Thursday, January 18, 2024
Cardiovascular Autonomic Dysfunction at Crisis Levels in Long COVID Patients
A group of cardiovascular-focused expert researchers spanning the United States, Canada, United Kingdom, Austria and Sweden investigate cardiovascular autonomic dysfunction (CVAD), a malfunction of the cardiovascular system triggered by deranged autonomic control of circulatory homeostasis. CVAD is a malfunction of the cardiovascular system caused by deranged autonomic control of circulatory homeostasis. CVAD is an important component of post-COVID-19 syndrome, also termed long COVID, and might affect one-third of highly symptomatic patients with COVID-19.
With effects present throughout the whole body, prominent observations include impairment of heart rate and blood pressure control, plus manifestation in specific body regions; for example, manifesting as microvascular dysfunction.
Corresponding author Arthur Fedorowski, M.D., Ph.D., a notable cardiology specialist-investigator with Karolinska University Hospital, as well as Lund University and colleagues, report long COVID patients meeting severe conditions “meet the diagnostic criteria for two common presentations of CVAD” including:
1) postural orthostatic tachycardia syndrome
2) inappropriate sinus tachycardia.
Other related CVAD-linked conditions are associated with hypotension, such as orthostatic or postprandial hypotension, and recurrent reflex syncope.
Any Research Breakthroughs?
Fedorowski and colleagues point out that the pandemic did manage to accelerate long COVID research investigation helping to identify “new potential pathophysiological mechanisms, diagnostic methods and therapeutic targets in CVAD.”
The clinician/specialist-scientists point to the need for clinicians in the field who may encounter patients with CVAD on a daily basis and point out that more important than ever is “knowledge of its symptomatology, detection and appropriate management.”
Findings
Summarizing the recent medical literature research review in the journal Nature, the cardiology-centered researchers both establish a working definition based on the unfolding long COVID dynamic not to mention delineate the condition’s major forms presently reported on in lost COVID-19 syndrome patients.
Describing etiologies
In this review, we define CVAD and its major forms that are encountered in post-COVID-19 syndrome and describe possible CVAD etiologies (cause of disease) the cardiovascular-focused collaboration seeks to establish a more detailed linking of CVAD and post-COVID-19 syndrome or long COVID.
The goal obviously is to help empower more clinicians to both diagnose and manage this unfolding situation, plus delineate a research trajectory with an aim of a more efficient treatment pathway to address the ever more prevalent and enduring medical condition.
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Japanese Vaccine Study Group Holds Press Release Six Months After Launch—Pervasive Safety Problems with MRNA COVID-19 Vaccines
Japan was the scene of a press conference for the General Incorporated Association Vaccine Issues Study Group in that Asian nation of 125.7 million, and the world’s third largest economy as measured by gross domestic product. A major pharmaceutical market, the Japanese group’s January 11, 2024, event centered around a concerted, systematic review of the medical literature covering COVID-19 vaccines. Professor Emeritus Masanori Fukushima, M.D., Ph.D., from Kyoto University cites the database of studies made possible by patient advocacy group React19 along with the TrialSite partnership to continuously promote the existence of a large body of peer-reviewed medical literature tracking adverse side effects, some of them injury causes, associated to the COVID-19 countermeasure program. The Japanese event occurred January 11, 2024.
The COVID-19 vaccines side effects can adversely impact every organ across the human body as more data supports the spike protein hypothesis. That is, that the mRNA induced spike protein can persist and travel in the human body for not only weeks, but months and even years.
Apparently, Japanese volunteer physicians have been amassing their own study hub, a set of documents derived from peer review case studies to more comprehensive population studies.
Substacker Aussie17 circulated the video snippet across the internet but few media picked up the event.
Ongoing medical censorship, according to the press conference, hinders physicians attempting to find ways to collaborate and care for patients. Then there’s the societal pressure, much like what we are experiencing in North America and Europe applying subtle and not so subtle pressure against any critical discussion about the COVID-19 vaccines, including vetting of mRNA-based vaccine injuries.
The participants also raised the specter of censorship at the level of scientific and medical journals, a phenomenon TrialSite has chronicled throughout the pandemic. TrialSite observed such censorship first with the discussion of alternative repurposed drugs such as ivermectin, then this same intuitive applied to critical discussion of the COVID-19 vaccines, or countermeasures as they are formally called by the U.S. government.
Professor Yasufumi Murakami went on the record at the event concerning adverse events, “One thing I want to say initially is that it is clear how the adverse effects occur, which is still holding many victims today. I believe it should be stopped immediately.”
Back to the spike protein hypothesis, not even acknowledged by the medical establishment in the developed nations, a mechanism of action now well understood, documented in multiple peer-reviewed studies and a recognition that the spike protein can at least in some cases circulate In the human body acting as an irritant with toxic impact.
Also problematic, at least for some patients, is the mRNA vaccines’ lipid nanoparticles (LNP), which can induce toxic reactions as well.
TrialSite reviewed and verified the General Incorporated “Association Vaccine Issues Study Group” and its press conference to discuss its report on six-month results.
Note that TrialSite includes multiple COVID-19 vaccine injury forums and publishes articles based on study after study suggesting government need for investment in ongoing investigation. Importantly many of the studies currently covering incidence involving side effects and the vaccine are case reviews, meaning they are not designed to establish causation.
Moreover, much dis-information and mis-information continues to circulate, especially from fringe groups claiming that the COVID-19 countermeasures were designed to specifically hurt people, such as part of a global cabal’s plan to depopulate the planet. This is dis-information and the more governments around the world withhold and suppress safety data the more these fringe groups benefit with an audience.
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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, January 17, 2024
How Moderna Came Up With a Vaccine Against Vaccine Dissent
Finances at the vaccine manufacturer Moderna began to fall almost as quickly as they had risen, as most Americans resisted getting yet another COVID booster shot. The pharmaceutical company, whose pioneering mRNA vaccine had turned it from small startup to biotech giant worth more than $100 billion in just a few years, reported a third-quarter loss last year of $3.6 billion, as most Americans refused to get another COVID booster shot.
In a September call aimed at shoring up investors, Moderna’s then-chief commercial officer, Arpa Garay, attributed some of the hesitancy pummeling Moderna’s numbers to uninformed vaccine skeptics. “Despite some misinformation,” Garay said, COVID-19 still drove significant hospitalizations. “It really is a vaccine that’s relevant across all age groups,” she insisted.
To get past the “misinformation” and convince the public to take continual booster shots, Garay briefly noted that Moderna was “delving down” on ways to partner “across the ecosystem to make sure consumers are educated on the need for the vaccine.”
What Garay hinted at during the call, but didn’t disclose, was that Moderna already had a sprawling media operation in place aimed at identifying and responding to critics of vaccine policy and the drug industry. A series of internal company reports and communications reviewed by RealClearInvestigations (RCI) show that Moderna has worked with former law enforcement and public health officials and a drug industry-funded non-governmental organization called The Public Good Projects (PGP) to confront the “root cause of vaccine hesitancy” by rapidly identifying and “shutting down misinformation.”
Part of this effort includes providing talking points to some 45,000 healthcare professionals “on how to respond when vaccine misinformation goes mainstream.” PGP and Moderna have created a new partnership, called the “Infodemic Training Program,” to prepare health care workers to respond to alleged vaccine-related misinformation.
The company has also used artificial intelligence to monitor millions of global online conversations to shape the contours of vaccine-related discussion. The internal files—shorthanded here as the Moderna Reports—show high-profile vaccine critics were closely monitored, particularly skeptics in independent media, including Michael Shellenberger, Russell Brand, and Alex Berenson. PGP, which was funded by a $1,275,000 donation from the Biotechnology and Innovation Organization, a lobby group representing Pfizer and Moderna, has identified alleged vaccine misinformation and helped facilitate the removal of content from Twitter, among other social media platforms, throughout 2021 and 2022.
Emails from that period show that PGP routinely sent Excel lists of accounts to amplify on Twitter and others to de-platform, including populist voices such as ZeroHedge.
The messages also suggested emerging narratives to remove from the platform. “People opposed to vaccines are capitalizing on the NYT [New York Times] article about the CDC withholding vaccine information. The articles do not contain misinformation themselves but are using the news to further prove the CDC is untrustworthy,” wrote Savannah Knell, PGP’s senior director of partnerships, in an email to a Twitter lobbyist in September 2022. In another email the following month, Kaitlyn Krizanic, PGP’s senior program manager, told Twitter to be on the lookout for “reports that Sweden is no longer recommending the vaccine for children.” In some cases, conservative accounts expressing outrage at restrictive pandemic policies, such as vaccination passports, were deemed by PGP as “misinformation” that warranted removal.
The Moderna Reports consistently show the company raising red flags about those reporting documented side effects of the vaccine the biotech company was selling. Such concerns, which may be typical of corporate public relations efforts that want their product shown in the best light, take on a darker cast when it involves medicine injected into people’s bodies.
Like the Twitter Files, the Moderna Reports highlight the push by powerful entities—especially government, Big Tech, and Big Pharma—to identify and brand dissenting opinions about establishment narratives as risky forms of speech. The growing network these efforts rely on shows the growth of what has been called the censorship industrial complex. Moderna’s faltering financials also suggest, at least for now, the limits of that project.
Public Good Projects and Moderna did not respond to repeated requests for comment.
In an internal email sent last July, Moderna notified its team of its latest efforts to shape the vaccine debate. “We have partnered with PGP (The Public Good Projects) and Moderna’s Global Intelligence, Corporate Security, Medical Affairs, Corporate Communications, Clinical Safety and Pharmacovigilance teams to provide media monitoring for misinformation at scale,” Marcy Rudowitz, the company’s customer program lead, wrote. “If and when a response is needed, our team will notify the appropriate stakeholders with recommendations,” she added.
The extent to which the company may intervene to shape content decisions is not clear. PGP continues to boast close relations with establishment institutions, including major medical associations.
The rise of censorship is inextricably connected to the pandemic, which emerged in the United States in early 2020. As federal, state, and local governments imposed unprecedented regulations on Americans in the name of public health, efforts arose to discredit counter-narratives that could be spread easily on social media. Early in the pandemic, criticism of policies such as lockdowns and vaccine mandates came almost entirely from independent media, which faced shadowbans and outright censorship on various platforms.
When they introduced their vaccines in 2021, manufacturers such as Moderna, Pfizer, and Johnson & Johnson also had a powerful financial interest in bolstering such censorship.
Moderna, perhaps more than other drug firms, is overwhelmingly reliant on the continued success of its vaccine. The company announced a price hike of up to $130 a dose this month, far higher than the $15–26 for American federal contracts, according to the Wall Street Journal. “We’re expecting a 90 percent reduction in demand,” Modena CEO Stéphane Bancel said, when he was asked to defend the decision. “As you can see, we’re losing economies of scale.”
Far from acting as a neutral arbiter, the Moderna Reports show that the company blurred the lines between public relations and public health. In many cases, Moderna’s intelligence and communications team targeted accurate information that had “the potential to fuel vaccine hesitancy” as menacing forms of misinformation in its reports. Given the size and scope and the censorship industrial complex, it can be difficult to draw a clear straight line between Moderna’s surveillance and actions taken against specific articles, posts, and writers. Instead, as Garay suggested, the company is one stream in an evolving ecosystem aimed at undermining dissent.
Alex Berenson
Independent journalist Alex Berenson is a repeated subject of the company’s surveillance efforts. A former reporter for the New York Times, Berenson quickly emerged as one of the most outspoken critics of vaccine-related policies. He was among the earliest to cast doubt on the Biden administration’s false claim that the vaccinated people could not transmit the COVID-19 virus to others. After government pressure on Twitter, Berenson was banned from the platform in 2021, only to return after successfully litigating against the company.
He appears to still be in the crosshairs. In September 2023, Moderna flagged a tweet from Berenson that highlighted the CDC’s data showing that among 1 million mRNA-vaccinated teenagers, there were from zero to a single COVID death and up to 200,000 side effects.
The company cited Berenson’s tweet under a report headline “Attacks on pediatric COVID-19 vaccines escalate” and claimed he had “cherry-picked data.” However, the company did not directly rebut any of Berenson’s claims in its report. Rather, Moderna noted the “high-risk” danger of Berenson’s viral tweet related to the potential for low child COVID-19 vaccination rates. “Fears about side effects and long-term dangers are major reasons parents report not vaccinating their children,” the report stated. It further concluded that “resistance to COVID-19 vaccines for children can be a gateway to broader anti-vaccine beliefs.”
Other Moderna reports flag Berenson’s tweets for “misinformation about mRNA safety” and claim that he is a “conspiracy theorist” for suggesting that health authorities have not properly taken into account the documented risks of myocarditis (inflammation of the heart muscle) for young men receiving the vaccine. Such questions have been posed by an increasing number of health professionals, but the misinformation reports dismiss any Berenson criticism as inherently false.
“It’s nice to know Moderna is watching me,” said Berenson, when asked about his response to the revelations. “I’m watching them too. mRNA shots carry unacceptably high heart risks for teenagers and young adults. Nearly the entire rest of the world accepts this reality and now discourages or bans people under 50 from taking mRNA Covid boosters. It is unconscionable that Moderna and Pfizer continue to market them to non-elderly adults.”
“They can call me whatever they like,” he noted, “but they can’t stop my reporting.”
Russell Brand
Russell Brand, the British commentator and comedian, is also a repeated name in the Moderna misinformation files. The left-leaning populist routinely pillories the pharmaceutical industry for exploiting the pandemic to generate unprecedented profits.
Moderna has closely monitored Brand’s criticism of the drug industry.
In various “low-risk” reports produced in August 2023, Moderna flagged videos produced by Brand twice. In one, Moderna noted that Brand had broadcast a monologue about Jonathan Van-Tam, a former senior health official who helped formulate COVID-19 policies in Britain. Van-Tam had just taken a position with Moderna, a move that raised eyebrows with many in the press. In the video, Brand noted that the company had just “made a fortune during the pandemic selling vaccines to the government,” and that the “government worker that bought all those vaccines” was now moving through the revolving door.
In another report, Moderna alleged that Brand “claimed that COVID-19 vaccine mandates were based on a lie in a recent podcast episode.” The video was broadly accurate. The monologue highlights CDC documents that had come to light showing that officials were aware that the virus would “break through” and still infect vaccinated patients. In an ironic twist, Brand finished the segment with a discussion of efforts to censor debate around the vaccine.
Moderna noted they were not yet taking action on this broadcast, but “we are monitoring with our partner, the Public Good Projects.”
The following month, several media outlets reported that several women who insisted on anonymity were claiming that Brand had abused them nearly twenty years ago. The ensuing media firestorm, which led to YouTube demonetizing his account, became fodder for other Moderna misinformation reports. The company warned that the cancellation of Brand was sparking a backlash among social media users, who believed that he may be targeted by government and corporate censors for his outspoken opposition to pandemic narratives.
In a Moderna high-risk report, the company noted that speculation was swirling that “allegations are part of a conspiracy to silence the comedian, who has been a vocal opponent of COVID-19 vaccines.” The report linked an X video of Brand sharply criticizing Moderna and Pfizer for generating “$1,000 of profit every second” in 2021. The specific claim of profiteering was a mainstream claim, a statistic that was produced by Oxfam.
Nowhere in its reports on Brand did Moderna highlight any incorrect information. But the reports noted that they monitored Brand because he “has a large platform with over 6.6 million YouTube subscribers and over 21 million followers across multiple social media platforms.” Moreover, his “videos are widely circulated in anti-vaccine spaces where he is viewed as a truth-teller and threat to authority,” and that Brand maintained support from Tucker Carlson and Elon Musk.
Michael Shellenberger
The Moderna misinformation reporting system reveals that the pharmaceutical firm maintained an interest in pandemic-related issues that go beyond vaccine policy, overlapping with general issues surrounding the unexplained questions that still swirl around the source of the pandemic.
The company, for instance, flagged discussions around news last year of a congressional whistleblower who came forward with allegations that the CIA suppressed an assessment from analysts that COVID-19 originated at the Wuhan Institute of Virology. The story has garnered widespread coverage in NBC, Science, and ABC News, among other outlets.
But Moderna’s misinformation alerts flagged Sen. Rand Paul (R-Ky.) and journalist Michael Shellenberger for distributing information about the CIA allegation. Shellenberger—with whom this reporter has worked on the Twitter Files—had exclusively reported earlier last year that U.S. government sources believed that the “patient zeros” of COVID-19 were a group of Chinese scientists at the Wuhan lab—a major revelation later confirmed by the Wall Street Journal.
Despite his work on the issue, Moderna dismisses Shellenberger in its reports as among its known “misinformation authors.”
“Moderna has spent years spreading disinformation about their vaccines and so it makes sense that they would smear the scientists and journalists who expose them as conspiracy theorists and sources of misinformation,” Shellenberger told RCI.
“The question is why is Moderna spreading disinformation on the high probability that Covid escaped from the Wuhan Institute of Virology lab?” he added. “A company that makes its money selling a coronavirus vaccine shouldn’t care where Covid came from.”
More here:
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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, January 16, 2024
DNA Contaminants in COVID Vaccines Are ‘Beyond the Pale’: Florida Surgeon General Explains the Call for Vaccine Halt
On Jan. 3, the office of Florida Surgeon General Dr. Joseph Ladapo issued a statement calling for the halt in the use of COVID-19 mRNA vaccines, citing the recent discovery of DNA contaminants in the vaccine vials.
On the Jan. 12 episode of EpochTV’s “American Thought Leaders,“ Dr. Ladapo explained why he called for a halt, saying that while there are also safety concerns with the COVID mRNA vaccines linking them to a multitude of adverse events, the recent discovery is ”beyond the pale.”
“DNA is a common contaminant of many biological products,” he told the show’s host, Jan Jekielek. “We can use DNA to produce different drugs like insulin, other biologics—and that’s a wonderful innovation, and normally, that DNA doesn’t pose a problem.”
Human cells are resistant to DNA entry, and this prevents harming the integrity of the cell’s DNA.
However, since the mRNA vaccines use lipid nanoparticles, which deliver mRNA into the cells directly, DNA contaminants could also be able to enter the cells. Some scientists, like Dr. Ladapo, are concerned that the DNA from the vaccine may integrate with the human genome.
Prominent officials at the U.S. Food and Drug Administration (FDA) disagree.
On Dec. 6, Dr. Ladapo sent a letter to FDA commissioner Dr. Robert Califf and the U.S. Centers for Disease Control and Prevention (CDC) director, Dr. Mandy Cohen. In his letter, he asked if there have been risk assessments of the vaccine DNA integrating into human DNA, especially regarding the controversial SV40 promoter/enhancer region found in Pfizer’s vaccine.
Other questions included whether risk assessments have been done on DNA integration in reproductive cells and if the current levels of DNA residuals are acceptable under the FDA’s standards.
“We’ve gotten ... lengthy responses that don’t answer the question,” Dr. Ladapo said.
In his response, Dr. Marks wrote that DNA integration “is quite implausible,” adding that animal studies show “no evidence indicative for genotoxicity.”
No tests were mentioned that would assess if DNA integration is occurring.
Dr. Ladapo believes it would be reckless not to test for DNA integration, a potential risk once DNA enters the cell.
“Their position is, oh, no, it’s fine. Everything’s fine; safe and effective. That’s not only not good enough, but it’s completely unacceptable,” Dr. Ladapo said. “And that’s why I made that determination, and it’s absolutely the correct call.”
DNA Contamination: The SV40 Promoter Controversy
Both Moderna and Pfizer mRNA vaccines contain DNA contaminants, but only the Pfizer vaccines have also been found to contain SV40 promoter/enhancer DNA, which has since become a topic of debate.
SV40, or simian vacuolating virus 40, is a DNA virus that sometimes causes cancer in animals.
However, the SV40 promoter/enhancer found in the vaccines is only a tiny section of the DNA; it is not equivalent to the entire SV40 virus or its protein.
Promoter-enhancers are sections of DNA that can control the activity of other DNA.
“With DNA, there are different regions that tell other parts of DNA whether to be active or not,” Dr. Ladapo said. “This type of control process is very important ... The absence of control can, for example, lead to cancer ... [and] other metabolic abnormalities.”
In his letter to the FDA, Dr. Ladapo asked about the additional risk of the SV40 promoter/enhancer region’s DNA integration.
Dr. Marks answered that there were no genes for SV40 proteins nor SV40 proteins themselves present in the vaccine.
But Dr. Ladapo believes Dr. Marks is intentionally not answering the question. “No one’s talking about SV40 protein ... we talked about the promoter/enhancer region. They have to be doing it intentionally,” Dr. Ladapo said.
The Risks of DNA Integration
It is currently unknown whether DNA introduced into the body is being integrated into the cell’s human genome; and if it’s integrated, what impact will it have.
Only around 1 percent of the human DNA produces protein; the job of the other 99 percent of DNA is mostly unknown.
“There’s ... a lot of uncertainty about our genome—what it does, how it supports life and creates life, and creates the miracle of each individual human being,” Dr. Ladapo said. “What we do understand is that some of the potential risks of DNA integration include development of cancers, because ... of the regulation of different aspects of DNA and cell growth.
“Other possibilities include the disruption of the normal expression of some proteins, which then subsequently could lead to disruption of normal human function.”
Since biodistribution studies in rats have shown that the mRNA vaccines can accumulate in the reproductive organs, Dr. Ladapo’s letter expressed concern that there may also be DNA integration of reproductive cells.
“We are the most complex beings—the most complex machines, if you will—living machines that exist on this Earth. So I do believe that our genome is part of our connection to God. So that is to say that there’s quite a lot at risk in terms of not taking proper precautions and sensible precautions, with maintaining the integrity to the best that we can—life ain’t perfect, but to the best that we can with our human genome.”
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FDA Launches Fresh Bid to Toss Out High-Profile Ivermectin Case
The U.S. Food and Drug Administration (FDA) is seeking to persuade a federal court to dismiss a lawsuit challenging its repeated advisories against using ivermectin to treat COVID-19.
The FDA in a sealed motion asked the U.S. District Court for the Southern District of Texas to dismiss the suit, which was brought by three doctors who allege the FDA’s warnings were illegal.
The late 2023 motion was sealed because exhibits the government cited “include confidential information” from a separate legal proceeding, according to a government brief.
Government lawyers said they would file redacted versions of the motion for public perusal but still haven’t done so.
Attorneys for the doctors said on Jan. 12 that the court should reject the government’s fresh bid to throw out the case.
“The FDA exceeded its authority by repeatedly issuing public directives not to use ivermectin for COVID-19, even though the drug remains fully approved for human use,” they wrote.
The government motion came after an appeals court found that the FDA likely overstepped its authority with the warnings.
“FDA can inform, but it has identified no authority allowing it to recommend consumers ’stop' taking medicine,” U.S. Circuit Judge Don Willett, an appointee of then-President Donald Trump, wrote in the ruling.
The appeals court remanded the case back to U.S. District Judge Jeffrey Brown, who said in 2022 that the doctors failed to prove their allegations.
The FDA in the sealed motion asked Judge Brown, another appointee of President Trump, to dismiss the case.
According to lawyers for the doctors, the FDA’s motion includes the argument that the plaintiffs haven’t suffered injuries that are traceable to the FDA and that can’t be remedied by a ruling in favor of the plaintiffs.
“The FDA is wrong,” the lawyers said. “Plaintiffs have suffered interference with their practice of medicine and the doctor-patient relationship, economic harm, reputational harm, and increased exposure to malpractice liability, and have been subject to disciplinary proceedings and forced resignations, all of which clearly trace to the FDA’s campaign against ivermectin and would be remedied by equitable relief.”
The Federal Food, Drug, and Cosmetic Act enables the FDA to authorize or approve drugs for a specific use, but doctors are free to prescribe cleared drugs for other purposes, in what’s known as “off-label” prescribing. The law doesn’t grant authority to the FDA to regulate off-label use.
The plaintiffs include Dr. Robert Apter, who was investigated by medical boards in two states for prescribing ivermectin to treat COVID-19. The referrals to the boards include some of the FDA’s warnings against using the drug as a COVID-19 treatment.
The FDA’s position in seeking a dismissal stems in part from the negative actions against the plaintiffs being taken by third parties such as pharmacies, according to a description of the sealed motion. It was quoted as saying that the referrals “are not fairly traceable” to the FDA’s statements.
An exhibit included by the FDA, however, showed that one of the referrals came from a pharmacist who cited FDA documents as a reason for “increased scrutiny” with regard to ivermectin prescriptions. The pharmacist wrote that Dr. Apter wouldn’t provide a “valid medical reason” for the ivermectin prescription and was thus engaging in “inappropriate prescribing.”
“The FDA is the common thread through all of [the] plaintiffs’ injuries, which began only after the FDA embarked on its campaign to stop the use of ivermectin for COVID-19 and which often involve explicit invocation of the FDA’s directives and recommendations,” the plaintiffs’ lawyers said.
They are seeking an order that would force the FDA to rescind or amend its warnings. That would remove the justification of the parties that have taken actions against the plaintiffs, the lawyers added.
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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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Monday, January 15, 2024
Nurses Share Experiences In Hospitals During COVID-19--Incredibly Disturbing If Accurate & Generalizable to Broader Health System
An early internet marketing pioneer now retired, during the COVID-19 pandemic became one of what has become a small army of dedicated citizen journalists seeking to dig deeper, uncover and expose, and importantly, address what many believe to have been an unacceptable state overreach severely damaging the American economy and society. For Ken McCarthy this pursuit for truth came in the form of a series of hard-hitting interviews with experienced nurses. Based on recurring themes emerging from these interviews, McCarthy identifies a shocking potential reality: the top-down protocols promulgated across American health care systems contributed to the enormous U.S. COVID-19 related death toll.
During the spring of 2020 McCarthy started interviewing seasoned nurses working in hospital ICUs treating COVID patients. He questioned these providers about the reasonableness, efficacy, and safety of government-recommended and hospital-enforced COVID protocols. What he learned would profoundly shake him to the core.
Actually, McCarthy was not alone in investigating hospital COVID-19 protocols. Already some nurses and physicians resigned, at times in protest over what they deemed a violation of the Hippocratic Oath.
Mostly censors continuously eradicated any such talk materializing on social media channels, while the mainstream media of course mostly avoided such journalism all together. But there was some flare up of interest in select media, with some coverage and even chatter online that would eventually be scrubbed.
A Pioneer
Ken McCarthy literally helped mature the commercial capacity of the internet during the first part of the 1990s, as a marketer conducting experimentation to help develop pay-per-click advertising for example, as well as early attempts to establish monetization of online videos.
Suffice to say McCarthy did well for himself financially which later in life would come in handy for his career out of retirement: COVID-19 sleuth with a particular focus on hospital protocols.
What started as a deep concern, translated into a pursuit of journalism with a series of in-depth interviews of experienced nurses and other credentialed health care professionals. The topic: their experiences during the COVID-19 pandemic.
Does McCarthy’s nurse interview-sourced discovery fit into an ongoing thesis as to why so many people died in the United States during the pandemic?
With 1,191,815 deaths attributed to COVID-19 in the United States, mortality was higher, far higher, than any other nation. But how could this be? The world’s richest economy with over $4 trillion spent annually on health care! And apparently more fortunes were spent during the pandemic as the federal government incentivized hospitals and health systems, not surprisingly, accompanied by top-down protocols of care. Then of course the entire countermeasure value chain, all protected with near universal liability assumption by the government.
After several in depth interviews McCarthy wasn’t sure any more about the official narrative pertaining to the causes for COVID-19 death. This led to the book titled What the Nurses Saw.
McCarthy connected with TrialSite founder Daniel O’Connor to discuss his book, a summary of findings and his point of view as to any underlying rationale or reasons.
McCarthy shared that he first started the nurse interviews in the late spring of 2020 during the first surge of the SARS-CoV-2 pandemic. However, for at least a while he put the matter aside, but revisited the topic three years later when it became obvious that no one else was going to.
The nurses point of view during the pandemic most certainly seems quite important. Often silenced with no voice in their place of employment, also out in the medical freedom community the nurse voice was often silenced by the prominent critical doctors gaining and keeping the spotlight,
TrialSite’s O’Connor mentioned “We thought it was important, given that Ken McCarthy worked tirelessly investing in his own budget to capture and share the voices of highly experienced nurses and their points of view as to what happened.”
The book includes in-depth interviews with eight veteran nurses from the U.S., one from the UK, and two from Canada plus a veteran respiratory therapist with 23 years of clinical experience. Their consistent narratives raise alarm and suggest that in addition to all the other problems COVID-19 caused, that possibly the U.S. government led response also precipitated a collapse of medical practice, ethical standards, and common sense that may have been the cause or a major contributing factor to what is a currently uncounted number of iatrogenic deaths and injuries.
Meaning that potentially thousands if not tens of thousands or more deaths were possibly linked to COVID-19 protocols for example aggressive intubation and ventilation, overuse of remdesivir and the like.
The author was even told of hospitals that did not allow providers to treat hospitalized COVID-19 patients with ibuprofen or steroids to reduce inflammation. Some of the nurses also reported that their specific employer was incentivized based on duration of stay, use of remdesivir and other activities.
Need for Serious Inquiries
Although the book is based on anecdotal evidence, nonetheless the interview topics, the observations and allegations are based on direct nurse testimonials.
While not a medical professional, McCarthy studied science in undergraduate and went on to a very successful career as mentioned above. Over the years he advocated for using the internet to publish, as well as a tool for challenged communities where he developed strategies to use the internet to organize citizens and engage in education, outreach and community empowerment.
An environmentalist as well, McCarthy’s community organizing helped to defeat what was planned to be along the Hudson River North America’s largest coal-fired cement plant.
Combining his technical -minded skills with citizen journalism , publishing and community activist McCarthy’s now on a mission to understand any hospital culpability during the pandemic. According to his interview subjects, various hospitals became dangerous places during COVID-19, not just due to the novel coronavirus, but because of the unprecedented transformation of medicine.
The ultimate culprit? The author informed TrialSite’s Daniel O’Connor that he suspects the federal government’s hand, via the emergency apparatus triggered by the announcement of federal health emergencies.
TrialSite plans on a video interview with the author and will support him in various research endeavors. For example, a nagging question: were the same intubation and ventilation protocols the standard for previous respiratory ailments involving acute respiratory distress syndrome (ARDS)? What about for the first two coronavirus surges—SARS-CoV and MERS?
If the protocols were not the same, meaning new standards of care suddenly appeared with SARS-CoV-2, why would the Centers for Medicare and Medicaid, part of the U.S. Health and Human Services offer more payments for such deviations to existing practices? What was the rationale?
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Australia: Pregnant nurse Ella refused to get a Covid jab and was duly sacked from her job at a children's hospital. Now she's plotting revenge
A passionate nurse is threatening legal action after she was sacked this week for refusing to get a Covid jab in 2021 - even though the mandate for healthcare workers was repealed in September 2023.
Ella Leach, 29, secretary of the Nurses Professional Association QLD, sued Queensland Health for her 'unfair dismissal' last weekend.
The seven-months pregnant mum-to-be is also demanding an apology from Industrial Relations Minister Grace Grace for making 'misleading' comments about her case.
Ms Leach claims that by firing more than 1,200 nurses in a similar position, the state's government is 'just trying to prove a point' in the middle of a health care worker shortage.
'Terminating experienced nurses in a critical workforce shortage after keeping them in limbo for over two years, which to all appearances seems to be a power play… .I don't think, passes the pub test,' she told Daily Mail Australia.
'This is not about me. This is about thousands of healthcare workers prevented from working in their profession.'
Ms Grace had said there had been 'specific circumstances' behind Ms Leach's firing when she was asked about the decision to sack her.
According to Ms Leach however, the only allegation listed in her termination letter regarded her refusal to comply with the vaccine mandate.
'Ms Grace has my permission to elaborate further about the 'specific circumstances' surrounding my case,' she told the Courier Mail.
'Considering another pregnant nurse was sacked from Queensland Health two days after myself, I know that this is not an isolated incident.'
The Minister had previously said that 'there was more' to Ms Leach's case than met the eye, but that she was unable to disclose any extra details due to privacy concerns.
'It's very hard to comment on an individual case, but I think there's more to this case in relation to this,' Ms Grace said.
'We are doing all that we can to attract health workers but quite clearly, when directions are given, we expect them to be followed.'
In a letter replying to the Minister, Ms Leach wrote that she had 'relinquished any right to privacy' and was 'eager' to hear the circumstances that Ms Grace was referring to.
'I am yet to receive any further information ... beyond what was espoused in my termination letter,' Ms Leach wrote.
'Otherwise, I would like to receive an apology from you for portraying my circumstances of dismissal as anything other than what they were - a pregnant Queensland Health nurse being dismissed for disobeying a Health Employment Directive that is no longer in force.'
Queensland's hospital system has been plagued since the pandemic by long waiting times and ambulance ramping.
Ms Leach believes this is almost entirely due to a chronic lack of staffing.
'Nurses are pushed to the point of burn out, women are unable to give birth in our rural facilities and forced to have caesarians far from home - and all exacerbated by the fact that we don’t have enough nurses and midwives in our healthcare facilities.'
Daily Mail Australia has contacted Ms Grace's office and Queensland Health for comment.
Ms Leach worked as a registered nurse for seven years and had experience in neurosurgical, neurology, orthopaedics, medical and oncology.
Prior to the pandemic she had never been subject to disciplinary processes or management intervention.
Speaking to Sky News Australia on Tuesday, Ms Leach said that the drama had taken her attention away from her pregnancy.
'I should be focused on the joys of becoming a first time mum but it has been overshadowed by this whole process,' she said.
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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, January 14, 2024
CDC Ordered to Disclose Crucial Information From COVID-19 Vaccine Surveillance System
The top U.S. public health agency must disclose information provided by people who experienced problems following COVID-19 vaccination, a federal court has ruled.
The U.S. Centers for Disease Control and Prevention (CDC) is being ordered to produce 7.8 million free-text entries from V-safe, one of its vaccine surveillance systems.
Data from the system released under court order in 2022 showed that 25 percent of V-safe participants missed school, work, or other normal activities due to post-vaccination issues, and nearly 8 percent of participants reported seeking medical attention, such as hospitalization after receiving a shot. That data, from boxes checked by users, came through an order in a case that started as a Freedom of Information Act (FOIA) request.
But the CDC resisted releasing the free-text entries, arguing that many of them include information that should remain private.
“CDC determined that many of these responses contain personally identifiable information, the disclosure of which would publicly link participants to highly sensitive health information,” government lawyers representing the agency said in one brief. “And because it would take tens of thousands of workhours to manually review and redact millions of free-text responses, CDC determined that segregating the non-exempt information within these responses would be unreasonably burdensome and was therefore beyond its FOIA obligations.”
The CDC said it would take one worker 59 years to complete the work if it were ordered.
The government’s arguments were rejected by U.S. District Judge Matthew Kacsmaryk, an appointee of former President Donald Trump, in response to a fresh lawsuit.
“While the burden to produce the requested free-text responses may be heavy, this court does not find that it is unreasonable,” he said in the new ruling.
The CDC can go through the records and redact personally identifiable information as allowed by FOIA but must do the work and produce the records with the redactions, he added later. Evidence produced in the case indicates that about 93 percent of the records will require no redactions.
The materials will be important for people who experienced problems following vaccination, the judge said.
“Production of the free-text data will permit independent researchers to put the government agencies to their proof by considering all of the available data,” he said. He noted that CDC studies on v-safe data only covered data from the first week or two after vaccination but that the surveys collected data for up to one year after receipt of a shot.
The CDC must produce at least 390,000 free-text entries by Feb. 15. Freedom Coalition of Doctors for Choice, which brought the case in 2023, said the entries would be posted to its website.
The CDC did not respond to a request for comment.
V-safe is a system run by the CDC. Introduced during the COVID-19 pandemic, it features people inputting information through a phone application. Participants are asked to provide basic information such as their name and check boxes that answer various questions, such as whether they missed school or work after vaccination. They can add additional information in a free-text area.
The portion where participants checked boxes did not include many adverse events the CDC thought the COVID-19 vaccines might end up causing, according to previously released documents.
Lawyers say the free-text entries will provide crucial details on those health issues and others.
The Informed Consent Action Network, which brought the case that resulted in the disclosure of some of the V-safe data, obtained a free-text entry from a V-safe user that showed her writing, at one point, “Help me!” She said she suffered from a number of symptoms, including nausea and vomiting, and went to the emergency department. Six months later, she wrote, “Still no response from CDC, no help from public health.”
“This ruling,” the network said in a statement, “sends a clear message to our federal agencies: we are not moving on and forgetting about the pandemic or the actions they took.”
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Nurses in Queensland who were stood down during the pandemic for refusing to get a Covid vaccine are being sacked despite the lifting of mandates
Nurses in Queensland who were stood down during the pandemic for refusing to get a Covid vaccine are being sacked despite the lifting of mandates months ago.
Ella Leach, secretary of the Nurses Professional Association QLD, was one of those who was recently notified through a letter she had been fired, even though she is seven months pregnant.
'I should be focused on the joys of becoming a first time mum but it has been overshadowed by this whole process,' Ms Leach told Sky News Australia.
When asked why the Queensland Health Department would continue pursuing employees who are no longer in breach of any vaccine rule, Ms Leach said she felt the authority was 'doubling down' on its position during the pandemic.
In September 2021 all Queensland Health staff working in facilities where healthcare was provided were told they must be vaccinated for Covid, however, this directive was repealed in September 2023 by new director-general Michael Walsh.
'They're just trying to prove a point with us,' Ms Leach said. 'There's no sensible reason why they would continue with this action.'
'We know that our hospitals are screaming out for staff. We're seeing ambulances ramped outside hospitals, people dying in ambulances, our rural areas are suffering.'
Ms Leach said she was one of at least 50 staff she knew of that had been fired since September 25 last year.
Ms Leach's former employer Children's Health Queensland said in a statement it is 'unable to comment publicly on the employment situation, including disciplinary action, of individual staff'.
'Employee disciplinary matters are handled on a case by case basis and governed by robust and equitable processes.'
Ms Leach said she was aware some staff had been told they could reapply for their old jobs. 'In my role as the secretary I've seen hundreds of letters sent to staff about this matter.'
'They say they've been looked at on a case by case basis but they are templated letters and they insert what you've written back to them and say ''even if we haven't addressed your concern don't think we haven't taken it into account'',' she claimed. 'Then they just terminate you, it's disgraceful'.
'I've spoken to nurses who have lost their homes over this'.
In repealing the vaccine mandate, Mr Walsh said wide ranging advice had been submitted that informed the decision. This included employee feedback, expert clinical advice, official immunisation advice, and a 'human rights assessment'.
Similar vaccine mandates for health workers were lifted in NSW at the end of 2022 but the mandate still stands in Victoria.
https://www.dailymail.co.uk/news/article-12941457/Vaccine-mandates-nurses-stood-Queensland.html
********************************************Management of Oral Lesions after COVID-19 Vaccination
I was always a bit prone to mouth ulcers but a natural remedy fixed them rapidly for me. A mouthful of salted peanuts taken during the day usually resulted in no ulcers the next day -- an extremely effective remedy. JR
By Peter A. McCullough, MD, MPH
I recently had a patient who had salivary gland problems after vaccination and when I looked in her mouth I saw unusual lesions at the orifice of the parotid duct. I wondered if there were any solutions.
Joseph et al published a brief summary of the litany of oral/facial problems that develop after COVID-19 vaccination.
“Most common oral lesions reported in the literature following COVID-19 vaccination include maculae, petechiae, desquamation, edema, erythema multiforme-like lesions, erosions, and ulcers on the hard palate, oral floor, lips, tongue, and gingiva (Chun et al., 2022; Mazur et al., 2021; Sayare et al., 2021). Few studies also reported pemphigus vulgaris, bullous pemphigoid, herpes zoster, lichen planus, Stevens–Johnson syndrome, Behçet's disease, Bell's palsy, facial swelling, and lips, face, or tongue swelling associated with anaphylaxis, burning mouth syndrome, and oral candidiasis (Chun et al., 2022; Mazur et al., 2021; Thongprasom et al., 2021).”
Then the authors go on to give some very practical solutions I plan to keep in mind for my clinic.
“In most cases, after consulting a physician to rule out any other medical issue, application of 0.1% dexamethasone solution thrice daily, 50 mg/g nystatin syrup five times daily, acyclovir ointment, and 0.1% chlorhexidine gargle twice daily relieved the symptoms. Similarly, lichen planus in the buccal mucosa resolved with 0.1% dexamethasone solution, nystatin solution (100,000 U/mL), and 0.1% dexamethasone gargle thrice daily. Neuropathic pain following the COVID-19 vaccination was managed by 0.5 mg clonazepam and 150 mg pregabalin daily. Burning-mouth syndrome was relieved using a 2% lidocaine gargle daily and 10 mg nortriptyline. Oral candidiasis cases found relief using 0.5 mg clonazepam and fluconazole syrup regularly. All cases were resolved within a varying period of 1 week to 1 month, while some even took up to 2 months. These treatments significantly relieved all symptoms, including tongue pain and ulcerative lesions. However, erythema of palatal gingiva took a few weeks longer (Chun et al., 2022).
It is recommended that after COVID-19 vaccination, patients may avoid high-intensity workouts, alcohol consumption, and smoking for a few days after vaccination.”
https://www.trialsitenews.com/a/management-of-oral-lesions-after-covid-19-vaccination-a97e5d49
********************************************************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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