The Totally Civil Covid Thread. (Closing 31/05)

  • In This interview in a German Media Outlet, Dr. Peter Doshi begins by politely addressing the “lack of media coverage” of the research his group has managed to get published in Peer Reviewed journals. Presents a politely balanced view that anyone with a pinch of common sense would find impossible not to agree with. Article and questions in the video are in German, but Dr. Doshi answers in English.


    US-Pharmazieprofessor Peter Doshi im Interview mit dem MDR-Magazin "Hauptsache Gesund" (in englischer Sprache) | MDR.DE
    Daten-Nachprüfungen bei geimpften Versuchsteilnehmern hätten mehr schwere Gesundheitsschäden ergeben als in Studien festgestellt, erklärt der…
    www.mdr.de

    I certainly Hope to see LENR helping humans to blossom, and I'm here to help it happen.

  • Exactly why we can not allow amnesty to the corrupt bought and paid media, who, nih, FDA and politicians who fully backed these Covid mandates!!!!

    I’ve heard a lot of chatter about this “amnesty” stuff, but haven’t got myself to look more into it, can you provide us with an overview of who proposes it and what it entails?

    I certainly Hope to see LENR helping humans to blossom, and I'm here to help it happen.

  • Wasn’t the mantra back then “follow the Science”? When did it turn into a vaccine cult?


    Unvaccinated People Are Dumb?
    NY governor Kathy Hochul suggests unvaccinated people are dumb. This is what it has come down to? Do evidence and facts not matter? Is it all just about…
    odysee.com

    I certainly Hope to see LENR helping humans to blossom, and I'm here to help it happen.

  • I’ve heard a lot of chatter about this “amnesty” stuff, but haven’t got myself to look more into it, can you provide us with an overview of who proposes it and what it entails?

    Obviously a dupe for big pharma floating this idea we should all forgive and forget. I will never forgive or forget


    LET’S DECLARE A PANDEMIC AMNESTY

    Let’s focus on the future, and fix the problems we still need to solve.


    By Emily Oster

    Let’s Declare a Pandemic Amnesty
    We need to forgive one another for what we did and said when we were in the dark about COVID.
    www.theatlantic.com

  • OMG that was awful to read.

    I certainly Hope to see LENR helping humans to blossom, and I'm here to help it happen.

  • Even short-term vaccine efficacy against severe COVID in doubt

    Even short-term vaccine efficacy against severe COVID in doubt
    Shortly after the worldwide roll out of COVID-19 vaccines, signs of “waning” efficacy began to be reported. By the summer of 2021, the outright…
    www.trialsitenews.com


    Shortly after the worldwide roll out of COVID-19 vaccines, signs of “waning” efficacy began to be reported. By the summer of 2021, the outright failure of COVID-19 vaccination was observed. However, the vaccination campaign continued at full pace in the United States and elsewhere. Rather than prevent disease transmission, health officials assured the public, the value of COVID-19 vaccination was for the prevention of severe disease. On July 16, 2021, Rochelle Walensky, the CDC Director informed the public that “The good news is that if you are fully vaccinated, you are protected against severe COVID, hospitalization, and death …”.


    The claim of vaccine protection from severe COVID is supported by clinical trial results. In the randomized trial of BNT162b2 mRNA, an efficacy of 96.7% against severe disease defined by the presence of various signs of physical distress such as hypoxia. Similarly, in the trial of mRNA-1273 an efficacy of 98.2% was observed. Since that time, there have been numerous reports from the CDC and in the peer-review literature of the value of COVID-19 vaccination in markedly reducing severe disease, often defined by hospitalization or death. In virtually all, if not all studies, COVID-19 vaccines, a high degree of protection against severe disease was reported.


    Into this backdrop, on October 22, 2022, the International Journal of Epidemiology published the findings of Kerr et al. Kerr eschewed “binary” analysis of vaccination efficacy in favor of analysis of the evolution of vaccine efficacy over time. Using a time-dependent Poisson model for the incidence of severe COVID in this population, the investigators estimated the risk of severe COVID-19 relative to the date of vaccination.


    Comparisons were made between groups of subjects without vaccination, with one dose vaccination and with two doses of vaccination. As noted in the abstract, vaccine efficacy for one dose of ChAdOx1 (Oxford– AstraZeneca) turned negative between days 60 and 80. The same was true for BNT162b2 (Pfizer - Pfizer–BioNTech). The study did not directly compare vaccine efficacy between the group without vaccination with the group with two doses. Instead, the study estimated the relative vaccine efficacy between the one-dose and two-dose groups. For both vaccines, the relative vaccine efficacy was found to “wane” in the time frame of 0 to 105 days post-vaccine.


    Most notably, however, no change in the risk of severe COVID is observed post-vaccination. Relative vaccine efficacy is 71% at day 14 and even declines slightly to 70% by day 28 post-vaccination for BNT162b2.




    Relative risk of severe COVID between two-dose and one-dose BNT162b2 groups for days since vaccination. Maximal apparent vaccine efficacy seen at day 14, too early for true physiological effect of vaccination.


    The authors provide a likely explanation:


    “Our estimates of VE/rVE against COVID-19 hospitalization or death tended to be notably high immediately after vaccination, on a timescale that was too short to be plausibly explained by the immune response generated by the vaccine. This may have been due to behavioural changes associated with the vaccination programme.”


    This conclusion raises the following concern:


    The authors suggest that early in the post-vaccination period, the apparent vaccine efficacy and relative vaccine efficacy are due to behavioral changes; in other contexts referred to as the healthy vaccinee effect. The presumption is that that effect is transient. The question is: What is the basis for assuming that this bias is limited to the early post-vaccination period? More to the point: Is it possible that this bias predominates in the estimate of vaccine efficacy throughout the entire post-vaccination period?


    In reality, even short-term positive vaccine efficacy for either of these vaccines is purely speculative on the basis of this study. Moreover, despite the large number of studies reporting efficacy of COVID-19 vaccines in severe disease, the quality of those studies has generally been low, typified by a study with potential for misclassification bias due to the lack of validation of the linkage between the vaccination registry and hospitalization records. Thus the case for the theory of vaccine efficacy against severe COVID remains dubious.

  • Why is COVID-19 Response So Militarized?

    Why is the COVID-19 Response So Militarized?
    Most folks in the US, based largely on our mainstream media, likely believe that the military’s role in our COVID-19 pandemic is limited to logistics and…
    www.trialsitenews.com


    Most folks in the US, based largely on our mainstream media, likely believe that the military’s role in our COVID-19 pandemic is limited to logistics and other peripheral efforts. This would certainly make sense given the urgent nature of the emergency and the need for such logistical support, coordination and the like. Yet publicly available contracts, and even press releases, demonstrate what appears as a far more profoundly militarized regime around vaccine production. A review of contracts suggests a greater role for the military than what is presented to the mainstream. Upon procurement review—such as a publicly available contract document executed July 2020 from the US Army Contracting Command in Picatinny Arsenal, New Jersey is a case in point. This record notes that Pfizer is to produce its vaccine as a prototype: “Success of the prototype project is defined as manufacture of 100M doses of Pfizer and BioNTech's mRNA-based COVID-19 vaccine….” (Italics added.) The contract is a “prototype project” since Pfizer will “prove out” at-scale manufacturing, “in order to assess the feasibility to support the necessary quantity of safe and effective doses required for vaccination of the U.S. population and deliver those doses within challenging cold chain requirements….” Success of this prototype project, “will demonstrate Pfizer's capability to (i) rapidly manufacture products, which can be further scaled-up to meet mutually agreed to surge requirements with limited advance notification and (ii) distribute large quantities of the FDA-approved or authorized drug product….” To make matters even muddier, Pfizer is defined in the contracts as a “Non-Traditional Defense Contractor.” This means that it is not “subject to full coverage under the cost accounting standards prescribed” by law. What follows is a summary of military and civilian COVID-19 entanglements—a disturbing situation when considering the lack of transparency, accountability, any liability for even gross negligence on the part of the vaccine producers (Pharma) and associated pandemic-time profiteering.


    This media has explained when the Food and Drug Administration (FDA) executed an unorthodox “approval” of the Pfizer COVID-19 mRNA vaccine (BNT162b2 and Comirnaty) that this approach was executed under the emergency conditions established via the triggering of the Public Health Emergency Act (PREP), originally signed into law by then-President George Bush in 2005.


    A controversial liability shield against torts, vaccine manufacturers and in fact the entire supply chain from distributors to providers such as health systems benefit from a complete waiver of any liability (but for a few incredibly difficult allegations to prove), thereby markedly reducing financial risk associated with medicinal products. See the link. The part of the PREP Act affording drug makers and the vaccine supply chain universal protection was codified at 42 U.S.C. § 247d-6dQ.


    Drug companies now benefited thanks to complete immunity from any activity associated with the production, testing, development, distribution, administration, and use of medical countermeasures in response to chemical, biological, radiological, and nuclear agents of terrorism, epidemics, and pandemics.”


    The legislation while emphasizing the defense-related elements in response to pandemic would consolidate and strengthen the position of the secretary of Health and Human Services (HHS) in case of any litigation against such pharmaceutical makers of vaccines for example. To a great extent the law made its way through thanks to the lobbying power of the pharmaceutical industry lobby organization known as PhRMA https://phrma.org/ or the Pharmaceutical Research and Manufacturers of America. Was too much power handed over by the American people (Congress) to an entangled Executive Branch and pharmaceutical industry alignment?


    Who backed the PREP Act?

    Who put their political capital behind the PREP ACT anyway? The answer is a lot of the people’s representatives. Bill Frist was a key player—a American physician, businessperson and politician who served as a Tennessee U.S. Senator for 12 years from 1995 to 2007. A Republican, Frist was the Senate Majority Leader from 2003 to 2007. Congressman and ex-felon Dennis Hastert was also a key player driving the PREP Act. Also, a Republican, he represented Illinois 14th congressional district from 1987 to 2006 while serving as the 51st speaker of the U.S. House of Representatives from 1999 to 2007—actually., the longest-serving speaker of the House in history.


    After resigning Hastert became a lobbyist. Hastert found himself in serious legal trouble ultimately doing time as a felon for bank fraud conviction associated with an effort to pay off a former student he sexually abused back when he was a high school wrestling coach.


    During the selling of the law on the House floor Nathan Deal (a Democrat converted to Republican) in the House of Representatives pleaded on the House floor to support the bill of what would become the PREP Act. “Absolutely critical legislation” argued Mr. Deal back in 2005.


    By December 19, 2005, the House of Representatives approved the appropriations bill that was the PREP Act legislation in a 308 to 106 vote (2 voted Present and 18 not voting). Then by December 22 the legislation sailed through the Senate 93 go 0 (7 not voting). On December 30, 2005, then-President George Bush singing the bill into law.


    Was there any Resistance?

    Absolutely. Ironically at the time it was primarily Democrats and liberal-minded folks that stood firmly opposed to the bill, such as the consumer group Public Citizen founded by consumer rights champion Ralph Nader.


    Activist groups from the anti-war left concerned about George Bush’s military adventures in Iraq and Afghanistan to libertarians expressed concerns that the law handed over far too much legislative power to the executive branch of the American government---some even believe the law violated core U.S. Constitutional principles.


    What was Bills' Intention?

    Combined with a hurricane response provision, the PREP Act made sense to many—establishing the means to mobilize the vast resources of the United States government in case of a potential public health threat with an emphasis on mitigation of liability risk for pharmaceutical manufacturers. The idea was to encourage, much like what we experienced during COVID-19 and Operation Warp Speed, a supportive environment for rapid production of medical countermeasures—such as vaccines or therapeutics—to protect people of America.


    But front and center to this legislation emerged the real core intention of the law—a complete waiver of pharmaceutical company liability along with other disclaimers of any financial risk so that pharma had a green light to accelerate vaccines to market.


    Overseen by the HHS secretary (including the power to declare an emergency), this liability protection applied to the entire vaccine value chain from outsource manufacturers and contract research organizations in clinical development to physicians involved with the administration of the so-called countermeasures.


    Operation Warp Speed Contracting

    Early on during the pandemic President Donald Trump and his administration announced Operation Warp Speed, an ambitious program to accelerate the development of a COVID-19 vaccine—similar in concept to the Manhattan Project. And as would be reported by September 2020 in an investigational piece by NPR’s Sydney Lupkin, just as secretive.


    The Republic administration with backing from Democrats would spend billions and billions on the development of vaccines. Importantly this was just one procurement vehicle as other government-driven pandemic-based drug development efforts allocated and marshalled taxpayer dollars from consolidated efforts of the National Institutes of Health (NIH)-led public-private partnership called the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV), to the HHS Biomedical Advanced Research and Development Authority (BARDA), used for the procurement and development of medical countermeasures most against bioterrorism and pandemic influenza and emerging diseases.


    Interestingly enough, BARDA was established just one year after Bush’s signing enacted the PREP Act via the Pandemic and All-Hazards Preparedness Act (PAHPA), reporting to the Office of the Assistant Secretary for Preparedness and Response (ASPR).


    TrialSite chronicled the extensive bias for example ACTIV evidenced favoring Big Pharma novel vaccines and therapeutics over the study of repurposed, lower-cost existing therapies. See TrialSite’s “NIH’s Therapeutic Management of Patients with COVID-19 & Some Unanswered Questions about Disturbing Chasms.” This media also emphasized how ACTIV excluded community and regional hospital and health system clinicians granting drug development decision-making to pharmaceutical executives and academics that greatly live off of NIH and industry funding. See “ACTIV: Centralization an Important Part of COVID-19 Fight, But Smaller Players and Community Left Out.” A survey of ACTIV leadership found overwhelmingly an elite group of white men as well.


    TrialSite’s founder Daniel O’Connor shared with this writer:


    “It must be understood in this context, with all of these enabling laws that Operation Warp Speed set up a massive entangled militarized contracting apparatus to spending tens of billions of taxpayer money to develop vaccines in what undoubtedly led to the accelerated delivery of existing COVID-19 vaccines, monoclonal antibodies and antivirals associated with Pfizer, Merck, and Gilead.”


    The TrialSite founder emphasized, however:


    “But they wanted an accelerated efficiency and a lack of prying eyes, so they embraced the use of overarching public health emergency law, defense industry contracting entanglements and procedures to avoid transparency or any accountability. They set up a contracting intermediary with a company called Advanced Technologies International Inc. among other initiatives.”


    According to the NPR piece in late 2020 Trump officials told the public media that the government chose to use the intermediary for Operation Warp Speed contracts “to take advantage of certain acquisition authorities provided by Congress that are available to address situations like the coronavirus pandemic.”


    The Intermediary

    The Trump administration embraced a defense contractor intermarry called Advanced Technologies International Inc (ATI) to bypass the typical transparency rules that would be required of typical public procurement contracting.


    ATI’s history goes back to the 1980s as a part of a nonprofit called the South Carolina Research Authority (SCRA) which served to help expand research activities in that state’s universities. ACT was a division of SCRA focusing on supply chain sustainment of legacy weapons systems parts and the development of industry interoperability standards.


    By 1998 the group spun out of SCRA to develop consortium management offerings in Department of Defense (DoD) research and development (R&D) programs.


    So, the point here is that ATI, a nonprofit DOD contracting entity, managed many of the COVID-19 vaccine development efforts with the pharmaceutical companies.


    The table below features some of these initial contracts:

    Company


    $Amount


    Pfizer


    $1.95b


    Novavax


    $1.6b


    Sanofi


    $1.79b


    J&J


    $1b



    As reported by Accountable, groups such as American Oversight and Lower Drug Prices submitted numerous requests for access to the COVID-19 vaccine contracts. Over a half-year period only three contracts were shared—but heavily redacted including Moderna, J&J, and Sanofi.


    According to a declaration in late 2020 from Lower Drug Prices Now campaign director—Margarida Jorge


    “Transparency on how public officials is spending public money to beat COVID should not be a high bar to reach.” Ms. Jorge continued “ The Trump Administration has already handed billions of taxpayer dollars to its selected Operation Warp Speed drug corporations with no strings attached including no transparency, accountability or guarantee of affordability for the COVID-19 vaccines and therapeutics they are developing. Entering into additional contracts with Big Pharma though a for-profit intermediary without transparency or accountability for how taxpayer funding is spent and who benefits from the expenditure continues to raise concern about whether this administration’s decisions service public health or corporate profits.”


    Thanks to the taxpayer-funded contracts, some of which via DoD linked to the ATI intermediary companies such as Moderna and Pfizer wouldn’t be bothered with burdensome requests for transparency while developing the mRNA-based vaccine products.


    A Different Contractual Vehicle

    The Trump administration’s Operation Warp Speed used the Advanced Technology International (ATI) intermediary among other tools, using the contracting instrument called Other Transaction Agreement or OTA. These contracts manage and coordinate the vaccine development contracting dealings with the government in association with several academic medical centers, companies, and other entities less the typical oversight needs.


    TrialSite would introduce readers to this contracting umbrella by June 2022 as they were discussed as a defense for Pfizer during ongoing litigation. See TrialSite’s “Pfizer Defense Against Vaccine Fraud Case: Does ‘Other Transaction Authority’ Contractual Exemption Grant Pfizer a Pass?”


    This wasn’t a new concept as OTAs according to Ms. Lipkin’s accounting emerged in the late 1950s in association with NASA. They were set up to streamline and rationalize government procurement processes which had already even by then become entangled in bureaucratic inefficiencies. New upstarts focusing on engineering for example were disincentivized by onerous, expensive bureaucratic barriers to entry to contracting with the government.


    Decades later during the pandemic, the OTA was yet another instrument or tool used to get around bureaucracy but also to potentially shield vaccine makers from any liability which is apparent in an ongoing whistleblower lawsuit against Pfizer—more on that later.


    Importantly with the introduction of the Bayh-Dole Act which opened up the floodgates of financial deals between the NIH and other government agencies and academic medical centers to incentivize the development of valuable intellectual property (IP). Moving forward academic medical centers became profit centers if they could develop the right IP demanded by the market.


    In the decades after universities for example were motivated to secure grants from the NIH to go and develop biomedical IP to go and sell to Big Pharma or biotech to develop. The potential for patent royalties, milestone payments and revenue share deals were compelling. Today a complex, intertwined system exists around the NIH’s $40+ billion in research and development outlay. Anyone wonders why Dr. Anthony Fauci has so much influence and power—that’s why. Robert Kennedy covers this topic in The Real Anthony Fauci.


    But at least in theory Bayh-Dole clauses did open up universities and any companies taking money to be subject to accountability should they be caught profiteering, but the OTA served to protect the companies. In reality, certain “OTAs…weakened or excluded Bayh-Dole clauses” meaning that these procurement instruments further shielded the pharma while evidencing a tightening up of biomedical crony capitalism—that is tightening bonds between the state and industry and their academic IP sourcing grounds.


    Expansion into Military Land

    Operation Warp Speed already had established a partnership with the Department of Defense (DoD) but in fact, a prominent feature was even greater military integration of the whole COVID-19 response. The two (OWS and DoD) were already partnered up and exploiting OTAs for efficient and streamlined (And less public) contracting for vaccines and therapeutics.


    It turns out that the DoD managed another consortium of academic medical centers and biotech ventures focusing on developing medical countermeasures to protect against any threats against the U.S. military. Known as the medical CBRN Defense Consortium, ATI would add this to the existing OTA. The goal: expand further for COVID-19 response simply by adding requests for proposal procedures.


    For example, as reported by NPR Pfizer and Novavax were simply added to the Medical CBRN Defense Consortium membership based on a notice in the Federal Register.


    Interestingly according to Robert Tuohy, a now-retired former Chief Operating Officer of ATI, the organization (ATI) “was never explicitly told it was helping with Operation Warp Speed” as Tuohy referred to the relationship and function as “invisible” to the nonprofit. See the NPR’s “How Operation Warp Speeds Big Vaccine Contracts Could Stay Secret.”


    Healthy Incentives vs. Profiteering?

    Now thanks to Operation Warp Speed and incentives set up with NIH’s ACTIV, BARDA and other entities the pandemic era “winners” could literally mint money less any liability or frankly questionable responsibility for product quality.


    With Pfizer generating nearly $100 billion when combining a couple years’ worth of COVID-19 vaccine and Paxlovid sales and plans to boost price by as high as 400% it’s pretty clear what’s the motive behind much of this activity. Remember this is in the context of a vaccine product that requires boosts nearly every four months or so due to the confluence of viral mutation, durability, and related issues. With the latest bivalent Omicron booster for BA.4/BA.5, this is the third boost and fifth dose in just under 23 months or a booster every 4.6 months. Emergency conditions aside, this isn’t what we think of as a normal vaccine, where one gets a shot and doesn’t worry about the disease anymore.


    While the effectiveness of the mRNA vaccines hugely impressed the research and medical establishment after the large Phase 3 clinical trials—those trials were cut short in that all the participants were given the actual product long before study’s end, stopping any blinding. The products were rushed along to first emergency use authorization by December 2020, just six months after Pfizer inked the “prototype” contract via the DoD (Army) legal instrument.


    Importantly given the emergency the federal government via the HHS (CDC, etc.) spent billions more on vaccination campaigns, essentially socializing marketing and promotion expenditure onto the taxpayer. All the profits would go to the company, but the tradeoff was long-term protection….right? Wrong. The American public received primarily short-term prevention although it’s arguable that the vaccine-elicited antibodies protected against more serious disease for several months.


    Protecting the People or Priming the Pump of Vaccine Demand?

    But then came the unorthodox approval of the Pfizer-BioNTech product (BNT162b2 or Comirnaty) and the ensuing unprecedented mandates which triggered a medical freedom movement across America. Although stereotyped as mostly conservatives, TrialSite reported that concern about mandates cut across broader segments of the American population—at least more than the mass media would let on.


    But did the mandates make sense? A vast mass vaccination program was underway not only in America but across the world’s governments. While such mandates would probably make much sense if the vaccine product actually stopped viral transmission against a pathogen with a significantly high death rate, they did not. By the emergence of the Delta variant, it was clear that the unfolding science led to the conclusion that vaccine durability issues in the face of a mutating RNA virus made it clear that the vaccines would not stop viral transmission.


    At that point, the ethics of the mass vaccination operation became a topic of great concern among many—with Pfizer and Moderna all but minting money, absolutely zero liability and at least some evidence from this media evidencing corner cutting during the preclinical and clinical development process (see lawsuit summary below for but one example). A confluence of forces from the authority of the Prep Act to other enabling laws, shielded defense-related contracts and a bipartisan lack of consumer-friendly advocacy in the face of a public health emergency led to the current industry-favored reality.


    While the majority of American society still bought into the government’s narrative, chinks in the medical-industrial complex armor emerged. Growing numbers of the public started publicly questioning the need for booster after booster shot in the face of real-world issues such as breakthrough infections and growing numbers of fully vaccinated elderly that still feel quite ill, some even dying.


    This in the face of an emerging parallel crisis involving long COVID. A crisis involving anywhere from 10% to 30% of persons falling ill to SARS-CoV-2, regardless of vaccination status, as it was clear that while the vaccines might afford some protection, many numbers of fully vaccinated persons were succumbing to long COVID. And with not nearly enough the total numbers not accessing proper care could number in the tens of millions in America alone.


    What about the Voiceless?

    And then there is the completely ignored, marginalized group of post-COVID-19 vaccine injured. Represented by groups such as React19 (the largest such COVID vaccine injury group in the world), growing numbers of people reported serious side effects and injuries that remain all but ignored by the mainstream medical establishment and the mainstream media which has lost true critical investigational reporting long ago.


    For those doctors that try to raise awareness about the topic on social media? They find themselves subject to a systematic censorship regime led by both big media and the social network companies as well as dangerous harassment by state licensing boards monitoring their members at the request of federal umbrella organizations thanks to federal government pressure. See TrialSite’s “Feds Coming After Doctors & Pharmacies that Market Ivermectin as Effective & Safe for COVID-19.”


    The reality: any physician that discussed alternative therapies or concerns about the vaccines was potentially subject to censure or worse. A climate of fear resulted among physicians. As a sizable percentage of physicians work in large health systems this influential profession has already lost considerable clout in the context of sprawling powerful health systems. During the pandemic, independent physicians that sought to challenge the party line in any way faced serious repercussions indirectly via the federal government. The result: few doctors publicly step up to help the post-COVID-19 vaccine injured.


    From federal pressure on umbrella national board and licensing body associations, this pressure went downstream to the state medical licensing boards as an example. See TrialSite’s “Prominent Medical Boards’ Message to Physicians: Keep Quiet on COVID-19m Vaccine or Risk Loss of Licensure & Economic Livelihood.”


    The Pfizer Lawsuit

    The protective natures of the OTA contractual schemes emerge in the aftermath of the pandemic In one ongoing lawsuit against Pfizer, a whistleblower, Brook Jackson worked at a trial site organization/contract research group called Ventavia supporting the pivotal Phase 3 Pfizer COVID-19 vaccine trials. A large amount of alleged data manipulation and fraud-related activities was observed by Ms. Jackson who could not in good conscience does not say anything.


    She notified her employer and the FDA, but nothing happened but harassment from her employer. A tough, resilient individual, Jackson secured counsel and took the pharmaceutical giant to court.


    As TrialSite reported in “Pfizer Defense Against Vaccine Fraud Case: Does the ‘Other Transaction Authority’ Contractual Exemption Grant Pfizer a Pass.”


    TrialSite’s Sonia Elijah based in the UK interviewed Ms. Jackson. While Ms. Jackson worked for a contract research organization called Ventavia Research Group (Ventavia) on the pivotal Phase 3 Pfizer COVID-19 vaccine study, she alleges that she witnessed many critical, compliance-violating anomalies needing immediate attention. Ms. Jackson emailed the complaint concerning alleged violations of good clinical practices as well as various compliance frameworks and laws to the FDA in September 2020, however, the executive branch agency in charge of enforcement of alleged violations opted to not even open an investigation. The study continued, and Pfizer didn’t make any adjustments working with Ventavia. But the CRO did sack Ms. Jackson for alleging that they were involved with fraudulent manipulation of data and other allegations.


    As TrialSite reported, Ms. Jackson opted to take legal action, filing a lawsuit in the United States District Court for the Eastern District of Texas, Beaumont Division. Alleging a violation of the False Claims Act, the plaintiff sought action for the violation of federal laws and associated compliance standards, such as good clinical practice. The U.S. Department of Justice opted to pass on any involvement.


    During the case, Ms. Jackson violated a gag order and lost her attorneys. However, she was picked up by attorney Robert Barnes. In this case (and relevant to our story) Pfizer argues that thanks to a “Other Transaction Authority” procurement clause---associated with Department of Defense-related contracts, for example, the pharmaceutical company [Pfizer] isn’t liable for the standard federal procurement rules governing such contracts. But Ms. Jackson’s attorney, Mr. Barnes reports in an interview that they would be allowed to continue with discovery associated with Pfizer’s motion to dismiss the case.


    A big question here. Assuming Ms. Jackson’s claims are correct--Does Pfizer get a pass from the rule of law for violating laws and rules as alleged by the plaintiff and her attorney in a recent interview? According to Ms. Jackson’s attorney, this case could be the biggest False Claims Act whistleblower case in U.S. history.


    But according to Pfizer’s legal defense the American pharmaceutical giant can effectively lie to the government about safety or efficacy issues “because the government was in on it with them,” reports attorney Robert Barnes.


    Even Prominent Medical Journals Censored that Raise the Jackson Claims

    Back in November 2021, TrialSite reported that the prominent medical journal The BMJ, to its credit, reported on the Jackson situation with Ventavia and Pfizer. In fact, The BMJ was even censored by Facebook for doing so! In “The BMJ to Facebook—Stop Censoring Us and Shut Down Your Incompetent Fact-Checkers,” this media reported that the “Trusted News Initiative” moved again to censor content—this time, an elite medical journal! Why? Because they reported on the allegations of fraud, including the prospect of data manipulation associated with the COVID-19 vaccine trials. This apparently triggered Zuckerberg’s algorithms, suggested TrialSite.


    Military Awards Pfizer $3.5 Billion

    Back to the start of this story: the naïve among us may ask why is it that the much-heralded “public-private partnerships” that are so popular need the US Military as the main “partner.” If we are truly dealing with a public health, as opposed to a military, issue, why isn’t Health and Human Services or another civilian entity the contracting party? But this article demonstrates a complex web of government and DoD/military not to mention myriad complex public-private partnership interests ultimately serving as a means to further streamline contracting while also protecting contractors such as major the pharmaceutical company “winners” of the pandemic.


    While America has a long history of separating civilian and military functions, largely because Americans don’t want a militarized society, a parallel reality of government, defense and private sector exists starting with the Manhattan Project which actually showcased to various internal government operators that alternative forms of contracting and doing business outside of the public eye could be good for business overall. Afterall to a great extent the effort to defeat the Japanese and Nazis benefitted from this approach.


    Some suggest the first seeds planted for the so-called “Deep State” occurred during the time when America was developing the first nuclear weapons to be used against the Japanese and potentially the Germans if they didn’t give up. Some suggest the actual target was preparation for the Cold War that ensued thereafter World War 2.


    Back to COVID-19 and the U.S. government using third party intermediaries, specialized defense contracts and a web of public-private partnerships, military connections throughout the COVID-19 response abound, even emphasized by recent press releases about later contracts last year for COVID-19 vaccines. In one Department of Defense release the Army notes that on July 30, 2021 Pfizer was awarded a, “$3,500,000,001 [!] firm-fixed-price contract for the procurement of 500 million doses of COVID-19 vaccine for the purpose of international donation.”


    The contracting authority is the U. Army Contracting Command at the Aberdeen Proving Ground, Maryland. Another DoD press release, this one from July 29, 2022, further outlines the military role in the vaccine industry. It notes that DoD awarded $1.74 Billion with Moderna, “to Secure Over 65 Million Doses of COVID-19 Vaccine for Fall Vaccinations.” They report that this is in addition to another 105 million doses recently purchased from Pfizer for the fall. Tellingly, “The DoD’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) led this effort in partnership with DoD’s Defense Assisted Acquisition Cell (DA2), U.S. Army Contracting Command, and HHS’s Biomedical Advanced Research and Development Authority (BARDA).”


    Some Final Thoughts’

    Is all of this truly serving the interests of the health of the American public? After all wasn’t SARS-CoV-2 just a virus that somehow either jumped from a bat to an animal and then to humans in Wuhan, China or perhaps a leaked gain-of-function experiment? Clearly, by extension, U.S. taxpayer funds are going to massive military-directed contracts for the COVID-19 vaccines overseas. True numerous benefits undoubtedly associate with this approach as was discussed above. How else would contracts get streamlined and accelerated in the face of what was a deadly pandemic. Over a 1 million people in America died in association with COVID-19. More people died in America than any other country despite the availability of lots of vaccines.


    But what are the risks of the approach the government, industry and various consortium took to take on COVID-19? It seems clear that overall oversight has all but diminished while another feature, mass exemption from existing laws and regulations designed to protect not only government and American taxpayers but also consumers raise serious concerns.


    Were third party intermediaries, OTAs and other entities leading to less transparency and more secrecy healthy for the American COVID-19 response? As was brought out in the Brook Jackson lawsuit, are these layers of government contracting and procurement exemptions, emergency laws and other provisions serving to endanger the American people more than to protect them? With little interest in either Democratic or Republican representatives for accountability unfortunately some of these questions may never be answered.

  • What We Knew In the Early Days ⋆ Brownstone Institute


    The claim is now everywhere: we had to lock down because we just didn’t know about this virus. It was all very confusing and we had to play it safe. We had no other option because we just had no clarity about what we were dealing with. The precautionary

    principle dictated the unprecedented actions.


    Actually, the precautionary principle goes both directions. It also dictates that we not enact policies that we know for sure would wreck lives and liberties. They did it anyway, without sufficient knowledge that the measures would achieve any positive good.


    We approach the third year and people have forgotten that all the harms of lockdowns were strongly warned about by many voices in many venues. In addition, the virus was much better understood back then and openly discussed. We knew for certain that the panic and fear were being wildly overblown.


    Below follows resources assembled by the ‘Robber Baron‘ and many others who write for the Brownstone Institute. These citations from newspapers, magazines, academic journals and interviews, with many respected voices, show that we certainly knew tremendous amounts in the early days. All the warnings and information were readily available to anyone paying attention.


    We certainly live in an age of short attention span but many these signs and warnings came weeks or months before the world locked down and they chronicled the damage as it was happening. Why all this came to be completely ignored remains the burning question.

  • Why is COVID-19 Response So Militarized?

    U.S. Covid Response Taken Over By National Security Council in March 2020 to Impose Pre-Prepared Lockdown Plan, Evidence Shows


    In previous articles I discussed the probability that Deborah Birx, the White House Coronavirus Task Force Coordinator, was not a representative of the public health agencies but, rather, was appointed by the National Security Council. I now have proof that this was, indeed, the case. I have also uncovered documents that show:


    .....


    It means our response to the Covid pandemic was led by groups and agencies that are in the business of responding to wars and terrorist threats, not public health crises or disease outbreaks


    I believe that the national security authorities took control of the Covid pandemic response not just in the U.S. but in many of our allied countries (the U.K., Australia, Germany, Israel and others) because they knew SARS-CoV-2 was an engineered virus that leaked from a lab researching potential bioweapons...


    U.S. Covid Response Taken Over By National Security Council in March 2020 to Impose Pre-Prepared Lockdown Plan, Evidence Shows
    In previous articles I discussed the probability that Deborah Birx, the White House Coronavirus Task Force Coordinator, was not a representative
    dailysceptic.org

  • Amnesty Plea? Lamposts and ropes



    TalkTV, UK: Plank Of The Week nominee Emily Oster

    [Note: TalkTV still pro-jab]

    External Content youtu.be
    Content embedded from external sources will not be displayed without your consent.
    Through the activation of external content, you agree that personal data may be transferred to third party platforms. We have provided more information on this in our privacy policy.

  • Bombshell #2 from California Clinicians: 22+m UK Real World Evidence—Vaccines Not Helping Against COVID-19 During Omicron Surge

    Bombshell #2 from California Clinicians: 22+m UK Real World Evidence—Vaccines Not Helping Against COVID-19 During Omicron Surge
    A group of California Central Valley primary care physicians and specialists continue to turn up disturbing findings associated with UK population-wide data…
    www.trialsitenews.com



    A group of California Central Valley primary care physicians and specialists continue to turn up disturbing findings associated with UK population-wide data and COVID-19 vaccine effectiveness (VE). Represented by corresponding author Dr. Venkata R. Emani, a cardiovascular specialist at Central Valley Cardiovascular Associates, Inc in Manteca, California just 80 miles inland from San Francisco, the clinician-investigators continue to investigate COVID-19 vaccination numbers in the United Kingdom, finding disturbing data based on a large, real-world evidence-based population-wide cohort retrospective study covering over 22 million persons in the UK. Like the previous study covered by TrialSite, these practicing clinician-real-world data investigators report bombshell outcomes that demand attention. At this point, there is trivial difference in outcome between vaccinated and unvaccinated across cases, hospitalizations, and death. The findings run counter to the one-size-fit-all mass vaccination theme that continues to emanate out of English-speaking nations from the UK, USA, Australia, to New Zealand. Rather, the California-based clinicians report a negative vaccine effectiveness impacted by key variables such as comorbidities, ethnicity, vaccination rates, and other factors. Fundamental to human health at this stage of the pandemic and “irrespective of vaccination” is the need for “uniform screening protocols and protective measures.” The group attempted to get published with their last study and unfortunately, found few takers, probably due to the fact that the findings diverge from the mainstream health establishment’s narrative. But the group of practicing primary care and specialist physicians continue to generate study outcomes that must be read carefully and understood.


    Previous Work

    TrialSite showcases previous work by the group in “California Physician-driven Study of UK Population: COVID-19 Cases, Hospitalizations & Deaths Show Fully Vaccinated Elderly at Significant Risk.” This study was also represented by Dr. Emani.


    Inquiring and analyzing nationwide data covering confirmed SARS-CoV-2 cases, hospitalizations, and deaths in the UK starting from the beginning of the pandemic to investigate infection patterns, hospitalization, and deaths across various age cohorts during the COVID-19 pandemic, the California-based group probed 22,072,550 cases, 848,911 hospitalizations, and 175,070 deaths due to COVID-19 across the UK. The analysis revealed that 11,315,793 (51.3%) of the cases, 244,708 (28.8%) of hospitalizations, and 28,659 (16.4%) of deaths occurred during the most recent Omicron surge. When comparing the period of February 28-May 1, 2022, with the prior 12-weeks, they observed a significant increase in the case fatality rate (0.19% vs 0.41%; RR 2.11 [2.06-2.16], p<0.001) and odds of hospitalization (1.58% vs 3.72%; RR 2.36[2.34-2.38]; p<0.001). At the same time, a significant increase in cases (23.7% vs 40.3%; RR1.70 [1.70-1.71]; p<0.001) among ≥50 years of age and hospitalizations (39.3% vs 50.3%; RR1.28 [1.27-1.30]; p<0.001) and deaths (67.89% vs 80.07%; RR1.18 [1.16-1.20]; p<0.001) among ≥75 years of age was observed. Disturbingly, the vaccine effectiveness (VE) for the third dose was in negative since December 20, 2021, with a significantly increased proportion of SARS-CoV2 cases, hospitalizations, and deaths among the vaccinated; and lower proportion of cases, hospitalizations, and deaths among the unvaccinated.


    Demonstrating the risks of co-morbidities, pre-existing conditions were present in 95.6% of all COVID-19 deaths. The physician-real-world investigators caution that various ethnicities, comorbidities, deprivation score, and vaccination rate disparities were noted that can adversely affect hospitalization and deaths among compared groups.


    Background

    Based in Stockton, California. Dr. Ventaka R. Emani recently sent the group’s most recent work to TrialSite that was uploaded to the preprint server medRxiv. Titled “Increasing SARS-CoV2 cases, hospitalizations, and deaths among the vaccinated populations during the Omicron (B.1.1.529) variant surge in UK,” the California group of cardiovascular specialists and primary care doctors were at it again, investigating what is not a popular topic to delve into in mainstream medicine.


    In a previous telephone conversation with TrialSite’s founder Daniel O’Connor, Dr. Emani shared that they weren’t sure if their last study would get accepted by any major journals.


    The Study

    Again, conducting a retrospective observational study, the California team analyzed COVID-19 cases, hospitalizations, and death during the pandemic in the UK. The group also analyzed various variables possibly impacting outcomes from ethnicity to vaccination disparities and co-morbidities in the form of preexisting conditions. Looking at a UK population ranging in age from 18 and up, they studied the period August 16, 2021, through March 27, 2022.


    What were the results?

    Like last time, this study evaluated a massive database covering the following:


    Categories


    Total


    Total Cases


    22,072,550


    Hospitalizations


    848,911


    Deaths due to COVID-19


    175,070



    They uncovered, via their real-world data analysis, the following events occurred during the Omicron variant surge as of May 1, 2022.


    Category


    #s


    %


    Cases


    11,315,793


    51.3%


    Hospitalizations


    244,708


    28.8%


    Deaths


    28,659


    16.4%



    Additionally, Dr. Emani and team report that toward the end of the Omicron variant-driven surge in the UK running from February 28, to May 1, 2022, they observed a slight rise in the proportion of cases (cases (23.7% vs 40.3%; RR1.70 [1.70-1.71]; p<0.001) and hospitalizations (39.3% vs 50.3%; RR1.28 [1.27-1.30]; p><0.001) among ≥50 years of age, and deaths (67.89% vs 80.07%; RR1.18 [1.16-1.20]; p><0.001) among ≥75 years of age compared to the earlier period (December 6, 2021-February 27, 2022) during the Omicron variant surge. “Using the available data from vaccine surveillance reports, we compared the Omicron variant surge (December 27, 2021-March 20, 2022) with the Delta variant surge (August 16-December 5, 2021). Our comparative analysis shows a significant decline in case fatality rate (all ages [0.21% vs 0.39%; RR 0.54 (0.52-0.55); p><0.001], over 18 years of age [0.25% vs 0.58%; RR 0.44 (0.43-0.45); p><0.001], and over 50 years of age [0.72% vs 1.57%; RR 0.46 (0.45-0.47); P><0.001]) and the risk of ><0.001) and hospitalizations (39.3% vs 50.3%; RR1.28 [1.27-1.30]; p<0.001) among ≥50 years of age, and deaths (67.89% vs 80.07%; RR1.18 [1.16-1.20]; p<0.001) among ≥75 years of age compared to the earlier period (December 6, 2021-February 27, 2022) during the Omicron variant surge.”


    The California group embraced vaccine surveillance reports to evaluate the delta between the Omicron variant surge (December 27, 2021-March 20, 2022) with the Delta variant surge (August 16-December 5, 2021).


    What does this comparative analysis reveal?

    First there was a significant decline in case fatality rate (all ages [0.21% vs 0.39%; RR 0.54 (0.52-0.55); p<0.001] for those persons 18 years of age and up [0.25% vs 0.58%; RR 0.44 (0.43-0.45); p<0.001] and over 50 years of age [0.72% vs 1.57%; RR 0.46 (0.45-0.47); P<0.001]) and the risk of hospitalizations (all ages [0.62% vs 0.99%; RR 0.63 (0.62-0.64); p<0.001], over 18 years and up [0.67% vs 1.38%; RR 0.484 (0.476-0.492); p<0.001], and over 50 years of age [1.45% vs 2.81%; RR 0.52 (0.51-0.53); p<0.001]).


    Both the unvaccinated (0.41% vs 0.77%; RR 0.54 (0.51-0.57); p<0.001) and vaccinated (0.25% vs 0.59%; RR 0.43 (0.42-0.44); p<0.001) populations of over 18 years of age showed a significant decline in the case fatality rate during the Omicron variant surge when compared to the Delta variant surge.


    What’s the California group’s findings summary?

    First, they report, not surprisingly, a marked decline in the risk of hospitalization for both the unvaccinated (1.27% vs 2.92%; RR 0.44 (0.42-0.45); p<0.001) and vaccinated (0.65% vs 1.19%; RR 0.54 (0.53-0.55); p<0.001) populations of over 18 years of age during the same period.


    In what could be considered bombshell evidence, the group of doctor’s report that they observed a negative vaccine effectiveness (VE) associated with the third booster dose of the vaccine since December 20, 2021, with a significantly increased proportion of SARS-CoV2 cases, hospitalizations, and deaths among the vaccinated.


    Conversely, Dr. Emani and colleagues report a decreased proportion of cases, hospitalizations, and deaths among the unvaccinated.


    Much like the last study, the California-based clinicians report that 95.6% of all COVID-19 deaths in the UK are associated with pre-existing conditions. Like before they note the data points to other elements to consider from ethnicity and deprivation score to vaccination rate disparities which can adversely impact key indicators from hospitalization and deaths among the compared groups.


    Bombshell Takeaway

    Emani et al. again, are attempting to wake up their colleagues with data and science. The team wrote in their conclusion:


    “There is no discernable optimal vaccine effectiveness among ≥18 years of age and vaccinated third dose population since the beginning (December 20, 2021) of the Omicron variant surge.” They noted that more specific, granular validation models targeting VE against hospitalization and deaths necessitates the incorporation of other variables mentioned above (e.g., pre-existing conditions, ethnicity, etc.).


    In a finding counter to the medical establishment, the authors report that there is little difference in outcome now between vaccinated and unvaccinated in the Omicron period. They declared:


    “Both the vaccinated and unvaccinated populations showed favorable outcomes with a significant decline in case fatality rate and risk of hospitalizations during the Omicron variant surge.”


    Fundamental to the clinician’s outlook based on the slicing, dicing and analysis of real-world data: the COVID-19 vaccines offer little benefit moving forward in the Omicron period. This directly counters what could be considered a one-size-fit-all message from most health authorities across Anglo-centric societies—whether the UK, the USA, Australia, New Zealand, etc.


    Showcasing the necessity of infection prevention targeting higher risk populations (e.g., the elderly) “irrespective of vaccination,” the doctors stress the use of “uniform screening protocols and protective measures.” These clinicians have something profound to say based on the data analysis out of the UK—are health systems., government, and industry listening?


    Principal Investigator Point of View

    Dr. Emani emailed some of his thoughts on the study to TrialSite:


    “As researchers, we have to stay within the scope of our data. All the available evidence suggests that the vaccine effectiveness is suboptimal, and protection is brief during the Omicron variant surge.”


    Emani continued:


    “Our data also shows that there are no adequate controls to compare the vaccine effectiveness for hospitalization, severe disease, and/or deaths as the unvaccinated population have more comorbidities and risk prone behavior than the vaccinated population.”


    In keeping with the data and undoubtedly tapping into the physicians’ real world clinic experience during the pandemic the Manteca, based clinical-scientists shared:


    “We recommend that all the risk factors including comorbidities and risk prone behavior should be adjusted at individual level than the population level while calculating VE for the hospitalizations, severe diseases and or deaths through models that should be validated in the same lines as the Randomized Controlled Trials.”


    Finally, the group recommends a two-pronged approach to improving pandemic response at this point during the tail end of the pandemic—as Dr. Emani concludes:


    “The recommended population (especially elderly with high risk) should get vaccinated per the current health department guidelines, but at the same time, should also take precautions to avoid contracting disease based on the data from our study. We also suggest that nation’s top Health policy bodies should look at all the emerging data carefully and come up with guidelines to protect public.”


    Limitations

    The study acknowledges limitations with this nature of retrospective observational study based on publicly reported data.

    Generalizability of the findings?—the study data is based in the UK

    The various time periods that were used in our statistical analysis are based on the timing of the start of a surge and/or changing patterns of an increased proportion of cases, hospitalizations, or deaths during the surge that were observed on the plotted data

    The retrospective analysis of data based on the changing patterns of outcomes yields valuable epidemiological information that can be used for public safety during the emerging pandemic as we have shown in our data analysis

    The team wasn’t able to adjust the data for behavior among the compared groups which can affect the chances of contracting the disease.

    Several other points are raised in the preprint uploaded to medRxiv.


    Lead Research/Investigator

    Venkata Emani, MD, Central Valley Cardiovascular Associates, Corresponding Author, Manteca, CA

    A cardiologist, Dr. Emani oversees practice at Central Valley Cardiovascular Associates, Inc.

    Vivek K.Pallipuram, University of the Pacific, Stockton, School of Engineering & Computer Science

    Kartik K.Goswami, San Joaquin Critical Care Medical Group

    Kailash R.Maddula, Central Valley Cardiovascular Associates

    RaghunathReddy, Stockton Primary Care

    Abirath S.Nakka, Stockton Primary Care

    SravyaPanga, Central Valley Cardiovascular Associates

    Nikhila K.Reddy, Stockton Primary Care

    Nidhi K.Reddy, Stockton Primary Care

    DheerajNandanoor, Synergy Med

    SanjeevGoswami, San Joaquin Critical Care Medical Group

    Call to Action: Why aren’t more physicians, researchers, and health systems leadership discussing the findings of this group of Central Valley providers?


    Reference

    Emani VR, Pallipuram VK, Goswami KK, Maddula KR, Reddy R, Nakka AS, et al. (2022) Increasing SARS-Cov2 Cases, Hospitalizations, and Deaths among the Vaccinated Populations during the Omicron (B.1.1.529) Variant Surge in UK. J Vaccines Vaccin. S21:001.


    References

    Increasing SARS-CoV2 cases, hospitalizations, and deaths among the vaccinated populations during the Omicron (B.1.1.529) variant surge in UK
    BACKGROUND There were increased SARS-CoV2 hospitalizations and deaths noted during Omicron (B.1.1.529) variant surge in the UK despite decreased cases, and the…
    www.medrxiv.org

  • There is no discernable optimal vaccine effectiveness among ≥18 years of age and vaccinated third dose population since the beginning (December 20, 2021) of the Omicron variant surge.

    We here reported this just in time starting from October 2021!


    The real data is even worse as the infected/recovered are counted as vaccinated too and are not in a separate group. So the reality is that vaxx only is at least 3x worse than reported...

  • External Content youtu.be
    Content embedded from external sources will not be displayed without your consent.
    Through the activation of external content, you agree that personal data may be transferred to third party platforms. We have provided more information on this in our privacy policy.


    Community COVID-19 Respiratory Illness is Not Associated with Myopericarditis

    Community COVID-19 Respiratory Illness is Not Associated with Myopericarditis
    The public has been confused with messaging from academia concerning myocarditis. During 2020, there was a focus on heart inflammation with the respiratory…
    www.trialsitenews.com


    The public has been confused with messaging from academia concerning myocarditis. During 2020, there was a focus on heart inflammation with the respiratory illness, with large studies attempting to “find” cases. For example, the Big Ten college athletic league had an exhaustive program offered to >9600 students measuring cardiac troponin, as well as additional studies including MRI in the 30% of athletes who contracted the respiratory illness.[i] After finding just a handful of suspected cases in thousands of studies and no hospitalizations and deaths, the program closed just before the students were encouraged, and for some, later mandated to undergo COVID-19 vaccination, which has a Food and Drug Administration warning indicating the vaccines are associated with higher risk of myocarditis.


    It was a tragedy to close a costly screening program just before the REAL CAUSE of myocarditis was introduced into the colleges. Joy et al. performed a detailed prospective cohort study with troponin and multimodality cardiac imaging in healthcare workers who contracted COVID-19, and no evidence of heart damage was found.[ii]


    One UK-based medical literature review associates myocarditis incidence with COVID-19 but acknowledges that “Unfortunately, the incidence of COVID-19-induced myocarditis is unclear.” The seemingly targeted messaging out of academia that somehow “COVID-19 causes more myocarditis than the vaccines,”[iii] is not only questionable in veracity but also misses the point of the proper risk-benefit calculus for substantial numbers in the population.


    Importantly, some of the research reviewed by this cardiologist-scientist suggests flawed inpatient studies of acute severe COVID-19 where troponin levels are commonly elevated due to critical illness without adjudicated myocarditis. This is very different from healthy individuals who take a vaccine and then develop chest pain, effort intolerance, ECG changes, dramatic troponin elevations, and have confirmation by MRI. Community studies, such as a recent one by Tuvali et al. from Israel, are far more likely to find a “signal” if it exists in the time period before vaccines were introduced.[iv] As you can see, there was no increase in myocarditis above the very low baseline rate of those without COVID-19 in Israel.




    This is reassuring since we can focus on COVID-19 vaccination as the likely determinant of myocarditis and pericarditis in 2021 and beyond. For a wonderful teaching video regarding this paper, see the YouTube by the venerable Professor John Campbell.


    So, the next time a young person is seeking medical clearance to participate in sports, be sure to mention COVID-19 vaccination as part of the medical history and to prompt the doctor to evaluate, if warranted, any signs of heart damage that may have occurred.


    Check out Courageous Discourse, and for more writings from Dr. Peter McCullough and John Leake.


    [i] Daniels CJ, Rajpal S, Greenshields JT, Rosenthal GL, Chung EH, Terrin M, Jeudy J, Mattson SE, Law IH, Borchers J, Kovacs R, Kovan J, Rifat SF, Albrecht J, Bento AI, Albers L, Bernhardt D, Day C, Hecht S, Hipskind A, Mjaanes J, Olson D, Rooks YL, Somers EC, Tong MS, Wisinski J, Womack J, Esopenko C, Kratochvil CJ, Rink LD; Big Ten COVID-19 Cardiac Registry Investigators. Prevalence of Clinical and Subclinical Myocarditis in Competitive Athletes With Recent SARS-CoV-2 Infection: Results From the Big Ten COVID-19 Cardiac Registry. JAMA Cardiol. 2021 Sep 1;6(9):1078-1087. doi: 10.1001/jamacardio.2021.2065. PMID: 34042947; PMCID: PMC8160916.


    [ii] Joy G, Artico J, Kurdi H, Seraphim A, Lau C, Thornton GD, Oliveira MF, Adam RD, Aziminia N, Menacho K, Chacko L, Brown JT, Patel RK, Shiwani H, Bhuva A, Augusto JB, Andiapen M, McKnight A, Noursadeghi M, Pierce I, Evain T, Captur G, Davies RH, Greenwood JP, Fontana M, Kellman P, Schelbert EB, Treibel TA, Manisty C, Moon JC; COVIDsortium Investigators. Prospective Case-Control Study of Cardiovascular Abnormalities 6 Months Following Mild COVID-19 in Healthcare Workers. JACC Cardiovasc Imaging. 2021 Nov;14(11):2155-2166. doi: 10.1016/j.jcmg.2021.04.011. Epub 2021 May 8. PMID: 33975819; PMCID: PMC8105493.


    [iii] Singer ME, Taub IB, Kaelber DC. Risk of Myocarditis from COVID-19 Infection in People Under Age 20: A Population-Based Analysis. medRxiv [Preprint]. 2022 Mar 21:2021.07.23.21260998. doi: 10.1101/2021.07.23.21260998. PMID: 34341797; PMCID: PMC8328065.


    Tuvali O, Tshori S, Derazne E, Hannuna RR, Afek A, Haberman D, Sella G, George J. The Incidence of Myocarditis and Pericarditis in Post COVID-19 Unvaccinated Patients-A Large Population-Based Study. J Clin Med. 2022 Apr 15;11(8):2219. doi: 10.3390/jcm11082219. PMID: 35456309; PMCID: PMC9025013.


    References

    Community COVID-19 Respiratory Illness is Not Associated with Myopericarditis
    Cannot Shift Blame Away from COVID-19 Vaccination
    petermcculloughmd.substack.com

  • Fraud In the NIH Sponsored ACTIV-6 Study of Ivermectin

    Fraud In the NIH Sponsored ACTIV-6 Study of Ivermectin
    The National Institutes of Health (NIH) sponsored ACTIV-6 ivermectin trial for early COVID published in JAMA claimed ivermectin didn't work for mild-moderate…
    www.trialsitenews.com


    The National Institutes of Health (NIH) sponsored ACTIV-6 ivermectin trial for early COVID published in JAMA claimed ivermectin didn't work for mild-moderate COVID. Medscape and MedPage Today reviewed the trial and had experts comment on it. All said the study, not unexpectedly, showed no benefit for the third time in a large, randomized trial, and that ivermectin was dead as a therapeutic.


    In the ACTIV-6 trial reported in JAMA, the study team first enrolled patients on 6/23/21, when we already had about 30% delta variant in circulation. Based on India and Great Britain, delta was certain to dominate soon. ACTIV-6 randomized patients to a placebo or a dose they had planned to use for alpha, 0.4 mg/kg for 3 days on an empty stomach. By the time they had enrolled about 10% of the patients on 8/6/21 when they had 80% delta, the same dose they were using was reported to not show statistically significant benefit in the TOGETHER trial.


    They should have looked to see that by then what the Front Line COVID-19 Critical Care Alliance (FLCCC) was recommending: 0.4-0.6 mg/kg with food for 5 days or until symptoms resolved for delta. Dr. David Boulware of ACTIV-6 had discussed dosing with FLCCC in Feb 2021, when alpha was the predominant variant of concern. ACTIV-6 should have stopped the trial and restarted with the FLCCC dose vs. placebo but instead chose to enroll another 1400 patients and randomize them to placebo or the same dose of ivermectin, 0.4 mg/kg for 3 days on an empty stomach, a dose of ivermectin they knew, or should have known did not work in another trial of a less virulent COVID variant, and 40% of what FLCCC recommended. A second trial of an ineffective dose of ivermectin was not needed. What was needed was a trial including a potentially effective dose. Ivermectin has no appreciable toxicity at much higher doses.


    Not surprisingly, their dose of ivermectin did not shorten the duration of illness. They reported their results in a preprint and the JAMA article but did not acknowledge that they knew they had underdosed ivermectin. As evidence that they knew that they HAD IN FACT known they severely underdosed ivermectin, in February 2022, ACTIV-6 continued the trial with 3 times the cumulative dose: 0.6 mg/kg for 6 days.


    Medscape, MedPage Today, and all their consultants failed to mention that the higher dose had been in use since February which, of course, meant that the patients had been undertreated in the ACTIV-6 trial reported in JAMA. This meant that the patients in TOGETHER and COVID-OUT were also underdosed since they had gotten the same dose. All 3 studies were not going to test at adequate doses, and all the publicity about ivermectin failing in 3 large, randomized trials was in this author’s opinion, nonsense.


    COVID-OUT at University of Minnesota shared Dr. David Boulware with ACTIV-6. They started a month earlier with ivermectin at a 10% higher dose. They had the same problems as ACTIV-6. They chose a dose for alpha instead of delta and got swamped with delta. Unlike ACTIV-6, which could have added a higher dose arm, they couldn't add another arm because as Dr. Boulware emailed this author, they had no more money. Like ACTIV-6, ivermectin didn't shorten the duration of illness. They reported their results in NEJM and didn't acknowledge that they knew during the trial that they had severely underdosed the ivermectin patients.


    ACTIV-6 can’t claim they didn’t know about TOGETHER or that they had 80% delta in early August. I don’t know who they can find to say that 0.4 mg/kg for 3 days on an empty stomach was an appropriate dose for delta. There is no logic that 0.4 mg/kg on an empty stomach for 3 days was likely to be effective. It’s hard to believe that no one looked at the FLCCC website.


    On October 18, 2021, when ACTIV-6 had enrolled 40% of the patients, this author emailed multiple people at ACTIV-6 that based on the recommendations of the FLCCC Alliance, were giving 40% of the correct dose on an empty stomach when ivermectin is better absorbed with food. (Email to Dr. Susanna Naggie attachment). I got acknowledgement from Dr. Cliff Lane, deputy chairman at NIAID that it was received.


    ACTIV-6 made no changes and randomized another 900 patients to placebo or a dose of ivermectin they were now sure didn’t work. They could have added a high dose arm but didn’t.


    This article I wrote for TrialSite News after the preprint was published, one of 26 articles I’ve authored about the pandemic, explains ACTIV-6 in great detail. Recruitment was not linear. I miscalculated the percentage of delta as 70%. About 40% of the patients were recruited in the last 7 weeks and were almost all infected with the omicron variant. About 52-55% were delta not the 70% I reported in the article.


    Ivermectin Fails to Shorten COVID Recovery Time in NIH Sponsored ...


    The only 3 studies of absorption of ivermectin with food show 18%, 25%, and 2.6 times increases in blood levels when taken with food.


    In the high dose ivermectin study which started in February, there won't be enough hospitalizations or deaths to tell anything. Patients didn't get ivermectin until an average of 6 days into symptoms in the initial trial. Late treatment is a problem for these centralized trials which mail out medications. Giving high dose ivermectin at 6 days into symptoms for omicron is unlikely to shorten duration of the illness. There were 90 patients who presented with severe illness in the initial trial. They benefited from ivermectin, but it wasn't statistically significant. There will be fewer in the high dose study because they will be all omicron instead of half delta. Ivermectin could show statistical benefit.


    By far, the most important part of the high dose ivermectin study is looking to see if high dose ivermectin prevents long COVID which occurs in 10-15% of omicron patients including some with mild illness. No drug trial has shown conclusive benefit in preventing long COVID so far, although multiple physicians claim almost no long COVID with early multiple drug regimens in over 20,000 patients. They didn't randomize patients because they felt it was unethical.


    Had ACTIV-6 run the trial with an appropriate dose of ivermectin for delta starting in late June or August, there is a reasonable chance ivermectin would have demonstrated statistical benefit for the delta patients and omicron patients which became dominant by December. With the higher dose of ivermectin, those patients randomized to ivermectin may have not suffered as much. Ivermectin might have shown significant benefit early, issued an EUA, and been in use all over the world today, preventing a lot of sickness and death. Instead, it will be a while before the high dose study is completed, analyzed, and reported.


    My guess is it was NIH which insisted on maintaining the lower dose and the trialists who insisted on the increased dose in February. They need to be questioned under oath. Perhaps, after the midterms, a change in government could lead to COVID hearings.


    In this author’s opinion, ivermectin should have received an EUA a long time ago, Uttar Pradesh, India, 241 million people, started using ivermectin on August 6, 2020. By December 2020, their mortality rate was 0.26 per 100,000, 9% of the US. See Ivermectin for COVID attachment.


    An Unlikely Nation Is Kicking This Pandemic. Guess Which. Then Why.


    Recently, they have about 100 new cases and 1 death a day. Half of the districts have been declared COVID free.


    Uttar Pradesh is ivermectin's best practice story


    TrialSite was one of the few media chronicling the Uttar Pradesh situation especially in the intense delta surge where a pervasive public health response including pairs of health care teams armed with combination ivermectin kits for home use led to a dramatic turnaround for the better.


    Why would anyone want to sabotage ivermectin?


    An EUA for ivermectin would have possibly prevented the vaccines from securing EUA as there would have been an excellent FDA approved drug treatment available. It also would have made paxlovid unnecessary. Who stood to gain from preventing ivermectin from being used? DRUG COMPANIES!!! Who did all the dirty work to keep ivermectin from being used? NIH, FDA, CDC, the media, social media, and Bill Gates.


    The FDA portrayed it as a horse dewormer, even though 3.7 billion doses have been safely given to humans. It got a Nobel Prize, and the WHO lists it as an essential medicine. Doctors still wanted to use it, so the FDA got pharmacies not to sell it and weaponized medical review boards to persecute those who ordered an FDA approved drug off-label.


    Medscape, MedPage Today and their experts completely missed that ACTIV-6 is ongoing and tripled the cumulative dose of ivermectin in February 2022 to 0.6 mg/kg for 6 days. This is from clinicaltrials.gov


    ACTIV-6: COVID-19 Study of Repurposed Medications


    Most disturbing are the comments of Dr. Adharsh Bhimraj in Medpage Today, head of COVID recommendations for IDSA. He had appeared to have no knowledge of what the dosing should have been. He apparently had no knowledge that patients in ACTIV-6 COVID-OUT also were underdosed. He didn't mention that ACTIV-6 was ongoing with 3 times the cumulative dose of ivermectin since February. Is it believable that he didn’t know? He went to medical school in India. Is it really possible for him to not know about Uttar Pradesh?


    I emailed both Drs. Eric Topol and Jeremy Faust of Medscape and MedPage Today about the major errors in their articles and asked them to print the truth.


    Ivermectin: Still on a Losing Streak as COVID-19 Treatment MedPage Today


    Ivermectin for COVID-19: The final nail in the coffin? Medscape


    What would make these two medical news sources present questionable, to outright fraudulent data? They will claim they didn't realize that ACTIV-6 was ongoing with a higher dose. It was just a mistake. Is there a reason they could not have looked at clinicaltrials.gov. or looked into the appropriate dosing of ivermectin? They could have asked the investigators. Is there someone with more expert knowledge than the FLCCC Alliance regarding ivermectin dosing? Why didn't they ask the FLCCC? Both news sources have printed nothing but negative things about ivermectin. Both news sources also minimize evidence of significant vaccine toxicity. It sounds like more government propaganda. See the compendium of data above.


    I think the real-world use of ivermectin in Uttar Pradesh crushing COVID in 241 million people is a lot better evidence of ivermectin's benefit than 31,500 patient remotely run randomized trials which severely underdosed the patients at the behest of the drug companies, NIH, FDA, and Bill Gates? ACTIV-6 was run by Duke and funded at least in part by NIH. Bill Gates donated $327 million to Duke and $30 million to University of Minnesota who ran COVID-OUT. He subsidized TOGETHER, and the study was run by Dr. Edward Mills who may have close ties to Gates and other possibly biased interests. Mills conducted some questionable activity, sharing pertinent information. Bill Gates is heavily invested in vaccines. He controls WHO with his money. He is well aware that WHO has been involved with population control in Africa by secretly having drug companies covalently bond HCG to tetanus vaccines.


    This video is very disturbing Infertility: A Diabolical Agenda


    How Bill Gates and partners used their clout to control the ...pandemic


    No one can possibly think NIH or FDA wanted ivermectin to show benefit.


    Why would JAMA not have checked to see what an appropriate dose of ivermectin should have been before publishing the results of ACTIV-6? Why did NEJM publish TOGETHER and COVID-OUT and not consider that they both severely underdosed their patients? They were told about it in no uncertain terms after TOGETHER. COVID-OUT used about the same dose.


    NEJM has been involved in other fraud including publishing that the vaccines are safe in pregnancy, when 82% of the women vaccinated in the first two trimesters in the trial they published had miscarriages. See attachment: Compendium of Data. COVID Injections in pregnant women lead to 8 times increase in spontaneous abortions and 3 times increase in stillbirths


    The fact is that all 3 large randomized ivermectin trials severely underdosed ivermectin, all giving about the same dose. JAMA editor in chief, Dr. Kirsten Bibbins Domingo, and former editor in chief Dr. Phil Fontanarosa has my email alleging very obvious fraud. I asked that the article be revised to tell the truth, which is what I prefer, or be retracted. Let’s see if they do anything. Director of Duke Health, Sarah Avery has my email above. I have emailed many at Duke about the fraud and no one has responded. So far it appears that everyone I mentioned who has had anything to do with the large randomized ivermectin trials has been dishonest, and it has knowingly caused great harm to patients. Please watch this 13-minute video:


    Ivermectin: The Truth


    This is for those of you who want to take a deep dive, especially the infectious disease doctors who worship Dr. Fauci and religiously adhere to NIH, CDC, and FDA recommendations. They have caused immense harm during the pandemic. If there is a Nuremberg II, they will be among the first to face questioning.


    Dr. Pierre Kory: The Publication of Fraudulent Ivermectin Trials by the High .Impact Journals Part I


    Dr. Pierre Kory: The publications of fraudulent ivermectin meta-analyses and editorials in high impact journals Part II


    The data on the fraud with ivermectin in the large, randomized trials could not be more obvious. Ivermectin would have ended the pandemic long ago. Many of you used ivermectin and hydroxychloroquine despite the risks, but it is understandable that some could not risk their job. The ACP needed to act so that you didn't need to decide between doing the best for your patient and keeping your job. You should prevail on your leadership to fight for you. They need lawyers and some guts.


    Here’s more ivermectin data you probably haven’t seen, including its superb efficacy for COVID prophylaxis and benefit in long COVID and vaccine induced injury.


    Among 223,128 people in Itajai, Brazil, those who didn’t use ivermectin 4 times a month for COVID prevention were twice as likely to get infected, 7 times more likely to die of COVID, and 12.5 times more likely to die overall than the 8,325 patients who reliably took ivermectin, even though those who reliably took it were older and had more risk factors. No patient who reliably took ivermectin reliably needed hospitalization for COVID.


    Reliable use of ivermectin 4 times a month lowered COVID infections 50%, COVID admissions 100%, COVID death by 7 times and all cause death 12.5 times in a town of 220,000


    Ivermectin for Long COVID and Vaccine Induced Illness

    The FLCCC Alliance has found ivermectin to be their most beneficial drug for long COVID. Like paxlovid, it’s a 3CL protease inhibitor and can kill the virus. It also decreases inflammation, seems to help with the scavenging of spike protein debris, and has a beneficial effect on the gut microbiome which COVID damages.


    Struggling with long COVID, Brandon Sutter is taking ivermectin


    Treating long COVID, not surprisingly, requires a lot of different therapies and trial and error. It’s not one size fits all.


    I-Recover Long COVID


    I-RECOVER: Post-Vaccine Syndrome


    With a population of 241 million, Uttar Pradesh, India started ivermectin widely 8/6/20. By December 2020, its mortality rate of 0.26 per 100,000 was 9% of the US. Recently, it has been averaging less than 100 new COVID cases daily in the last three months, and less than 20 a day in the last three weeks. The deaths average one a day in the last six weeks. More than half of its districts or provinces have been declared COVID-free with zero active cases.


    Uttar Pradesh is ivermectin's best practice story


    FLCCC Alliance: Ivermectin in COVID=19


    Dr.Theresa Lawrie meta analysis shows a 62% decrease in mortality due to ivremectin


    Ivermectin’s three large randomized trials all underdosed ivermectin by at least 60%. All of the authors are guilty of fraud by underrating the patients and not admitting to it. Bill Gates and many others were involved in the fraud to prevent ivermectin from preventing an EUA for the vaccines and preventing Pfizer’s massive profits from paxlovid.


    There were four 1500 patient randomized trials of ivermectin for early COVID planned. Randomized trials were portrayed as the holy grail of medicine. Physicians and the public have no idea how easy it is to manipulate the results and how many fraudulent studies are published. Medical researchers are as dishonest as politicians. The NIH and FDA claimed that these trials were the only thing which could determine if ivermectin was effective.


    Numerous people in the media were sent data that showed starting August 6, 2020, ivermectin had crushed COVID in the 241 million people of Uttar Pradesh India but this was kept silent. Had that been recognized, the vaccines would not have been needed. Had ivermectin been proven effective in the randomized trials, it would have prevented all of Pfizer’s $24 billion in sales this year on paxlovid and crushed its vaccines sales. Pfizer, the media, and our government wouldn’t let it happen.


    PRINCIPLE in London stopped their trial using 0.3 mg/kg for 3 days on an empty stomach when I told them their dose was way too low, and their data would be worthless and falsely show ivermectin ineffective. Five days later, they shut down their ivermectin arm.They claimed publicly that it was because they didn’t have a reliable supply of ivermectin which was ridiculous.


    TOGETHER from Canada was run by Bill Gates’ chief trial designer, Dr. Edward Mills. Vaccine maven, Bill Gates, went to great lengths to hide its funding by the Bill and Melinda Gates Foundation and did his best to see that ivermectin showed no benefit. Read all about it. Gates also was the principal funder of Unitaid which got researcher, Dr. Andrew Hill to falsify his preprint on ivermectin’s efficacy. His admission was video recorded by Dr. Tess Lawrie and appears in the movie, The Real Anthony Fauci.


    TOGETHER, NIH’s ACTIV-6, out of Duke, and COVID-OUT from the University of Minnesota basically all used the same dose of 0.4 mg/kg for 3 days on an empty stomach. The FLCCC Alliance recommended 0.6 mg/kg with food for 5 days for delta, which was the majority of the patients in ACTIV-6 and COVID-OUT. Delta had 1000 times the viral load as the Wuhan strain and was hard to treat.


    TOGETHER had mostly gamma which was almost as bad as delta and needed a much higher dose than what TOGETHER gave. FLCCC was consulted when ACTIV-6 thought they would have almost all alpha in February 2021, but not when they actually had almost all delta in August 2021. I told ACTIV-6 of their underdosing in October 2021, but they didn’t increase the dose, add a higher dose arm, or admit that they randomized patients to placebo or a dose they knew didn’t work. At that time, they still had to enroll 900 patients. As far as they knew they would all be delta, and they were fine with randomizing them to placebo or a dose they knew didn’t work. In December omicron was the dominant variant, and the last 600 patients were omicron. Ivermectin didn’t show great benefit for any of the variants at that dose.


    None of the studies showed significant benefit. No one in mainstream medicine or the press even suggested the possibility that they had underdosed ivermectin. Major newspapers published the results. No one asked for a comment from FLCCC, the main ivermectin proponents and experts. None of the reporters looked at whether a higher dose should have been used as any investigative journalists would normally do.


    The New England Journal of Medicine, allegedly the world’s greatest journal, didn’t seem to notice and published the TOGETHER and COVID-OUT studies, not noting the severe underdosing of ivermectin.


    JAMA Network published the ACTIV-6 study. Neither the authors, IDSA’s head of COVID recommendations, Dr. Adarsh Bhimraj nor Cornell internist, Dr. Matthew McCarthy, who had comments in MedPage today, noted that ACTIV-6 had tripled the ivermectin dosage to 0.6 mg/kg in February. I told them they had given patients 40% of the correct dose for delta.


    JAMA: Time to recovery of outpatients randomized to ivermectin or placebo


    Ivermectin: Still on a Losing Streak as COVID-19 Treatment


    It is Hard Not to See Collusion and Fraud


    The big elephant in the room is Bill Gates, who is heavily invested in vaccines. Ivermectin is much better than vaccines for prophylaxis and much better than paxlovid for treatment. He invested heavily in TOGETHER. It was run by his personal trial designer, Edward Mills, who announced when the data first came out that ivermectin showed “absolutely no benefit,” except lowering admissions 9% and death 18%.


    From an Interested Party

    I would like to introduce the group to a body of work and growing dossier on the wicked practice of discrediting safe drugs being used in successfully early treatment and preventative treatment protocols for Covid19


    The parent substack:

    Is the Bill and Melinda Gates Foundation a tool to Hijack Medical Research
    Covid19 has been the most disruptive world influence since World War 2. It's death Toll may yet climb to and surpass World War 2. Yet the Death Toll does not…
    tribeqr.com


    ACTIV-6 was run by Duke and funded by NIH. Bill Gates is a close friend of Dr. Fauci. He donated $327 million to Duke. He donated $30 million to University of Minnesota who ran COVID-OUT.


    Is the Bill and Melinda Gates Foundation a mechanism to hijack medical research


    Bill Gates tried to hide it, but he subsidized the TOGETHER study, and the study was run by his personal trial designer, Dr. Edward Mills. Bill Gates' funding of TOGETHER


    This also has links to a directory collecting evidence of the ties to the Bill and Melinda Gates Foundation. It shows its shareholdings and its grants, outing the bigger recipients and their participation in designed to fail trials.


    A subsequent substack looks at the recent hit piece on Ivermectin.

    When I delve into the author's affiliations with the Bill and Melinda Gates Foundation (BMGF), it uncovers what could be called a viper’s nest of grant recipients.


    Grants Identified so far were to these affiliates:


    Duke University $327,737,456.00 - Lead Author(s)

    University of Minnesota $30,106,045.00 Dr. Boulware

    Vanderbilt University $21,772,416.00

    Cornell University, parent University of Weill Cornell Medicine $252,673,940.00

    Johns Hopkins University $1,000,711,384.00

    University of Pittsburgh $62,084,198.00

    University of Colorado $36,651,234.00

    University of Florida $22,411,438.00

    Here is the substack

    Ivermectin 01 : Another Sponsored Study With a Design That Will Fail.
    If Successful Off Patented Drugs or Treatments are Discredited it paves the way for Expensive Patented Drugs; Who would do such a thing ?
    tribeqr.com


    The War on Ivermectin. Dr. Pierre Kory’s story of massive fraud to ensure drug company profit


    Lawsuit against the FDA for its fraudulent characterization of ivermectin


    References

  • COVID-19 mRNA Vaccines May Integrate into the Human Genome

    COVID-19 mRNA Vaccines May Integrate into the Human Genome
    New research has illuminated the mechanisms of potential mRNA vaccine integration into genes. This research adds to the ongoing debate about whether mRNA…
    www.trialsitenews.com


    New research has illuminated the mechanisms of potential mRNA vaccine integration into genes. This research adds to the ongoing debate about whether mRNA vaccines can alter human DNA. In an effort to curb the uncontrollable spread of SARS-CoV-2, mRNA vaccines were broadly administered to the global population. Though mRNA technology enabled the quick development and deployment of the much-needed vaccines, its long-term safety is now at the forefront of concern.

    Intracellular Reverse Transcription of Pfizer BioNTech COVID-19 mRNA Vaccine BNT162b2 In Vitro in Human Liver Cell Line
    Preclinical studies of COVID-19 mRNA vaccine BNT162b2, developed by Pfizer and BioNTech, showed reversible hepatic effects in animals that received the…
    www.mdpi.com

    COVID-19 spread globally at an unprecedented rate. Governments and public health agencies were not adequately prepared to battle a highly contagious, infectious, and spreadable viral pathogen. While SARS-CoV-2 behaves similarly to known influenza viruses, existing vaccines were not equipped to induce immunity against it, since the viral structures and molecular interactions are so different. The development of a new vaccine became a top priority, necessitating a short timeline to save as many lives as possible.


    Pfizer/BioNTech’s BNT162b2 and Moderna’s mRNA-1273 (Spikevax) are two approved and widely administered mRNA vaccines for SARS-CoV-2. These vaccines use an mRNA copy of the spike protein to direct intracellular production of the protein, eliciting an immune response. mRNA vaccines can be developed and deployed on a large scale more quickly than conventional vaccines, making them suitable for pandemic situations. A second cited advantage is that, unlike DNA-based vaccines (for example, plasmid DNA or viral vectors), mRNA vaccines cannot be integrated into the genome.


    mRNA vaccines have not been administered to the general public on such a large scale in the past. In fact, it is a relatively new vaccine technology. Research is still ongoing into the long-term efficacy and side effects of COVID-19 mRNA vaccines.


    A previous research study challenges the idea that genome integration is impossible with mRNA vaccines. In that study, the authors found that vaccine mRNA could be converted into DNA through a process called reverse transcription, where cellular enzymes recognize specific mRNA strands and, instead of using them to make functional proteins, can convert them into DNA. This is only one step away from possible genome integration.

    New Study: mRNA Vaccines Alter Human Liver DNA In Vitro?
    Pfizer’s BioNTech vaccine causes intracellular reverse transcription of BNT162b2 mRNA into human DNA in vitro, renewing concerns that vaccines may introduce…
    www.trialsitenews.com

    mRNA Vaccine Retroposition: Possible Cause and Effect

    According to a preprint research article from 2021, the possibility of mRNA vaccine retroposition has largely been overlooked, despite accepted knowledge in the scientific community about mRNA retroposition.

    mRNA vaccines: Why is the biology of retroposition ignored?
    The major advantage of mRNA vaccines over more conventional approaches is their potential for rapid development and large-scale deployment in pandemic…
    osf.io

    Retroposition occurs when mRNA is reverse transcribed and inserted into the genome. This process occurs naturally and very often in certain mammals, including humans.


    As described in the article, much of the retroposition that occurs in mammals is mediated by L1. L1 is a complex cellular mechanism that converts mRNA sequences into DNA and also mediates the integration of converted DNA into the cells’ own genes. L1-mediated retroposition recognizes a motif on target mRNA sequences called a “poly-A tail” – a long section that predominantly contains the RNA building block adenosine.


    mRNA vaccines also contain “poly-A tails”. These help to mimic native human mRNA, increase efficient translation into proteins, and increase stability. Consequently, L1 may be able to recognize the poly-A tail on an mRNA vaccine and insert it into the genome.


    Another preprint article discusses the potential mechanisms and implications of the integration of vaccine mRNA into the human genome. In addition to supporting the role of L1 in mediating retroposition, the article also covers possible correlations between mRNA vaccines and diseases, including cardiovascular diseases and cancer.

    Potential Mechanisms for Human Genome Integration of Genetic Code from SARS-CoV-2 mRNA Vaccination
    Background The findings of a sequence embedded in Human DNA that was almost identical to a sequence in the SARS-CoV-2 genome, and the identification of…
    www.authorea.com

    According to the authors, stem cells and gametocytes would be the first to have normal cell function disrupted by unwanted RNA insertions. They refer to the extensive genetic modifications that went into the mRNA vaccine preparations as a major point of uncertainty when it comes to long-term health effects. Stem cells are of particular concern because the spike protein can induce cancer formation in these cells.


    Further Considerations

    There appears to be a consensus among public health agencies across the globe that mRNA vaccines cannot alter human DNA, as seen in these two examples from the U.S. Centers for Disease Prevention and Control (CDC) and the Australian Government Department of Health and Aged Care (DoH).


    This stance is also seen in Reuters' fact-checked articles, including this article regarding information circulating on social media about mRNA vaccines altering human DNA, and Reuters’ response to research from biologists at the Massachusetts Institute of Tech (MIT). The MIT team claim that the SARS-CoV-2 virus itself can alter human DNA, and that retroposition of the SARS-CoV-2 viral genes explains why some patients still have positive viral RNA detected through PCR long after infection.


    Another review article focuses on the complex behavior of mRNA vaccines in the body, and cautions against treating them in the same way as conventional vaccines. The authors liken mRNA vaccine behavior more closely to that of a prodrug than that of a traditional vaccine, since the mRNA vaccine on its own cannot elicit an immune response until the body produces spike protein using the mRNA template. This article does not directly take a stance on whether mRNA vaccines can alter genomic DNA, but the authors recommend further study into the pharmacology of the novel and complex vaccine technology.

    Understanding the Pharmacology of COVID-19 mRNA Vaccines: Playing Dice with the Spike?
    Coronavirus disease-19 (COVID-19) mRNA vaccines are the mainstays of mass vaccination campaigns in most Western countries. However, the emergency conditions in…
    www.mdpi.com

    Final Thoughts

    While the claim that the COVID-19 vaccines cannot alter human DNA is present in numerous sources, as briefly discussed above, there does not appear to be any primary research that supports this claim. The studies that suggest retroposition may warrant additional investigation into mRNA vaccine retroposition, and the long-term effects it may cause.

  • Paul Offit, Philly’s most vocal vaccine advocate, on science, truth, and why he’s not a fan of the latest COVID boosters

    Paul Offit says he is standing up for science, but was in the minority on the FDA panel of scientists who recommended the bivalent COVID vaccine now being offered across the nation.

    Paul Offit, Philly’s most vocal vaccine advocate, on science, truth, and why he’s not a fan of the latest COVID boosters
    Paul Offit says he is standing up for science, but was in the minority on the FDA panel of scientists who recommended the bivalent COVID vaccine now being…
    www.inquirer.com


    Philadelphia’s most prominent immunization expert isn’t planning to get the latest COVID-19 booster shot, and doesn’t think most others need to either.


    Paul Offit, who is among the Food and Drug Administration’s advisers on which vaccines the public should receive, disagrees with the current recommendations of the White House, FDA, and Centers for Disease Control and Prevention that everyone over the age of 5 should get the new vaccine.


    Offit says he is standing up for science. He has dedicated his career to advancing vaccines to save children from preventable illnesses. He thinks the new vaccines are safe but notes the Biden administration issued recommendations without strong evidence they offer significantly greater protection than the shots being given since 2020.


    “This product was grossly oversold,” said Offit, who was in the minority on the FDA’s panel of independent experts who voted 19-2 in June to recommend that the COVID vaccines used for boosters should be updated to the bivalent vaccine now being offered across the nation.

Subscribe to our newsletter

It's sent once a month, you can unsubscribe at anytime!

View archive of previous newsletters

* indicates required

Your email address will be used to send you email newsletters only. See our Privacy Policy for more information.

Our Partners

Supporting researchers for over 20 years
Want to Advertise or Sponsor LENR Forum?
CLICK HERE to contact us.