the proximate but not the ultimate cause—that they trigger autoimmune conditions in patients with underlying genetic predispositions. That hypothesis is bolstered by the observations from the NIH’s informal study, which it published in a preprint paper on May 17, 2022. Of 23 patients studied, the median age was 40, and 21 were women. The paper concludes “that a variety of neuropathic symptoms may manifest after SARS-CoV-2 vaccinations and in some patients might be an immune-mediated process.” An NIH spokesperson says the observational study has concluded. In an April 25, 2023, article for the journal Neurology, Dr. Nath wrote that “there is a great need to conduct research for identifying the underlying factors and subcellular mechanisms that result in the neurological manifestations from vaccines.”
Ms. Dressen says institute scientists stopped corresponding with React19 members at the end of 2021. “Sorry, we do not have any clinical trial for such vaccine related complications. It is best for such patients to receive care from their local physicians,” Dr. Nath wrote Ms. Dressen on Dec. 15, 2021.
The NIH says the FDA and CDC are best able to address questions and concerns about possible vaccine side effects and that its clinical center is a research hospital, not a routine medical center.
FDA officials continued to meet and correspond regularly with React19 members until this past December. They still haven’t warned the public about potential vaccine-related neurological complications. “FDA has made us many, many promises, and I think they’ve followed up on one or two,” Ms. Dressen says. Public-health officials, she adds, have misled the public by claiming they have a robust system to identify rare adverse events from vaccine: “I trusted that these programs that they are telling the public are there, but they are not.”
Officials may worry that recognizing severe side effects will fuel vaccine opposition and hesitancy. But the lack of transparency can only feed public distrust. And the lack of recognition “has left us as further collateral damage from the pandemic,” Ms. Dressen says.
One silver lining is that advocacy is giving purpose to the lives of those who have been harmed. “I worked 12- to 14-hour days as a physician,” Dr. Hertz says. “Now I have a new job—advocating for the injured, helping them get medical care and treatment. People contact me every day. So I feel like I am helping and using my medical background to help people. This new job honestly saved my life.”
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14 May, 2023
Messenger RNA COVID-19 Vaccines Had No Effect on Overall Mortality: Trial Data Reanalysis
The Pfizer and Moderna COVID-19 vaccines did not impact overall mortality, a reanalysis of clinical trial data found.
The two vaccines, both based on messenger RNA (mRNA) technology, protected against deaths from COVID-19 but that effect was offset by vaccinated trial participants being more likely to die from cardiovascular problems, Christine Stabell Benn, a health professor at the University of Southern Denmark, and other researchers reported in April in the Cell journal.
On the other hand, vaccines that utilized adenoviruses, such as the Johnson & Johnson vaccine, had a favorable impact on both COVID-19 mortality and overall mortality, according to the reanalysis.
The research analyzed data from randomized clinical trials (RCTs) reported by the companies that manufacture the vaccines.
“In the RCTs with the longest possible blinded follow-up, mRNA vaccines had no effect on overall mortality despite protecting against some COVID-19 deaths. On the other hand, the adenovirus-vector vaccines were associated with lower overall mortality,” researchers said.
“The differences in the effects of adenovirus-vector and mRNA vaccines on overall mortality, if true, would have a major impact on global health,” they added later.
Study
Benn and colleagues took data from three RCTs for the mRNA vaccines and six RCTs for the adenovirus-vector vaccines that had mortality data available. They compared the overall deaths in the vaccinated arms with the placebo arms. They also broke deaths down into different categories: attributed to COVID-19, cardiovascular problems, other non-COVID-19 causes, accidents, and non-accident, non-COVID-19 causes.
“We extracted the number of deaths from the studies that led to approval of the new mRNA and adenovirus-vector COVID-19 vaccines. We calculated the relative risk of dying, overall, and for various causes of death, for each vaccine type,” Benn told The Epoch Times in an email.
The Pfizer and Moderna vaccines, the researchers found, were associated with lower COVID-19 mortality but higher cardiovascular and non-accident, non-COVID-19 mortality. There was no difference in overall mortality between the vaccinated arms and the placebo groups.
The Johnson & Johnson vaccine was associated with lower overall mortality and with lower non-COVID-19 mortality, with no effect on COVID-19 mortality. AstraZeneca’s shot, never authorized in the United States but cleared in some other countries, performed well against overall mortality and other categories across several trials, except for one trial where slightly more vaccinated people died from non-COVID causes or non-accident, non-COVID-19 causes.
“The results suggest that adenovirus-vector vaccines compared with placebo have beneficial non-specific effects, reducing the risk of non-COVID-19 diseases. The most important cause of non-COVID-19 death was cardiovascular disease, against which the data for the current RCTs suggest that the adenovirus-vector vaccines provide at least some protection,” researchers said.
They noted that trial populations were largely healthy adults and that in the real world, even mRNA vaccines were expected to reduce overall mortality. But “the intriguing differences in the effects on non-accident, non-COVID-19 mortality are likely to persist and should be investigated in future studies,” they added.
Overall mortality spiked in a number of highly vaccinated countries after the vaccines were rolled out, including the United States. Researchers are divided as to the causes, with some arguing the vaccines primarily drove the increases and others blaming COVID-19 and other factors.
The study was published ahead of peer review in 2022, but the authors struggled to find a journal that would accept the paper, Benn said. Several journals rejected it without explaining why, causing a delay in publication.
Immune System Impact
Several experts complimented the paper. “This is a good article that raises food for thought,” Dr. Peter Gotzsche, professor emeritus and director of the Institute for Scientific Freedom in Denmark, told The Epoch Times via email.
Gotzsche wrote about research conducted by Peter Aaby, one of Benn’s co-authors, in his book “Vaccines: Truth, Lies, and Controversy.” Some of Aaby’s other papers have supported the hypothesis that live attenuated vaccines like adenovirus vectors help decrease overall mortality while vaccines that contain the killed version of a germ that causes a disease increase total mortality.
Such “unexpected results” can complicate public health messaging, Gotzsche wrote.
Previous research, including a 2013 paper from Benn and Aaby, has suggested that some vaccines provide non-specific effects, or increased protection against unrelated pathogens. They posited that the adenovirus-vector COVID-19 vaccines might “prime the immune system in a way similar to a ‘live’ vaccine,” while noting that the Pfizer and Moderna vaccines increase inflammation, which could lower the immune system’s protection against other illnesses.
Benn, Aaby, and other experts said in a separate paper in April that the current framework for testing and regulating vaccines needs to be updated because of how vaccines may impact the risk of contracting unrelated diseases.
Criticism
Dr. David Boulware, a professor of medicine at the University of Minnesota’s Medical School, was among the critics of the new study. He told The Epoch Times in an email that it was poorly designed because of differences in where the trials were conducted. That’s because some countries, such as the United States, have better health care, he said.
The researchers acknowledged that might be true in the limitations section, writing that “differences between the study populations in the RCTs of the two vaccine types could have biased the comparison as different disease patterns and level of care could have influenced the measured effect of the vaccines on overall mortality.”
The researchers added: “More individuals were infected with COVID-19 in the mRNA RCTs than in the adenovirus-vector vaccine RCTs, but there were more COVID-19 deaths in the adenovirus-vector RCTs. This suggests that participants in the mRNA RCTs may have had access to better health care during COVID-19 infection, and this may have reduced the impact of mRNA vaccination on overall mortality.”
Boulware also said that real-world data “does not support the conclusions of the paper,” pointing to observational data from Israel and Minnesota. “Clearly the mRNA vaccines protect better against COVID than adenovirus vector vaccines,” he said.
Benn said the study was “built on a meta-analysis of placebo-controlled RCTs—the highest degree of evidence in the evidence pyramid.” and that the key point of focus was overall mortality.
“He is discussing COVID-19—we are studying all-cause mortality,” Benn said. “It is irrelevant if a vaccine protects better against COVID-19 than another vaccine, if it reduces overall mortality to a lesser degree—unless you think that COVID is worse than death.”
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Judge Orders FDA to Speed Up Release of COVID-19 Vaccine Trial Data From 23.5 Years to Just 2
A federal judge in Texas this week ordered the Food and Drug Administration (FDA) to make public data it relied on to license COVID-19 vaccines—Moderna’s for adults and Pfizer’s for children—at an accelerated rate, requiring all documents to be made public by mid-2025 rather than, as the FDA wanted, over the course of around 23.5 years.
In a decision hailed as a win for transparency by the lawyer representing the plaintiffs (the parents of a child injured by a COVID-19 vaccine) in a lawsuit (pdf) against the FDA, the Texas judge ordered the FDA to produce the data about ten times faster than the agency wanted.
“Democracy dies behind closed doors,” is how U.S. District Judge Mark Pittman opened his order (pdf), issued on May 9, which requires the FDA to produce the data on Moderna’s and Pfizer’s COVID-19 vaccines at an average rate of at least 180,000 pages per month.
The FDA had argued it would be “impractical” to release the estimated 4.8 million pages at more than between 1,000 and 16,000 pages per month, which would have taken at least 23.5 years.
Aaron Siri of Siri & Glimstad, who represents the plaintiffs in the legal action against the FDA, called the decision “another blow for transparency and accountability” that builds on an earlier court order targeting Pfizer’s COVID-19 vaccine data for those aged 16 and older.
The January 2022 order (pdf), also issued by Pittman, forced the FDA to produce all its data on Pfizer’s COVID-19 vaccine for those aged 16 and older at a rate of 55,000 pages per month, or much faster than the 75 years the agency had sought.
“That production should be completed in a few more months,” Siri said in a statement, referring to the earlier Pfizer data for those aged 16 and up.
The latest order requires the FDA to produce all of its data on Pfizer’s COVID-19 vaccine for 12- to 15-year-olds (and Moderna’s product for adults) by June 31, 2025.
‘Stale Information Is of Little Value’
While the judge noted in his order that the court recognizes the FDA’s limited resources dedicated to freedom of information requests (FOIA), he argued that “the number of resources an agency dedicates to such requests does not dictate the bounds of an individual’s FOIA rights.”
“Instead, the Court must ensure that the fullest possible disclosure of the information sought is timely provided—as ‘stale information is of little value,'” Pittman wrote.
In order to ensure the FDA can meet the accelerated deadline—so around ten times faster than the agency wanted—the judge ordered the parties to the lawsuit to confer and submit a joint production schedule for the data by May 23, 2023.
In the earlier case adjudicated by Pittman, the FDA had argued it only had the bandwidth to review and release around 500 pages per month of an estimated total 450,000 pages of material about the Pfizer COVID-19 vaccine for those aged 16 and older.
The FDA has not disputed in either case that it has an obligation to make the information public but it has argued that its short-staffed FOIA office could not meet the pace of production sought by the plaintiffs.
The judge disagreed, arguing in both cases that the imperatives of transparency and accountability are of paramount importance.
In the January order, Pittman said that too much foot-dragging and secrecy on the part of federal agencies feeds conspiracy theories and reduces the public’s trust in government.
Confidence in the FDA over COVID-19 vaccine approvals was shaken by the disclosure that regulators sped up the approval of Pfizer’s vaccine.
Republicans on the House Select Subcommittee on the Coronavirus Pandemic in March announced they were seeking answers after recently released emails indicated that the FDA rushed the approval of COVID-19 vaccines and boosters to accommodate vaccine mandates.
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11 May, 2023
The shocking refusal of medical treatment to the unvaccinated
Vicki Derderian desperately needs a lifesaving heart. She suffered from heart failure in 2020 before doctors inserted a ventricular assist device, a mechanical pump that circulates blood to help both sides of her heart function. However, she has been turned away by the Alfred Hospital in Melbourne because of vaccine mandates which are still enforced by the Victorian government.The Hospital insists that she must receive the Covid vaccine even though Vicki has a permanent vaccine exemption provided by the Australian Technical Advisory Group (ATAGI). As reported, the Hospital has refused to recognise her permanent vaccine exemption. ‘They want her to have three vaccines so they can do surgery on her.’Vicki, a wife and a mother of three, has not been vaccinated because of concerns that her medical condition makes her unsuitable to receive a Covid vaccination. She insists that she is not an ‘anti-vaxxer’ and only decided against such a vaccine after ‘reading up on all the information’. Indeed, Dr Peter McCullough, a leading and renowned cardiologist, agrees with her that ‘under no circumstances’ should she, or any heart transplant patient, receive a Covid vaccine ‘because of the damage it can do to the heart’. According to him, ‘if Vicki’s heart sustains any more damage it is almost certainly going to be lethal’. This is so because evidence shows that heart damage can be caused by an mRNA vaccine.Vicki’s reluctance to receive vaccinations, especially in her perilous condition, is a sensible and understandable response to the realisation that Covid vaccines remain experimental and their long-term effects on its recipients are largely unknown. Dr Jessica Rose, a Canadian researcher with multiple degrees in immunology, computational biology, molecular biology, and biochemistry, says that, while conventional vaccines take approximately 10 years to be available in the market, the Covid mRNA vaccines were rushed through clinical trial testing in less than a year. According to her, ‘these trials were basically the foundations upon which all the decisions were made and the mantra that we’ve been hearing for three years, “safe and effective”, were based on’.The rigid enforcement in Victoria of its vaccine mandate in hospitals is reminiscent of its ‘no jab, no job’ mandate. While such a mandate destroys the livelihood of people, withholding medical care may be a matter of life or death. In this context, Ed Yong, in a perceptive article published in The Atlantic, argues that ‘medical care should be offered according to the urgency of a patient’s need, not the circumstances leading up to that need’. Carla Keirns, a professor of medical ethics and palliative medicine at the University of Kansas Medical Center, told Yong that it is a fundamental medical principle that ‘everyone has an equal claim to relief from suffering, no matter what they’ve done or haven’t done’.The refusal to operate upon Vicki is a baffling and despotic example of bureaucratic decision-making. Even the Australian Human Rights Commission, on its website, encourages service providers ‘to carefully consider the position of vulnerable groups in the community before imposing any blanket Covid vaccination policies or conditions’.In addition, the Australian Medical Council’s Good Medical Practice: A Code of Conduct for Doctors in Australia stipulates, in Article 2.4, that decisions about patients’ access to medical care ‘need to be free from bias and discrimination’ and exhorts doctors not to prejudice the care of their patients on the ground that ‘a patient’s behaviour has contributed to their condition’. Relevantly, the Code also states that even if a patient poses a risk to their treating doctors and staff, ‘a patient should not be denied care’ if reasonable steps can be taken to protect the treating staff.Indeed, a refusal to treat a patient because of their vaccine status adversely affects the democratic principle of equality before the law. The deliberate exclusion of unvaccinated Australians from life-saving medical treatment discriminates against them on the ground of vaccine status. In other words, if the unvaccinated face such serious restrictions of fundamental rights to bodily autonomy and lifesaving medical treatment, these restrictions directly violate the principle of equality before the law. Accordingly, in Leeth v Commonwealth, Justice Deane and Justice Toohey argued that ‘the essential or underlying theoretical equality of all persons under the law and before the courts is and has been a fundamental and generally beneficial doctrine of the common law and a basic prescript of the administration of justice under our system of government’.Furthermore, even international law fully recognises that certain inalienable rights must never be violated. Accordingly, the right of an individual to refuse vaccination is codified in the Nuremberg Code, an ethics code. This Code has as its first principle the willingness and informed consent by the individual to receive medical treatment or to participate in an experiment. To deny a patient much needed medical assistance – a potentially life-saving transplant – because she did not give consent to vaccination, constitutes a gross violation of this Code.To make Vicki’s plight worse, scientists have now discovered that mRNA vaccines, not Covid infection itself, may cause brain and heart damage. For instance, a study published in October 2022 in the journal Vaccines reports the fascinating results of the autopsy of a patient who had no history of Covid infection. The article provides compelling evidence that the patient’s death was directly caused by the mRNA vaccine. ‘In the heart, signs of chronic cardiomyopathy as well as mild acute lympho-histiocytic myocarditis and vasculitis were present. Although there was no history of Covid for this patient, immunohistochemistry for SARS-CoV-2 antigens (spike and nucleocapsid proteins) was performed’.Dr Young Dong, a medical doctor who has more than 20 years of experience in virological and immunological research, believes that, at the general population level, the risks of imposing vaccine mandates substantially exceeds the benefits. According to John Ionnidis, professor of medicine and epidemiology at Stanford University, the average rate of death for Covid, when adjusted from a wide age range and unreported cases, could be as low as to that of influenza. According to him, more than 80 per cent of those who get the virus have no symptoms or these symptoms are actually very mild. In fact, even the World Health Organisation (‘WHO’) acknowledges that ‘most people infected with the virus will experience mild to moderate respiratory illness and recover without requiring special treatment’.Jennifer Margulis and Joe Wang report that, in the 2021-22 period, there has been a sudden and unexplained surge of age-inappropriate deaths in at least 30 countries in the industrialised world. They refer to research undertaken by Ed Dowd for his book Cause Unknown: The Epidemic of Sudden Deaths in which he argues that ‘the sudden deaths in young people in industrialised countries are due to mRNA vaccines’. Relevantly, Dowd shows that ‘the number of excess deaths in America attributed to Covid in 2020 was actually much lower than the huge spike in sudden deaths that began in 2021 after the Covid vaccines started being widely distributed’.With such low risks for most people, why is the entire population of Australia being coerced to be vaccinated with Covid vaccines? This is especially so given the potential for side effects which can lead to death, as is demonstrated by the dramatic surge in sudden deaths in countries around the world, including Australia, Canada, the United States, and the United Kingdom, of which many have been causally related to mRNA vaccines.Australia closely followed World Health Organisation’s guidelines since the start of the pandemic. By the end of 2021, the nation reached a vaccination rate of 80 per cent of the population. Despite having such an impressive vaccination rate, last year, 174,000 deaths were registered in Australia, which is 20,000 more than projections estimated. This represents the highest number of excess deaths on record since the end of the first world war.These excess deaths are mostly related to cancer and heart issues, including heart failure, stroke, atrial fibrillation, myocardial infraction, and heart disease. The U.S. Centers for Disease Control and Prevention has acknowledged that the evidence shows that mRNA vaccines have caused many types of heart conditions, including myocarditis. Myocarditis is a condition that inflames and weakens the heart muscle, which can result in death. In fact, a considerable number of blind-reviewed academic papers have directly linked these vaccines with a higher risk of myocarditis, and even Pfizer scientists now acknowledge that there may have been increased cases of myocarditis after vaccination. Dr Ross Walker, a practicing cardiologist with 40 years of clinical experience, believes that mRNA vaccines are ‘very pro-inflammatory’, and so they should never have been mandated. On 24 November 2022, he stated the following about such vaccines and heart conditions:I don’t think we should be having the mRNA vaccines. I’ve seen in my own practice as a private cardiologist 60-70 patients over the past 12 months who have had similar reactions to this. Whether it’s pericarditis or the more serious myocarditis. I’ve seen a lot of people get chest pain, shortness of breath, heart palpitations.Dr Kenji Yamamoto, a cardiovascular surgeon who works at Okamura Memorial Hospital in Shizuoka, Japan, recently called for the discontinuation of Covid booster shots. In a letter to the peer-reviewed journal Virology, he explains that he and his colleagues have ‘encountered cases of infections that are difficult to control’ including some that occurred after open-heart surgery and were still not under control after several weeks of treatment with multiple antibiotics. ‘As a safety measure, further booster vaccinations should be discontinued,’ Dr Yamamoto wrote.Given the already known potential harms of mRNA vaccines, the decision of the Alfred Hospital to force Vicki to receive such vaccination regardless of her health conditions is plainly wrong and not scientific. It is now patently clear that mRNA vaccines prevent neither infection nor transmission. Speaking on these very vaccines, a member of the Australian Technical Advisory Group on Immunisations (ATAGI), now acknowledges that ‘the more doses you get, the less benefit you derive from them and then we start to worry about causing side effects’.The latest research confirms that mNRA vaccines are not being able even to stop the spread of the disease. Those who are vaccinated can still catch and transmit Covid. As evidence of the inefficacy of these vaccines, in a study supported by Centers for Disease and Prevention contracts, members of the Upper Midwest Regional Accelerator for Genomic Surveillance founded by the Rockefeller Foundation, concluded that vaccinated people can still catch and transmit Covid and, once infected, the vaccinated are as likely to infect others as the unvaccinated.In other words, these Covid vaccines do not stop transmission of the virus, and the protection provided at best is very limited. Dr Jayanta Bhattcharya, a professor of medicine, economics, and health research and policy at Stanford University, believes that, from a medical perspective, the necessary conditions for vaccine mandates are not present. If a vaccine fails to stop disease transmission, then ‘the idea that you need to vaccinate other people so that I’m protected is just false’, he says.These sobering scientific facts militate against the imposition of vaccine mandates and make the refusal to treat people like Vicki particularly odious.With such high risks for some people, particularly those with heart conditions, why is Vicki being forced to be vaccinated with defective Covid vaccines? Indeed, the Alfred Hospital, which is owned by the State Government, has denied Vicki a place on the transplant list because she has not received Covid vaccines. They are trying to force a person in desperate need of a heart transplant to get a vaccine that has known cardiac side effects, in order to get a heart transplant!To add insult to injury, as mentioned above Vicki actually has a legitimate vaccine exemption which the hospital is deliberately choosing to deny. In an attempt to get the authorities to respect her vaccine exemption, Vicki and her husband, John, have asked Senator Ralph Babet to raise her case in the Senate, which he did. ‘We’re being pushed in the corner and coerced to take something that goes against what we believe in, or not receive lifesaving treatment,’ she says. She has recently applied to the Victorian Civil and Administrative Tribunal (VCAT) to have her case heard. Let’s hope that justice finally prevails, and Vicki can undergo a desperately needed heart transplant regardless of her vaccination status.https://www.spectator.com.au/2023/05/the-shocking-refusal-of-medical-treatment-to-the-unvaccinated**************************************************
10 May, 2023
Another blow for the statin religion: Negligible benafit found from taking statins
Evaluating the Association Between Low-Density Lipoprotein Cholesterol Reduction and Relative and Absolute Effects of Statin Treatment
Paula Byrne et al.
Abstract
Importance The association between statin-induced reduction in low-density lipoprotein cholesterol (LDL-C) levels and the absolute risk reduction of individual, rather than composite, outcomes, such as all-cause mortality, myocardial infarction, or stroke, is unclear.
Objective To assess the association between absolute reductions in LDL-C levels with treatment with statin therapy and all-cause mortality, myocardial infarction, and stroke to facilitate shared decision-making between clinicians and patients and inform clinical guidelines and policy.
Data Sources PubMed and Embase were searched to identify eligible trials from January 1987 to June 2021.
Study Selection Large randomized clinical trials that examined the effectiveness of statins in reducing total mortality and cardiovascular outcomes with a planned duration of 2 or more years and that reported absolute changes in LDL-C levels. Interventions were treatment with statins (3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors) vs placebo or usual care. Participants were men and women older than 18 years.
Data Extraction and Synthesis Three independent reviewers extracted data and/or assessed the methodological quality and certainty of the evidence using the risk of bias 2 tool and Grading of Recommendations, Assessment, Development and Evaluation. Any differences in opinion were resolved by consensus. Meta-analyses and a meta-regression were undertaken.
Main Outcomes and Measures Primary outcome: all-cause mortality. Secondary outcomes: myocardial infarction, stroke.
Findings Twenty-one trials were included in the analysis. Meta-analyses showed reductions in the absolute risk of 0.8% (95% CI, 0.4%-1.2%) for all-cause mortality, 1.3% (95% CI, 0.9%-1.7%) for myocardial infarction, and 0.4% (95% CI, 0.2%-0.6%) for stroke in those randomized to treatment with statins, with associated relative risk reductions of 9% (95% CI, 5%-14%), 29% (95% CI, 22%-34%), and 14% (95% CI, 5%-22%) respectively. A meta-regression exploring the potential mediating association of the magnitude of statin-induced LDL-C reduction with outcomes was inconclusive.
Conclusions and Relevance The results of this meta-analysis suggest that the absolute risk reductions of treatment with statins in terms of all-cause mortality, myocardial infarction, and stroke are modest compared with the relative risk reductions, and the presence of significant heterogeneity reduces the certainty of the evidence. A conclusive association between absolute reductions in LDL-C levels and individual clinical outcomes was not established, and these findings underscore the importance of discussing absolute risk reductions when making informed clinical decisions with individual patients.
https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2790055
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Local and Private COVID Vaccine Mandates at Health Care Facilities Being Reversed, Struck Down Across US
Efforts to overturn vaccine mandates for both hospital patients and health care workers appear to be gaining momentum across the United States.
In what’s seen as a major victory for transplant patients who didn’t take the COVID-19 vaccine, one of the largest transplant centers in the United States reversed its policy to require the vaccine in order to be eligible for an organ transplant.
The University of Michigan (UM) announced its new policy on May 4, just before court proceedings started in a lawsuit filed against it for declaring patients ineligible for an organ transplant unless they agreed to receive the vaccine.
The suit was filed on behalf of several patients by David Peters of Pacific Justice Institute, who, in celebrating the reversal, simply said “We’re winning!”
According to a written statement by UM, “new information” led to the “voluntary decision” to reverse its policy.
“The University hereby gives notice to the Court that in light of developing epidemiological and other actuarial circumstances, effective April 27, 2023, it has changed its Transplant Center COVID-19 Vaccination Requirement for Adult Transplant Candidates,” the statement reads. “Relevant to this litigation, COVID-19 vaccine will no longer be required prior to wait-listing of potential adult solid organ transplant recipients.”
The UM decision came on the same day that a federal judge chastised Maine Assistant Attorney General Kimberly Patwardhan for filing a motion to dismiss a lawsuit filed on behalf of health care workers who lost their jobs for refusing to get the COVID-19 vaccine.
“You obviously have not been reading the U.S. Supreme Court precedent on this or else you would not have filed your motion to dismiss,” Judge Sandra Lynch said to Patwardhan.
Lynch made the comments during oral arguments in the case before a three-judge panel of the 1st Circuit Court of Appeals in Boston. The case is being argued by Matt Staver, founder of Liberty Counsel, on behalf of the health care workers.
In addition to the ban, Maine Gov. Janet Mills also threatened to revoke the licenses of all health care employers who fail to mandate the COVID-19 vaccine for all workers.
Maine is one of six states—along with New York, California, Connecticut, West Virginia, and Mississippi—that banned religious exemptions from vaccine mandates.
In April, in Mississippi, in what many parents opposed to vaccines are hoping will become a national precedent, a federal judge ruled that outlawing religious exemptions from vaccines, including school-required immunization, was unconstitutional and ordered the provision restored.
Such rulings follow a Supreme Court decision that found that it’s discriminatory for states to consider other kinds of exemptions from the vaccine while denying religious ones.
However, Peters said he believes that the SCOTUS ruling is only part of the reason hospitals are starting to voluntarily reverse COVID-19 vaccine mandates.
Peters, who holds a doctorate in medical sociology and a master’s in medicine, said the hospitals are starting to own up to the reality that the vaccines are “if not hurtful, useless.”
He has several other pending cases against transplant centers that have denied patients a spot on a list, including some in need of life-saving heart transplants, because they weren’t vaccinated against COVID-19.
Peters said he’s planning to file “tons” more across the country.
Liberty Counsel has also partnered with lawyers in states including Florida to bring similar lawsuits on behalf of patients and health care workers.
Florida attorney Jenna Vasquez represents nursing students on behalf of Liberty Counsel in pending litigation against their colleges for refusing to let them complete their clinicals unless they get the COVID-19 vaccine.
“And yet we are being told we are in a nursing crisis,” she told The Epoch Times.
In Maine, another group, Health Choice Maine, has filed a separate lawsuit on behalf of EMTs who were fired for not taking the vaccine.
The Mills administration continues to enforce the mandate for EMT workers despite a critical shortage of technicians and drivers in Maine, which has the largest elderly population in the United States.
One of the largest U.S. hospitals has also been taken to court over its denial of religious exemptions from the COVID-19 vaccine.
Oral arguments are scheduled for May 10 in a case against Mass General Brigham in Boston.
In the lawsuit, 159 workers question why the hospital granted 230 employees religious exemptions but denied their requests. The hospital cited “hardship” as the reason but didn’t explain what it meant, the complaint shows.
The hospital has filed a summary judgment asking the court to dismiss the case.
Massachusetts attorney Ryan McLane of McLane & McLane, a law firm affiliated with Liberty Counsel, is representing the 159 health care workers in the case.
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Increased Risk of Serious Eye Problem After COVID-19 Vaccination: Study
People who received a COVID-19 vaccine have an increased risk of a serious eye problem, according to a new study.
The risk of retinal vascular occlusion “increased significantly” after a first or second dose of the messenger RNA (mRNA) COVID-19 vaccines, researchers reported in a study published by Nature.
The Pfizer and Moderna COVID-19 vaccines both use mRNA technology.
Retinal vascular occlusion refers to the blockage of veins or vessels that carry blood to or from the retina. It can cause sudden vision loss.
Out of 207,626 Pfizer vaccine doses administered in the population that was studied, 226 cases of the eye problem were detected after two years. Among 97,918 Moderna vaccine doses administered, 220 cases were detected over the same time.
While some cases were detected among AstraZeneca recipients, the risk wasn’t statistically significant.
The risk of retinal vascular occlusion was 3.5 times for vaccinated people compared to an unvaccinated group after 12 weeks and 2.19 times higher after two years. An increased risk was found shortly after vaccination.
“We demonstrated a higher risk and incidence rate of retinal vascular occlusion following COVID-19 vaccination, after adjusting for potential confounding factors,” Chun-Ju Lin, an eye doctor, and other Taiwanese researchers reported in the study.
Patients on medications that could alter blood osmolarity should be especially aware of the risks identified in the study, although further research is needed to figure out whether COVID-19 vaccines actually cause the eye problem, the researchers said.
They drew data from TriNetX, a global network, and adjusted the results with a model that included excluding people with a history of retinal vascular occlusion.
Limitations include not confirming the accuracy of diagnoses listed in the system
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9 May, 2023
NIH Clinical Investigator Acknowledges Rare Neurological-Related Injuries Associated with COVID-19 Vaccines: What Are You Going to Do About It?
Avindra Nath, M.D. knows a thing or two about the COVID-19 vaccines and the neurological issues, although rare, that may ensue. Far earlier in the pandemic when the AstraZeneca vaccine was still undergoing testing in clinical trials, a group of patients including React19 co-founder Brianne Dressen engaged with Nath and others at the National Institutes of Health (NIH). Dressen and some others experienced neurological problems associated with the AstraZeneca COVID-19 vaccine.
In fact, as myriad issues emerged with that experimental product the decision was made to not consider that particular COVID-19 vaccine for distribution as a countermeasure under the Emergency Use Authorization. Nath and others conducted an observational study that was never peer-reviewed, uploaded to the preprint server medRxiv and essentially forgotten.
TrialSite reported on the study where Nath and colleagues emphasized that more time was necessary for scientists and physicians to determine the true nature of any causal relationship between the COVID-19 vaccines and neuropathies. So, lots of time has passed—what more does the NIH Principal Investigator have to say on the topic?
It should be noted that during those early days of the pandemic not only Nath via his National Institute of Neurological Disorders and Stroke (NINDS), part of the NIH but also representatives from other federal agencies such as the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) were aware of these early reports of neurological-related vaccine injuries.
Brianne Dressen has explained to TrialSite that numerous upbeat promises were made by the agencies to support the COVID-19 vaccine injured with research and access to care. But particularly after the political winds blew hard as 2020 transitioned to 2021, with the outgoing Trump administration fiasco, the January 6th uprising, plus Biden’s new intensified focus on vaccination, it led to the worst possible political storm impacting the vaccine injured, raising questions about the COVID-19 vaccine or unbelievably just claiming an industry tarnished a person in the eyes of many. Essentially the topic was intensely politicized and remains so. In some societal circles, it’s a taboo topic, one that can divide what were friends, even family.
In Nath’s most recent article in the journal Neurology titled “Neurologic Complications with Vaccines: What We Know, What We Don’t, and What We Should Do” Nath, an NINDS Senior Investigator highlights first the impact of vaccination generally over the last half century, nearly eradicating potentially deadly infections that in days gone by were constantly taking lives. He is correct. Vaccination has played a vital role in individual and collective health despite the trendiness of elements in the medical freedom movement to deny that reality.
However, Nath and most in positions of influence and power in health-related research today treat vaccines as if they were all alike. But they are not. Importantly, not all vaccines are the same, even when the FDA has approved them as safe and effective. But it’s as if this classification immediately delegitimizes any critique of these medicinal-based products. An either-or false dilemma narrative is set up. Either you believe that it's universally good or you don’t. But that’s not how the real world works, especially with medical products with side effects.
The reality is that some vaccines have better safety track records than others, and at least historically, the vaccines that we have that are tried and true have a lengthy development lifecycle and several iterations of advancement.
The number of vaccines on the CDC childhood schedule continues to grow. As of this writing, there are 18 vaccines on the CDC’s Child and Adolescent Immunization Schedule for children from birth to 18 months, and this includes the COVID-19 vaccine. Importantly, the particular version of the vaccine now in circulation remains experimental (investigational) in that only the bivalent Omicron BA.4/BA.5 product became available as recently reported by TrialSite.
There are another 18 vaccines on the CDC’s schedule from the age of 18 months to 18 years. While many of these vaccines remain a bedrock of personal and public health, TrialSite continues to have questions about the placement of the COVID-19 vaccine, again, still investigational (despite the licensure that did occur with the monovalent product), on the childhood vaccination schedule from birth to 18 months.
Nath in his generally cursory piece emphasizes that despite an evolution toward more sophisticated vaccines (mRNA or protein-based) and “well-defined” manufacturing process (see Emergent BioSolutions fiasco for glaring examples of production problems with the COVID-19 vaccines) he acknowledges that well, “despite such measures, vaccines are not without side effects including those that impact the nervous system.”
So, there is an explicit acknowledgment that neurological issues are present, at least on rare occasions. A wealth of information exists in various monitoring systems today, yet as will be noted below Nath calls for a more complex reporting scheme, involving global platforms, with full industry buy-in. A tall order that in all reality is years away. What about people with debilitating conditions today?
Nath points to “numerous case reports and case series” implying “possibilities” of such potential serious adverse events. But the NIH scientist isn’t squaring with the American public. The “React19 Scientific Publications & Case Reports,” database houses a collection of 3,400 peer-reviewed case reports and studies involving post-COVID-19 vaccine reports of serious adverse events. Including 24 therapeutic categories, the repository includes 628 studies associated with neurological issues associated with post-COVID-19 vaccine adverse events. 628 studies, even if only case series, is a lot and should be well studied, reported on and translated to the clinic to educate and empower more doctors and health care professionals to help patients. Isn’t that what it’s all about?
The NIH scientists remind all of the universal immunity the U.S. government grants to bio-pharmaceutical companies developing vaccines during the national public health emergency under the Public Readiness and Emergency Preparedness (PREP) Act. Industry, and in fact, the entire value chain of vaccination from pharma companies to healthcare clinics has absolutely no liability associated with the mass vaccination campaign during the emergency. Any compensation for injury must come from what TrialSite has identified as a dismal failure—the Countermeasures Injury Compensation Program (CICP). To date, despite over 11,000 claims only three have been awarded. This is an outrageous reality. This demonstrates the government’s intention, which is to leave the vaccine injured to fend for themselves.
Importantly, vaccine makers generally don’t have liability for any injuries even before COVID-19. That dismissal of liability emerged with the National Childhood Vaccine Injury Act of 1986 which shifted liability from industry to government under the National Vaccine Injury Compensation Program (VICP)---an alternative to traditional products liability and medical malpractice litigation for people injured by the receipt of one or more standard childhood vaccines. While VICP is far better than CICP, it as well needs to be updated and modernized.
Nath reminds us of all that the government is busy monitoring for COVID-19 vaccine injuries thanks to both the “active and passive surveillance programs” in place by the CDC and FDA (think VAERS). TrialSite has reported on heretofore not conceivable volumes of adverse event reports in the VAERS system. Yet we are constantly reminded that despite the fact that the system was billed as a key to monitor for safety signals, VAERS doesn’t do much to help us because causation isn’t proven. This is true, however, when the incidence is reported in VAERS just one or two days after the administration of the COVID-19 vaccine the probability of some causal connection markedly increases, all things being equal.
With 672 million doses of COVID-19 vaccines administered in the United States from December 14, 2020, through March 1, 2023, serious adverse events are indeed rare. But they are occurring. Out of the 19,476 preliminary reports of deaths associated with the vaccines a substantial percentage of these occurred shortly after vaccination. Again, that doesn’t mean the vaccine triggered the death. But deaths are occurring—we have been reporting on them around the world. Some nations such as Taiwan and Singapore seem to have more reasonable and responsible government compensation schemes as compared to the United States, United Kingdom and Canada.
Nath continued in his journal entry, “While most side effects of vaccines are benign and transient, such as headache or fatigue, more serious side effects, including devastating neurological complications may occur.”
So, what does Nath propose to do to help this vulnerable population? Where is the health equity agenda in this case? According to his paper, “future research” is necessary to better understand the neurological complications of the COVID-19 vaccines (which he acknowledges involve other vaccines as well
Nath is also big on working to build influential, global monitoring systems with complete industry buy-in. Does he understand how difficult, how time-consuming the realization of such a vision entails?
What about the patients with vaccine injuries struggling now? Does he care about this vulnerable population? Nowhere therein does Nath really address what to do with the COVID-19 vaccine-injured population today.
The stakes here are bigger, more severe given the intense mandates and societal pressures that emerged during the pandemic, along with what was clearly federal agencies playing fast and loose with the law. True informed consent for example wasn’t really practiced during the pandemic in most cases. Although classified as rare, considerable risks continue to be associated with the COVID-19 vaccines, particularly for certain cohorts (Myocarditis for young men as an example), but during the emergency, the specter of catching COVID terrified the society far more than the rare prospect of an injury, which most likely would be mild.
At TrialSite we continue to carefully monitor the topic, and while we cannot prove our vaccine-injured estimations, we consider them reasonable. The extent to the scope and scale of the vaccine-injured population varies depending on point of view, outrageously, often even political point of view given the overall politicization of the topic.
We’ll simplify and call out two extremes—the so-called medical freedom movement extreme and the mainstream medical establishment, which we believe systematically suppresses accurate insight into the topic.
While the more extreme groups classified as “anti-vax” may declare millions have died from the COVID-19 vaccines in all reality there is no real evidence to make this claim. Any algorithms used to generate such high numbers are quite suspect and not validated anywhere. We are concerned by the growing tendency toward sensationalism to drive attention and eyeballs and in many cases monetization among the anti-vax crowd.
On the other hand, from a mainstream point of view, government estimates may vary but there is no formal, systematic research on the matter, at least that we are aware of. The government has only acknowledged a few deaths associated with the COVID-19 vaccines even though nearly 20,000 were registered in VAERS (again that doesn’t mean they are connected to the vaccine).
At least some of the research Nath proposes in his paper has been suppressed, or even shut down. There isn’t much money in studying COVID-19 vaccine injuries. And this is unlikely to change barring some extreme unforeseeable changes.
TrialSite reminds all that in the United States 270 million people alone received their primary series and based on nearly 2.5 years of ongoing monitoring of data and study sources worldwide, we estimate that a range from anywhere from half a million to 2 million people are struggling with material health issues that persist since the administration of the COVID-19 vaccine. We acknowledge that not all of these are because of the vaccine solely—long COVID and other issues very well could be factors. It’s a complex difficult situation for those that are struggling, ill, in pain and left to fend for themselves in most cases.
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Climate misinformation from "The Guardian"
Leftist organ quick to misallocate blame
The Guardian Australia has made multiple corrections to content it published about misinformation and Sky News Australia.
The online news outlet published a podcast titled, “Fox News and the consequences of lies with Lenore Taylor”, only to later amend it after making false claims relating to Sky News.
A note published on the Guardian’s website underneath the podcast by Taylor, the editor of the Guardian Australia, read: “An earlier version referred to adverse findings by the Australian Communications and Media Authority against Sky News Australia in respect of programs containing misinformation ?about C?ovid-19,” the correction states.
“This was incorrect.
“The programs were broadcast by Foxtel Cable Television Pty Limited on the Daystar channel.”
The embarrassing correction comes just one week after the Guardian also made false claims in relation to complaints lodged with the media regulator, the Australian Communications and Media Authority.
The complaints were made about content relating to commentary by Sky News Australia host Rowan Dean on climate science, however the article incorrectly said the complaints were made by “Australians for a Murdoch Royal Commission”.
In a statement on its website it later corrected the record to state the complaints were made by former prime minister Kevin Rudd.
“This article was amended on 28 April 2023 to clarify that the initial complaints to ACMA were made by Kevin Rudd personally, not by Australians for a Murdoch Royal Commission,” the correction said.
A Sky News Australia spokeswoman said in a statement: “This latest factual error is particularly ironic given the purported expertise of the presenters on the podcast, discussing misinformation.”
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8 May, 2023
COVID-19 Vaccine Effectiveness Drops Near Zero Within Months
The effectiveness of COVID-19 vaccines fell below 20 percent a few months after vaccination, with booster shots seeing effectiveness drop below 30 percent.
The review, published in the JAMA Network journal on May 3, analyzed 40 studies estimating vaccine effectiveness (VE) over time against laboratory-confirmed COVID-19 infection and symptomatic disease. The studies were selected from 799 original articles, 149 reviews published in peer-reviewed journals, and 35 preprints. The review found that the vaccine effectiveness of a primary vaccination cycle against the Omicron infection and symptomatic disease was lower than 20 percent at 6 months from the administration of the last dose.
Booster doses restored vaccine effectiveness to levels similar to those seen after administration of the primacy cycle dose. However, nine months after the booster dose, vaccine effectiveness against Omicron was found to be lower than 30 percent against infection and symptomatic disease.
“The half-life of VE against symptomatic infection was estimated to be 87 days for Omicron compared with 316 days for Delta. Similar waning rates of VE were found for different age segments of the population.”
“These findings suggest that the effectiveness of COVID-19 vaccines against laboratory-confirmed Omicron or Delta infection and symptomatic disease rapidly wanes over time after the primary vaccination cycle and booster dose,” the study said.
“Putting together the bulk of available evidence on the waning of VE over time against COVID-19 variants has crucial implications for future interventions and vaccination programs.”
Effectiveness by Vaccine Brand
Vaccine effectiveness against Omicron infection was 44.4 percent a month after the completion of the primary vaccination cycle. This fell to 20.7 percent at six months and then to 13.4 percent at nine months. Vaccine effectiveness was found to be higher against the Delta variant as compared to the Omicron variant.
“Pooled estimates of VE after any primary vaccination cycle against symptomatic disease after Omicron infection show a marked waning over time,” the study stated.
Effectiveness against symptomatic disease fell from 52.8 percent a month after completion of the primary vaccination cycle to 14.3 percent at six months and 8.9 percent at nine months.
“Our estimates suggest that the initial VE could be different depending on the vaccine product, with higher VE found at one month from the second dose administration for Moderna and Pfizer-BioNTech compared with AstraZeneca and Sinovac.”
With regard to age, vaccine effectiveness was found to be similar in younger and older age groups against the Omicron variant infection.
No “significant differences” were observed between the two age groups regarding vaccine effectiveness against Delta variant infection. “A significantly lower VE was found for both age groups for Omicron compared with Delta,” it stated.
Vaccine Harms
COVID-19 vaccines have been known to lead to several medical conditions. One study that examined 9,500 women found that those who had taken COVID-19 shots had a slightly higher risk of heavier menstrual bleeding. In the study, 40 out of 1,000 women saw bleeding increase after just a single dose of a vaccine.
Earlier research from the same team had found that the length of the menstrual cycle increased by 3.7 days on average among women who had taken two doses of COVID-19 vaccines compared to those who hadn’t taken a shot.
According to a study from February published in the British Medical Journal, heart failure and deaths have occurred among those who have taken COVID-19 shots.
Researchers found that more people experienced myocarditis after COVID-19 vaccination than after being infected by the virus. Myocarditis is a type of heart inflammation.
A March report from Phinance Technologies, a global macro investment firm co-founded by former BlackRock portfolio manager Edward Dowd, estimates that COVID-19 vaccine damages in the United States resulted in more than 26 million people being injured last year, with such injuries costing almost $150 billion to the economy.
Misleading Effectiveness Claims, Compensation for Injuries
Texas Attorney General Ken Paxton is also looking at whether Pfizer, Moderna, and Johnson & Johnson misrepresented the efficacy of their COVID-19 vaccines.
According to Paxton, the companies may have violated the Texas Deceptive Trade Practices Act, which bars people intending to sell a product from disseminating a statement that they know “materially misrepresents the cost or character of tangible personal property, a security, service, or anything he may offer.”
It also bans representing that a product is “of a particular standard, quality, or grade … if they are of another.”
Paxton has asked the three companies to submit relevant documents and information, including any concerns with regard to the vaccine trials.
Meanwhile, letters from U.S. officials that were reviewed by The Epoch Times show that authorities rejected multiple individuals who had sought compensation for injuries suffered as a result of taking a COVID-19 shot despite diagnoses from doctors.
One such individual is agricultural pilot Cody Flint who began suffering from adverse reactions to Pfizer’s COVID-19 vaccine after taking a shot. Four doctors confirmed that his medical complication, including experiencing intense head pressure, were linked to the COVID-19 vaccine.
Flint sent the medical files to the U.S. Countermeasures Injury Compensation Program (CICP), which is tasked with compensating people who prove that they were injured due to getting vaccinated against COVID-19.
However, CICP rejected Flint’s claim, saying that it did not find the “requisite evidence” necessary to prove that his health issues were caused by the Pfizer vaccine.
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Delirium Cases in the Elderly After COVID-19 Vaccination
The elderly are a particularly vulnerable population to COVID-19 infection so they were prioritized when it came to the COVID-19 vaccination. However, we now know that COVID-19 vaccines might also on rare occasions cause some adverse events. One of these that has been reported is delirium, and it appears to affect mainly the elderly. TrialSite previously reported on the neurological side effects of COVID-19 vaccines. This article will summarize a case series that reports delirium in the elderly after COVID-19 vaccines.
Delirium is characterized by poor concentration, disorientation, paranoia, memory loss, agitation and sometimes hallucinations. The presentation of these symptoms varies from person to person and symptoms may also involve sleep problems and behavioral disruptions such as hyper or hypoactivity. The symptoms of delirium should not be explained by any other neurocognitive condition but rather by an underlying medical problem. Causes of delirium can vary widely from stress to anesthesia due to surgery.
The case series
Researchers conducted the study at a nursing home (NH) with 514 beds during the period of COVID-19 vaccination for the residents. Participants were 70 years and older. Participants who had positive COVID-19 results or who had a history of alcoholism, were nonverbal, were deaf or blind, or could not speak English were excluded.
After the participants had been recruited, they were examined for conditions that could cause a change in their health status. The study considered vaccination against COVID-19 as a condition that might affect the health status. A day after the vaccination, participants were tested using the Confusion Assessment Method-Severity (CAM-S) instrument, a method used to assess the severity of delirium symptoms. A random sample was selected based on the results of CAM-S. After the initial selection, participants completed a more structured assessment involving the following:
Severe Impairment Battery?8 (SIB?8), a brief assessment method for people with severe Alzheimer’s disease.
The Montreal Cognitive Assessment (MoCA), a screening test for mild cognitive impairment (MCI). This condition is characterized by a cognitive decline that does not affect an individual’s daily functioning but is still noticeable to others.
The Confusion Assessment Method (CAM), a method to use to identify delirium.
Researchers diagnosed delirium using the criteria listed in the Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM?5), a reference manual for the diagnosis of mental illness and neurocognitive disorders, based on the residents’ test results at baseline and after vaccination. The participants were diagnosed either with delirium or subsyndromal delirium, defined as a condition where one shows delirium symptoms but does not meet the DSM-5 criteria.
Demographic information was also collected from the participants including:
Previous delirium history
Presence of dementia
Presence of MCI
Results
The study involved 40 participants; 39 of them had their third dose of the COVID-19 vaccine and one received the second dose.
Demographic information was as follows:
The average age of the participants was 82 years.
45% of them were males.
13% of the ethnicity was Latino/Hispanic and non-Whites were 43%.
65% of the participants had dementia and 35% had MCI.
18% of the participants had a previous history of delirium.
Out of the 40 participants, 10% showed symptoms; three showed delirium (7.5%) a day after the vaccination and one participant was diagnosed with subsyndromal delirium (2.5%). A day after the vaccination, these four participants had increased CAM-S scores and decreased MoCA scores compared to their baseline scores.
Within two weeks participants’ scores went back to normal and delirium was resolved. SIB-8 scores also showed the same pattern.
Among 26 people with dementia, three (26%) experienced delirium; among 14 cases without dementia, one (7%) experienced delirium, among seven cases of participants with a previous history of delirium, none experienced delirium after the COVID-19 vaccine, and among 33 participants without a previous delirium history, four (12%) experienced delirium.
https://www.trialsitenews.com/a/delirium-cases-in-the-elderly-after-covid-19-vaccination-927f9650
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7 May, 2023
Do Vaccinations INCREASE the Risk Of COVID Infection?
A study from a distinguished medical organization says they do. The study has however generated a lot of hysteria, as you might expect. See
The criticisms of it are largely ad hominem so should be disregarded. The claim that the study is ONLY a preprint should also be disregarded. I have read the study and see that it is perfectly orthodox in methodology with no obvious flaws.
The real limitation of the study is a familiar one in epidemiologcal research: There is no clear causal chain. We have to ask WHY some people had more vaccinations than others. Perhaps because they had reason to be nervous about their health. So the findings could simply indicate that people with more health concerns got more Covid. Simple
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German Study Claims Mask Wearing May Be Harmful
Exposure to Carbon Dioxide (CO2)
The study claims wearing face masks may raise the risk of stillbirths, testicular dysfunction and cognitive decline in children. According to the study, “Fresh air has around 0.04% CO2, while wearing masks more than 5 min bears a possible chronic exposure to carbon dioxide of 1.41% to 3.2% of the inhaled air. Although the buildup is usually within the short-term exposure limits, long-term exceedances and consequences must be considered due to experimental data. US Navy toxicity experts set the exposure limits for submarines carrying a female crew to 0.8% CO2 based on animal studies which indicated an increased risk for stillbirths. Additionally, mammals who were chronically exposed to 0.3% CO2 demonstrated a teratogenicity with irreversible neuron damage in the offspring, reduced spatial learning caused by brainstem neuron apoptosis and reduced circulating levels of the insulin-like growth factor-1. With significant impact on three readout parameters (morphological, functional, marker) this chronic 0.3% CO2 exposure has to be defined as being toxic.”
The study was done as part of a scoping review where literature was “systematically” reviewed regarding CO2 exposure and facemask use. The study also says, “Circumstantial evidence exists that extended mask use may be related to current observations of stillbirths and to reduced verbal motor and overall cognitive performance in children born during the pandemic. A need exists to reconsider mask mandates.” The research team acquired data from 43 previous studies of mask-wearing and pregnancy. Apparently, mask-wearing creates a “dead space” that traps CO2 leading to more inhaled and rebreathing of the gas.
Conclusions are questioned
The researchers looked at studies focusing primarily on mice and rats, and that appears to be one of the main issues with the research because the data was taken from animals and not humans. Researchers also noted none of the studies they looked at involved mask use, miscarriages or infertility and neurodevelopment disorders. They also said that the exact effects of toxic levels of CO2 on unborn life are not known in great detail.
Additionally, the lead researcher of the analysis, Kai Kisielinski, who describes himself as an “independent researcher” has written other papers claiming mask wearing may cause significant health problems. Kisielinski is also a surgeon in Dusseldorf, Germany. Since the beginning of the Covid pandemic there has been a debate about mask-wearing. Now it seems an argument has been introduced claiming mask-wearing may be unhealthy. There appears to be one constant with the Covid pandemic. It continues to foster divisiveness and debate.
https://www.trialsitenews.com/a/german-study-claims-mask-wearing-may-be-harmful-faa40d71
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Un-informed consent
Dr Julie Sladden
‘I had my shots but I’m not having any more’ is a phrase I’ve heard more than once.
A little over a year ago – I know, it feels longer – thousands marched the streets of Australia protesting the mandates. I was one of them.
In many cases, the mandates were facilitated through emergency powers enacted by the state governments. But some sectors (for example Universities) and employers (for example airlines) brought the mandates in all by themselves.
It makes me wonder, if the government and employers tried it on again, how many would march the streets in protest now?
This is an important question as none of the legislative powers that made the ‘mandate nightmare’ possible have been wound back. And only a handful of workers have successfully defeated the mandates.
Meanwhile, the mandate hangover continues…
I recently received a call from a worker who was ‘mandated’ to have a booster. They wanted to discuss options.
‘Just say no,’ I offered. A simple option, possibly not without consequence, but one I would place top of my list. Saying ‘no’ in the current climate is far more likely to be accepted than it was twelve months ago. And I know people who have successfully done so, without losing their jobs.
But there’s something more important at stake: who owns your body?
I asked the caller, ‘Do you really want to continue to work for an employer who is going to require you to have a jab every six months just so you can earn a living?’
It’s a question we should all ask because under those conditions, there is no bodily autonomy (that is, your employer owns your body) and it’s impossible to give legally valid informed consent. Being coerced into having a jab, to keep your job, is not informed consent. It’s the antithesis of informed consent.
In considering the requirements for legally valid informed consent – which can only be given voluntarily and in the absence of undue pressure, coercion, or manipulation – it becomes clear that anyone ‘mandated’ is unable to give informed consent. Why? Because mandates and informed consent are mutually exclusive. If someone is being told they have to have a jab to keep their job then informed consent is not possible, regardless of whether they are willing to receive it for those reasons.
Many understood this, and the seriousness of the new ‘no jab, no pay’ territory we were entering. Tragically, thousands of people walked from jobs and careers that spanned decades, in what might be the biggest government-enforced-mass-exodus of a skilled working population. Even more tragically, hundreds of thousands, perhaps more, were coerced into having the jab to keep their job. And let’s not talk about those who were injured or worse.
This, in a so-called ‘free’ country.
Informed consent was not just ‘impossible’ for the mandated. I have serious doubts about whether anyone in Australia gave informed consent to the Covid injections.
Let me explain.
During the Covid years, Australians were subject to politicians and medical technocrats who told us how miserable our lives were going to be if we didn’t get vaccinated. The disgust was tangible, and the message was clear. Somehow we allowed Australian authorities to subject us to the ‘largest clinical trial, the largest global vaccination trial ever’ despite treaties, agreements, and codes of conduct that are supposed to protect against such things. I believe the ’95 per cent’ Covid ‘vaccination’ rate was achieved through undue pressure, coercion, and manipulation of the Australian population.
Were you told you wouldn’t be able to attend weddings, funerals, birthdays, social events, schools, or community services if you didn’t get vaccinated? Undue pressure.
Were you told that you would be unable to work, return home, travel, visit sick relatives, enter a hospital, or obtain medical care if you didn’t get vaccinated? Coercion.
Were you told it was your duty, your social contract, and a way to ‘love your neighbour’ by getting vaccinated? Manipulation.
‘The vast majority of people taking vaccines did it under duress,’ said Dr. Peter McCullough on his recent visit to Australia. ‘They did it under duress. They had to try to keep their job or maintain their position … and my heart is broken that so many people have taken the vaccine, and so many have been harmed.’
This same pattern of pressure, coercion, and manipulation was seen around the world.
In the UK, the Lockdown Files revealed how the government employed military-grade psyop-style strategies to make sure they ‘frightened the pants off everyone’ into compliance.
‘You’ve got to look at the definition of coercion,’ explains UK Doctor of Psychology Christian Buckland. ‘The Encyclopedia Britannica states, “It’s the threat or use of punitive measures against states, groups or individuals in order for them to undertake or desist from specified actions… and those threats include psychological pressure and social ostracism.”’
Buckland continues, ‘This is really important because the (Lockdown Files) prove that psychological pressure was applied to the public. That means any consent to immunisation that was given, whether they asked you or didn’t, or if you agreed or didn’t agree … was not valid.’
‘So what?’ you may ask. Well, if consent was not valid then who is accountable?
Buckland explains, ‘One of the most important questions that is going to emerge from this issue is going to be one of accountability and liability for all the people who have been greatly injured or been left bereft, because of the Covid vaccine. Because they gave their consent for an injection that they couldn’t give consent to. There has to be some form of accountability, based on the fact that no one could give informed consent.’
This issue of informed consent is about so much more than bodily autonomy. It is inextricably linked to medical freedom… and more.
‘Your medical freedom is inextricably linked to your social freedom and your economic freedom,’ says Dr McCullough. ‘When that medical freedom is broken, and you begin to do things to your body for other reasons, outside of medicinal reasons, it infringes upon these other circles of freedom, and this can cascade down. We have to bring ourselves out of this.’
I agree.
We, the people, need to re-draw the line in the sand. The line where the government ends and our bodily autonomy begins. The ‘informed consent’ line.
Informed consent isn’t some optional extra in medical ethics. It is foundational in medicine and foundational to freedom.
Without it, we lose far more than the right to refuse an experimental jab.
https://www.spectator.com.au/2023/05/un-informed-consent
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5 May, 2023
The Dangerous Illusion of Scientific Consensus
Science is the process by which we learn about the workings of material reality. Though modern innovations—built on the fruits of science—would look like magic to people living only decades ago, they result from the time-tested scientific method. Contrary perhaps to media portrayals of science, the scientific method depends not on the existence of a mythical consensus but rather on structured scientific debates. If there is a consensus, science challenges it with new hypotheses, experiments, logic, and critical thinking. Ironically, science advances because it believes it has never arrived; consensus is the hallmark of dead science.
One of us is a college student with an unpremeditated career in alternative indie journalism. The other is a professor of health policy at Stanford University School of Medicine with an M.D., a Ph.D. in economics, and decades of experience writing on infectious disease epidemiology. Despite the wealth of differences in our backgrounds and experiences, we converge on foundational scientific and ethical principles that public health authorities abandoned during the COVID pandemic. Principles like evidence-based medicine, informed consent, and the necessity of scientific debate serve as the bedrock on which the public can have confidence that science and public health work for the benefit of the people rather than regardless of it.
The illusion of scientific consensus throughout the COVID-19 pandemic led to disastrous policies, with lockdowns the primary example. It was clear even on the eve of the lockdowns in 2020 that the economic dislocation caused by them would throw tens of millions worldwide into food insecurity and deep poverty, which has indeed come to pass. It was clear that school closures—in some places lasting two years or longer—would devastate children’s life opportunities and future health and well-being wherever they were implemented. The emerging picture of catastrophic learning loss, especially among poor and minority children (with fewer resources available to replace lost schooling), means that lockdowns will fuel generational poverty and inequality in the coming decades. And the empirical evidence from places like Sweden, which did not impose draconian lockdowns or close schools and which have among the lowest rate of all-cause excess death in Europe, suggests that lockdowns failed even narrowly to protect population health during the pandemic.
The illusion of consensus around the proper use of the COVID vaccines was another major public health disaster. Public health officials everywhere touted the randomized trials on the COVID vaccines as providing complete protection against getting and spreading COVID. However, the trials themselves did not have the prevention of infection or transmission as a measured endpoint. Rather, the trials measured protection against symptomatic disease for two months after a two-dose vaccination sequence. Prevention of symptomatic infection is obviously a distinct clinical endpoint from prevention of infection or transmission for a virus that can spread asymptomatically. In the fall of 2020, Moderna chief medical officer Tal Zaks told The BMJ, “Our trial will not demonstrate prevention of transmission … because in order to do that, you have to swab people twice a week for very long periods, and that becomes operationally untenable.”
Despite these facts, public health officials botched the public health messaging surrounding the COVID vaccines. Based on an illusion of scientific consensus, public health authorities, politicians, and the media pushed vaccine mandates, vaccine passports, and vaccine discrimination. Prominent officials, including Anthony Fauci and CDC Director Rochelle Walensky, told the public that science had established that COVID vaccines stop transmission. CNN anchor Don Lemon advocated for “shaming” and “leaving behind” unvaccinated citizens from society. Meanwhile, neuroscientist Sam Harris—who has built a well-earned reputation of intellectual honesty and ethical integrity—openly demonized the unvaccinated male waiters at a restaurant as deranged conspiracy theorists in a 2021 episode of his podcast, Making Sense. Countries such as Italy, Greece, and Austria sought to punish their unvaccinated citizens with heavy financial penalties of up to $4,108. In Canada, the government stripped unvaccinated citizens of their rights to travel anywhere via plane or train and their ability to work at banks, law firms, hospitals, and all federally regulated industries.
The premise was that only the unvaccinated are at risk of spreading COVID. An illusion of consensus emerged that getting the shots was a required civic duty. Phrases such as “It’s not about you, it’s to protect my grandparents” became widely popularized. Ultimately, as people observed many vaccinated people around them contract and spread COVID, the public trust in these authorities collapsed. Early last month, the Biden administration extended its foreign traveler mRNA vaccine requirement to May 11th (which is now coming to an end) after the restriction was set to expire on April 11th. None of these policies ever had any scientific or public health rationale or epidemiological “consensus” to support them—and they certainly do not in 2023.
Related errors are overstating the necessity of the COVID vaccine for the young and healthy and downplaying the possibility of severe side effects, such as myocarditis which has been found mainly in young men taking the vaccine. The primary benefit of the COVID vaccine is to reduce the risk of hospitalization or death upon COVID infection. There is more than a thousand-fold difference in the mortality risk from COVID infection, with children and young & healthy people facing an extremely low risk relative to other risks in their lives. On the other hand, the mortality risk for older people from infection is considerably higher. So the maximum theoretical benefit of the vaccine is meager for young, healthy people and children, while it is potentially quite high for elderly people with multiple comorbid conditions.
Institutional public health and medicine ignored these facts in the push to vaccinate the entire population, regardless of the balance of benefits and harms from the vaccine. Public health appropriately prioritized COVID vaccines for the most vulnerable groups—the elderly, the immunocompromised, and others. Meanwhile, public health should have cautioned young and healthy people regarding the uncertainty regarding vaccine safety for a novel vaccine. For the young and healthy, the small potential benefit does not outweigh the risk, which—with the early myocarditis signals—turned out not to be theoretical in nature. A rigorous independent analysis of Pfizer and Moderna’s safety data shows that mRNA COVID vaccines are associated with a 1 in 800 adverse event rate—substantially higher than other vaccines on the market (typically in the ballpark of 1 in a million adverse event rates).
To maintain an illusion of consensus, public health authorities and media thought it necessary to suppress these facts. In June 2021, for instance, Joe Rogan stated healthy 21-year-olds do not need the vaccine. Despite his correct medical judgment which has indisputably stood the test of time, all sectors of the corporate media and social media platforms unanimously pilloried him for spreading “dangerous misinformation.”
Worse, many people who suffered from legitimate vaccine injuries were gaslighted by the media and medical personnel about the cause of their condition. One of us has devoted the past several months interviewing victims of the illusory scientific consensus that COVID vaccines are on net beneficial for every group. For example, there is a 38-year-old law enforcement officer in British Columbia who was coerced into vaccination against his conscience to keep his job. Nearly two years later, he remains disabled from vaccine-induced myocarditis and has been unable to serve his community. National data from countries in France, Sweden, Germany, Israel, and the United States shows a substantial rise in cardiac conditions among younger populations after the distribution of the COVID vaccine.
The illusion of consensus surrounding COVID vaccination—wrongly viewed in the same light as hand-washing, driving within speed limits, or staying hydrated—has led to greater political divisions and discriminatory rhetoric. The failure of the traditionally well-regarded public health agencies like the FDA and CDC—with perverse influences from pharmaceutical companies in tandem with the powerful forces of censorship on social media—has destroyed trust in public health institutions. Disillusioned with the “illusion” of consensus, a growing number of Americans and Canadians are distrustful of scientific consensus and are beginning to question all things.
The project of science calls for rigor, humility, and open discussion. The pandemic has revealed the stunning magnitude of the political and institutional capture of science. For this reason, both of us—Rav and Jay—are launching a podcast devoted to investigating the concoction of pseudo-consensus in science and its ramifications for our society.
https://www.theepochtimes.com/the-dangerous-illusion-of-scientific-consensus_5243068.html
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Why all the unexpected deaths?
Late on Friday 28 April, the Australian Bureau of Statistics (ABS) released its Provisional Mortality update. It’s a time-honoured practice known in media circles as ‘taking out the trash’ although in this case it should probably be called ‘burying the bodies’.
Why the ABS bothers hiding the bad news is a mystery since the mainstream media’s reflex response is to avert its gaze from anything that challenges the official Covid narrative. This is understandable if inexcusable. Nobody likes to admit they were wrong. The mainstream media has spent the last two-and-a-half years repeating the government mantra that the Covid vaccines are safe and effective and still supports vaccine mandates even though it is blindingly obvious that the vaccines failed to end the pandemic, prevent people from getting ill or dying and have caused injuries and death.
This week even the Biden administration announced that it would the drop its Covid vaccine mandate from 12 May for healthcare workers in facilities certified for Medicare and Medicaid services, federal employees and contractors, and international air travellers. It is the last Western nation to ban unvaccinated visitors apart from micro nations such as Puerto Rico and Palau and bastions of liberty and science such as Pakistan, Libya and Turkmenistan.
As for the latest ABS data, it quietly reveals some deadly truths. The best that can be said of it is that mercifully there weren’t as many deaths this January as last January, although even that isn’t true for women aged less than 45. Their death rate was higher this January than last. Overall, deaths were more than 12 per cent above the baseline average. That’s a 10.5 per cent improvement on January 2022 but still 1,605 deaths more than expected and only 731 of those people died of Covid. Were these deaths part of a pandemic of the unvaccinated? Nobody has mentioned that phrase for more than a year so it seems safe to deduce that there is no evidence supporting that assertion.
What about the other 874 people who died unexpectedly in January? This is where it gets interesting. The ABS has created a whole new category called ‘other cardiac conditions’. Deaths in this group were 18.2 per cent above the baseline average in January 2023. That’s only 1.4 per cent below the number recorded in January 2022.
And what sort of deaths do you suppose were included in the new group? They look like vaccine deaths; healthy people who died suddenly and didn’t have chronic cardiovascular disease. The deaths were caused by acute myocarditis and pericarditis which are both recognised side effects of the Covid mRNA vaccines. They also include deaths caused by cardiomyopathies, cardiac arrhythmias and heart failure all of which can be caused by myocarditis – inflammation of the heart – if it is left untreated. Unfortunately, it often is left untreated because people may feel fatigue, shortness of breath or chest pain or they may feel nothing at all. Yet even when myocarditis is asymptomatic it can still cause heart failure, heart attack, stroke, arrhythmia and sudden cardiac arrest particularly after strenuous exercise or in the early hours of the morning while sleeping. Ever since the vaccines were rolled out professional and amateur athletes have been dropping dead in disconcerting numbers as have other seemingly healthy young people. Now there is an ABS category that captures that group with heart failure the number one cause of death killing 264 people in January and cardiac arrhythmia in second place, responsible for 206 deaths.
Deaths due to dementia are more than 14 per cent above the baseline average. Deaths due to Lewy body dementia and fronto-temporal dementia have been added to the category to reduce the number of uncategorised deaths, increasing dementia deaths by 3 to 4 per cent. One explanation for the rise in dementia deaths is that the vaccine-induced spike protein can cross the blood brain barrier causing neuro-inflammation and releasing pro-inflammatory cytokines that can accelerate disease progression in Alzheimer’s, Lewy body dementia and fronto-temporal dementia.
Cancer deaths – the biggest single disease group in the report – are up by 4.3 per cent above the baseline average. What might explain this? Dr. Angus Dalgleish, Professor of Oncology at St George’s University of London wrote to the British Medical Journal last November reporting that he was seeing people with stable cancers rapidly progress after being forced to have a booster, usually so they could travel. He dismissed the notion put forward including by the TGA that this was simply a coincidence since the same pattern is being reported in the US and Germany as well as Australia. Rather, he hypothesised that the suppression of the innate immune system which occurs after Covid mRNA vaccination is allowing blood and lymph cancers and melanomas to progress that are normally held in check by the immune system. And that is before consideration of reports that the spike protein, produced in large quantities by the body post-vaccination can inactivate the p53 tumour suppressor protein allowing cancers normally controlled by that protein to emerge or re-emerge.
Dalgleish is calling for the vaccines to be withdrawn immediately saying the link between vaccines blood clots, myocarditis, heart attacks and strokes are now well accepted as is the link with myelitis and neuropathy which he and colleagues predicted in an article in June 2020. That may be so but governments are dragging their heels in admitting that vaccines cause so many injuries.
World-renowned British cardiologist Dr Aseem Malhotra will tour Australia starting on 27 May also calling for the suspension of all Covid vaccines pending a full investigation into vaccine injuries. He is supported by the Australian Medical Professionals’ Society, a non political union representing doctors who want to reclaim medical ethics and the primacy of the doctor patient relationship, many of whom are still unable to work due to vaccine mandates.
In the the US, the National Academies of Sciences, Engineering, and Medicine has appointed a committee to determine the relationship between vaccines and adverse events. It will assess causality and inform injury compensation recommendations. Unfortunately, the report won’t be published until March 2024. How many more bodies will be buried by then?
https://www.spectator.com.au/2023/05/burying-the-bodies/
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4 May, 2023
Long COVID Hits Trans Population Highest, Blacks & Latinos Hit Worse Than Whites
It is tempting to speculate why transexuals fare so very badly. My guess is that their abnormal state stresses them out. Stress often goes with illness
A study sponsored by the United States Census Bureau suggests Blacks and Hispanic/Latinos are afflicted more than any other ethnic/racial group by long COVID-19 symptoms. This conclusion is the result of the most recent Census Bureau’s Household Pulse Survey (HPS), an experimental online survey representative of the U.S. adult population at both the state and national level. The survey asked about long COVID symptoms in July 2022, over two years after the onset of the COVID-19 pandemic.
While TrialSite continues to analyze studies finding that anywhere from 10% to 30% of persons infected with COVID-19 end up having symptoms lasting three months or longer, this most recent survey found that 31.1% of the respondents ages 18 and up experience long-lasting COVID-19 symptoms.
Long COVID afflicting women more than men
Survey respondents were asked if they had ever tested positive for or had been told by a health care provider, “They had COVID-19.” Respondents who answered “yes” were then asked if they had symptoms or that they did not have pre-COVID-19 that they still experienced at least three months later.
The U.S. Census HPS data tool allows users to explore a number of different national, state and metro area estimates, including the percentage of adults who experienced long COVID symptoms.
Who suffers Long COVID?
The U.S. Census reports that Hispanic respondents were the most likely to report long COVID symptoms and non-Hispanic Asian respondents were the least likely (Figure 1).
Though less likely than Hispanic respondents, Black respondents were more likely than White or Asian respondents to suffer long COVID.
Women were more likely than men to say they suffered long-lasting symptoms.
Persons identified as “Transgender” or “None of these” listed genders were far more likely to suffer from long COVID than those identifying as male or female.
Respondents identifying as gay/lesbian or straight were the least likely to suffer from long COVID symptoms and were not statistically different from one another.
People between ages 40 and 59 were the most likely to report long COVID symptoms, while those in the oldest age category (70 and over) were the least likely.
Does Long COVID vary by education and income?
Respondents without a high school degree were the most likely to report long COVID symptoms, while those with a college degree were the least likely (Figure 2). This suggests some socio-economic factors involved with the condition, not surprising, given the influence of the social determinants of health in America.
The U.S. Census reported on an interesting finding---those with a high school degree or less were the least likely to report having tested positive for COVID-19 while those with at least some colleges were the most likely (those with some college educations were not significantly different from those with a college degree). This could potentially be explained by the fact that young people may not get tested due to several factors.
The HPS income question is categorical, so to avoid conflating different types of households the universe was limited to two-adult/two-children’s households.
Not all estimates were significantly different but it is clear that those at the top income distribution (more than $100,000) were less likely than those at the bottom (less than $100,000) to report long COVID.
Are Long COVID sufferers worse off in other areas?
What about measures of well-being?
The recent U.S. government release shared some definitions. A person faces financial insecurity if they respond that it had been very difficult for their household to pay for usual household expenses. They are in multidimensional hardship (MHI) if they reported at least two of the following:
Mental health.Feeling down, depressed or hopeless more than half the days in the previous week.
Job insecurity. Not being employed due to illness, caring for others or losing a job due to the COVID-19 pandemic.
Food insufficiency. Living in a household that sometimes or often did not have enough food to eat in the last 7 days.
Housing insecurity. Little or no confidence in their ability to make mortgage or rent payments the next month.
Approximately 27% of long COVID sufferers were financially insecure, compared to 18% of people who never tested positive for COVID-19, and 15% of people who did but did not have long COVID symptoms. The overall pattern was the same for each measure. Respondents with long COVID symptoms reported the highest level of hardship defined by each measure.
Respondents reporting that they never tested positive for COVID-19 actually faced higher levels of hardship than those who did test positive but reported no long-lasting symptoms.
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Major US Agency to Keep COVID-19 Vaccine Mandate Despite White House Announcement
A major federal agency is keeping its COVID-19 vaccine mandate in place even as most agencies are ending their vaccination requirements.
The Department of Veterans Affairs (VA) is retaining its mandate, Secretary Denis McDonough said in a message to employees reviewed by The Epoch Times.
The White House’s announcement that many mandates are ending “will not impact” the VA, McDonough said.
“To ensure the safety of veterans and our colleagues, VA health care personnel will still be required to be vaccinated at this time,” he told workers.
“As we transition to this new phase of our response to the pandemic, the vaccine (including booster shots) remains the best way to protect you, your families, your colleagues, and veterans from COVID-19.”
A VA spokesperson declined to provide any data that informed the decision to keep the mandate in place.
The VA’s website claims that vaccines “help protect you from getting severe illness” and “offer good protection against most COVID-19 variants,” pointing in part to observational data from the U.S. Centers for Disease Control and Prevention (CDC) that indicate the vaccines provide poor protection against symptomatic infection and transient shielding against hospitalization.
No clinical trial efficacy data has been made public for updated shots from Moderna and Pfizer, and none of the vaccines prevent infection or transmission.
The VA is the second largest federal agency, employing nearly 400,000 people. It was the first U.S. agency to mandate vaccination for its workers.
“We’re mandating vaccines for Title 38 employees because it’s the best way to keep veterans safe, especially as the Delta variant spreads across the country,” McDonough, an appointee of President Joe Biden, said in a statement on July 26, 2021.
The mandate was later expanded to most Veterans Health Administration (VHA) employees and volunteers. It covers personnel such as psychologists, pharmacists, housekeepers, social workers, volunteers, and contractors.
“Effectively, this means that any Veterans Health Administration employee, volunteer, or contractor who works in VHA facilities, visits VHA facilities, or provides direct care to those we serve will still be subject to the vaccine requirement at this time,” McDonough said on May 1.
VA employees who aren’t health care personnel aren’t covered by the mandate.
Mandates imposed by two other agencies, the National Institutes of Health (NIH) and the Indian Health Service, are also remaining in place while the agencies review the requirements, the Biden administration stated.
The NIH didn’t respond by press time to a request by The Epoch Times for comment, and the health service declined to provide more details.
Most of the administration’s mandates are ending on May 11, the White House stated this week. That includes mandates for federal workers and contractors imposed by Biden that were struck down by courts, a mandate for foreign travelers arriving by air, and the requirement that some foreigners arriving by land present proof of vaccination.
Biden had ruled out such requirements before taking office but later claimed that not enough people were getting vaccinated. The mandates were imposed after evidence began emerging that indicated that the protection bestowed by the vaccines waned over time, and officials have since cleared multiple booster shots in a bid to restore the flailing protection.
More than 1.13 million people in the United States have died of COVID-19 since the pandemic began more than three years ago, including 1,052 people in the week ending April 26, according to the CDC. That was the lowest weekly death toll from the virus since March 2020.
“While I believe that these vaccine mandates had a tremendous beneficial impact, we are now at a point where we think that it makes a lot of sense to pull these requirements down,” White House COVID-19 coordinator Dr. Ashish Jha said.
Critics decried statements from White House officials regarding the lifting of the mandates.
“They’re patting themselves on the back for unnecessarily coercing people to get a medical product they may not have wanted or stood to benefit from. It didn’t even protect others,” Dr. Tracy Hoeg, a U.S. epidemiologist, wrote on Twitter.
More than 270 million people in the United States, or about 81 percent of the population, have received at least one dose of a COVID-19 vaccine, according to the CDC. But booster uptake has been low, and so has the receipt of vaccines among children, the last population for whom vaccines were authorized.
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3 May, 2023
Meta-Analyses of School Closures by University of Oxford
New research out of the United Kingdom points to heightened levels of harm associated with COVID-19 lockdowns and school closures, with an emphasis on the particularly adverse impacts of the latter. Led by Professor Kamal R. Mahtani, and colleagues at University of Oxford, the findings were telling. After a systematic review, the team had their findings published in the British Medical Journal drilling into the actual positive and negative impacts of school closures. The team finds a lot of problems with school closures (mental health, learning, etc.) as well as some positive outcomes (reduce transmission, etc.). But in-school mitigation also can help. The quality of the evidence associated with the underlying systematic reviews was low to very low. The point here is that with any pandemic, evidence-based approaches should be taken, not just what public health authorities decide on a whim.
Employing use of a critical appraisal tool for systematic reviews that include both randomized and non-randomized studies involving healthcare interventions (or both) called AMSTAR 2, the UK-based researchers sought to evaluate confidence in the included systematic reviews. They also used GRADE to assess the certainty of evidence associated with the studies looking into the impacts of school lockdowns. GRADE, or “Grading of Recommendations, Assessment, Development, and Evaluations,” is a transparent framework for developing and presenting summaries of evidence, thus contributing to a more systematic approach for making clinical practice recommendations.
Key study questions pursued by the Oxford-based investigators included:
(1) What is the impact of school closures on COVID-19 transmission, morbidity or mortality in the community?
(2) What is the impact of COVID-19 school closures on mental health (e.g., anxiety), physical health (e.g., obesity, domestic violence, sleep) and learning/achievement of primary and secondary pupils?
(3) What is the impact of mitigations in schools on COVID-19 transmission, morbidity or mortality in the community?
(4) What is the impact of COVID-19 mitigations in schools on mental health, physical health and learning/achievement of primary and secondary pupils?
The findings
Out of 578 reports, the team included only 26 based on the application of rigorous inclusion/exclusion criteria.
In this study, the team identified a total of 132 unique primary studies involving the effects of school closures on transmission of COVID, morbidity and mortality; 123 on learning; 164 on mental health, 22 on physical health; 16 on sleep with 7 concerning domestic violence. Finally, 69 of the individual studies focused on the effects of in-school mitigations on transmission/morbidity/mortality report the study authors.
The authors communicate in The BMJ:
“Both school closures and in-school mitigations were associated with reduced COVID-19 transmission, morbidity and mortality in the community. School closures were also associated with reduced learning, increased anxiety and increased obesity in pupils. We found no SRs that assessed potential drawbacks of in-school mitigations on pupils. The certainty of evidence according to GRADE was mostly very low.”
Overall, the Oxford academic researchers considered the whole body of evidence as weak when considered holistically. However, this doesn’t take away from numerous concerns in the form of negative effects on children involving school closures.
The study authors concluded that while school closures lead to both positive and negative impacts, the overall level of evidence confidence is mostly very low. Importantly they could not find any systematic reviews investigating the potential drawbacks of in-school mitigations on children, which should be studied.
https://www.trialsitenews.com/a/meta-analyses-of-school-closures-by-university-of-oxford-f92697a8
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Singapore Academic Medical Research Climate Healthier and More Open Than America: At Least When It Comes to COVID-19 mRNA Vaccines
While Singapore is known as somewhat of an authoritarian place, albeit free and relatively open for business and some labor, when it comes to an open discussion about the problem of COVID-19 vaccine injuries, its press is far more open and freer than that of the United States. Two well-known COVID-19 researchers, part of elite Singapore-based academic medical centers, bring real talk to the COVID-19 vaccine topic. They want to see highly efficacious vaccines that have less side effects—implicitly acknowledging problems with the current mRNA-based products. Delving into the risk-benefit analyses, they are free to speak their mind in Singapore, while Americans peers generally cower in economic fear. Some commonsense talks now come out of Singapore, the type that is sadly lacking in most top American academic medical/research circles.
During the COVID-19 pandemic, the City-State implemented “circuit breakers and lockdowns” in a bid to control the spread of the pandemic—much like other Asian nations and even Australia—they also implemented mass vaccination schemes to reduce the risk of severe symptomatic COVID, also part of the quest to transition out of the pandemic. Of course, the scale and magnitude of the mass vaccination program was but a fraction of the effort in the United States, given that over 270 million people in America received their primary series vaccination out of a population of 330 million.
Singapore, with its population at 5.5 million, through a combination of mandates and incentives, saw over 92% of the City-State’s population vaccinated against COVID-19. By the late summer of 2021, they were classified by the German press as the world’s most vaccinated place against COVID-19.
The press there have been open about two tragic deaths associated with the COVID-19 vaccines. As reported by the Singapore news outlet CNA and covered by TrialSite as well, a 43-year-old Filipino woman died just four days after vaccination with the Pfizer-BioNTech mRNA jab (BNT162b2), while at the end of 2021, a 28-year-old Bangladeshi man died three weeks after the first dose of the mRNA-based Moderna COVID-19 vaccine known as mRNA-1273 or Spikevax.
In a commentary from Ooi Eng Eong of Duke-NUS Medical School, and Paul Ananth from NUS Yong Loo Lin School of Medicine, they point out that:
“There is no vaccine or medication in the world without the risk of rare severe adverse events, so their use must always be guided by risk-benefit analyses.”
It’s interesting, the timing and topic of this opinion piece in the prominent Singapore multi-channel media. This isn’t the fringe, some politically charged platform, but rather the mainstream in the heart of a very orthodox and mainstream place at this point .
While both Drs Eong and Ananth remind all that a known potentially dangerous side effect associated with the mRNA COVID-19 vaccines—myocarditis, can also occur directly as a result of SARS-CoV-2 infection, the two absolutely mainstream medical research professionals remind us of all to learn from both smallpox and poliomyelitis.
With a refresher on the history of these vaccines, and a reminder that on very rare occasions risks of serious side effects can and do occur. In fact, in Singapore, the risks associated with the vaccine became unacceptably high:
“With poliomyelitis having been eliminated in most parts of the world, the risk of vaccine-associated paralysis became unacceptably high. Singapore, like many countries, has switched fully to the injected form, which is composed of killed polioviruses and has no risk of paralysis.”
Overall, the Singapore-based academic medical researchers are pleased with the COVID-19 vaccination outcomes, but they believe more can be done to make these and other vaccines even safer.
Arguing that unfortunately, COVID-19 won’t be the least pandemic likely in the next decades, they point out that “in just the first 23 years of the 21st century, the world has witnessed nine major outbreaks that spread rapidly across national borders.” So obviously, they point out, “For public health authorities, the next pandemic is not a question of “if” but “when.”
What’s recommended?
While Ooi Eng Eong and Paul Ananth don’t go too far in the critique—this wouldn’t be publishable—they do hint that perhaps, the COVID-19 vaccines were expedited a bit too fast. For example, the two note, “For any vaccine to be licensed, including the COVID-19 vaccines developed in record time, it will have to be tested in preclinical animal models as well as tens of thousands of human volunteers for safety and efficacy.”
Importantly, both Pfizer-BioNTech and Moderna’s mRNA vaccines included some limited animal research and Phase 3 trials with 30,000+ participants.
TrialSite has access to numerous data, documents and testimony that these studies were overly rushed, with glaring problems that were covered up. Accessing some of the documentation in the Brook Jackson lawsuit (now dismissed), it’s clear that one major investigator site network’s quality track record was unacceptable, and in normal times this alone would have paused the clinical trial.
Other findings from the disclosed Pfizer regulatory documentation (See Sonia Elijah articles) or how the company cut some corners not conducting any controlled IND-enabling preclinical studies are further glaring examples that the compressed research during the pandemic was far from optimal.
Both Eong and Ananth know this, but of course, cannot articulate such points in mainstream media or for that matter, in their respected academic medical departments.
But they both do emphasize the importance of safety for any licensed medicinal products, including vaccines, noting that “Vaccines that produce side effects that are not well tolerated will fail clinical development and will not be marketed.” They continued pointing to the current situation with Pfizer and Moderna:
“However, despite clinical trials involving tens of thousands of volunteers, rare side effects that occur in the region of 1 in 100,000 vaccinations or less will likely be missed for simple statistical reasons.”
Yet they pair point out that clinical trials programs needing hundreds of thousands of volunteers just would not be viable.
Instead, the two Singapore-based COVID-19 experts point out that the key is to better understand what’s causing vaccine side effects. Why? “So that we can reduce them while maintaining the benefits of vaccination.”
Critically important, Eong and Ananth point out the logic that seemed so apparent in America—that “side effects do not indicate and are not required for good immunity, contrary to some popular views.”
Their point is that according to their research, “Vaccinated individuals who experience side effects do not develop better or higher levels of protection against COVID-19 than those who do not.”
Those healthy clinical trials volunteers with a healthier immune system during vaccination would be more likely to experience mild COVID-19 after mRNA vaccination. Yet an “Over-activation of a specific gene and low-level chronic inflammation contributed to the development of cardiac complication after booster COVID-19 mRNA vaccination,” the authors report in their research published in Cell Press journal.
They point to the need for the development of a “a detailed map of the molecular processes that lead to side effects and rare severe adverse events will lay the foundation for the development of safer vaccines, including potentially for the next emerging infectious disease.”
With ongoing research, the authors point out in their CNA editorial what are the next steps to both building protection via vaccination, while improving pandemic control hopefully done in a more responsible way.
Some common sense talks out of Singapore, the type that is sadly lacking in most top American academic medical/research circles.
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2 May, 2023
Texas Attorney General to Investigate Whether COVID-19 Vaccine Makers Misled Public
The highest-ranking prosecutor in Texas is launching an investigation into whether the three top COVID-19 vaccine manufacturers have misled the public.
Texas Attorney General Ken Paxton is probing whether Moderna, Pfizer, and Johnson & Johnson misrepresented the efficacy of their COVID-19 vaccines, the Republican announced on May 1.
The companies may have violated the Texas Deceptive Trade Practices Act, Paxton said. That state law bars people from disseminating a statement that they know “materially misrepresents the cost or character of tangible personal property, a security, service, or anything he may offer” for the purpose of selling a product or service.
It also prohibits representing that goods are “of a particular standard, quality, or grade … if they are of another.”
Most of the COVID-19 vaccine doses administered in the United States have been manufactured by Moderna or Pfizer and its partner, BioNTech, according to federal data. Johnson & Johnson’s vaccine has been the third most popular in the country. No other vaccines were available until 2022.
Also at issue is whether the companies engaged in research to make a virus or pathogen more dangerous by increasing its transmissibility or pathogenicity and misleading the public about doing so.
Paxton sent civil investigative materials to all three companies that demand the production of documents and information within 30 days, including whistleblower reports and concerns regarding COVID-19 vaccine trials.
The materials also demand documents showing the rates of side effects for each vaccine and when the companies became aware of “unexpected or additional adverse events, side effects, injuries and/or deaths” related to their COVID-19 vaccines.
The companies also were told to hand over documents showing all investigations that were opened by federal, state, county, and local agencies, including law enforcement officials, related to representations made about the safety and effectiveness of the shows.
“The development of the Covid-19 vaccine, and the representations made by and knowledge of Pfizer, Moderna, and Johnson & Johnson, are of profound interest to the public’s health and welfare. This investigation aims to discover the truth,” Paxton said in a statement.
“This pandemic was a deeply challenging time for Americans. If any company illegally took advantage of consumers during this period or compromised people’s safety to increase their profits, they will be held responsible. If public health policy was developed on the basis of flawed or misleading research, the public must know. The catastrophic effects of the pandemic and subsequent interventions forced on our country and citizens deserve intense scrutiny, and we are pursuing any hint of wrongdoing to the fullest.”
While the manufacturers are largely shielded from lawsuits because of the Trump administration’s Public Readiness and Emergency Preparedness Act in 2020, there’s an exception for actions or failures to act that constitute “willful misconduct.” That’s an act or omission that’s taken “intentionally to achieve a wrongful purpose,” “knowingly without legal or factual justification,” and “in disregard of a known or obvious risk that is so great as to make it highly probable that the harm will outweigh the benefit.”
While being recorded without his knowledge, a senior Pfizer employee said in video footage released in January that Pfizer was aiming to “preemptively develop new vaccines” by mutating COVID-19.
“If we’re going to do that though, there’s a risk of like, as you could imagine—no one wants to be having a pharma company mutating [expletive] viruses,” Dr. Jordon Walker, a director of research and development at Pfizer, told nonprofit Project Veritas.
He said scientists at Pfizer were “optimizing” a process to mutate COVID-19 but were going slow “because everyone is very cautious.”
Pfizer later acknowledged that it had been conducting experiments that involved using the original COVID-19 virus “to express the spike protein from new variants of concern.”
“This work is undertaken once a new variant of concern has been identified by public health authorities,” the company stated. “This research provides a way for us to rapidly assess the ability of an existing vaccine to induce antibodies that neutralize a newly identified variant of concern. We then make this data available through peer reviewed scientific journals and use it as one of the steps to determine whether a vaccine update is required.”
Dr. Robert Malone, who helped develop the messenger RNA technology on which Pfizer’s vaccine is based, said that the experiments Pfizer described met the definition of gain of function.
“What they’re describing is almost identical to what was apparently done at the Wuhan Institute of Virology”—the laboratory from which some experts believe that COVID-19 escaped—Malone told NTD.
The Chinese laboratory was conducting risky experiments on mice, U.S. authorities have said, and is located in the same city where the first COVID-19 cases were detected.
Walker used the term “directed evolution” while speaking to Project Veritas, which Malone said is so similar to gain of function as to be irrelevant.
Paxton’s civil demand requests all communications and documents related to Pfizer engaging in either gain of function or directed evolution “in the study, analysis, trials, or preparation of the COVID-19 vaccine.” The same demand was made to Moderna and Johnson & Johnson.
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CDC Eases COVID-19 Vaccination Requirements for Foreign Travelers
A single dose of the most widely utilized COVID-19 vaccines is sufficient for international travelers to meet the requirements to enter the United States, the U.S. Centers for Disease Control and Prevention (CDC) said in an update.
Foreign travelers who receive a single dose of the Pfizer or Moderna vaccines meet the requirements, according to the CDC.
“Because some traveler vaccine records might not specify whether recent Moderna or Pfizer doses received were bivalent, CDC will consider anybody with a record of a single dose of Moderna or Pfizer vaccine issued on or after August 16, 2022, to meet the requirements of the Amended Order to board a plane to the United States,” the CDC website reads.
The bivalent vaccines from Moderna and Pfizer were first introduced in the United States as boosters in the fall of 2022. They’re now available as a one-dose primary series for most Americans, replacing the old vaccines. The CDC does recommend that some people get an updated shot as a booster even if they already received one, despite fleeting protection against hospitalization and poor shielding against infection.
The United States has required noncitizen nonimmigrants to provide proof of COVID-19 vaccination since 2021, under a proclamation issued by President Joe Biden. Exceptions are given for certain reasons. No religious exceptions are accepted.
The vaccination requirements state that a traveler arriving by air must be fully vaccinated, defined as two weeks after receiving a dose of an accepted single-dose vaccine or the second dose of an accepted two-dose series.
The CDC previously required two doses of the Moderna or Pfizer vaccines to meet the requirements. A single dose of the Moderna or Pfizer vaccines is now acceptable, alongside a single dose of the Johnson & Johnson vaccine, available in the United States and elsewhere, or a single dose of the Convidecia vaccine, which isn’t available in the United States.
Two-dose vaccines include Novavax’s vaccine, available in the United States; AstraZeneca’s vaccine, available in Europe and some other countries; and Sinopharm, a Chinese vaccine. People who received a two-dose series of the old Moderna or Pfizer vaccines can still travel to the United States.
To present proof of vaccination, a person must show a digital or paper record such as a vaccination certificate from the European Union.
The United States is one of a small number of nations that still require proof of vaccination to enter the country.
It’s not clear whether the foreigner vaccination requirements will remain in place beyond May 11, when the U.S. public health emergency over COVID-19 is set to expire. The COVID-19 national emergency was already rescinded after Biden signed legislation that was approved by Congress.
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Washington Post Editorial Points to Covid Vaccine’s Disruption of Women’s Menstrual Cycle
In a recent editorial in the Washington Post, Kate Clancy, a biological anthropologist and professor at the University of Illinois, wrote about how after she received her first dose of the Covid vaccine she got her period and the bleeding was so heavy she “was swapping out overnight-strength pads every hour.”
Clancy tweeted out her experience and expected a response of only about 500 people. Instead, she heard from 165,000. The responses spoke volumes. After the vaccinations women had changes in their periods. “Changes in menstruation were uncomfortable and often painful, people reported. Strangers described bleeding through their clothes at work.
Postmenopausal people were terrified they had cancer.” What seemed to surprise Clancy the most was the response of the medical community. “It is medical scientists’ duty to predict, look for and, if found, disclose side effects — and here is where I believe some in the medical community fell short.” In fact, Clancy cites medical authorities who claim excessive bleeding after Covid vaccination was a result of ‘pandemic stress”. Dr. Melissa Viray, Deputy Director for the Richmond City and Henrico County Health Districts doesn’t believe there’s a physiologic link between the vaccine and a woman's menstrual cycle, and would not classify it as a side effect of the Covid vaccine. “That’s just not how these vaccines work -- so I’d be very surprised," said Dr. Viray.
However, Viray did concede the Covid vaccine puts stress on the body. "Any time you put a stressor on the body, there are definitely -- there are definite changes that occur," Dr. Viray said. "...I could see where it might have, it might influence menstrual cycles in a little way, but just in the way that any stressor or any change to the environment for some individuals can change their menstrual cycles."
Medical Community “Fell Short”
According to Clancy, there is no question the vaccine saved lives. TrialSite has concurred with this point of view, although the products first rapidly authorized after less than a year of clinical development did come with rare side effects that may not seem so rare given that over 270 million people in America alone received the primary vaccination dose.
Clancy points out “clinical trials of the coronavirus vaccines did not ask questions about menstruation beyond inquiring about date of last menstrual period at the start of the study, to ensure participants were not pregnant. A participant in one of the trials emailed me to say it took two tries to persuade her trial site to include anything in her chart about her menstrual changes — the first time, they refused on the grounds that she was probably just perimenopausal.” In September of last year the National Institutes of Health (NIH) released an article about a study which confirmed a link between the Covid-19 vaccination and an increase in a woman’s menstrual cycle.
However, the NIH report claimed the increase in length, post Covid vaccine, was temporary. The study didn’t answer all the questions women had about the corona vaccine and the connections to women’s periods. Specifically, that the vaccine can make a woman’s period worse. But Clancy raises a bigger problem.
‘Menstrual changes matter to millions of people, and pharmaceutical companies, medical professionals and politicians need to invest in research and provide incentives for redesigning research so that it accommodates menstruation. Medical treatments and vaccine trials — for coronavirus and other maladies — will continue to disserve those bodily systems about which they ask no questions. We deserve better than to be surprised when a new treatment makes us bleed on our office chair.”
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1 May, 2023
US Officials Reject Compensation for People Diagnosed With COVID-19 Vaccine Injuries
U.S. authorities rejected multiple people who sought compensation for COVID-19 vaccine injuries, despite diagnoses from doctors, documents show.
Letters from U.S. officials reviewed by The Epoch Times show officials contradicting doctors who treated patients as they turned down requests for payment.
Cody Flint, an agricultural pilot, was diagnosed by four doctors with a severe adverse reaction to Pfizer’s COVID-19 vaccine. Shortly after being vaccinated, Flint experienced intense head pressure, which led to problems such as perilymphatic fistula, the doctors said.
Flint sent a slew of medical files, including evidence of the diagnoses, to the U.S. Countermeasures Injury Compensation Program (CICP), which compensates people who prove they were injured by a COVID-19 shot.
But administrators for the program rejected Flint’s application in a denial letter, saying they “did not find the requisite evidence that the Pfizer COVID-19 vaccination caused” the conditions from which he suffers.
Flint, in his 30s, felt his first symptoms within an hour of vaccination. An onslaught of severe symptoms followed while he was flying two days later.
“One second I went from having burning in the back of my neck and tunnel vision to the very next second I was slumped over in my airplane. The best way I know to describe it, it was like a bomb went off inside my head,” Flint said.
CICP administrators told him that “compelling, reliable and valid medical and scientific evidence does not support a causal association between the Pfizer COVID-19 vaccine and benign paroxysmal positional vertigo, perilymphatic fistulas, increased intracranial pressure, Eustachian tube dysfunction, hearing loss, or loss of eyesight.”
They also tried to pin the problems on barotrauma. Colloquially known as airplane ear, barotrauma happens when air pressure suddenly changes, and is common as planes climb higher in the sky. Barotrauma causes the fistulas and symptoms of the fistulas “began while flying,” administrators wrote.
Flint and his doctors asserted in appeal letters that the barotrauma theory doesn’t hold up because Flint flies low as he dusts crops. Flint’s condition is “not from barotrauma,” Flint’s doctors told the CICP. “As an agricultural pilot, he does not fly more than a couple of hundred feet off the ground which is not of a magnitude to where he is at risk for barotrauma.”
“Elevated intracranial pressure has been recognized as a complication of COVID vaccination, and given the sequence of events, more probable than not, it is the cause of Mr. Flint’s elevated intracranial pressure, which had been documented on lumbar puncture,” they added. “The elevated intracranial pressure led to his perilymphatic fistula. Elevated intracranial pressure is a cause for perilymphatic fistula and more probable.”
The CICP determination was reviewed by a panel that sided with administrators. The panel found that the COVID-19 vaccine “did not cause Mr. Flint to develop bilateral perlympathic fistulas and related symptoms,” Suma Nair, an administrator, told Flint in a final denial letter. “There is no compelling causal connection between the Pfizer COVID-19 vaccine and the symptomology Mr. Flint experienced; the more likely cause of Mr. Flint’s symptoms is trauma from flying a plane, which would have developed over time.”
Administrators cited no studies or other evidence in their letters.
Flint said that the determination was wrong, pointing to a number of papers detailing post-vaccination intracranial and other neurological issues. He also noted a study that said intracranial pressure can cause perilymphatic fistulas.
Nair also said the panel concluded: “given the timeline of symptoms, it was not plausible for the Pfizer COVID-19 vaccine to have caused the otologic and vestibular issues experienced by Mr. Flint.”
“It’s just all comical to me,” Flint told The Epoch Times. “I get the shot, I’m injured within 48 hours, and they say that that makes it implausible.”
Difficulty Getting Compensation
The case highlights how people who experienced problems after vaccination have struggled to get money from the federal government, even when doctors diagnose vaccine injuries.
Flint is one of 76 people who were rejected as of April 1 because administrators determined they did not “show that a covered serious physical injury was sustained as the direct result of the administration” of a COVID-19 vaccine.
“The CICP may only make such determinations based on compelling, reliable, valid, medical and scientific evidence,” the program says.
More than 8,100 applications, as of April 1, have been submitted to the CICP for compensation for a COVID-19 vaccine-induced injury or death. Three hundred and sixty-two in total have been turned down. Just 23 have been accepted. All but two are for a type of heart inflammation called myocarditis or a related condition known as pericarditis, both of which U.S. authorities say are caused by COVID-19 vaccination.
Documents on the denials and acceptances have been largely withheld from the public. Freedom of Information Act (FOIA) requests, successful in unearthing information about COVID-19 vaccine safety, have yielded few documents. Administrators located 652 records in response to one request seeking all claims and associated documents. They only released 52 heavily redacted documents, citing exceptions to FOIA. A similar request returned a single page that wasn’t already public.
COVID-19 vaccine injuries fall under the CICP, a little-used program before the pandemic that was created by Congress in a 2005 bill, because of a Public Readiness and Emergency Preparedness Act declaration entered during the Trump administration that has not yet been rescinded.
Most administered vaccines in the United States fall under the National Vaccine Injury Compensation Program, enabling people with alleged or actual injuries to take their cases to federal judges in a no-fault system that paid out $4.8 billion between 1988 and 2022.
Decisions on CICP petitions, in contrast, are decided by the Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA)—the same agency that operates the program.
That “potentially creates a conflict of interest,” researchers wrote in a 2022 paper, advising Congress to initiate major reforms by either relocating the program or allowing judicial review of determinations.
Some members, including Sens. Cindy-Hyde Smith (R-Miss.) and Ron Johnson (R-Wis.) have expressed interest in reform but no bills have gained traction yet in the divided Congress.
People who apply to the CICP are only eligible for money for unreimbursed medical expenses and lost pay. Survivors of people who die can get death benefits. The National Vaccine Injury Compensation Program covers past and future healthcare costs, pain and suffering, lost earnings, and legal fees.
The CICP has paid just $6 million to date, including under $5,000 total to the only three people who were injured by COVID-19 vaccines and have been compensated.
‘All These People Are Going to Get Denied’
Dr. Joel Wallskog was one of the first people to receive Moderna’s COVID-19 vaccine. He got a shot on Dec. 30, 2020. Within days, he experienced symptoms including a loss of balance, headaches, and leg weakness.
“I was completely healthy, very active,” Wallskog, 53, told The Epoch Times. “Now I take 20 medicines.”
Wallskog was diagnosed with transverse myelitis, or spinal cord inflammation. At least two doctors have concluded the injury was caused by the vaccine, records show.
Wallskog transmitted medical records and supplementary documents, such as a study from National Institutes of Health researchers that discussed reports of neuropathic symptoms following COVID-19 vaccination. The same researchers diagnosed multiple people with vaccine injuries.
CICP administrators rejected Wallskog’s petition.
“The current medical and scientific evidence does not show a causal link between the Moderna COVID-19 vaccine and transverse myelitis, other neuro-inflammatory disorders, myelopathy, or thrombotic disorders, including spinal cord infarction,” Dr. George Reed Grimes, director of the HRSA’s Division of Injury Compensation Programs, wrote in the denial letter.
“Furthermore, there is no evidence that your symptoms of lower extremity numbness and tingling with neck flexion, and chronic thoracic pain with weakness and numbness in your legs, is caused by the Moderna COVID-19 vaccine,” he added.
Administrators did not note the doctors’ diagnoses or cite any studies.
One doctor had written in office notes that Wallskog suffered a “significant reaction from Moderna COVID vaccination.”
Wallskog disputed the determination, writing in an appeal that “an exhaustive work-up revealed no other cause of my symptoms besides my Moderna shot.”
An appeal, or request for reconsideration, sends the determination to “a qualified panel, independent of the program,” according to federal law. The panel reviews the determination and sends its recommendation back to the program, which makes the final determination.
Twenty-eight studies have documented transverse myelitis following COVID-19 vaccination, a systematic review published in October 2022 found. Those include case reports of transverse myelitis after a Moderna shot. Researchers said the exact mechanisms for vaccine-induced transverse myelitis remain unclear but posited genetic factors play a role.
Wallskog said that as of now, only people who suffer a narrow set of injuries can expect to be compensated by the U.S. government.
“Many people have this false sense that the CICP is going to be their answer, and it’s not,” he said. “All these people are going to get denied unless they have myocarditis, anaphylaxis, or certain blood clotting conditions.”
Vaccine manufacturers are not liable for injuries due to laws like the PREP Act. That leaves people with few options when they’re injured.
Wallskog helped found a group called React19, which describes itself as a “science-based non-profit offering financial, physical, and emotional support for those suffering from long-term COVID-19 vaccine adverse events.”
Drawing from a pool of donated money, the group has so far paid $556,652 to the vaccine injured, with 81 people receiving compensation.
Applicants must provide a medical note or consultation documenting symptoms and signs they’re related to vaccination.
Group officials, including Wallskog, review each application and make a determination during weekly board meetings. They give out grants of up to $10,000.
The donations come from what the group describes as a care fund.
“Unfortunately, the care fund is on hold right now because we’re low on money,” Wallskog said. “I always say we wish we had more money but at the same point we’re doing with React what our healthcare organizations and our federal agencies should be doing.”
The program could help people like Angie Bluford, who did not apply to the CICP because of the one-year deadline. Bluford wasn’t diagnosed with a vaccine injury until 18 months after getting a Moderna COVID-19 vaccination.
React19 is also advocating for reform of the CICP or moving injury claims from the CICP to the National Vaccine Injury Compensation Program, widely considered the superior option. That would require adding the COVID-19 vaccines to the routine immunization schedule, which has already been done; adding vaccines to the vaccine injury table, and congressional approval of an excise tax. Coverage under the national program should be retroactive, React19 says.
It’s taken more than a year for some injured people to get a determination. There were still 7,771 applications pending as of April 1.
One was sent in by Steve Wenger, a project manager whose COVID-19 vaccination caused Guillain-Barre syndrome, a disorder that damages the immune system.
Wenger, who got vaccinated to avoid losing his job, submitted his application in March 2022. He didn’t receive confirmation until July 2022. He’s still waiting for the outcome.
“The CICP cannot estimate when the medical review will begin or how long it may take to complete,” administrators told him in a letter.
“It’s a waiting game,” Wenger told The Epoch Times. “To be honest, I’m waiting on my rejection letter, because that’s what I’m expecting.”
Wenger’s pessimism stems from the high rejection rate and the fact no claims for Guillain-Barre syndrome have been approved despite U.S. authorities acknowledging the Johnson & Johnson COVID-19 vaccine causes the disorder.
Wenger has been dealing with large medical bills, including thousands of dollars for biweekly treatments with intravenous immunoglobulin, one of the few drugs that have helped those with lingering injuries from the vaccines. Even if CICP approves Wenger’s petition, the money likely wouldn’t last long.
“I’ve read stories that medical debt has just absolutely destroyed people, financially buried them,” Wenger said. “I never envisioned myself being one of those people. But you know, here I am.”
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