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

  • Kerryn Phelps..wide spectrum of side effects from RNA vaccines

    Australia ex head of the AMA... national GPs organistion

    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.

  • three weeks ago.. masks for confetti..

    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.

    That’s a pissed off Japanese! I have no way to know if the translation is accurate, but certainly if it’s, then Bravo! to Dr. Fukushima.

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

  • World wide fear mongering against Chinese tourists!


    We know that the Japanese medical rotary mafia still upholds PCR tests for arrivals and thus this is not new for Chinese tourists.


    But why testing at all for an illness that since months is one of the most harmless if you are not vaxxinated ? So Switzerland does not require PCR tests for all tourists. Our positive rate still goes down by about 20%/week...


    Of course thanks to no masks and silent immunization and low booster rate.

  • COVID-19 Vaccine Induced Axillary Lymphadenopathy

    Abnormal Mammograms Driving Clinical Concerns and More Testing

    COVID-19 Vaccine Induced Axillary Lymphadenopathy
    Abnormal Mammograms Driving Clinical Concerns and More Testing
    petermcculloughmd.substack.com


    By Peter A. McCullough, MD, MPH


    There has never been a vaccine that has caused more problems for practicing doctors than the genetic COVID-19 vaccines (Pfizer, Moderna, Janssen, AstraZeneca). Once injected into the arm, the lipid nanoparticles laced with mRNA or adenoviral DNA are freely flowing in the bloodstream within an hour. We know from the CDC V-safe data that 7-8% are so sick at this phase they seek emergency care and some are hospitalized. The lymphatic system begins to drain the vaccine product into lymph nodes where mRNA becomes trapped and local Spike protein production causes lymph node swelling and more inflammation. This “reactogenicity” becomes progressively worse with each additional, ill-advised injection. Raj et al reported that women who took the COVID-19 vaccine had a 10-fold increased rate of abnormal lymph nodes identified on breast cancer screening exams.

  • Large Study’s Disturbing Results: Questionable Bivalent Booster Performance--the Greater the Previous mRNA Doses the Greater the Risk for Infection

    Large Study’s Disturbing Results: Questionable Bivalent Booster Performance--the Greater the Previous mRNA Doses the Greater the Risk for Infection
    Cleveland Clinic researchers, led by physician and infectious disease specialist Dr. Nabin K Shrestha, conducted a large retrospective cohort study tapping…
    www.trialsitenews.com


    Cleveland Clinic researchers, led by physician and infectious disease specialist Dr. Nabin K Shrestha, conducted a large retrospective cohort study tapping into robust data associated with the Cleveland Clinic Health System (CCHS) involving 51,977 study subjects and a total of 10,804 employees that were bivalent vaccine boosted. How effective were these vaccines in stopping COVID-19? 89% of those (9595) were vaccinated with BNT162b2 (Pfizer-BioNTech), and the remaining 1,178 with mRNA-1273 (Moderna). By the 13th week of this study, 2542 employees (5%) contracted COVID-19. The observational study involving CCHS employees involved evaluation of those employees who received the bivalent COVID-19 vaccine released September 2022. The investigators embraced a methodology treating bivalent vaccination as a time-dependent covariate, allowing for determining vaccine effectiveness in real time. With a majority of SARS-CoV-2 cases in Ohio involving BA.4 and BA.5 Omicron sub-variants during the first 10 weeks of the study (Ohio Department of Health data), by December, the most active sub-variants become BQ.1, BQ.1.1, and BF.7 lineages. The CCHS investigators conducted a range of statistical analyses, from a Simon-Makuch hazard plot comparing the cumulative incidence of COVID-19 in the bivalent vaccinated and non-vaccinated states (bivalent vaccination treated as a time-dependent covariate), as well as multivariable Cox proportional hazards regression models fitted to evaluate the association of various study variables with time to COVID-19 (Bivalent vaccination included as a time-dependent covariate). Two models were constructed, including a primary model (all study subjects) and secondary model (persons with prior SARS-CoV-2 infection of vaccination). All analyses were crunched in the survival package and R version 4.2.2. The study authors found that the current bivalent vaccines were only about 30% effective overall in protecting against SARS-CoV-2 infection when the Omicron BA.4/BA.5 lineages were predominantly in circulation in Ohio. Furthermore, the data reveals the greater number of mRNA doses, the greater the incidence of SARS-CoV-2 infection. Unfortunately, this isn’t a great look.


    What do we learn from this study? What follows is a TrialSite breakdown. We remind that this study has yet to be peer reviewed, thus should not be cited as evidence.

    Source: Cleveland Clinic


    High level findings and TrialSite POV

    With a total of 51,011 Cleveland Clinic Health System employees, 20689 (41%) had a previous documented episode of COVID-19, and 42,064 (83%) received at least two doses of a COVID-19 vaccine. COVID-19 occurred in 2452 (5%) during the study. In a bombshell finding (but not surprising given growing data), the risk of COVID-19 increased with time since the most recent prior COVID-19 episode, and importantly, with the number of vaccine doses previously received.


    The investigators’ multivariable analysis revealed that there was some decent news in that the bivalent vaccinated state was independently associated with lower risk of COVID-19 (HR, .70; 95% C.I., .61-.80), leading to an estimated vaccine effectiveness (VE) of 30% (95% CI, 20-39%) for this point in time. Compared to last exposure to SARS-CoV-2 within 90 days, the last exposure 6-9 months previously was associated with twice the risk of COVID-19, and last exposure 9-12 months previously with 3.5 times the risk. Importantly, the mRNA COVID-19 vaccines continue to exhibit durability challenges, and the 30% vaccine effectiveness rate will likely wane rather quickly. Given the risk for COVID-19 increases with the number of vaccine doses previously received, the whole premise of the current COVID-19 vaccination scheme must be reconsidered. If looked at as a tool used for surges during the pandemic to mitigate risk of serious infection, they can be considered successful less a true independent analysis of actual risks to various age cohorts. But declaring these products as a universal success given the tremendous social upheaval associated with the program (mandates, etc.) represents more of a political agenda than a scientific one.


    What’s the strength of this study?

    Although the results must still go through peer review, the Cleveland Clinic-based study includes the following elements making this a robust study:


    Large sample size

    Conducted in a healthcare system, it demonstrates early recognition of importance of maintenance of effective workforce during pandemic led to devotion of resources to generate an accurate accounting of who had COVID-19, who received vaccines, and when (robust, accurate records).

    What are key limitations to this study?

    As with all observational studies, limitations must be accounted for. The authors provide several limitations, and their interpretation of how and why the risks associated with these limiting factors may be mitigated. For those interested in a deep dive, we recommend a direct read.


    What is a possible explanation for weaker than expected vaccine effectiveness?

    A substantial part of the study population may have had a prior asymptomatic Omicron variant infection. For instance, the authors point out that approximately 33% of SARS-CoV-2 infections have been estimated to be asymptomatic in studies that have been done in different places.


    So, if this was in fact the case, the “protection from the bivalent vaccine may have been masked because those with prior Omicron variant infection may have already been somewhat protected.” For example, the authors back this claim with a CDC seroprevalence study done in February 2022 showing that:


    “64% of the 18-64 age-group population and 75% of children and adolescents had serologic evidence of prior SARS-CoV-2 infection, with almost half of the positive serology attributed to infections that occurred between December 2021, and February 2022, which would have predominantly been Omicron BA.1/BA.2 lineage infections. With such a large proportion of the population expected to have already been previously exposed to the Omicron variant of SARS-CoV-2, there could be some concern that a substantial proportion of individuals may be unlikely to derive substantial benefit from a bivalent vaccine.”


    Of course, this observation begs the question: if the CDC’s own data reveals this likely reality, why push the bivalent booster so hard to so many people?


    What are the implications of these findings?

    Rather than outright saying the original approach declaring that the vaccines would control the pandemic—one driven by a dynamic mutating RNA virus—the authors suggest that rather “a more nuanced approach to assessing the potential impact of vaccination” is now required. For example, “additional factors beyond vaccine effectiveness need to be considered.”


    What was an unexpected reality associated with the study findings?

    The study findings showed an association of greater risk of COVID-19 infection with higher numbers of prior vaccine doses. Put simply, the more people vaccinated, the more the SARS-CoV-2 transmission.


    What is a possible explanation for this unexpected finding?

    Persons that received more doses were likely at higher risk for COVID-19 anyway. That is the elderly, persons with comorbidities, immunosuppressed, etc. But this doesn’t make too much sense. The study authors themselves acknowledge:


    “However, the majority of subjects in this study were generally young individuals and all were eligible to have received at least 3 doses of vaccine by the study start date, and which they had every opportunity to do.”


    So, the authors point out that those persons that avoided CDC recommendations actually got infected less than those that followed CDC recommendations getting infected more?

    Yes. The authors declared, “Despite this, their risk of acquiring COVID-19 was lower than those who received a larger number of prior vaccine doses.”


    Are there other studies that find a possible association of higher prior vaccine doses and higher risk of COVID-19?

    Yes. The authors point to a large study that found that those who had an Omicron variant infection after previously receiving three doses of vaccine had a higher risk of reinfection than those who had an Omicron variant infection after previously receiving two doses of vaccine. See the link. Note, this too is not peer reviewed yet.

    COVID-19 primary series and booster vaccination and immune imprinting
    Background Epidemiological evidence for immune imprinting was investigated in immune histories related to vaccination in Qatar from onset of the omicron wave,…
    www.medrxiv.org

    Another study uncovered that those persons who received two or three mRNA COVID-19 vaccine doses following prior COVID-19 faced a higher risk of reinfection than receipt of a single dose. See the link. (also needs peer review).

    Coronavirus Disease 2019 (COVID-19) Vaccine Boosting in Persons Already Protected by Natural or Vaccine-Induced Immunity
    Background The purpose of this study was to evaluate whether boosting healthcare personnel, already reasonably protected by prior infection or vaccination,…
    www.medrxiv.org

    Should some humility be involved here?

    Absolutely. The authors importantly convey that “We still have a lot to learn about protection from COVID-19 vaccination, and in addition to a vaccine’s effectiveness it is important to examine whether multiple vaccine doses given over time may not be having the beneficial effect that is generally assumed.”


    What does the Cleveland Clinic-led team conclude?

    The authors in the TrialSite opinion to some degree protect their professional positions by declaring the bivalent booster vaccines bring an “overall modest protective effect” for protecting working-aged adults against COVID—19. Given the findings that the more mRNA doses are associated with greater number of infections, the implications are considerable for dynamics such as immune tolerance, and the authors concur that “the effect of multiple COVID-19 vaccine doses on future risk of COVID-19 needs further study.” The true value of these COVID-19 vaccines must be pegged to actual contribution. They indeed helped reduce risk at times of key surges less associated risks not fully studied or understood.


    But mounting data also suggests in the aggregate that more doses equal higher risk, and this reality, if accurate, doesn’t align well with the universal success story branding program governments and industry continuously promulgate nor the vast economic taking vaccine producers have secured.


    Lead Research/Investigator

    Nabin K Shrestha, MD, MPH infectious disease specialist and Corresponding Author

    Source: Cleveland Clinic


    Patrick C. Burke, Infection Prevention, Cleveland Clinic

    Amy S. Nowacki, Quantitative Health Sciences, Cleveland Clinic

    James F. Simon, Enterprise Business Intelligence, Cleveland Clinic

    Amanda Hagen, Occupational Health, Cleveland Clinic

    Steven M. Gordon, Departments of Infectious Diseases, Cleveland Clinic

    References

    medRxiv

    Effectiveness of the Coronavirus Disease 2019 (COVID-19) Bivalent Vaccine
    Background The purpose of this study was to evaluate whether a bivalent COVID-19 vaccine protects against COVID-19. Methods Employees of Cleveland Clinic in…
    www.medrxiv.org

  • ACTIV-6 600 Proves That Giving High Dose Ivermectin 5+ Days Into a 9-10 Day Omicron Infection Doesn’t Shorten the Illness

    ACTIV-6 600 Proves That Giving High Dose Ivermectin 5+ Days Into a 9-10 Day Omicron Infection Doesn’t Shorten the Illness
    The NIH sponsored ACTIV-6-400 ivermectin trial ran from 6/23/21-2/4/22. This author reported previously that it certainly appeared (at least, to this author)…
    www.trialsitenews.com


    The NIH sponsored ACTIV-6-400 ivermectin trial ran from 6/23/21-2/4/22. This author reported previously that it certainly appeared (at least, to this author) that the investigators appeared to do everything possible to ensure ivermectin wouldn’t be effective. Tracking this study carefully, a series of fishy data points raise serious questions that need answering.


    What follows are some observations based on the ongoing, meticulous tracking of this program:


    By the time the study team started the trial, the prevailing SARS-CoV-2 variant was 40% delta—definitely harder to treat than previous strains. They used a dose for alpha, 0.4 mg/kg on an empty stomach for 3 days.

    While author David Boulware reports that the FLCCC conveyed that the dose was “totally reasonable.” On the FLCCC website it recommended for delta, 0.4 mg/kg with food for 5 days or until resolved. This means that there is a concerning discrepancy that needs to be resolved.

    ACTIV-6 never changed the dose or added another arm even when they knew the same dose didn’t work in the TOGETHER trial. Within a month of that FLCCC recommended 0.6 mg/kg with food for 5 days or until symptoms resolved.

    The ACTIV study team gave ivermectin on an empty stomach even though the Merck stromectol package insert said that after a 30 mg dose the blood level was 2.6 times higher when taken with food.

    They had a 90 kg weight limit for no medical reason. Those over 90kg, 42% of those in the trial, were at higher risk and had their dose lowered for no good reason. COVID-OUT running at the same time had a 174 kg limit.

    On average, patients didn’t get their medicine until 6 days into symptoms, 25% 8 days of later. This, of course, is a concern as other ivermectin studies pointed to treatment at symptom onset.

    Ivermectin still showed benefit at 7 and 14 days, but the investigators changed the primary endpoint to shortening duration of symptoms to 28 days which was absurd. There was still a 91% efficacy, but the trialists claimed it did not show benefit and should not be used.

    It should be no surprise that ACTIV-6 would do another trial to make it seem that ivermectin was ineffective. This time they used higher doses, gave it late, and this time, treated Omicron patients who get better quicker with no treatment (generally, Omicron while more transmissible, is a more mild upper respiratory infection).


    There was no change in dosing until February 16, 2022, after the ACTIV-6 400 trial was completed. The study then tripled the cumulative ivermectin dose to 0.6 mg/kg on an empty stomach for 6 days (ACTIV-6 600) to treat Omicron patients. A preprint was just published in MedRxiv. Six days of ivermectin at a dose of 600 μg/kg did not reduce recovery time for patients with early, mild to moderate COVID-19.


    In ACTIV-6 600, 60% of the patients received ivermectin within 5 days of first symptoms, meaning the average time to receive ivermectin overall was 5-6 days, after a time when patients would have been eligible to receive paxlovid. The study reported time to resolution of symptoms for 3 consecutive days. That was 11-12 days for both ivermectin and placebo. Patients on average first reported being symptomatic at 9-10 days after the onset of symptoms.


    ACTIV-6 600 proved that giving ivermectin 5+ days into a 9–10-day Omicron infection is ineffective in reducing duration of illness. It’s certain paxlovid would have failed as would anything else. Data is supposed to be coming on whether ivermectin prevents long covid. A retrospective VA analysis suggested paxlovid lowers long COVID 26%. Prospective data on paxlovid and long covid is coming from Pfizer.


    Paxlovid has no randomized trial data for Omicron. Its EUA was based on interim results from EPIC-HR which enrolled unvaccinated delta patients with up to 5 days of symptoms, but they only reported on those treated within 3 days of symptoms. It concluded: “Treatment of symptomatic Covid-19 with nirmatrelvir plus ritonavir resulted in a risk of progression to severe Covid-19 that was 89% lower than the risk with placebo, without evident safety concerns”.


    When the results were published, not everyone was impressed.


    Paxlovid showed benefit in an observational trial in Israel where 4737 of the highest risk patients were treated within 3 days of a positive COVID test. It showed significant benefit regarding decreased O2 saturation, admissions, and death in those over 64 years old.


    In lower risk patients, paxlovid did not show significant benefit.


    Given that 0.6 mg/kg for 6 days on an empty stomach given at 5 days for Omicron is ineffective we now know for certain that 0.4 mg/kg for 3 days on an empty stomach given at 6 days didn’t work for Omicron patients in ACTIV-6 400. The data for patients in ACTIV-6 should be reanalyzed to see if it showed statistical benefit for those patients prior to December when omicron hit. Knowing if ivermectin is of value against a more virulent variant is not moot.


    Had ivermectin not been sabotaged in the delta patients, it is highly likely that it would have shown great benefit and gotten an EUA. That EUA would not have been revoked because we later had Omicron. Paxlovid got its EUA based on delta patients, and the US spent $10 billion on it for Omicron even though there is no randomized data that it is beneficial for Omicron.


    There should be little doubt that what is needed is a randomized trial of paxlovid vs. ivermectin 0.6 mg/kg with food for 5 days in Omicron patients with symptoms less than 5 days in all age groups. That makes a lot more sense than spending billions of dollars on paxlovid in the US and other places around the world. It will only happen with private money.

  • House Committee Bombshell: FDA Inappropriate Approval Backed Biogen’s Quest for Profits Over Americans Need Safe & Effective Alzheimer’s Drug

    House Committee Bombshell: FDA Inappropriate Approval Backed Biogen’s Quest for Profits Over Americans Need Safe & Effective Alzheimer’s Drug
    When the U.S. Food and Drug Administration (FDA) accelerated the approval of Biogen’s Alzheimer’s disease drug Aduhelm despite less than robust…
    www.trialsitenews.com


    When the U.S. Food and Drug Administration (FDA) accelerated the approval of Biogen’s Alzheimer’s disease drug Aduhelm despite less than robust clinical data, TrialSite reported that this action was so much of a concern that then Acting Director Janet Woodcock called for internal Office of Inspector General (OIG) reviews of the approval process. Concern mounts that the agency, or least elements within that government agency, are too close to industry. Now, the U.S. House Committee on Energy & Commerce has released a batch of documentation from the FDA and Biogen related to this review and accelerated approval process. The findings aren’t good. As many have suspected, industry's influence and clout grow stronger. Do these findings have any implications for how the once Gold Standard agency oversaw the pandemic?


    On Thursday, the Oversight and Reform Committee Chairwoman Carolyn B. Maloney (D-NY), and Energy and Commerce Committee Chairman Frank Pallone, Jr. (D-NJ), released a staff report after an 18-month investigation into the FDA regulatory review and approval process of Biogen’s Alzheimer’s disease drug Aduhelm, as well as the biotech company’s Aduhelm pricing scheme. It was billed as a “wake up call for the FDA to reform its practices” as well as a call to Congress to ensure they are doing their job overseeing Big Pharma “to ensure they don’t put profits over patients.”


    What follows is a brief breakdown to bring the TrialSite community up to date.


    What caused not only this House inquiry but also Janet Woodcock’s call for an internal OIG look into the FDA?

    The FDA approved the Biogen Alzheimer’s disease drug despite the traditional requirement for a key FDA advisory committees greenlight. Yet leading up to November 2020, FDA and Biogen prepared and presented a joint briefing document on Aduhelm to the key FDA advisory committee. Following the presentation, none of the committee members voted to recommend traditional approval for Aduhelm.


    After the advisory committee meeting, Public Citizen, a non-profit consumer rights advocacy group, wrote to FDA expressing concern over alleged close collaboration between the agency and Biogen. In response, FDA conducted an internal review of the agency and Biogen’s interactions prior to the November 2020 advisory committee meeting. The previously unreleased internal FDA review, which was completed in May 2021, was released yesterday with the Committees’ report.


    Despite the advisory committee’s lack of recommendation for approval, as well as internal concerns raised by experts about the inconsistency of the drug’s clinical data, FDA granted accelerated approval to Aduhelm on June 7, 2021, based on Aduhelm’ s effect on a proxy for clinical benefit.


    Following the drug’s approval, several members of the FDA advisory committee publicly resigned in protest. Later that month, U.S. House Committee on Energy & Commerce Chairs Maloney and Pallone announced the Committees’ investigation into FDA’s decision to grant accelerated approval to Aduhelm.


    What information did the Committees’ report uncover?

    What follows is a recent summary of the House Committees’ findings along with TrialSite’s comment where appropriate:


    FDA’s interactions with Biogen were atypical and failed to follow the agency’s own documentation protocol. Documents obtained by the Committees show that FDA staff and Biogen engaged in at least 115 meetings, calls, and substantive email exchanges over a 12-month period beginning in July 2019. Despite FDA guidance that substantive interactions between agency staff and drug sponsors should be documented, the agency confirmed the total number of meetings between agency staff and Biogen during this time is unknown because FDA lacked a “clear record” of the informal meetings and other interactions between agency staff and Biogen. The Committees’ investigation identified an additional 66 calls and substantive email exchanges among the subgroups of the working group that were not memorialized.

    This is most disturbing. Why wouldn’t the food and drug regulatory follow its own documentation protocols? Clearly, some sort of agenda was present between elements within the agency and the biotech company.


    FDA and Biogen inappropriately collaborated on a joint briefing document for a key advisory committee. The Committees obtained evidence that FDA and Biogen staff worked closely for several months ahead of the November 6, 2020, Peripheral and Central Nervous System Drugs Advisory Committee meeting to prepare the joint briefing document for the committee’s review. Documents show that using a joint briefing document afforded Biogen advance insight into FDA’s responses and direct guidance from the agency in drafting the company’s own sections, including sections drafted by FDA that were then included in Biogen’s portion of the document. In addition, the document did not adequately represent differing views, and the FDA’s own internal review concluded that “the use of the joint briefing document was not an appropriate approach in this instance” given the substantial disagreement among FDA offices.

    This evidence, in at least some instances, is a breach of regulatory duty. The agency’s mission statement:


    “The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.”


    The evidence suggests the FDA was more concerned with getting a subpar medicinal product to market earlier than a holistic oversight of industry per their mission statement.


    FDA pivoted to using the accelerated approval pathway for Aduhelm on a substantially abbreviated timeline. Documents and information obtained by the Committees show that FDA considered Aduhelm under the traditional approval pathway used for most drugs for nine months, before abruptly changing course and granting approval under the accelerated approval pathway after a three-week review period.

    What triggered the FDA’s change of mind clearly benefiting the biotech company? TrialSite suggests members inside the FDA aligned more with the company’s mission (including investor return) than the public’s health and safety.


    FDA approved and Biogen accepted a broad label indication for Aduhelm, despite lack of clinical data on all Alzheimer’s disease stages and Biogen’s reservations. Materials obtained by the Committees demonstrate that the FDA recommended and approved a broad label indication, despite the lack of clinical data on disease stages other than mild cognitive impairment and mild Alzheimer’s disease. Internal documents show that Biogen accepted this broad indication statement for Aduhelm, despite internal reservations about the lack of evidence of clinical benefit for patients at disease stages outside of the clinical trials, and an unknown safety profile.

    A truly disturbing finding. Again, this points to an unacceptable alignment with industry, putting the American public at risk.


    Biogen initially set an unjustifiably high price for Aduhelm, at $56,000 per year, to “make history” for the company, despite the impact on patients and the Medicare program. Documents obtained by the Committees show that Biogen viewed Aduhelm as an unprecedented financial opportunity—estimating a potential peak revenue of $18 billion per year—and developed aggressive launch and marketing plans to maximize revenue throughout the drug’s lifecycle. A September 2020 presentation to the Board stated, “Our ambition is to make history” and “establish ADUHELM as one of the top pharmaceutical launches of all time." Biogen received a report from third-party consultants, who provided strategic guidance on pricing Aduhelm, which suggested a price greater than $40,000 per year would maximize revenue, while a price less than $40,000 per year would limit both payer and physician pushback on the price.

    This is evidence that FDA regulators involved with this approval aligned more with the company and its shareholders than the public.


    Biogen expected Aduhelm to be a burden to Medicare and costly to patients. Internal company documents show that Biogen was aware that the financial burden of its high price for Aduhelm would fall primarily on Medicare. Biogen estimated that the drug would cost Medicare $12 billion in one year—representing 36 percent of Medicare’s 2018 Part B budget. Documents also show that Biogen knew from early pricing models that some Medicare patients would struggle to afford Aduhelm.

    The American public should be outraged!


    Biogen planned to spend billions to market Aduhelm, despite the financial impact on patients and the health care system. Internal company documents show that Biogen planned an aggressive outreach and marketing campaign to launch Aduhelm, focusing on direct outreach to providers, patients, patient advocacy groups, payers, and even policymakers. In some long-range plans, Biogen anticipated spending more than $3.3 billion on sales and marketing for Aduhelm from 2020 to 2024—more than two and a half times what Biogen spent in total development costs for aducanumab from 2007 until approval in June 2021.

    This is clearly, more evidence that the approval was about helping Biogen monetize their intellectual property.


    What’s some of the Committee’s key points of view?

    Oversight and Reform Committee Chairwoman Carolyn B. Maloney (D-NY) went on the record:


    ““One of my top priorities as Chair of the Committee on Oversight and Reform is ensuring that the American people have access to effective and affordable medications.”


    Maloney then opened up:


    “The number of patients and families impacted by Alzheimer’s disease will continue to increase, and it is crucial that FDA and drug companies adhere to established procedures and conduct themselves with the transparency necessary to earn public trust. I am hopeful these findings are a wake-up call for FDA to reform its practices and a call to action to my Congressional colleagues to continue oversight of the pharmaceutical industry to ensure they don’t put profits over patients.”


    While Energy and Commerce Committee Chairman Frank Pallone, Jr. (D-NJ) reinforced:


    “This report documents the atypical FDA review process and corporate greed that preceded FDA’s controversial decision to grant accelerated approval to Aduhelm.” Chairman Pallone continued:


    “While we all support the search for new cures and treatments to address devastating diseases like Alzheimer’s, we must ensure that expediency does not take precedence over protocols that ensure the independence and scientific rigor of FDA. Patient safety and drug efficacy must remain at the core of our nation’s pharmaceutical regulatory review process. FDA must continue to take corrective actions to re-earn the trust of the American people, and Biogen and other pharmaceutical manufacturers must also learn from the issues outlined in this report and implement our recommendations to place the well-being of patients over profits.”


    What are some of the Committee’s recommendations to the FDA to help restore the American people’s trust in the agency’s processes and assurances of drug safety and efficacy?


    Based on the investigation’s findings, the Committees’ report makes several recommendations to the FDA intended to get the agency back on track to its core mission—protecting the public. The report also recommends actions that Biogen and other drug sponsors take in the future to fulfill their responsibility to the patients and families who rely on their treatments.


    Click here to read the Committees’ full report.


    Click here to read selected investigation documents from the Food and Drug Administration.


    Click here to read selected investigation documents from Biogen.

  • Off-Patent Liver Disease Drug Could Stop COVID-19 and Protect Against Future Variants

    Off-Patent Liver Disease Drug Could Stop COVID-19 and Protect Against Future Variants


    Cambridge scientists have identified an off-patent drug that can be repurposed to prevent COVID-19 – and may be capable of protecting against future variants of the virus – in research involving a unique mix of ‘mini-organs’, donor organs, animal studies, and patients.


    The research, published recently in the journal Nature, showed that an existing drug used to treat a type of liver disease is able to ‘lock’ the doorway by which SARS-CoV-2 enters our cells, a receptor on the cell surface known as ACE2. Because this drug targets the host cells and not the virus, it should protect against future new variants of the virus as well as other coronaviruses that might emerge.


    FXR inhibition may protect from SARS-CoV-2 infection by reducing ACE2

    FXR inhibition may protect from SARS-CoV-2 infection by reducing ACE2 - Nature


    It's all about vitamin D

    Serum vitamin D level is associated with disease severity and response to ursodeoxycholic acid in primary biliary cirrhosis

    Serum vitamin D level is associated with disease severity and response to ursodeoxycholic acid in primary biliary cirrhosis - PubMed
    25(OH)D level is associated with biochemical and histological features in PBC. Pre-treatment vitamin D status is independently related to subsequent response…
    pubmed.ncbi.nlm.nih.gov


    Selective activation of vitamin D receptor by lithocholic acid acetate, a bile acid derivative

    Selective activation of vitamin D receptor by lithocholic acid acetate, a bile acid derivative
    The vitamin D receptor (VDR), a member of the nuclear receptor superfamily, mediates the biological actions of the active form of vitamin D, 1α,25-dih…
    www.sciencedirect.com

  • DISINFORMATION—Let’s Call It What It Is

    DISINFORMATION—Let’s Call It What It Is
    Webster’s dictionary defines disinformation as: “false information deliberately and often covertly spread (as by the planting of rumors) in order…
    www.trialsitenews.com


    Webster’s dictionary defines disinformation as: “false information deliberately and often covertly spread (as by the planting of rumors) in order to influence public opinion or obscure the truth.”


    Dictionary.com defines it as: “deliberately misleading or biased information; manipulated narrative or facts; propaganda.” I find NPR’s definition of disinformation quite interesting.


    “My choice of "disinformation" needs some explaining. It isn't a new word — just one of the family of names we give to the malignancies that contaminate the public discourse, along with "propaganda," and in particular, "misinformation" and "fake news." Each of those last two was chosen as word of the year by some dictionary or organization in 2017… Dictionaries typically define "disinformation" as the dissemination of deliberately false information, and modern disinformation campaigns all make use of the mendacious techniques we associate with the Orwellian propaganda of the totalitarian states of the last century.”


    Let’s take a look at what we know. We have all heard the conclusions from the Pfizer clinical trial data that the relative risk associated with the mRNA “vaccine” was 95%. This is a most impressive statistic for sure. Unfortunately for them, buried in a 242 page document created by our FDA, entitled Communicating Risks and Benefits - An Evidence-Based Guide, we’re told that “Patients are unduly influenced when risk information is presented using a relative risk approach”.


    On page 60, in chapter 7, #2 states:


    Provide absolute risks, not just relative risks. Patients are unduly influenced when risk information is presented using a relative risk approach; this can result in suboptimal decisions. Thus, an absolute risk format should be used.

    On the NIH website, there’s an interesting article discussing relative and absolute risk.


    Relative and absolute risks

    How do you interpret the results of a randomized? A common measure of a treatment is to look at the frequency of bad outcomes of a disease in the group being treated compared with those who were not treated. For instance, supposing that a well-designed randomized controlled trial in children with a particular disease found that 20 percent of the control group developed bad outcomes, compared with only 12 percent of those receiving treatment. Should you agree to give this treatment to your child? Without knowing more about the adverse effects of the therapy, it appears to reduce some of the bad outcomes of the disease. But is its effect meaningful?


    This is where you need to consider the risk of treatment versus no treatment. In healthcare, risk refers to the probability of a bad outcome in people with the disease.


    Absolute risk reduction (ARR) – also called risk difference (RD) – is the most useful way of presenting research results to help your decision-making. In this example, the ARR is 8 percent (20 percent - 12 percent = 8 percent). This means that, if 100 children were treated, 8 would be prevented from developing bad outcomes. Another way of expressing this is the number needed to treat (NNT). If 8 children out of 100 benefit from treatment, the NNT for one child to benefit is about 13 (100 ÷ 8 = 12.5).


    We now know that the FDA, the CDC, and the NIH were all well aware of the reality that the American public was being given information that would “unduly influence them” to accept and take an experimental injection. To add insult to injury, or should I say, to add another critical element of disinformation, we were told by those very officials, that it was our moral responsibility as good citizens to protect our family (especially grandma), our friends, our neighbors, and our co-workers by taking this EUA injection in order to save their lives and to help put an end to this deadly pandemic.


    In October, the EU parliament, during a committee meeting requesting answers from a Pfizer senior executive, determined that there had never been any testing to determine if their vaccine would prevent transmission. Talk about shocking. The reality is that the NIH, the FDA, and the CDC all knew that to be the case, yet they deliberately convinced the public otherwise. They even counseled the President of the United States with this false information, who then went on national television to tell the American people that it was their duty, their obligation to get vaccinated to stop transmission of this deadly virus. President Biden went so far as to say that this was a “pandemic of the unvaccinated”. Rachel Maddow also told her viewing audience that by getting vaccinated, you literally stopped the virus in its track. It ended right there with you if you got the shot. Unfortunately, even Rachel stopped doing her job. She never investigated the information she was providing, choosing instead to trust our public health agencies reporting on the topic and failing miserably as an investigative journalist.


    So here it is in black and white. We have been deceived. We now have clear evidence that the FDA believed, prior to the pandemic, that it was very important to inform the public about absolute risk in order to provide them with necessary information before making an informed decision about a medical procedure, treatment or vaccine. Why then could they blatantly and purposely fail to provide that critical information to the public, especially when they are being asked to take an EUA novel injection? To add to that inexcusable offense, they then chose a group of citizens, the unvaccinated, to become the lepers of the pandemic. Is this any different from what the Nazis did to the Jews, homosexuals, and gypsies? They needed the masses to focus their fears, their distress, their anger, and their hatred onto a group of people to blame, and our public health officials chose the unvaccinated.


    There are so many ways one can try to shine a light on our public health officials’ disinformation tactics. Nothing to date seems to work consistently, however. I really hoped that once the Pfizer senior representative answered the question from the EU Parliament subcommittee, finally stating that the vaccines were never tested against transmission, that might be the game changer. That happened in October and was followed by a Press Conference on the 22nd where the Associated Press was in attendance. The results, however, Silence!


    I do love the Australian Parliamentarian’s short video where he expressed his profound upset and anger at his health minister and his colleagues. It provides an excellent example of a vaccinated person who wakes up to the realization that he’s been deceived. My vaccinated friend called it a “rant” from a guy who “sounded like he was Australian” - suggesting that the video was a fake. You can’t make this stuff up. I have not seen this level of avoidance and denial since my work as a psychologist with substance abusers.


    So, what have we learned? Apparently, our public health officials were completely aware, all along, that there were never any tests, during the clinical trial, to determine if transmission was halted by the vaccine. Despite that, they led a disinformation campaign that clearly stated that it was the moral obligation of every citizen to get vaccinated so that we could all work together to end this pandemic. They told us that this was a pandemic of the unvaccinated. They told us that the unvaccinated were the cause of unnecessary deaths and suffering. They blatantly lied in their failed attempt to get everyone vaccinated. They are the cause of my friend saying that I had “blood on my hands” because I was too selfish to get vaccinated, and that I’m spreading misinformation on my substack.


    It is ironic to me that despite this reality, despite the fact that people are no longer listening to the public health pleas to get boosted, the public still can’t accept that they were gaslighted. I hold MSM entirely responsible for that. They were always supposed to be our gatekeepers. Independent, investigative journalists, whose job it was to dig deep and honestly report their findings, not only failed to look behind the curtain, but used a megaphone to spread the false statements from our public health agencies and inflame the growing animosity against the unvaccinated. They fueled the fire that was burning through our democracy.


    The truth is we’ve lost many things during this pandemic. We lost hundreds of thousands of people to Covid unnecessarily because our public health agencies refused to accept the mountain of evidence supporting the use of early treatment with FDA approved medicines. We lost a much-valued freedom - Free Speech due to profound scientific censorship. We lost the hard won right, following the Nuremberg trial, of informed consent. Countless people lost their jobs. Honest and previously well-respected physicians lost their medical licenses. Countless people lost their financial well-being. Millions of people lost their health. What we learned from January 6th is that ultimately, we’ve lost our very democracy.


    It is such a sad day for every human being on this planet. Oh yea, we’re doing a terrific job of killing that as well. Despite the massive evidence of climate change, drought, unprecedented wildfires, floods, the melting of our icecaps, hurricanes, tornados, rising temperatures etc. we have a large section of the population who, still, don’t believe that’s real either.


    May 2023 bring much-needed insight, peace, and reform to our deeply troubled world.

  • We have all heard the conclusions from the Pfizer clinical trial data that the relative risk associated with the mRNA “vaccine” was 95%.

    This figure (95%) was invented by Pfizer marketing and the given target to the study slaves. Just to remind you that > 1200 person in the vaccine arm had CoV-19 symptoms and no PCR tests have been made. So the real figure in fact is -95% protection.

    A Pfizer jab makes you highly vulnerable to Covid. This has been proven by high CoV-19 death numbers after jab by several country data. The trick always was to count all dead until 14 days post jab as CoV-19 deaths not vaxx induced Cov-19 deaths.

  • Another clip of Dr. Fukushima’s passionate statements, with better paced subtitles that give enough time to read them. I wish I was able to assess if the translation is accurate or not. One can tell, however, he is really pissed off.



    JedRothwell , regardless if you agree or not with what is being said, can you share if you think the translation is accurate?

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

  • About the white knights... :: https://www.thedesertreview.co…ed-b981-ff6314bc9b2c.html



    Of course, the heart of the problem was that it was so effective, cheap, and safe that it threatened Big Pharma profits, so it had to be stopped. Dr. Marik had to be discredited and now fast forward to his current Wikipedia Page. In sharp contrast, Dr. Marik's 2022 Wikipedia page is defamatory and is filled with words like misinformation, unsupported claims, reprimand, and false.



    Life Insurance statistics now reveal a 40 percent increase in death among the healthiest employed groups in our population.


    According to Edward Dowd, a Wall-Street financial expert, this unexplained increase in worldwide deaths commenced not with the pandemic but only after the mRNAinjection roll-out.


    [52:40] I recently got a text message from a well-known cardiologist who doesn't want to be named in the UK. To summarize, in his view, we are dealing with the biggest crime against humanity since WWII.

  • 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.

  • Pfizer, Unbridled Power at What Cost?

    Pfizer, Unbridled Power at What Cost?
    Throughout the pandemic TrialSite News chronicled Pfizer’s influence and leverage—or outright power and how the multinational pharmaceutical…
    www.trialsitenews.com


    Throughout the pandemic TrialSite News chronicled Pfizer’s influence and leverage—or outright power and how the multinational pharmaceutical corporation has gained unprecedented new clout on an international scale. The nonprofit group Public Citizen has reported on the strength of Pfizer and how the corporation can actually “bully” countries into accepting contract terms in exchange for the delivery of the Covid vaccine. Reportedly, Pfizer can “silence governments, throttle supply, shift risk, and maximize profits in the worst public health crisis in a century.”


    Even given wars in Europe and gluts of COVID-19 vaccine product this news revealed how Pfizer refused to budge on contracts with countries. But Pfizer insists on completion of the contract even when an absolutely legitimate “force majeure” is invoked.


    The corporation’s Chief Executive Officer, Albert Bourla, addressed the World Economic Forum in Davos, Switzerland last year and warned of complacency around the globe due to the politicization of the pandemic while pushing Pfizer’s vaccine product. In the third financial quarter of 2022, the pharmaceutical company projected their yearly turnover to be between $99 and $100 billion. Pfizer’s earnings just from their Covid remedies, both the vaccine and antiviral pill, was expected to be $56 billion: $34 billion for the vaccine, and $22 billion for Paxlovid, their Covid treatment medication. Some could argue that this dynamic has crossed over into some form of profiteering.


    High Profits, Big Influence, Questionable Efficacy

    There is no question that the introduction of the Covid vaccine helped blunt the full force of the pandemic, especially earlier on in the pandemic. During the initial stages of the Covid epidemic, Israel used Pfizer as the primary vaccination for its population. But when an Israeli doctor discovered a link between the Pfizer jab and myocarditis the pharma giant ignored the physician for four months. Additionally, Israel was one of the first countries to announce the waning of Pfizer’s Covid vaccine. However, the Mediterranean country expressed its gratitude to Albert Boula by awarding him The Genesis Prize which acknowledges an individual’s contribution to humanity.


    In September, Israel announced a deal with Novavax for use of their Covid vaccine and recently, a court in Jerusalem announced the Israelis can no longer locate their agreement with Pfizer. The corporation has formalized at least 73 deals for its Covid vaccine. As of October 2021, according to Transparency International, only five contracts have been published. “Pharma companies have concerns,” said Julia Barnes-Weise, director of the Global Healthcare Innovation Alliance Accelerator. “One of them is, especially for a not-yet-approved vaccine, that they could be held liable for any injury that that vaccine seems to have caused.”


    The United States does indemnify the vaccine manufacturers. In many of the contracts negotiated by Pfizer the company has a lot of leeway, including changing delivery schedules and in the cases of contracts with Brazil, Chile, Colombia, the Dominican Republic, and Peru the governments were required to sign a document saying each country “expressly and irrevocably waives any right of immunity which either it or its assets may have or acquire in the future.” Four of the named countries had to waive immunity against “precautionary” seizure of their assets. Pfizer truly exploited the pandemic situation to maximize its interests but given the were exploiting a WHO and national public health emergencies national governments could have balanced the situation. But all along there was evidence of perhaps too cozy a tie between national and even supra-national government (think of the private texts between Pfizer CEO Bourla and EU Commission President Ursula von der Leyen as TrialSite reported. Local MEPS called for her ouster.


    Perhaps, Pfizer’s power comes from the payments it’s made to government agencies like the Food and Drug Administration (FDA), and that could also explain why Pfizer hasn’t experienced the same kind of “scrutiny” as Moderna, which actually has a hand in developing the mRNA vaccine.


    In Case of Accident Will Pfizer be Accountable?

    As TrialSite’s Sonia Elijah reported early on after the Emergency Use Authorization (EUA) was given by the FDA for the Pfizer vaccine, there were major concerns with the Covid jab. Yet the vaccine was still distributed and authorized. There is no question of Pfizer’s influence on the United States Government, and as said earlier, the company should be credited for blunting the full force of the pandemic. But the question here is if there is a potential problem with the vaccine, will Pfizer answer for any misdeeds?


    In 1975 the film Rollerball was released starring James Caan. The movie focused on the idea that governments no longer controlled nations, corporations did. Perhaps, Rollerball’s future prediction is happening now.

  • Von Professor Haditsch - Direktor einer Impfklinik auf Deutsch:

    Prof. Haditsch head of a vaccine institute talks straight out in his "WWIII" against humanity talk.


    3 Jahres-Rückblick Teil 1 von 3
    In den letzten drei Jahren hat sich viel getan - Zeit einmal Rückblick zu halten.Dies ist der erste von drei Teilen, alles auf einmal wäre wohl schwer verdau...
    youtu.be



    3-Jahres-Rückblick Teil 2 von 3
    In den letzten drei Jahren hat sich viel getan - Zeit einmal Rückblick zu halten.Dies ist der zweite von drei Teilen, alles auf einmal wäre wohl schwer verda...
    youtu.be

  • Big pharma has no intention of developing drugs to fight Covid unless governments pony up research money. Why spend profits on development when governments pay the freight!!!


    Once-favored Covid drugs ineffective on Omicron may be putting millions at risk

    While antiviral pills are plentiful and remain an option for some with weak immune systems, they won’t work for everyone — Pfizer’s Paxlovid interacts with many widely prescribed drugs.

    Once-favored Covid drugs ineffective on Omicron may be putting millions at risk
    While antiviral pills are plentiful and remain an option for some with weak immune systems, they won’t work for everyone — Pfizer’s Paxlovid interacts with…
    www.politico.com


    The lack of specialized Covid-19 treatments for people with weak immune systems has left millions of Americans with limited options if they get sick as the pandemic heads into an uncertain winter.


    Once heralded as game-changers for Covid patients considered at risk for getting seriously ill — one was used to treat then-President Donald Trump in 2020 — monoclonal antibodies are now largely ineffective against current Covid variants. Easier-to-administer antiviral drugs, such as Paxlovid, have largely taken their place but aren’t safe for all immune-compromised people because they interact with many other drugs.

    But the federal government funding that drove drug development in the early days of the pandemic has dried up, and lawmakers have rebuffed the Biden administration’s pleas for more. Without that, there’s little incentive for drugmakers to work on new antibody treatments that could be more effective.

  • Mainstream Media Reporting on Vaccine Injury Scandal Under Biden Admin: Claims Skyrocket & Government Won’t Resolve for Decades

    Mainstream Media Reporting on Vaccine Injury Scandal Under Biden Admin: Claims Skyrocket & Government Won’t Resolve for Decades
    At the current glacial pace that the U.S. government’s Countermeasures Injury Compensation Program (CICP) is moving, it will take literally decades to…
    www.trialsitenews.com


    At the current glacial pace that the U.S. government’s Countermeasures Injury Compensation Program (CICP) is moving, it will take literally decades to help compensate for the COVID-19 vaccine injury. That’s an assessment not from some right-leaning vaccine-critical website, but a piece from Reuters. This recent Reuters entry demonstrates that the mass media, starting with the UK-based outfit, is moving to report on the scandal that is the COVID-19 vaccine injured in America. Under the Biden administration, an accumulating roll of injury claims are sent to a tribunal that has eight full time people. This, despite 80% of the 332 million U.S. population having received at least one dose of COVID-19 vaccine. Elected officials demonstrate their priority by their budgets. While countless billions of dollars have gone into promoting mass vaccination, little to no real investment nor material actions were taken to take care of the injured; but all corporate interests involved in the COVID vaccination program—from the manufacturers and contractors to health care systems that naturally might make mistakes in the vaccination process along the way are completely shielded from any liability by the U.S. government under the Public Readiness and Emergency Preparedness Act. Reuters is likely just the start, as more of the mainstream will start reporting on this scandal. The U.S. government has only processed 12 COVID-19 vaccine injuries in the first two years since 80% of the population has been vaccinated. With an accumulating backlog of 7,500 (and that figure to grow much higher), the Biden administration assigned 8 full time staffers for this “herculean” endeavor.


    With over 7,500 people now on the list for claims, that number grew from 2,300 just last year, reports Jenna Greene writing for one of the largest media organizations in the world. Reuters’ Ms. Greene emphasized that this gargantuan backlog representing a “staggering workload” of claims is clearly burying alive this tiny, understaffed, and underfunded government tribunal charged with adjudicating the petitions. Before the COVID-19 pandemic in 2020, the CICP had resolved less than 500 cases during its entire history.


    See the backlog which includes many deaths. Ms. Greene is very careful with her language so as to not be labeled an “anti-vaxxer.” In fact, she even declares for the record, “To be clear, I don’t come at this from an anti-vax perspective.” The Reuters writer reminds the reader that “Evidence abounds that COVID vaccines have prevented millions of hospitalizations and deaths.” However, signaling a change in the mass media, she continued, “But it is inevitable that if you give something—anything—to 265 million people, at least a handful will have adverse reactions.”


    TrialSite has chronicled this situation carefully and estimates the number of vaccines injured could be at 1% of the total number of vaccinations, which would put the total figure across the United States at over 2 million injured—it may be less or it could even be a higher figure. But it is more than “a handful.”


    How can an underfunded tiny tribunal deal with this accumulating backlog of injury claims? And note, the list of 7,500 is likely to grow far higher. A CICO spokesperson informed Ms. Greene at Reuters, “We are actively bringing on additional administrative staff and claims reviewers to process these claims as quickly as possible.”


    Indicating the mainstream media is coming in to investigate the COVID-19 vaccine injured situation, Reuters reviewed budget documents showing that CICP’s “herculean” goal looks nearly impossible, given they had just eight full-time employees last year according to the government budget.


    The Biden administration and Congress are showing their true colors in a very unfortunate way. Priority of power is reflected by the budget. While billions in the aggregate flowed into the largest mass vaccination campaign in history, next to nothing went into helping those injured. If this isn’t a glaring example of priority, we can’t think of a clearer example.


    Ms. Greene reminds all that all liability from Pfizer, Moderna, the health systems, and other suppliers are completely shielded via the Public Readiness and Emergency Preparedness Act meaning all claims go as “no-fault” to CICP. TrialSite has discussed this situation for a couple years now.


    What is the CICP record thus far in adjudicating claims?

    Not surprisingly, bad. To date, Reuters reports the CICP has approved only 12 COVID-19 vaccine injury claims (dollar amounts to be determined) since the first emergency use authorization made the vaccines available in mid-December 2020. Ten of those 12 are for myocarditis injuries, one is for pericarditis, and another for anaphylaxis, writes Ms. Greene. 68 claims were denied, but there’s no explanation as to the rationale for this decision. Reuters’ Ms. Green aptly declares, “The rest—7,544 by my calculations—remain in limbo.”


    Greene elicited an important quote from Renee Gentry, director of the Vaccine Injury Litigation Clinic at the George Washington University Law School—follow the link to read.


    Also, a vaccine injured person’s story is introduced. Contracting Guillain-Barré syndrome from the Johnson and Johnson COVID-19 vaccine, a 60-year-old Virginia man, William Phillips, has been informed the tribunal will take at least a half year to validate his claim.


    Greene reports that trial lawyers, academics, and even Pfizer support moving the vaccine injury cases from the CICP to the National Vaccine Injury Compensation Program (VICP), which at least is designed to manage more injury cases. VICP is also underfunded, not surprisingly, and in dire need of modernization.


    Why is Pfizer behind more expeditious injury adjudication? Sharon Castillo, who heads up communications, told Reuters the company understands that this could “bolster public confidence in vaccines by ensuring access to a reliable, permanent, and more efficient compensation program.” Moderna failed to respond to Reuters’ request to talk.


    TrialSite commends Reuters and Ms. Greene as one of the first of the big corporate mainstream media to come forth and start exposing this situation less the propaganda. Check out the article.

    COVID vaccine injury claims in 2022 were stuck in limbo. What's next?

    COVID vaccine injury claims in 2022 were stuck in limbo. What's next?
    Just over a year ago, the backlog of claims by people who allege they’ve been injured from the COVID-19 vaccine stood at nearly 2,300 – a staggering workload…
    www.reuters.com

  • ...and part 3....


    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.

  • COVID-19’s Genetic Secrets Revealed: HIV Sequences “Added,” Said Now Deceased Nobel Virologist

    COVID-19’s Genetic Secrets Revealed: HIV Sequences “Added,” Said Now Deceased Nobel Virologist
    The presence of HIV genetic material in the original SARS-CoV-2 genome could indicate, according to some labeled by the mainstream as conspiratorial-minded,…
    www.trialsitenews.com


    The presence of HIV genetic material in the original SARS-CoV-2 genome could indicate, according to some labeled by the mainstream as conspiratorial-minded, that the virus was being developed into an HIV vaccine, according to French Nobel Prize winner, the late Professor Luc Montagnier. His voice joins that of other scientists who believe the pandemic originated in a lab. Montagnier described the virus as “recombinant” and warned that scientists should obey the ethical rules of research to prevent future pandemics. The interview was published on last year, and Professor Montagnier passed away less than two weeks after the interview strangely enough, on February 8, 2022.


    In an interview with C-News, Professor Luc Montagnier, renowned virologist and 2008 Nobel Laureate in Medicine, explained that his research team’s examination of the SARS-CoV-2 virus genome concludes that the virus was in fact “manipulated”. As well as the classic pattern of a coronavirus, closely related to those seen in bats, the team identified genetic sequences “that someone added” – including sequences from HIV, the virus that the professor helped discover and has studied closely for most of his career.

    Luc Montagnier HIV Nobel Prize Winner Says Virus "Bio-engineered" in Lab
    Original Video Date: 17 April 2020 2008 Nobel Prize winner Luc Montagnier says that COVID-19 coronavirus disease was artificially created in a lab by…
    rumble.com

    Montagnier’s findings were published in July 2020, in a paper in which he and his co-author, Jean-Claude Perez, outlined a hypothesis that the COVID-19 genome was “partially synthetic”. In the paper, they describe 16 fragments within the genome that appear to have been derived from HIV-1, HIV-2, and related viruses, as well as one related to Plasmodium yoelii, a malaria parasite.

    COVID-19, SARS AND BATS CORONAVIRUSES GENOMES PECULIAR HOMOLOGOUS RNA SEQUENCES | International Journal of Research -GRANTHAALAYAH

    The authors also noted that 12 of these elements were located in two of the COVID-19 genes: the ORF1ab gene, which produces non-structural proteins related to viral replication and processing; and the S spike gene, which encodes the surface spike protein of the coronavirus that enables it to enter cells. Changes to the genetic code of these functional genes could change the proteins that are produced when the virus infects a cell.


    A Potential Vaccine Gone Wrong

    When asked who had made these additions, the Nobel Prize winner responded that he did not know, but the insertion of multiple short sequences of HIV code within the chain of 30,000 coronavirus RNA nucleotides ruled out natural mutation or combination. He described it as a “meticulous job,” the work of a professional molecular biologist.


    Montagnier also elected not to speculate on the purpose of adding these sequences to the coronavirus, stating that his role was to expose the facts, not to accuse anyone. He did, however, allude to the fact that inserting sequences from a virus such as HIV into the coronavirus may have occurred in the process of trying to develop a vaccine against HIV itself, and stated that the evidence did not support a theory of the viruses being combined for military purposes which would help neutralize a rampant accusation of some conspiracy theorists.


    Discussing the potential consequences of these findings, Montagnier clarified that there was not enough HIV material in the SARS-CoV-2 genome to create an entire HIV protein, but there would be enough to create a partial protein or antigen. He said that it would be interesting to study whether people recovering from COVID-19 infection have also made antibodies against one of these HIV proteins.


    The professor also explained that as the COVID-19 virus has mutated, the HIV sequences have been almost entirely removed. He explained that this would be expected from artificial insertions, as the HIV sequences don’t benefit the virus and evolution favors changes that improve the fitness of the virus. “Nature loves harmony,” Montagnier said.


    A Cover Up?

    When asked whether this was related to the rumor that COVID-19 was created in a lab, which was then written off by the authorities, Montagnier replied that there has been an effort to “cover-up” the findings. He made reference to an Indian research group that had also published similar conclusions but was “forced” to withdraw their publication. TrialSite has reported that the intelligence community is split on the origin theories—lab leak vs. zoonotic. Despite investigations, no source has been identified to date.


    The paper in question is still available on the bioRxiv preprint server, in which Pradhan et al. not only identified four HIV-1 sequences in the SARS-CoV-2 spike gene but also modeled that these four sections of the resulting protein would come together during the folding process, to form a receptor binding site. Of course, the scientific community hasn’t peer reviewed this output yet, thus the artifact carries little weight for citation purposes.

    Uncanny similarity of unique inserts in the 2019-nCoV spike protein to HIV-1 gp120 and Gag
    We are currently witnessing a major epidemic caused by the 2019 novel coronavirus (2019-nCoV). The evolution of 2019-nCoV remains elusive. We found 4…
    www.biorxiv.org

    The official DOI page for the paper states that the authors wish to review their manuscript in response to feedback related to their technique and interpretations.


    Montagnier also mentioned other groups doing similar work but staying under the radar. Montagnier felt that because of his age and status as a Nobel Prize winner, he was able to work freely and was not subject to the same pressures.


    What about Vaccines?

    The presence of manipulated genes in the SARS-CoV-2 genome raises concerns about the consequences for COVID-19 vaccines, especially as many of the flagged regions are located in the spike gene which was used for the vaccines.


    While not discussed in the C-News interview, Montagnier’s views against COVID-19 vaccination are well documented. He highlighted the role of vaccination in providing evolutionary pressure on the virus and promoting new variants, as well as the role of Antibody-Dependent Enhancement (ADE) in causing worsening symptoms. He described the global vaccination protocol as an “unacceptable mistake.”


    TrialSite previously reported on Montagnier and Perez’s work that identified a prion region in SARS-CoV-2 spike proteins. The authors raised concern that prion disease from the vaccination may affect “millions of children” who have received vaccinations based on the spike gene.


    All the COVID-19 vaccines in use are based on either the full COVID-19 spike protein (in the case of protein-based, inactivated, or subunit vaccines) or the genetic code of the spike protein (in the case of mRNA vaccines and adenovirus vector vaccines) that allows the person’s cells to produce the spike protein on its own. While updated vaccines contain components based on more recent variants, they all contain material based on the original genome that Montagnier studied.


    As a result, Montagnier’s findings imply that people who have received COVID-19 vaccines could potentially have been exposed to these manipulated proteins. There are already several unknowns about the spike protein produced in the human body, in the absence of other viral factors that would usually play a role in its formation; the additional variable related to these genetic insertions further clouds the picture.


    In August 2022, researchers from Weill Cornell found that mRNA COVID-19 vaccines stimulate the production of HIV RNA in latently-infected cells, with the Pfizer vaccine producing a stronger effect than the Moderna one. In their paper, published in Nature, the researchers conclude that the vaccines reactivated latent HIV in the cells. Unlike other reactivating agents, the mRNA COVID-19 vaccines did not stimulate the body’s immune response against HIV. They also reported that they “did not observe significant depletions of intact proviruses,” suggesting that the cells were not producing entire HIV genomes as would normally be expected in reactivation.


    In light of the potential that the COVID-19 vaccines contain sections of HIV code, the question arises whether the HIV RNA detected in the study originated from the infected cells or the vaccine. While the study included a negative control in the form of influenza vaccine being applied to HIV-latent cells, the use of COVID-19 vaccines on non-HIV cells was not reported. A direct comparison of the RNA sequences would help shed some light on this possibility.


    Final Thoughts

    Montagnier said in conclusion, that the origin of the COVID-19 virus, although interesting, is not the central concern. The bigger question is “what will happen to all of us?” He expressed hope that the virus would destroy itself through mutation and said the pandemic had highlighted a need to respect the ethical rules of research. This doesn’t sound like the ramblings of a deranged anti-vaxxer, but rather a concerned Nobel Prize winning scientist proposing possible alternative hypothesis that should be discussed and debated where and when relevant. Rest in peace, Luc Montagnier.

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.