Friday, June 02, 2023
What’s the United Kingdom’s Covid Inquiry and Why Are UK Ministers So Hell Bent on Stopping It?
The UK’s Covid-19 Inquiry, headed by a Baroness, is an independent public inquiry into the British government’s handling of the COVID-19 pandemic across the UK. With public hearings expected to commence this year, Boris Johnson announced the inquiry May 12, 2021, to commence the spring of 2022. But many of the Ministers will have nothing to do with it if they have their way.
In fact, as reported by Michael Savage and Toby Helm writing for The Guardian, the UK Ministers have little time to assess the pros and cons of launching an unprecedented legal attack against the Covid Inquiry. Now, 10 Downing Street appears to be scrubbing some of their texts, communications and notes. Suddenly they claim they don’t have to save everything on WhatsApp. Sounds fishy.
Why do they want to stop this inquiry? According to the liberal mainstream media founded in 1821, the political governing apparatus (e.g., the political ruling class of Britain) seeks to maintain a slew of secret sensitive messages involving the likes of former and present-day UK Prime Ministers Boris Johnson and Rishi Sunak.
On Saturday, The Guardian reported just 48 hours remaining before the deadline to hand over unredacted messages and notes involving the former PM (Johnson) and the ministers. The Observer reported over the weekend that the government would remain resolute in not sharing any internal communications or notes, despite the fact that they are quite public in nature.
Well, those 48 hours are up, and the political class has bought itself more time to try to hide COVID-19 secrets, reports The Guardian today.
In what is sure to raise some eyebrows, even in the UK, the Covid Inquiry extended the deadline to receive the former PM’s messages, while No. 10 declares that “some of the PM’s messages at the time were not permanently stored.” What?
That’s right. Now, the political class in the UK at the highest levels is claiming that some of Boris Johnson’s messages sent via WhatsApp aren’t ‘permanently stored.’
Downing Street, which is the PM and their officials, has gone on the record that some of the former PM’s COVID-19 pandemic messaging just may not be stored.
Of course, this means that the British ruling political class, likely in an attempt to cover up various shenanigans during the pandemic, now is in a frenetic effort to destroy as much evidence as possible, right in plain sight!
The latest report from The Guardian points out that the heads of the British government claim there is no requirement to retain every WhatsApp message after the Cabinet Office informed the Covid-19 Inquiry it cannot hold all of the evidence requested about the former PM. Johnson’s spokesperson went on the record, “We do not permanently store or record every WhatsApp.”
TrialSite provides a brief summary of some of the more contentious issues.
Why is this conflict so heavily reported and important?
With an imminent public hearing, the inquiry will expose prominent Tories such as David Cameron and George Osborne interrogated about their instructions to underlings to prepare for the COVID-19 pandemic, as well as their quite private discussions about any impacts on austerity on the British National Health System (NHS).
Does the PM and Cabinet Office believe they have privacy exemptions for COVID-19 pandemic preparedness?
Yes. In fact, according to an account in The Observer, the Cabinet Office believes it has the power to supersede any Covid Inquiry powers to compel it to hand over unredacted material that the elites deem “unambiguously irrelevant.”
What’s the rationale—the basis for excluding themselves from such a public inquiry?
According to lawyers representing the top ministers, such disclosures of information would inhibit or impede comparable future policy discussion, establishing what they argue is a dangerous precedent. Human Rights Act and data protection laws are cited as bolstering sources of protection.
What’s the position of senior political figures countering the Ministers?
Represented by Tory attorney Dominic Grieve, the forces behind the Covid Inquiry are adamant as to the prospects of disclosure. The Guardian reported comments from Mr. Grieve:
“They’ve either got to hand the material over, or they have got to bring judicial review proceedings on the basis that her request is unreasonable. I think it is likely they will be given a pretty short shrift if they turn up at court to argue that.”
“Seeing that Heather Hallett is cleared to a very high level of security, why should it matter that she sees the entirety of [the material]? She will decide what is relevant.”
So, what does the Baroness have to do with it?
A Baroness, Heather Carol Hallett, a retired English judge of the Court of Appeals and a crossbench life peer, was just the fifth woman ever to sit in the Court of Appeal. She led independent inquest into the 7.7 bombings. And by December 2021, the Baroness was announced as the chair of the UK’s Public Inquiry into the UK Government’s handling of the COVID-19 pandemic.
For those Anglophiles interested in British political intrigue in more detail follow the link to the local press. TrialSite tracks this inquiry based on ongoing interest in the COVID-19 pandemic, involving a confluence of forces from the biomedical research apparatus, government and health systems.
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The Cape Byron Lighthouse Declaration: a ‘suspended’ guide to making healthcare great again
Julie Sladden
Lighthouses have served mariners for centuries, warning of nearby dangers. Cape Byron is no exception, guiding the route of countless mariners with its beams offering security and guidance. It seems, therefore, a fitting place for three resolute Australian health professionals, to gather and make a declaration against the censorship, coercion, and medical tyranny of the past three years.
These three would call themselves ordinary Australians, but when you hear their stories, you realise they are anything but. Critical care and anaesthesia specialist doctor Paul Oosterhuis, mental healthcare doctor Robert Brennan, and ‘former psychologist’ Ros Nealon-Cook did not know each other three years ago, but their paths brought them to the same point in September 2021. And that point can be described with one word: suspended. Their crime? Speaking out against Australia’s Covid pandemic response.
Rather than step back into the shadows, they have instead renewed their vows to stand and propose a blueprint for the redemption of healthcare in The Cape Byron Lighthouse Declaration.
Each of their stories is different and you can listen to a full version online, but I’ll give you the abridged version here. Dr. Brennan was suspended following complaints for distributing flyers and his association with the Covid Medical Network (now Australian Medical Network). Dr. Oosterhuis was suspended following anonymous complaints regarding his social media posts. And Ros Nealon-Cook was suspended following ten complaints about a video she released outlining serious harm to children due to the Australian government’s pandemic response measures.
Hardly crimes of the century. In fact, not crimes at all.
When you consider that one of AHPRA’s purposes is to ‘protect the public’ what possible motive could there be for suspending a qualified, experienced, and respected health practitioner for expressing their professional opinion in the context of a health issue?
I digress.
Ros Nealon-Cook describes how these three found each other and the idea for the declaration:
‘We were all suspended within several days of each other in September 2021 and were all targeted. We became sort of like war buddies. Quite draconian measures were used by AHPRA, by the boards, by the Health Care Complaints Commission, and all these different tentacles of the government. We were threatened with criminal action and all sorts of things. It was just this constant campaign of bullying… They even came after me for a psychiatric evaluation, which I didn’t go to, but they did on me by transcribing interviews.’
Yep, you read that right: a psychiatric evaluation was done on a healthcare practitioner, without them even being there.
(Who are these people?!)
Nealon-Cook continues, ‘The idea for the declaration started as a bit of a joke, and one day I just said to Paul and Robert, “Oh for goodness sake, let’s do our own Great Barrington declaration… but we’ll make it all about the censorship and bullying of health professionals.” We had a bit of a laugh about it, and that was it.’
But, as many ideas do, the idea germinated. So, on the dawn of January 22, 2023, the Cape Byron Lighthouse Declaration was born. It states:
All silencing and censorship by bureaucrats and regulators, including of experienced practitioners and scientists must stop. There must be respect for every individual’s right to freedom of opinion and expression.
The right to ‘informed’ consent must be upheld – and must include being fully informed of relevant risks, as well as any benefits (proven or presumed).
Mandates and other forms of medical coercion are unethical – and must cease. Bodily autonomy is the inalienable right of every individual – and must be respected.
There is an urgent need for transparency and reform in science and medicine and to halt the increasing globalisation of public health. We demand the restoration of voice and decision power to individual practitioners – and those they serve.
Since its launch a few weeks ago, the declaration has received international attention and signatures from around the world including France, Germany, the Netherlands, Canada, the UK, and the US with numbers increasing daily.
Three years ago, I could not have conceived we would need such a declaration. But the Covid years have revealed the diseased underbelly of healthcare and its powerful influences. Healthcare, nor the people it serves, cannot thrive in the presence of censorship, coercion, and unethical behaviour. So, the time has come to remind ourselves, our governments, and our leaders of the core foundations.
If the stories of these three health professionals demonstrate anything, it is that silencing and censorship do not work. Eventually the dam wall breaks and such ‘ordinary people’ break through. ‘We didn’t die,’ says Oosterhuis. ‘We got louder.’
‘Paul Rob and I, we’re just normal people,’ says Nealon-Cook. ‘We’re not media trained, we fumble our words and stumble along. But would we do it again? Absolutely. Because we have to. We have to do this, and we’ve lost everything. We’ve lost our careers. We’ve lost our reputations. We’ve lost friends. It’s had really serious impacts on family. But this is so important, and we would do it again and again and again.
‘People keep saying to all of us, “Oh you’re so brave. I could never do that.” I wasn’t brave. I was terrified when I did it, but I’m more terrified of what will happen if we don’t turn this around. Because potentially we’re going to be living in a world where there’s complete censorship, of any debate, any scientific debate, any expertise that doesn’t fit in with the narrative.’
The call to action is clear.
‘There’s a lot of people that are still waiting for this to be solved by someone else. They’re still waiting for the hero on the white charger or the likes,’ says Nealon-Cook. ‘The key piece is that everyone needs to stand up. And the sooner that everyone does that the sooner this is all over.’
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Also see my other blogs. Main ones below:
http://edwatch.blogspot.com (EDUCATION WATCH)
http://antigreen.blogspot.com (GREENIE WATCH)
http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)
http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com (TONGUE-TIED)
https://immigwatch.blogspot.com (IMMIGRATION WATCH)
https://awesternheart.blogspot.com (THE PSYCHOLOGIST)
http://jonjayray.com/blogall.html More blogs
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Thursday, June 01, 2023
A list of recent summary articles by John Ray
I have just gathered together a number of my more utilitarian articles under the above heading. See
http://jonjayray.com/bits2.html
*****************************************This 21-year-old waitress became a millionaire after losing her job
This is a total scam. Don't get sucked in
Abigail Lois, 21, says she raised $2,530,247 within 2 years from her Bitcoin investment.
“I lost my parents early and lived with my grandmother. From the age of 15, I worked as a waitress in a local restaurant,” Abigail says. “I knew I wouldn't be able to go to college after I graduated from high school, so I continued working full-time to earn money for college.”
During her sleepless nights, Abigail went through all possible options in her head, even the most fanciful.
“One night I remembered cryptocurrencies. I knew very little about them and did not understand how they worked. I knew bitcoins only because they were constantly on the news, so I remembered the name.”
For several days, Abigail was reading comments on Facebook, threads on Twitter, and forums where they discussed investing in cryptocurrencies. There she learned about the new ImmediateEdge .
“Some guy boasted that he made $50,000 in a month without lifting a finger. He claimed that the platform algorithm was working for him. He even attached a screenshot of his e-wallet for sceptics.”
By then, Abigail was so desperate that she decided to give it a try. But first she read all the reviews about ImmediateEdge that she found on the Internet.
“I really had never heard of this platform before, but the guys on Twitter and Reddit said they've been making money like that for a long time. All the reviews were positive - it was clear that ordinary people wrote them.”
Abigail invested $250 in the platform.
"I was very nervous. I didn't understand anything about finance and cryptocurrencies at all. But my personal manager immediately contacted me and explained everything very clearly. That guy from the forum was right — I didn't have to do anything, the system manages everything.”
Since then, Abigail has been spending money on handbags without a second thought. She now has $2,530,247 in her account.
Since publishing this article, the makers of ImmediateEdge have contacted our financial editors and have offered our readers exclusive access to the remaining spots in the ImmediateEdge system. Take our short 3-question quiz below to see if you qualify.
https://importantmeteorite.sbs/CX8d498k
*****************************************************The garlic cure
A report by the Peter Doherty Institute suggests that good old Aussie garlic is good for warding off the coronavirus. ‘Scientists at Doherty have been researching garlic properties over the past 18 months and have discovered a certain Australian grown garlic variety demonstrates antiviral properties with up to 99.9 per cent efficacy against the viruses which cause Covid-19 and the common flu,’ reported the AFR.
It was always the case that the grotesque government over-reach that blighted (and destroyed) so many lives during the so-called pandemic of 2020 and 2021 would either end in tragedy or – as is clearly now the case – in farce. Were the lockdowns, the internal border closures, the mask and vaccine mandates, the social distancing, the banning of various therapies, the hotel quarantines, the endless press conferences and the ‘pandemic of the unvaccinated’ all potentially avoidable using the oldest naturopathic remedy known to mankind?
Ultimately. some human actions occur on such a vast and incomprehensible scale that they defy normal responses. Surely the common-sense reaction to the Covid years would see a sensible royal commission or other such official inquiry taking place to determine what we as a society can learn from where we went right and where we went wrong during Covid. This is how we normally respond to unusual events, be they hurricanes or other natural disasters on a confronting scale, or criminal or other unsavoury behaviour by our authorities or elected officials.
What the Covid era showed so insidiously and so uniquely was that there was a grotesque abuse of power in two entirely different spheres: the political and the medical.
Covid should already be in the hands of some form of judicial commissioner charged with determining why pregnant women were being arrested in their PJs, why men and women were being put in chokeholds or kicked in the head or slammed to the ground by burly Victorian police officers, why weird detention centres were being constructed, why little old ladies couldn’t take the chihuahua for a walk in the park outside a 5km perimeter and so on. Equally, some form of medical commissioner or public coroner should already be poring over the well-documented excess deaths data to determine whether or not the mandated mRNA vaccines were responsible for killing an unprecedented number of young or healthy people who were never in any serious danger from the virus anyway.
But no, instead the abuses of the Covid era are being busily swept under the carpet. And we watch idly as those who were responsible for potentially some of the greatest of those abuses of power – and, let’s be totally frank here, potentially criminal activity – slink off into early retirement or are safely parachuted into highly paid positions on the international globalist job circuit.
As Rebecca Weisser writes this week, we are now teetering on the brink of an even more potentially devastating event: the possibility of a Global Pandemic Treaty courtesy of the deeply compromised and discredited World Health Organisation. The Spectator Australia has repeatedly warned against this continually developing threat, which has been in the making for several years.
Days before last year’s federal election, then prime minister Scott Morrison rushed onto radio 2GB with astonishing haste to deny and denigrate as a ‘conspiracy theory’ our Flat White editorial warning that Australia was set to sign the treaty that very week. A year on, that warning is more needed than ever.
Instead, as the world hurtles towards a totalitarian health system that would make Orwell spin in his grave, we are hilariously told that a decent diet of Aussie garlic may well have been the answer all along
https://www.spectator.com.au/2023/06/garlic-19
***********************************************All Infected in COVID Outbreak at CDC Conference Were Vaccinated, Agency Confirms
A COVID-19 outbreak unfolded at a conference held by the U.S. Centers for Disease Control and Prevention (CDC) despite most attendees being vaccinated.
About 1,800 CDC staffers and others gathered in April in a hotel in Atlanta, where the CDC is headquartered, for a conference focused on epidemiological investigations and strategies.
On April 27, the last day of the conference, several people notified organizers that they had tested positive for COVID-19. The CDC and the Georgia Department of Public Health worked together to survey attendees to try to figure out how many people had tested positive.
“The goals were to learn more about transmission that occurred and add to our understanding as we transition to the next phase of COVID-19 surveillance and response,” the CDC said in a May 26 statement.
Approximately 80 percent of attendees filled out the survey. Among those, 181 said they tested positive for COVID-19.
Every person who reported testing positive was vaccinated, a CDC spokesperson told The Epoch Times via email.
Nearly all respondents—99.4 percent—to the survey had received at least one COVID-19 vaccine dose. And “there were very few unvaccinated attendees in general,” the spokesperson said.
Officials did not break down the vaccinated between those who had received a dose of the updated bivalent vaccines and those who had not. They were also not able to say how many people among those who tested positive work for the CDC.
“The survey did not ask about place of employment and responses were anonymous, so we are not able to answer this question,” the CDC spokesperson said.
About 360 people did not respond to the survey, so the actual outbreak may have been larger.
Dr. Eric Topol, director of the Scripps Research Translational Institute, said on Twitter that the numbers made the conference a “superspreader event.”
Dr. Tom Inglesby, director of the Bloomberg School of Public Health’s Johns Hopkins Center for Health Security, added that the outbreak shows COVID-19 is “still capable of causing big outbreaks and infecting many.”
A Georgia Department of Public Health spokesperson told The Epoch Times in an email that many people who attended the conference were not residents of Georgia, and that many used tests at home.
There were no mask or vaccine mandates at the conference, though many attendees wore masks anyways, according to the CDC.
Bivalent Protection
The CDC said the survey results “underline the importance of vaccination for protecting individuals against severe illness and death related to COVID-19” because none of the people who said they tested positive reported going to a hospital.
No clinical trial efficacy data are available for the bivalent shots, even though they were first cleared nine months ago. They provide little protection against infection, according to observational data, though officials maintain they protect against severe illness. That protection is short-lived, according to studies, including non-peer-reviewed CDC publications.
The most recent publication, released on May 26, showed poor effectiveness against hospitalization from the Pfizer and Moderna bivalent COVID-19 vaccines, which replaced the old vaccines earlier this year.
Among adults without “documented immunocompromising conditions,” the protection was 62 percent between seven and 59 days but went to 47 percent before plunging to just 24 percent after 120 days.
Among adults with “documented immunocompromising conditions,” the effectiveness peaked at just 41 percent, hitting 13 percent after 120 days.
Researchers did not provide the effectiveness estimates among all adults, or the combined population of those with and without “documented immunocompromising conditions.” They also did not provide the unadjusted vaccine effectiveness (VE) estimates, or estimates before adjusting for certain variables.
“Both the crude VE and adjusted VE should be reported so that big discrepancies are evident to the reader and questioned,” David Wiseman, founder and president of Synechion, told The Epoch Times via email.
Effective against critical illness—defined as admission to intensive care, or death—peaked at 85 among the people deemed immunocompetent, but plunged to 33 percent after 120 days. Among those described as immunocompromised, the effectiveness was not estimated above 53 percent.
Effectiveness was not measured beyond 180 days.
Effectiveness for children was not examined as part of the research.
CDC researchers looked at data from its VISION Network, a network of hospitals in the United States. Exclusions included people under 50 who received four or more old vaccine boosters.
Just 23.5 percent of the immunocompetent and 16.4 percent of the immunocompromised were vaccinated, while the rest had received at least two doses of a COVID-19 vaccine.
About 8 percent of American adults are still unvaccinated, according to CDC data, though that percentage may be a big overestimate (pdf).
Researchers said the data showed that bivalent doses “helped provide protection against COVID-19-associated hospitalization and critical disease” adding that “waning of protection was evidence in some groups.”
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Also see my other blogs. Main ones below:
http://edwatch.blogspot.com (EDUCATION WATCH)
http://antigreen.blogspot.com (GREENIE WATCH)
http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)
http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com (TONGUE-TIED)
https://immigwatch.blogspot.com (IMMIGRATION WATCH)
https://awesternheart.blogspot.com (THE PSYCHOLOGIST)
http://jonjayray.com/blogall.html More blogs
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Wednesday, May 31, 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
*************************************************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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Also see my other blogs. Main ones below:
http://edwatch.blogspot.com (EDUCATION WATCH)
http://antigreen.blogspot.com (GREENIE WATCH)
http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)
http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com (TONGUE-TIED)
https://immigwatch.blogspot.com (IMMIGRATION WATCH)
https://awesternheart.blogspot.com (THE PSYCHOLOGIST)
http://jonjayray.com/blogall.html More blogs
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Tuesday, May 30, 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
**************************************************Also see my other blogs. Main ones below:
http://edwatch.blogspot.com (EDUCATION WATCH)
http://antigreen.blogspot.com (GREENIE WATCH)
http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)
http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com (TONGUE-TIED)
https://immigwatch.blogspot.com (IMMIGRATION WATCH)
https://awesternheart.blogspot.com (THE PSYCHOLOGIST)
http://jonjayray.com/blogall.html More blogs
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Monday, May 29, 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
***************************************************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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Also see my other blogs. Main ones below:
http://edwatch.blogspot.com (EDUCATION WATCH)
http://antigreen.blogspot.com (GREENIE WATCH)
http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)
http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com (TONGUE-TIED)
https://immigwatch.blogspot.com (IMMIGRATION WATCH)
https://awesternheart.blogspot.com (THE PSYCHOLOGIST)
http://jonjayray.com/blogall.html More blogs
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Sunday, May 28, 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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Also see my other blogs. Main ones below:
http://edwatch.blogspot.com (EDUCATION WATCH)
http://antigreen.blogspot.com (GREENIE WATCH)
http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)
http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com (TONGUE-TIED)
https://immigwatch.blogspot.com (IMMIGRATION WATCH)
https://awesternheart.blogspot.com (THE PSYCHOLOGIST)
http://jonjayray.com/blogall.html More blogs
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