Covid-19 News

    Quote from Alan Smith

    THIS BOT IS TO PROPOSE TO THE FORUM TEAM THAT WE CLOSE THIS THREAD AS BEING DETRIMENTAL TO THE FORUM, SINCE SOME MEMBERS (THEY KNOW WHO THEY ARE) ARE USING IT TO ABUSE OTHERS.

    I blocked the everyones-a-criminal-mafia-W-guy (first time I've blocked anyone on any forum in almost 25 years) .. and now find this thread pleasant and informative. Keep.

    Quote from AlainCo

    https://www.sciencedaily.com/r…/2021/07/210706180911.htm

    People who receive mRNA COVID-19 vaccines are up to 91 percent less likely to develop the disease than those who are unvaccinated, according to a new nationwide study of eight sites, including Salt Lake City. For those few vaccinated people who do still get an infection, or "breakthrough" cases, the study suggests that vaccines reduce the severity of COVID-19 symptoms and shorten its duration.


    Alain -


    Just a slight qualification. UK is now pretty well 100% delta variant - and US will get there pretty soon. All vaccine efficacy is less good against delta since they were originally designed for not even alpha and we have had quite a lot of change since then.


    Even so - the vaccine still perform well in terms of personal protection from serious disease. You want your family to take them (except possibly those under 18 (14? I've not checked exact figures) where personal risk/benefit looks less clear.


    Figures from whole population testing against delta: 64 % effective against infection (but many infections are asymptomatic). > 90% effective against serious disease. (That means more than 10X less likely to get it than if unvaccinated).


    They do help reduce spread - but they maybe will not eliminate it. In the UK with 60% double vaccinated we are still getting massive spread. You need much higher vaccination rates and given we are not likely to vaccinate children i think the strategy is to let all the young people develop herd immunity from catching it. After which infection rates should reduce a lot. Till then infection rates will go very high.


    High risk to be older than 30 not not vaccinated though, because you can reckon unless you are seriously self-isolating all those unvaccinated will catch it over the next 6 months. That applies to UK and US. I guess serious self-isolation will remain possible in some low population country areas of US - but not in towns.


    You can argue that the best strategy is to get double-vaccinated and then deliberately catch delta - on the grounds that newer variants based on delta may escape the vaccine more than delta. But I'm not sure I am brave enough to do that.


    This also means that the risk comparison for all your family is quite simple. Are the vaccine risks higher or lower than the risks of catching COVID? Since you can reckon almost everyone unvaccinated will catch it some time.


    I would factor in, for COVID, the fact that its interference with the immune system affects the whole body and long COVID exists and seems to run at a rate 5X mortality. But don't quote me on that figure - it is not easy to define long COVID and it has not been studied that much yet, so any guesses about how bad it is, or how it varies with age, are preliminary.

    Dr. Hill Et al. Meta Analysis Evidences the Promise of Ivermectin: But More Studies Necessary


    https://trialsitenews.com/dr-h…t-more-studies-necessary/


    At the end of 2020, TrialSite reported that Dr. Andrew Hill was conducting a meta-analysis of ivermectin, sponsored by Unitaid, an organization affiliated with the World Health Organization (WHO). In fact, weeks later, Dr. Hill accompanied Dr. Pierre Kory with the Front Line COVID-19 Critical Care Alliance to present to the National Institute of Health (NIH) COVID-19 Treatment Guidelines Panel. An internationally influential investigator, Hill’s ivermectin meta-analysis had ivermectin proponents on an emotional roller coast, first with anticipation that a WHO meeting would use the inputs to declare an emergency use authorization, and then with grief that his findings suggested more research. But Dr. Hill’s paper was published recently in the Oxford Academic Open Forum Infectious Disease Journal. Hill’s results for the anti-parasite medication are impressive. They report a 56% reduction in mortality (Relative Risk 0.44 [95%CI 0.25-0.77]; p=0.004; 35/1064 (3%) deaths on ivermectin; 93/1063 (9%) deaths in controls) with favorable clinical recovery and reduced hospitalization. Seems inconceivable that those statistically significant results don’t lead to a more favorable conclusion. But, of course, a substantial number of the underlying studies weren’t peer-reviewed; the standard academic research center protocol forces the need for more clinical trials. This despite the fact that tens of billions spent thus far in the U.S. alone since the pandemic onset, not one early-stage treatment for COVID-19 has been approved, while the death toll from this pandemic mounts. Over 4 million have passed worldwide since the pandemic’s onset, and to this day, nearly 8,000 lose their life on a daily basis as of this writing. TrialSite contends that the market for early-onset, mild-to-moderate SARS-CoV-2 infection is sizable—Blockbuster size. After all, about 90% of the cases fall into this category, and a safe and effective treatment here would be a game-changer.


    A Dire Crisis

    The authors emphasize right up front the importance of treatment for the coronavirus known as SARS-CoV-2—COVID-19. With over 350,000 new infections and north of 7,000 fatalities per day, protective vaccines, while developed and seemingly effective and safe, are in abundance in places like America (vaccine hesitancy grows and becomes a real problem riveting health authorities) while in most low-and middle-income countries (LMICs), vaccine doses typically go to the rich and powerful first. As Hill et al. appropriately note, “…current supplies are too low to cover worldwide demand in the coming months.” Thus investigators are on the hunt for appropriate “interventions to prevent new infections, or prevent disease progression, and lessen disease severity for those already infected.”


    Critical Undercurrents

    TrialSite raises attention to the reader one point on vaccine hesitancy. It’s worse than many know. In Russia, which is going through its worst wave of the pandemic, only about 13% of the population has been fully inoculated. While the country has four vaccines to choose from, a majority of the people don’t trust the safety profile. In the United States, it’s a little better with 37.5% fully vaccinated. Huge swathes of the country are vaccine resistant, and the popular press would have it that they are all simply a bunch of right-wing loons or uneducated trailer trash, that have lost their way due to Russian or some other misinformation. But there is more to that story, and TrialSite will be one of the few places to read about it.


    The Ivermectin Conundrum

    One could make a strong case that these results, combined with the meta-analyses from the FLCCC and the BIRD Group, could justify health authorities in declaring emergency use authorization. And in fact, that has occurred in some nations. From Indonesia to Slovakia to Zimbabwe to even South Africa (via court), health authorities have accepted the drug in select scenarios during the pandemic. But as TrialSite has sounded to the world, many other treatments that have demonstrated some promise in studies are also routinely ignored, from Calcifediol or oral Vitamin D if given at symptom onset to statins, Fluvoxamine, melatonin, and others. Why? This will be discussed toward the end but suffice that evidence mounts for a strong pharmaceutical industry bias across drug regulatory bodies, health authorities, and academic medical centers. TrialSite refers to this as “regulatory capture.”


    Brief Overview

    This particular meta-analysis, titled “Meta-analysis of randomized trials of ivermectin to treat SARS-CoV-2 infection,” was funded by the Rainwater Foundation and launched by Richard E. Rainwater, a Fort Worth, Texas billionaire now deceased.


    In the study, the authors investigated 24 randomized controlled trials with a total of 3328 participants. Ranging from 24 to 400 participants per trial, eight of the studies were published, while nine were available via preprint, six went unpublished while one study’s findings were reported on a trial registry website. Nine of the studies’ protocols called for ivermectin administration as a single dose, while 15 trials designs called for multi-day dosing for up to seven days; four of these were dose-ranging. The majority of these trials investigated the use of the drug in mild-to-moderate SARS-CoV-2.


    The authors employed the Cochrane Collaboration tool as a means to identify and evaluate bias risk across their final outcomes, which included the following primary endpoints: viral load, and survival. Thus, in evaluating for primary outcome assessment, the authors shared that 6 out of the 24 (25%) such studies were assessed with a high risk of bias. The authors note that with more “objective outcomes,” e.g. viral load and mortality, “the number of high-risk studies was lower.” Based on their PCR assessment, studies deemed high risk included 3 out of 15 (20%) while in a survival assessment only 1 of the 11 (9%) were deemed high risk.


    Summary

    The authors concluded that the antiparasitic drug demonstrates in-vitro activity against SARS-CoV-2 at high concentrations. After a thorough review of 24 randomized controlled trials, including 3328 patents—found via a number of data sources such as PUBMED, EMBASE, MedRxiv and trial registries—the authors found that the generic, repurposed drug was in fact associated with lower inflammatory markers, accelerated viral clearance as measured by PCR. Furthermore, in probing the study data, they further found that treatment dose as well as duration correlated with viral clearance.


    The drug performed well in studies where it was administered to moderate-to-severe infected SARS-CoV-2 patients. In fact, Hill et al. report a 56% reduction in mortality (Relative Risk 0.44 [95% CI 0.25-0.77]; p=0.004; 35/1064 (3%) deaths on ivermectin; 93/1063 (9%) deaths in controls) inclusive of “favorable clinical recovery and reduced hospitalization.”


    As the world’s medical authorities seek peer-reviewed data, the fact that a number of the studies lacked that particularly important status led in part to the recommendation that more evidence is needed, despite the pandemic conditions. Thus, they report in the summary, “A network of large clinical trials is in progress to validate the results seen to date.”


    What about Safety?

    A convergence of industry, regulatory body and quasi-government health authority concerned about growing uncontrolled use of ivermectin issued a series of cautionary proclamations. Merck, an American pharmaceutical company, issued a press release declaring the drug could be dangerous. Of course, what the company didn’t share was that firstly, it has given out billions of doses worldwide (part of its Mectizan program) with an impressive safety outcome to date. But secondly, with the support of a $356 million taxpayer cash injection, the company directly targeted the lucrative COVID-19 early-onset antiviral treatment space. In fact, this market as TrialSite has raised, could be worth anywhere from $3 to several billion per annum in revenue.


    The drug’s discovery led to the winning of the Nobel Prize for its contribution, and in this meta-analysis, Dr Hill et. all share that “at standard doses, of 0.2-0.4mg/kg for 1-2 days, ivermectin has a good safety profile and has been distributed to billions of patients worldwide in mass drug administration programs.”


    Based on the underlying studies with higher ivermectin doses, up to 2 mg/lg, and those receiving longer courses—up to 4 days compared to those receiving standard doses, this safety track record prevailed. The authors note that the drug is not licensed for pregnant or breastfeeding women, or children.


    Care Now vs. the Long Game

    A deep chasm emerged among generally pro-ivermectin researchers, including 1) the pragmatic caregivers and 2) the long-game players. Those in the first category believe that at this stage, it is unethical to not declare emergency use authorization concerning ivermectin, given the totality of evidence already in hand. They argue it’s unconscionable that treatment isn’t encouraged earlier on. And that public health agencies are culpable.


    The long-gamers seek more plug-in-and-play in the medical authority establishment, supporting and conducting as many studies as necessary to drive the acceptance over the finish line. The former tend to be practicing physicians, often in the field understanding the need for care now while the latter may operate in academia more often than not. Both are well-intentioned and seek only that low-cost, effective, and safe drugs make it to the patient. They both need each other but will the system tear them apart?


    What’s Up on Social Media?

    Dr. Hill tweeted for the world that the meta-analysis made it to the publisher! Noting the milestone, the author declared, “There are much larger clinical trials now in progress, including over 32,000 patients. Randomized clinical trials must be continued.”


    Interestingly, hours preceding the meta-analysis tweet, Dr. Hill timed a vaccine article from Bloomberg titled, “When Lifesaving Vaccines Become Profit Machines for Drugmakers,” an article indicating that for “middle-income countries, protection from the virus can cost governments dearly.” Hill informed the world, “Worldwide COVID-19 vaccination is essential to lower deaths, but at what price?


    Yes, it went on, “worldwide vaccine sales could exceed $100 billion in 2021. Moderna COVID vaccines sold for up to 10x estimated cost price. Huge government grants for R&D and approval.” This could seem shocking to some civilized people but this kind of profiteering is actually celebrated in boardrooms and popular media generally. In some ways, the ivermectin conundrum really is symbolic for more deeply rooted conflicting, and contradictory priority and interests, accentuated by a deadly pathogen.


    Lead Research/Investigator

    Andrew Hill, Department of Pharmacology and Therapeutics, University of Liverpool, Liverpool

    Anna Garratt, Department of Infectious Diseases, University Hospital of Wales, Cardiff and Vale University Health Board, UK

    Jacob Levi, Department of Intensive Care, University College London Hospital, ULCH NHS Trust, London

    Jonathan Falconer, Department of Infectious Diseases, Chelsea and Westminster Hospital, Imperial NHS Trust, London, UK

    Leah Ellis, Faculty of Medicine, Imperial College London, UK

    Kaitlyn McCann, Faculty of Medicine, Imperial College London, UK

    Victoria Pilkington, Oxford University Clinical Academic Graduate School, University of Oxford, UK

    Ambar Qavi, Faculty of Medicine, Imperial College London, UK

    Junzheng Wang, Faculty of Medicine, Imperial College London, UK

    Hannah Wentzel, Faculty of Medicine, Imperial College London, UK

    Call to Action: TrialSite is a platform for all to discuss these challenging societal issues. For most of history, drugs appear at the nexus of power and politics. Let us not forget what products drove, to a great extent, the development of the Americas—tobacco, rum, and coffee.

    The FDA Expanded Pfizer Vaccine EUA based on a Failed Trial


    https://trialsitenews.com/the-…-based-on-a-failed-trial/


    The EUA expansion1 for Pfizer BNT162b2 vaccine for kids aged 12–15 was done after it failed (as I will show below) its pro-forma clinical trial2.


    Abysmal Safety

    Only 1,131 kids received at least one injection of the experimental vaccine. Most of them experienced side effects. Within a few days after the second shot, 66% of the kids developed fatigue, 65% developed headaches, 42% developed chills, and so on. The first shot was tolerated only slightly better. Symptoms varied from mild to severe. More than half of the kids had to resort to painkillers or antipyretics after the second injection. Given such frequency and severity of adverse effects, the sponsor had to either stop the trial because of safety, or to significantly increase its size to exclude high likelihood of death. At the trial size, if the risk of immediate death were 1 per 1,000, the trial had only a 32% probability of missing it. We are lucky that this is not the case.


    From 1, Table 17. Frequency of Solicited Systemic Adverse Events Within 7 Days After Each Dose, by Maximum Severity, Participants 12 Through 15


    Event BNT162b2 Dose 1, N=1127 n (%) BNT162b2Dose 2, N=1097n (%)

    Fatigue, any 677 (60.1) 726 (66.2)

    Fatigue moderate or severe 399 (35.4) 494 (45.1)

    Headache, any 623 (55.3) 708 (64.5)

    Headache moderate or severe 262 (23.3) 406 (37.0)

    Chills 311 (27.6) 455 (41.5)

    Chills moderate or severe 116 (10.2) 234 (21.3)

    Fever (≥38.0°C) 114 (10.1) 215 (19.6)

    Muscle Pain 272 (24.1) 355 (32.4)

    Muscle Pain moderate or severe 147 (13.1) 203 (18.5)

    Joints Pain 109 ( 9.7) 173 (15.8)

    Joints Pain moderate or severe 43 ( 3.8) 82 ( 7.5)

    Efficacy was not Shown

    The media heralded 100% efficacy in COVID-19 prevention because 16 kids (1.5%) in the placebo group had putatively developed COVID-19 within 2 months after the second shot, while no kids in the experimental group had. The study reported no severe cases in the placebo group. At closer look at the definition of a case and the conduct of the trial, very mild disease or even a positive test associated with non-specific symptoms were counted as cases.


    “For the primary efficacy endpoint, the case definition for a confirmed COVID-19 case was the presence of at least one of the following symptoms and a positive SARS-CoV-2 NAAT within 4 days of the symptomatic period: • Fever; • New or increased cough; • New or increased shortness of breath; • Chills; • New or increased muscle pain; • New loss of taste or smell; • Sore throat; • Diarrhea; • Vomiting.”


    Add to this that the trial was in winter and the researchers solicited answers about COVID-19 symptoms, encouraging kids to keep e-diaries. Thus, a kid getting a sore throat or fever for any reason and a positive PCR test within four days of each other was counted as a case. Solicitation leads for excessive reporting of symptoms. We do not know how many of the “cases” would be more correctly classified as asymptomatic infection if not for symptoms solicitation. Also, only 1.5% of the placebo group has got adverse symptoms, compared with at least 90% in the vaccinated group. Where is efficacy?


    Further, “The efficacy analysis for the 12-to-15-year-old cohort was planned as a descriptive analysis because the number of cases that would occur in the age subgroups was unknown.” Thus, this trial was a fiction from the beginning—an excuse for the HHS to start injecting 12-year-olds.


    The conclusion: the COVID-19 vaccine FAILED in both safety and efficacy for 12–15-year-olds.


    Possible Errors in the Trial

    There are indications of other errors in the study. With the rate of treatment adverse effects close to 100%, maintaining placebo blinding was very unlikely. If a kid comes home after an injection with an unusual fatigue and headache, what parent would believe he had received placebo?


    An interesting detail is that, within the first 2 months after the 2nd shot, 1.5% of the placebo group had a COVID-19 case, but only 0.3% had it within the next 2+ months. This is not necessarily an indication of foul play. It is another demonstration of uselessness of COVID-19 vaccination for kids.


    The way in which PCR testing was used in the trial raises additional questions. COVID-19 PCR tests are notorious for their inaccuracy and ease of manipulation, including by selecting the amplification cycles number. The Supplemental Appendix2 says:


    “The central laboratory NAAT [nucleic acid amplification test] result was used for the case definition. If no result was available from the central laboratory, a local NAAT result could be used if it was obtained using either the Cepheid Xpert Xpress SARS-CoV-2, Roche cobas SARS-CoV-2 real-time RT-PCR test, or the Abbott Molecular/RealTime SARS-CoV-2 assay.”


    This sounds like an open door for cherry-picking testing facilities on case-by-case basis.


    Legal Aspects

    Now this study is used to coerce and/or trick kids and young adults into getting vaccinated against COVID-19. Luckily, we have a legal recourse. Government-sponsored medical procedures require informed consent of the patients – see In re Cincinnati Radiation Litigation, 874 F. Supp. 796 – Dist. Court, SD Ohio 1995. Otherwise, they violate the due process clauses of the XIV and V Amendments. Deceit (including denying futility of COVID-19 vaccines for 12–15-year-olds, denying effectiveness of ivermectin for COVID-19 treatment and prophylaxis, or failure to disclose the risk of future ADE) and coercion (including blocking access to ivermectin and hydroxychloroquine) invalidate the apparent consent. For minors, consent of the parents is also mandatory. Medical procedures that involve no more than trivial risk might be an exception, but COVID-19 vaccines are certainly not such a case.


    The vaccination of the young people is not just government-sponsored, but almost entirely conducted by the government. The government cannot bypass the Constitution by relying on the opinion of the FDA, which is itself a government agency. Truth matters.


    The cherry on top of the cake: government officials carry personal responsibility for their actions in violation of this principle. They cannot assert qualified immunity.


    Reference

    1. FDA re-Amendment. Pfizer-BioNTech COVID-19 Vaccine EUA Amendment Review Memorandum 05262021. Published online May 10, 2021.


    2. Robert W. Frenck J, Klein NP, Kitchin N, et al. Safety, Immunogenicity, and Efficacy of the BNT162b2 Covid-19 Vaccine in Adolescents. New England Journal of Medicine. Published online May 27, 2021. doi:10.1056/NEJMoa2107456

    Israel Study Reveals mRNA-based Vaccine Loses Efficacy Against Delta VoC while Indian Study Indicates Looming Troubles with Delta


    https://trialsitenews.com/isra…ming-troubles-with-delta/


    Emerging delta variant data points indicate the growing risk associated with this evolving COVID-19-triggered pandemic as many nations’ cases count wane while others rise. But where this new variant of concern (VoC) shows up, trouble brews. TrialSite reported recently on the growing crisis associated with Russia’s third wave of the pandemic, powered by delta variant while the Health Ministry reported in Israel yesterday that the delta variant has cut the Pfizer-BioNTech’s vaccine’s strength by 64% in preventing infection. The most vaccinated nation, 62.4% of the population have at least one jab while 57.2% have been fully inoculated, trouble looms with spreading delta variant and a drop in mRNA vaccine effectiveness from 91.2% in preventing infection down to 64%. While the ministry reports the vaccine is still 93% at preventing more severe disease (e.g. hospitalization), the dramatic drop in vaccine efficacy concerns the Health Ministry. Officials received the data on Sunday indicating the exposure to the Israeli population to a potential third wave of the pandemic. But others there question the models used by health professionals, especially when COVID-19 tests are performed selectively. TrialSite also updates the Community on a troubling study in India, evidencing a growing problem with Delta variant. Vaccine hesitancy goes deeper in India than more recently political, government, or health system leadership may care to admit.


    Yesterday, Ido Efrati writing for Israeli online media Haaretz summarized the various unfolding point of view there. Until now, the latest research pointed out in Lancet that the Pfizer-BioNTech vaccine was 88% effective against the delta variant, just nominally lower than the 93% for the alpha variant. Based on the unfolding situation in Israel, Haaretz declared the delta variant is 1.5 times more contagious than the alpha and 2X more infectious than the original virus out of Wuhan, China.


    ‘Miles to go before one can Sleep in India’


    In the meantime, a recent study in India also raises concern about the delta variant as a recent three-site study involved over 100 healthcare workers and found that the delta variant 1) “dominates vaccine-breakthrough infections with higher respiratory viral loads compared to non-delta infection,s” and 2) “…generates greater transmission among the fully vaccinated healthcare workers.”


    Titled “SARS-CoV-2 B.1.617.2 Delta Variant Emergence and Vaccine Breakthrough: Collaborative Study,” the study included Indian principal investigators from Sir Ganga Ram Hospital, among others, and scientists from Cambridge Institute of Therapeutic Immunology and Infectious Disease. The study has yet to be peer-reviewed.


    Published in the online media HealthWorld, the large collaborative study revealed that the delta variant is about “eight-fold less sensitive to vaccine-elicited antibodies compared to Wuhan-1.” The study team concluded that delta is in fact “more transmissible and better able to evade prior immunity elicited by the previous infection, compared to previously circulating lineages.”


    Co-investigator Point of View

    Dr. Chand Wattal, chairperson of the Institute of Clinical Microbiology and Immunology, SGRH, and a co-investor was quoted on the findings: “From this study it appears that we have miles to go before we sleep in case of Covid-19 pandemics. These mutations are bound to happen if we lower our guard and allow ourselves to fall prey to this virus, giving it an opportunity to multiply.” Talking directly to vaccinated persons, the investigator declared, “This is a straight eye-opener to the fully vaccinated people that you cannot lower guard in the name of vaccination. The virus is on the prowl, still looking for its prey.”


    Vigilance in India—Controls to Stay

    While the third wave has waned, the world’s second-largest population is on edge. While fully vaccinated healthcare workers are still far more protected from severe disease, “breakthrough transmission clusters in hospitals associated with the delta variant are concerning and indicate that infection control measures need to continue in the post-vaccination era.”


    Vaccine Hesitancy in India

    While 21% of the country’s approximately 1.4 billion people have received one dose of a COVID vaccine, only about 4.7% are fully vaccinated despite the fact that three vaccines are authorized with a fourth (Sputnik) on the way—more on that below.


    One common mainstream media point of view in India is that most vaccine hesitancy among the educated classes really comes down to sophisticated misinformation. They share that the educated elite of India have a “poor grasp of science, an abundance of half-baked knowledge—much of it now easily available on the internet.” This, argues Science: The Wire, leads to “an impaired ability to critically analyze the available information.”


    Thus a number of assumptions emerge such as vaccines require at least four to ten years to develop, etc. Undoubtedly, there are cases like this but such a line of argument could also be insulting to many smart people with other critical concerns.


    Regardless, there is a great mistrust of vaccines in this country that hasn’t been overcome by a combination of government, health systems, and mainstream press publishing and promoting continuous positive educational messaging about the vaccines. Health leaders face a confluence of resistance forces, including among at least some of the more educated classes, a recent memory based on the legacy of clinical research experimentation here that led to major Supreme Court actions against the pharmaceutical industry. Thus, on the one hand, at least some in the educated classes have their healthy skepticism while, on the other end of the socio-economic spectrum, tribal classes circulate a number of rumors, conspiracy theories, and the like, dominating the discourse and leading to very low vaccine acceptance rates.


    Ethical Violations in Research

    TrialSite turns its attention for a moment to mistrust among pharmaceutical companies, investigational sites, and health systems more generally. While the mainstream press doesn’t touch this subject—perhaps for fear of losing advertising dollars or ticking off the government—one factor in India, especially among more educated classes, is the Supreme Court rulings against the drug industry’s clinical trials.


    Back in about 2010 to 2013, the popular media here often chronicled problems with clinical trials, with a frequent narrative that drug sponsors and investigational trial sites were using subjects, especially poor lower caste ones, as human guinea pigs. Trials plummeted due to a combination of media attention and public discourse.


    Not well known in North America or Europe, a famous Indian Supreme Court case Swasthya Adhikar Manch v. Union of India led to various government reforms to make clinical trials more ethical. While this chapter in recent Indian research history isn’t mentioned publicly, the legacy of some of those data points are buried in the subconscious of many a critical thinker. And yes, there’s a lot of crap on the internet that is most certainly classified as misinformation.


    Combine all of these societal forces and regardless of point of view, from buying into some half-baked idea to residual ethical concerns from previous clinical trials scandals to primordial fears in tribal castes, the overall trust level in pharmaceutical company vaccines at this point is still low.

    I agree with some of this analysis, and the overall conclusion, from the (highly opinionated and unreliable) trialsite.


    But note the inconsistency. They say that anti-vital activity correlates with dosage - e.g. you need high doses. Then, they cite as a safety indicator that standard doses are safe and have been widely distributed.


    The question for Ivermectin, as with all drugs, is can we find a dosing regime where the benefits outweigh the risks. I agree there is enough evidence for further trials and some interest, not that we should conclude this is a wonder-drug or start self-dosing (though frankly what other people do must be their business - we each make decisions for ourselves).

    Quote from Wyttenbach

    https://covid19criticalcare.co…v7_EF_letterhead_ML-1.pdf


    How Oxford produces big pharma FUD.

    Which reviewer was asleep at the wheel on the Roman study...?

    If we look at the bio's of the board there are a few illustrious institutions..

    Universities of California...Arizona Washington Alabama,,,

    Duke ..Vanderbilt Emery.. OUP is much more than O..

    I might write to the Aussie...alerting him before the car crash..

    https://academic.oup.com/cid/pages/Editorial_Board


    "It is inexplicable for the authors to have disregarded multiple public notices of substantive errors whilst on preprint. In failing to correct, the authors verge upon falsification of data.

    In the Journal’s statement of Publication Ethics this is deemed “unacceptable”.

    Most of the misreporting instances are conveniently collected on“PUBPEER”3 by various contributors.


    https://pubpeer.com/publicatio…8F3D4D39742CFFA8C1B023AA3


    All these errors make material differences. It is not sufficient to claim that the errors are
    minor and do not affect the conclusions. They do. Moreover, most were readily available to
    Reviewers exercising due diligence, simply by consulting the Comments in medRxiv..."

    Quote from THHuxleynew

    I agree with some of this analysis, and the overall conclusion, from the (highly opinionated and unreliable) trialsite.


    But note the inconsistency. They say that anti-vital activity correlates with dosage - e.g. you need high doses. Then, they cite as a safety indicator that standard doses are safe and have been widely distributed.


    The question for Ivermectin, as with all drugs, is can we find a dosing regime where the benefits outweigh the risks. I agree there is enough evidence for further trials and some interest, not that we should conclude this is a wonder-drug or start self-dosing (though frankly what other people do must be their business - we each make decisions for ourselves).

    Just who considers Trial site unreliable, or is that your opinion?


    https://www.businesswire.com/n…ical-Trials-to-the-Region


    Founded in late 2018, TrialSite has rapidly emerged as a globally-recognized independent and unbiased news and information platform supporting research sites, sponsors, and healthcare providers with timely information on a daily basis. TrialSite’s principals, including Daniel O’Connor, have extensive experience and expertise in developing technology and innovative solutions in support of robust clinical trial programs. Mr. O’Connor noted on this important partnership, “it’s been a real pleasure to collaborate with the MCA team to help contribute to their clinical research programs.” O’Connor continued, “If the MCA keeps up at this pace, El Paso will emerge as a major hub for diversification in clinical research, specifically engaging the Hispanic community.”

    The delta variant cometh..scientists brace for impact.....

    Martenson ..

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    Ivermectin is taboo but swapping poop is acceptable :rolleyes:


    Poop Transplants Have Been Linked to Improved COVID-19 in Two Patients in Poland


    https://www.sciencealert.com/t…d-symptoms-got-better/amp


    Scientists will soon begin proper clinical trials to see if poop transplants really can help people recover from COVID-19.

    The decision was spurred on by curious results from two recent hospital patients in Poland - an 80-year-old man with pneumonia, and an immunosuppressed 19-year-old man - who both received fecal transplants for severe C. difficile infections.

    Unbeknownst at the time, these patients also had COVID-19. Its symptoms began to show up shortly after the two received their poop transplant, and yet even though both individuals were particularly vulnerable to SARS-CoV-2, their cases were only mild and their fevers cleared up within just a couple days.

    There's no way to know how either would have coped without the poop transplant, so it's hard to pin down their fast recovery to any one source. That said, the coincidence is intriguing enough for scientists to investigate further.

    After all, this isn't the first time experts have proposed using poop transplants to treat COVID-19. A person's gut microbiota is closely linked to their immune system, and COVID-19 can cause distinct disturbances in the gastrointestinal tract.

    Some other initial reports suggest poop transplants can somewhat restore the balance of gut bacteria after COVID-19, but nobody has yet done any hard investigations on whether the treatment is useful clinically or even safe.

    Poop transplants are carefully screened for infections when used as treatment, but there's always the chance some dangerous pathogen sneaks through, and in a global pandemic that prospect is even riskier.

    Nevertheless, researchers think the two rapid recoveries in Poland are promising enough to merit further exploration. Most patients who develop COVID-19 show evidence of the virus in their feces for roughly 28 days, but in these two recent cases, the viral matter disappeared from stool samples much faster.

    The 19-year-old, despite having a compromised immune system, wasn't even treated for the SARS-CoV-2 infection; he simply got better on his own within a day.

    Meanwhile, the 80-year-old patient was given a cutting edge treatment that usually takes about 10 days to kick in. Two days after receiving a poop transplant, his fever broke and never recurred again.

    "Our main conclusion from these cases is that a fecal microbiota transplant appears safe and of comparable efficacy in treating recurrent C. difficile infection in patients with coexisting COVID-19," the researchers write in a letter describing the case.

    "A further more speculative question is whether a fecal microbiota transplant may impact the clinical course of COVID-19."

    It's possible, for instance, that poop transplants could boost the immune system in those with COVID-19, triggering a cascade of molecular changes from the presence of certain bacteria.

    Some research even suggests the gut's microbiome can impact the respiratory system; in turn, this could boost the lungs' resistance to COVID-19.

    We still know surprisingly little about how the gut impacts the immune system, or how poop transplants ultimately may contribute to the process, but it's worth investigating if this treatment really can help us clear severe viral infections. The authors of the current letter intend to begin recruiting for their clinical trials shortly.

    The case study was published in Gut.

    Vitamin D .. Ireland takes action... the UK sits on the fence..

    "Tuarascáil faoi aghaidh a thabhairt ar uireasa Vitimín D mar bheart sláinte poiblí in Éirinn


    https://data.oireachtas.ie/ie/…measure-in-ireland_en.pdf

    "

    11. Additionally, while large, well-designed, placebo-controlled randomised control trials
    of vit D supplementation against Covid-19 are awaited, the evidence from existing
    studies in this area already meets the Bradford-Hill criteria for causality

    These findings strongly support a causal relationship between low vit D status

    and increased risk and severity of Covid-19 infection.


    12. Irrespective of Covid-19, vit D supplementation is an essential public health

    measure required to address the widespread deficiency noted across the Irish population
    and the significant adverse health effects of this deficiency.



    External Content www.youtube.com
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    other studies..(no Bigpharma :) ) https://vdmeta.com/

    Dr. Robert Malone, mRNA Vaccine Inventor, on the Bioethics of Experimental Vaccines and the ‘Ultimate Gaslighting


    https://www.theepochtimes.com/…lighting_3889805.html/amp


    What would happen to the entire vaccine enterprise—I’m talking about pediatric vaccines, the fundamental bedrocks of public health—if we basically validate the criticisms of those that have been labeled anti-vaxxers?”

    In this episode, we sit down with mRNA vaccine pioneer Dr. Robert Malone to discuss questions surrounding the COVID-19 vaccines and repurposed drugs, as well as the bioethics of experimental vaccines.



    Below is a rush transcript of this American Thought Leaders episode from July 6, 2021. This transcript may not be in its final form and may be updated.

    Jan Jekielek: Dr. Robert Malone, such a pleasure to have you on American Thought Leaders.


    Dr. Robert Malone: Likewise, thank you.


    Mr. Jekielek: You’re, of course, an outbreak specialist, you’re the inventor of mRNA vaccine technology, and you’re also a biostatistician, which is an interesting collection of-


    Dr. Malone: Well, I would say that I’ve been trained in some biostatistics. That’s to be a biostatistician for me. That’s a step above where I’m at, but I do epidemiology and biostats, among other things.


    Mr. Jekielek: Well, so I really want to touch on this whole kind of censorship question, but before we do that, let’s talk about where do you stand right now when it comes to treatment for COVID-19 or vaccination for COVID-19, given everything we know as we speak and given your rather unique background.


    Dr. Malone: Okay. So that’s a good tee-up because you’re talking about both treatment and vaccines, and I’ve actually been primarily focused with the team that I’ve been working with on repurposing drugs for COVID. And we’re trying to launch three clinical trials right now, one India and two in the States, under IND (Investigational New Drug) for a drug combination involving anti-inflammatories that we’ve developed. And it’s already been tested and was initially discovered in a small hospital in Beloit, Wisconsin.


    I made an initial threat assessment in January, as we were discussing. Well, I got a signal at Wuhan and decided that I didn’t think that the time needed was available to develop new vaccines and get them safety tested in a timely fashion to mitigate the risks of the pandemic. So even though I’m a vaccine specialist, I also have started a company in the past, focusing on drug repurposing for Zika [virus], and so I have this background, and so I’ve seen both sides of what’s going on and how it’s rolled out.


    My take on the vaccines is that we have some new technologies in the mRNA vaccines. We have a fairly well-established genetic vaccine technology, so related to RNA, but using the gene therapy vector called recombinant adenovirus, we have two examples of those right now. People call them the AstraZeneca and the J&J. AstraZeneca-Oxford is that cluster that’s not licensed in the United States. So we’re right now in the States, we have patients, and everybody has access to three genetic vaccines.


    There is a more traditional vaccine that’s about to, I think, gain emergency use authorization from Novavax. That’s also showed greater than 90% protection against disease and death. So that’s in line with what the genetic vaccines are showing.


    And I think that that one offers options for those that are uncomfortable with the genetic vaccine strategy. And I know a lot of people that have been contacting me are interested in having an option, they’re uncomfortable with the genetic vaccines, and they’re interested in having an alternative that they can use. I think that Novavax could be a suitable alternative for them.


    Now, worldwide, there’s a number of more traditional vaccines, inactivated virus, vaccines, and many that are coming online that involve purified subunits, often at very low cost with more traditional antigens. We have the vaccines coming from the Soviet Union and also from China. Those are more traditional and have lower efficacy. Efficacy being these endpoints of death or disease in a structured clinical trial.


    So for the vaccines, there are more options worldwide. In the States, the options are currently restricted to the genetic ones. Many people that are uncomfortable with those for various reasons might be more comfortable with the Novavax product. I have no financial ties to Novavax, just to say the conflict of interest, I’m just expressing what I perceive as the vaccine landscape.


    In terms of therapeutics, I sit on the ACTIV committee at NIH, which is the Foundation for NIH committee. I’m not a voting member. I’m an observer. This is the committee that is managing these inpatient and outpatient trials for new agents and now repurposed agents. So they’ve just opened ACTIV-6, which is the first ivermectin trial that’s federally sponsored to the best of my knowledge here in the States. And it’s an outpatient virtual trial structure.


    With our group from the DoD (Department of Defense), we attempted to include an ivermectin included arm in the trial that we have pending with the agency as an IND right now, but the FDA raised so many objections and asked us to do some fundamental studies about demonstrating the mechanism of action of ivermectin that the Department of Defense decided that it just wasn’t worth the delay in time to get the trial started. And so they dropped the ivermectin arm.


    So the landscape right now for the therapeutics and prophylactic drugs looks like… I’m going to stick my neck out, but I’m in close contact with Andrew Hill, who’s doing the meta-analysis; I’ve seen the work of Tess Lawrie, who’s now published another meta-analysis from worldwide ivermectin data.


    I think the data keeps getting stronger and stronger in favor of ivermectin as having some protective activity within a safe dosing range. And that seems to be impacting in various emerging economies that don’t have access to vaccines and is impacting on event rate for severe COVID disease and death.


    So there’s some great kind of epidemiologic studies or data coming out of India where Indian States had been on ivermectin. The incidents of attack rate of disease was low. Then they withdrew it for political reasons. There was a change in regime. It went up. Then they reimplemented it. It went back down again. So that’s pretty strong evidence.


    There is also reasonable evidence for the use of ivermectin as a therapeutic, but there are many others. And it’s just the one that has gotten a lot of press, in part because of Pierre Kory, Senate testimony.


    And so ivermectin, even a whole host of anti-inflammatories, because what folks often don’t understand about COVID is that we have the SARS-CoV-2 virus infection event. And typically, that leads to a disease of varying severity at something in the range of four to seven or eight days afterwards. But that disease only happens in a subset of patients, maybe 80%, maybe 50% of patients taken across all age groups, maybe even less. And the disease is the hyperinflammatory response to the virus.


    So the disease is really our reaction to the virus. The good news is with drugs is that we have this rich library of anti-inflammatory drugs that appear to be quite useful against keeping people out of the hospital if it’s used early enough or treating them once they’re in the hospital.


    The antiviral that’s been licensed, remdesivir, in the United States, the WHO is not recommending remdesivir globally, and many physicians in the United States find remdesivir to be of limited use in special situations.


    So the idea of antivirals for this is really not panning out. And there are multiple other antivirals that have been tested. This is often the case with respiratory viruses.


    So we all know about Tamiflu and influenza. Tamiflu, in theory, should be good. And it may be, it has an impact, but you have to take it within 24 to 48 hours of first getting influenza. And during that period, often you don’t know that you have influenza. So it’s a little bit of a catch-22. Likewise, remdesivir it appears.


    The other agent that has gotten a lot of attention is dexamethasone that comes out of the recovery trial in Oxford. And that trial actually shows that the utility of dexamethasone is very limited. Now, here in the States, a lot of docs have kind of gone all in, and you may even recall the president when he was infected with even before, he wasn’t that severe, and yet they put him on dexamethasone.


    Now the actual indication of dexamethasone based on the recovery trial, you should already be on oxygen and high flow oxygen or even intubated. So it appears that in the States, dexamethasone is being overused. This is often the case when dexamethasone is often kind of a first-line go-to when you have a new inflammatory disease.


    Then, over time, additional agents come in that are more specific, and dexamethasone drop. Problem with dex is it’s super non-specific, and it hammers the lymphocytes. It hammers a lot of the cell populations that you actually need to recover from COVID long-term. So cynics might say that dex is a great way to get patients out of the hospital over the short term, but whether or not it’s actually helping them over the long-term, that’s actually never been studied. So that’s the landscape as I see it.


    The RNA vaccines obviously have gotten a lot of attention. They’re remarkable. The adenovirus vectored vaccines probably produce more protein over a longer period of time. They came out fairly early and were identified as associated with coagulation problems. Those coagulation problems are now being seen more with the RNA vaccines.


    And there’s an odd spectrum of symptoms, and the governments across the world have largely denied that there are any safety concerns with the RNA vaccines. That’s now not so tenable.


    We had the CDC come out last week, talking about the pericarditis and other cardiomyopathies that are showing up in the pediatric population. So this is up to the age of 18. And that is a significant safety risk. That was only recently identified about two months ago. It’s taken two months for the CDC to verify it.


    And there appear to be a number of other adverse events that are buried within the admittedly flawed databases that we have, that we’re mining data mining, to identify adverse events that are associated with the RNA vaccines. These include thrombocytopenia. Also, so this is low blood platelets, and that can be associated with bleeding or other problems.


    Clearly, there is a signal relating to blood clotting abnormalities, again, as with adenovirus vectored vaccines. There is cerebral venous thrombosis. That’s a big fancy word, but what it means is blood clots in the veins draining your brain. So you can imagine that that’s not a very good thing to have. It’s kind of related to stroke.


    And I think that there’s a good chance that we’re having some of these cardiac symptoms exist in older age cohorts, but they are subject to what’s called masking, which is this problem when you’re looking at databases of epidemiology or whatever, if you have a confounding variable, like for instance, certainly, I am in an age cohort where cardiac events are not rare. And the problem is if you have a relatively rare event associated with a drug or a vaccine, and it’s in a cohort, an age population that has a high background for related things, it’s really hard to pick out the stuff that’s coming from the new drug, as opposed to the background levels that’s masking.


    So I think that it may turn out over time that that cardiac signal that we’re seeing in the adolescent population, we can pick it out because they have such a low background level. So there’s very little noise. It’s easy to see the signal.


    In older age groups where there’s more noise, it’s harder to find the signal, but a lot of cardiologists and others are reporting things that are making people uncomfortable.


    So with the RNA vaccines, it is remarkable, the level of activity, the technology has enormous potential, but there’s these events. And it’s a little odd. Physicians are starting to talk about the overlap between long COVID, this is these chronic symptoms that come after you get the acute infection. And by the way, you don’t necessarily have to have the severe disease to get long COVID.


    Because these longer term adverse events and sickness problems that you can get after you get the disease, there seems to be overlap between those symptoms, that profile of symptoms, the disease-associated symptoms, and the vaccine-associated symptoms.


    So long COVID, COVID, and some of these vaccine adverse events seem to have some overlap. And there are physicians that are claiming that they can actually do laboratory tests and show that they’re having similar profiles in terms of laboratory abnormalities with these genetic vaccine, genetic COVID vaccine-related syndromes, and long COVID.


    So there’s things going on there with the vaccines. The problem is we don’t know how severe they are in general. What is the bell curve distribution for severity? And what’s the incidence? And often the question is asked, why don’t we? And the answer is because the FDA elected during this phase of emergency use authorization to not require that the drug manufacturers rigorously capture adverse events and efficacy signals.


    So we end up relying on really outdated antiquated systems that have been set up a decade or more ago for the most part or some systems that are self-reported like V-safe at the CDC, but those capture 1% typically of the events because they’re all self-reported.


    And because they’re self-reported, there are problems in interpreting those data because someone might say, “Well, aunt Mary died two days after vaccination, and we’re going to report this.” And this is one of the big controversies is there’s a large number of deaths reported, but they’re not verified as being vaccine-related. And so there’s a real arm wrestling going on about what do those mean both in the US and Europe.


    So that’s kind of where things are at right now, as I see it. And then there’s a whole cluster of issues around what would it actually take to get to herd immunity? And in this push that 70% often in many countries, Canada, for example, the government is saying, “We want 70% uptake of vaccine if we’re going to release restrictions on a community or something like that.”


    The problem is that we don’t have any data from these clinical trials about the impact of vaccination on transmission. So you can’t really make a real calculation to say, epidemiologically how much vaccine, how many people within a population have to have either been infected or vaccinated.


    So that’s kind of surfing the surface. There’s a lot of other stuff underneath, but it’s complex. It always is during an outbreak because there’s never enough information.


    Mr. Jekielek: Now I have about 15 questions for you, of course. But let’s start with this one. You give this example that there’s just a lot of, especially when it comes to the adverse effects. It could be an adverse effect. It could be just what would have happened normally to somebody, but wouldn’t some rigorous data collection around this actually help kind of elucidate?


    Dr. Malone: If we have had things done more rigorously from the get-go, we would be in a totally different situation, I believe, in terms of reassuring the public.


    Mr. Jekielek: Can we start right now?


    Dr. Malone: That could be done. And I’ve suggested to some philanthropic people that they could implement trial registry structure. And there are some that are starting to grow towards that, basically.


    Mr. Jekielek: What is that exactly?


    Dr. Malone: So a trial registry is one type of clinical trial. We talk about double-blind, randomized controlled prospective trials. You can also do more data collection type trials.


    And ideally, you ask that people register at the time they received the agent, and then you implement a system there’s a lot of different ways. It could be a call center, it can be electronic, it can be on your cell phone, a lot of different types of systems to follow up with those people and inquiry them about whether or not they’re experiencing this out of the other symptom, or are they experiencing any symptoms, those kinds of things.


    So that you get instead of a purely voluntary offering of, “I’ve experienced this, or my patient has experienced that, or aunt Mary said this, or whatever,” which is where we’re at right now, you have something that’s a lot more structured where people are identified, they’re put into some sort of a data collection tool, and then they’re followed over time.


    That is possible. Basically, that is what the Scandinavian countries do anyhow, because of their structure of their socialized medicine. Often, in these kinds of situations, we end up with the best data coming from Finland, Norway, Scandinavia because of the rigor with which they’re socialized medicine system captures those data.


    We had hoped to have rigorous data set from Israel, and the CDC and FDA had been very comforted by what they thought was a rigorous data set from Israel and the ability of the Israeli government-related epidemiologic monitoring people to data-mine that database and identify signals.


    The cardiac events in the adolescent population were actually first identified by an Oracle Biostatistician, working with people at the FDA that are outside of all this, and was data mining, the various publicly available database. He identified it, notified CDC. They identified it then and tracked it. They notify the Israelis, and then the Israelis were able to verify that they saw that signal in their database too. And how could this happen?


    The statistics of how you query these databases is not trivial because you can’t just ask everything under the sun, “is anything related?” Because you’ll end up with so much statistical noise. If you set a 95% confidence interval, 5% of all hits are going to be false.


    And so you end up with this massive amount of false information, false linkages, and somehow you got to pick the signal from the noise within that. So that’s the problem, but getting reassurance that the Israelis, we’re able to the fact that they hadn’t detected something gave reassurance up until this case. And now we’re in a different world, and we’re relying on the Dutch and the Norwegians and others.


    Mr. Jekielek: So you mentioned that Israeli data and Dutch data. And I think both of those, actually, I have to ask you about this because they intersect in this relatively new paper that has come out, which I understand is actually potentially being withdrawn. Maybe I’ll get you to comment on that, but basically this paper, the safety of COVID-19 vaccinations, we should rethink the policy, and in their abstract, essentially they say for three deaths prevented by vaccination, we have to accept two inflicted by vaccination. And that the conclusion is to rethink policy, but wow.


    Dr. Malone: Yeah. So we call it a risk-benefit ratio. And that gets to the core of all of this, is typically the advisory committee on immunization practices. And the truth is the world is looking to the United States for all of this stuff in a significant way, including the World Health Organization.


    Typically the advisory committee on immunization practices of the CDC for a new vaccine would be evaluating risk-benefit in a rigorous way, using quality-adjusted life years. This is actuarial table tool that the insurance industry uses. You can understand why the insurance industry would want to do it right because that’s how they make their nickel.


    So that’s been adapted for public health purposes and typically use that kind of a tool to make a risk-benefit, formal calculation for each population, stratified special populations. So those are adults, elderly adolescents, children, infants, pregnancy, and immunosuppressed typically. And you would do this calculation for each of those groups.


    And then the ACIP (Advisory Committee on Immunization Practices) would come out with a recommendation saying this vaccine is good to be used in, say, the elderly. And that’s pretty compelling in this case with these vaccines that even though there’s adverse events, their risk of COVID death or significant disease is pretty high. So that’s an easy one to say, yes.


    Adolescents, in contrast, have a very, very low probability of disease or death from COVID. And in some non-trivial level of adverse events, and we were just talking about the cardiac. And so that calculation doesn’t come out looking so good.


    And the paper that you’re referring to came out, and just to give you some history. We were talking about me being deleted from LinkedIn. Well, one of the things that’s happened over the last week is that the authors of those paper, that paper sent it to me and said, “Robert, what do you think about this? Can you get some feedback on this?”


    So I posted it without editorial comment on LinkedIn and Twitter, and it generated a lot of discussion. And obviously, a lot of folks were pretty alarmed by that, that you’ve just read. And it brought out some academics who felt that they needed to react strongly against this paper and come out and say, “No, this can’t possibly be true. This must be a statistical over statement or mis-analysis.”


    And it generated a whole lot of pushback from a subset of academics. And then people that were responding to that LinkedIn post decided that they would write these academics, write directly to the journal and say, “This should be withdrawn.”


    So that’s how that cascade happened. And the journal has now placed a note on the manuscript that it’s now being re-reviewed, even though it’s already been through peer review once.


    The essence of their concerns to my eye, and like I said, I’m not a full biostatistician, I know enough to talk to them, but the essence of their concern seems to be this same issue of a database where the relatedness between the reported event and the vaccine is not determined.


    In many cases, it’s not determinable. But these conclusions in that paper are drawn in such a way that those academics feel very strongly. They’re inappropriate because the database didn’t establish unequivocal linkage between the event and causation from the vaccine.


    This is always the case with these types of databases. And you have to word the findings carefully and say, “We have deaths that are temporarily associated or associated in some way, but not necessarily causative,” because you can’t determine causation very well retrospectively, particularly if you can’t review the patient’s chart.


    So that is a great example. I like to call it the academic thought police, and this is the self-appointed academic thought police. This has become a major problem throughout the whole sector, is there are lots of academics that feel it is their mission to block publication of papers that might compromise in some way the vaccine mission.


    And I think this is part of why it’s become so hard to publish anything about repurpose drugs because there’s a perception. And I think it’s probably valid as you can watch people when they talk about ivermectin.


    There’s a cohort of people that would rather take a drug than take a vaccine, a prophylactic drug. And if a drug is available for outpatient use that minimizes the risk of hospitalization disease, and death, then the risk-benefit ratio calculations for the vaccines become even more tenuous. And so that I think is what’s underlying a lot of this.


    Narration: The paper we talked about titled “The Safety of COVID-19 Vaccinations—We Should Rethink the Policy.” It had undergone the standard process of peer review.


    Mr. Jekielek: It’s pretty fascinating. I had a guest on recently Victor Davis Hanson. He was talking about the Platonic Noble Lie. This is one of our topics. And so this is almost like a preemptive because the point is we don’t know. And a lot of cases, what the answer is, but there’s certain types of information that you’re just not allowed to go there.


    Dr. Malone: Yeah.


    Mr. Jekielek: Right?


    Dr. Malone: Yeah. And I’ve never experienced this before. It’s reinforced by the social media platforms. And just to illustrate the point. One of the things that’s a little bit heartbreaking, and I get these calls from patients that are just distraught, crying.


    If you are somebody who has experienced symptoms after receiving vaccine, I’m saying that carefully. I’m not saying those are related. I’m not judging that. But imagine the mother who’s had a cascade of symptoms. She’s now debilitated. Perhaps she’s worried about her ability to conceive now because she’s had menstrual alterations and things like that.


    So she’s had this cascade of events, and she’s surrounded by friends, family, social contacts that all believe that the vaccines are fully safe, and she must be crazy. It can’t possibly be that there’s any relationship between vaccine acceptance uptake and her symptoms.


    So let’s say this person goes on Facebook and joins the Facebook group that’s being created for people that have had believed they’ve had symptoms that have been triggered by vaccines. So there’s a group there. They build up to about 150,000 people. Facebook deletes them.


    Now the practical implication is for this cohort of people that believe that they’ve had a vaccine, post-vaccination syndrome, whether or not they did, they’re getting all kinds of social messaging from the top of the government on down that these are perfectly safe vaccines. They couldn’t have had the symptoms that they’re experiencing.


    They’re getting that from all the people around them. They’re not even able to communicate on social media with others. And they’re all isolated, of course, to discuss what their symptoms are, as opposed to somebody else’s symptoms. It is the ultimate gaslighting, and for these people, it is profoundly depressing.


    Can you appreciate what I’m saying? I feel this is fundamentally wrong as a physician. We’re compromising not only people’s physical health, and we can argue whether their symptoms were related or not related. That’s the essence of this complaint against this paper is it can’t be proven with this type of database.


    But these people, these patients had symptoms. They’ve experienced something, and they’re not able to get any resolution. They’re told that it’s all in their head. That they’re crazy. That’s not right.


    The consequences of what we’re doing socially right now in this context, and I think it’s driven by fear. I think we’re kind of driving ourselves a little bit mad with our fear over this pathogen.


    Now I’ve had COVID, I’ve had long COVID, it’s changed my body. I don’t have the exercise tolerance I used to have. But I didn’t die. And I’m 61, I’m in a moderate risk group, but we fear it almost like the Africans fear Ebola in the West African outbreak. And it’s driving us, I think, to compromise some of our fundamentals, including with this censorship initiative.


    And I don’t know what that looks like on the other side, we’re eventually going to get through this, but it’s impacting on society in profound ways. And this censorship of information is those that are experiencing it, including myself, are profoundly disturbed by what we’re seeing. And the long-term meanings of that.


    Mr. Jekielek: One of the things that really strikes me when I think about this stuff is when you kind of shut off areas of inquiry or the opportunity to have an open discussion about exactly this question that you mentioned that actually breeds creation of all sorts of conspiracy theories. From wherever, whatever political side from wherever, because people just don’t know, they know that what they’re seeing doesn’t look right. There’s only one narrative.


    Dr. Malone: They’ve experienced something their friends have experienced something, and yet they’re told they couldn’t have. And I agree. So I posted something on my old LinkedIn account that’s now deleted, that went viral for LinkedIn. It had done 25,000 likes or whatever, which for LinkedIn was a big deal. I mean, I got almost 6,000 people, but usually, I’ve been to like 2000 people on my LinkedIn feed.


    So this went viral, and all it was, was I posed the question, what will happen to public trust in the public health system if it turns out that ivermectin is safe and has therapeutic benefit and the vaccines turn out to not be perfectly safe? And it generated a blizzard of responses.


    Now I elected not to add the third leg to that stool, which is the controversy about the lab leak hypothesis, which is another example that was shut down very hard and censored, and now has come to for that there is some merit to that. And as demonstrated by the current president seeking clear investigation on that.


    If any two or three of those come to pass, and I think there’s a chance all three will, in my opinion, that’s just my opinion, where do we go from there in terms of public trust in the world public health system? And I don’t know the answer and what I got back from people with this open-ended question was a lot of folks saying, “We can’t trust the government anymore. We can’t trust the World Health Organization.”


    The fear that I’ve had from the get-go with Warp Speed in the vaccine development enterprise as a vaccinologist, I’d spent my whole career in vaccines. I literally invented mRNAs vaccine technology when I was 28. And before that, I was involved in AIDS vaccine development at UC Davis. This is my whole life, since 1983, has been focused on vaccines.


    My fear has been in rushing this through that we would end up with problems. It’s kind of, how can you not end up with problems if you cut corners and rush these things, particularly the safety issues? What would happen to the entire vaccine enterprise and talking about pediatric vaccines, the fundamental bedrocks of public health.


    If we basically validate the criticisms of those that have been labeled anti-vaxxers, and that’s kind of a pejorative over-simplification too, that term, we’re labeling and excluding a whole block of debate and discussion by labeling it that way.


    But what if what we do in doing this validates what they’re saying about pharma and the FDA and the government playing fast and loose with lives with vaccines? I’m having people write me saying, “I’m not going to vaccinate my kids anymore. I can’t believe in this, this whole enterprise.”


    There was an interesting statistic I heard the other day on the Highwire when I was interviewed there that the baseline self-identified anti-vaxxer historically has a bit about 3% of the population. And according to them in the latest survey, it’s bumped up to 40% of the population is self-identifying as anti-vaxxer.


    Where does that go? And how by shutting down, as you point out, this information in this discussion, I mean, to lock me out of LinkedIn, because I have been carefully responsibly raising concerns and questions and trying to engage in discussion about those.


    I’m bonafide. I mean, you can’t say that I’m not an expert. Maybe some say I am the expert. But to block my ability to communicate, let alone all the others that have contacted me saying, “Hey, I can’t even say the things that you’ve been saying. So speak for me.” They now don’t even have me as a voice. That’s profoundly disturbing. We can’t get to scientific truth if we can’t discuss things.


    Narration: After Dr. Malone’s LinkedIn account was restricted, he submitted an appeal and received a response saying several of his posts about vaccine safety had violated LinkedIn’s policies, “Sharing content that contains misleading or inaccurate information.” His account has since been reinstated. But given the censorship, he says he’ll be migrating most of his discussions to Twitter and to his personal blog.


    Mr. Jekielek: Robert, on top of everything else, you’re actually a trained bioethicist. And you’ve already started addressing some of the ethical questions are conundrums around what’s happening or what you see happening. Give me a little bit of the scope of this as we start finishing-


    Dr. Malone: I wrote… Thank you for that. And for that lead-in, I personally, I think this is one of the most important topics, is the bioethics of use of an experimental medicine and experimental vaccine.


    And the genesis of this whole thought thread was a two-hour conversation with a Canadian physician a number of weeks ago, where he just poured his heart out about what he was seeing with his patients and what was going on in Canada. And I was left saying, “Well, thanks for sharing this, but I can’t help you. I don’t have anything.”


    I woke up that Sunday morning with an aha moment. And I said, “I know what I can do for this guy. I can write a piece about bioethics, the bioethics of vaccination under emergency use authorization.”


    So, I dug into rich literature that exists as well as federal law. That goes back to The Helsinki Accords, The Belmont report, et cetera, and looked at what are the fundamental principles of bioethics as they relate to use of an experimental product.


    So point number one just summarize that, and this is, you can find it in The Code of Federal Regulations, it’s referred to as the Common Rule. So this is actually Federal Law. It’s not just words that academicians agree to. So the first thing is that an emergency use authorization product, which is what all these vaccines are, and many of the drugs, is an experimental product. It’s not yet licensed. So that’s point number one. They’re all experimental products.


    Point number two, if you’re going to be administering experimental products to patients that falls under clinical research, medical research. And so, you have to follow the guidance for medical research. And I mentioned the Common Rule is codified in the Code of Federal Regulations.


    The first clause, importantly in the Common Rule, is there has to be complete disclosure of risk. You know, intuitively what that means because when you buy a bottle of aspirin, you pull out this little piece of paper, and you look at that, and you go, “Holy Moly, this aspirin is going to kill me.” If you read all the way through, it could cause heart attacks or gastric erosions, or whatever. And you look at that, and you say, “Oh, I don’t know if I want to take that aspirin.”


    But the truth is that the ones that are common are up at the top, and we all take aspirin or Tylenol or some version of that. That’s the level of disclosure of adverse event risk that must be provided to patients participating in clinical research. That level of information, as we’ve just been discussing, is censored. It’s not available. So we are not meeting the criteria for full disclosure of risk.


    Second key principle is that that full disclosure has to be comprehensible and comprehended. Earlier on, I referred to thrombocytopenia, and you were like, “What the heck was that?” And I said, “Low platelets.” That’s a great example. The first one was scientific jargon that was incomprehensible to you. The second one you could understand. So these risks have to be conveyed using language that people can comprehend.


    Third key principle, you cannot coerce. You cannot entice. The patient or the subject has to freely accept the experimental medicine of their own volition. All these messaging about, “You must take the vaccine. You must take the vaccine because otherwise and aunt Mary could get infected.” All of this messaging that the vaccine is safe, et cetera, all the peer pressure that’s happening around the vaccine, that’s coercion.


    Now it gets even more florid with those nations. I don’t think we’ve done it here in the States, but the Canada has. We’re going to give out ice cream cones to get the kiddies to come and take the jab that’s been done. That’s coercion and enticement.


    Then there’s the last little codicil in all this. We call it the age of consent. So we here in the States generally agree that the age of consent is 18. If you are at or below the age of consent, you need to have approval or consent from your parent or guardian to take an experimental medicine. They act as your agent because you’re not able to provide consent by definition.


    We cannot, by law, have infants, children, and adolescents receiving experimental products without authorization of their parents.


    Now, listening to this, [one] might say, “Well, we have this special case of an epidemic, and we have to all get vaccine. Why do we have to all get vaccine? What’s the logic behind that?” What we’re told is we have to all get vaccinated so we will reach herd immunity. That’s the logic.


    The problem is that that is a fallacy. We have not gathered the data to even be able to calculate in these clinical trials what would give us herd immunity? What would herd immunity mean? It would mean that we have what’s called sterilizing immunity, or in some way, if we get infected, we don’t spread it to somebody else. That means that we’re not producing virus and shedding virus.


    Just today, the World Health Organization made an announcement clear and unequivocal. You’ve got to start using masks because none of these vaccines are preventing infection. They’re preventing disease. They’re not preventing transmission, and they may be reducing transmission, but by how much we don’t know. And so we can’t calculate what the percent uptake is required to reach herd immunity, if we could reach herd immunity with these vaccines.


    So there’s an underlying logic that’s been pushed out globally about why we have to take vaccine and how many of us have to take vaccine. And it’s not actually supported by data. And to my mind, that’s a problem. And it’s kind of gone all the way through this outbreak where key public health officials have felt comfortable substituting their opinion for evidence-based medicine.


    And that always has to happen at the start of an outbreak because there’s no data. Somebody’s got to have expert opinion. We’re past that point. We have a lot of data, and it’s time we start relying on evidence to make public health decisions, and we’re not doing it.


    So to my eye, from the bioethics, we appear to be failing to meet the Code of Federal Regulations, Federal Law, let alone fundamental precepts that go back to the end of World War II. We’re not providing full disclosure of risk. We’re not doing so in a way that’s readily comprehended by the public. And we are enticing, compelling, coercing, and otherwise not respecting the rights of the individual to choose what happens to their body.


    And in my mind, that’s bedrock is we all have in Western society, the right to choose the State does not own our body, we do. Particularly for an experimental product.


    I argue that we’ve crossed a line. It’s a bioethical line. It may actually be Federal Law that we’ve crossed. Inadvertently, I’m sure for all the best reasons, but if you go back, read the code, read the Nuremberg Code. What we’re doing is not aligned with fundamental principles. And as you know, this happens from time to time during war and crisis.


    Cultures decide that it’s okay to bend the rules on some fundamentals of ethics, whether it’s torture, internment of populations, whatever. I believe they almost universally end up regretting it. And so, I’m trying to responsibly ethically with the credibility that I have in my CV, and because of my role in inventing this technology to alert people that I believe that we’re pushing and crossing some key lines here that we really should be respecting.


    Mr. Jekielek: Robert, we’re going to have to finish up shortly, but I have probably about a few hours more worth of questions for you at this point. So we’ll have to actually invite you back. Any final thoughts before we finish up for today?


    Dr. Malone: Yeah. If I can speak to your audience, like I said, it’s your body. In my recommendation, general recommendation is, in my opinion, these vaccines are saving lives. They’re saving many lives, particularly in the elderly. I get asked the question all the time, “Should I take this vaccine or that vaccine because I have this preexisting condition, an autoimmune disease, or whatever?”


    And my recommendation is that you know your body best, you and your medical care provider, and that you have the right to accept or not accept a vaccine product, particularly an experimental one. And that you make your own decision. I can’t advise you, in the end neither can your physician completely advise you.


    It’s up to you. It’s your body. It’s your choice. And I just suggest strongly that you take the time to get informed, do the best you can, and then make the decision that you think is right for you.


    Mr. Jekielek: And Robert, again, just before we finish up, is there a resource that you would recommend to be able to kind of see the broader totality of the picture?


    Dr. Malone: Unfortunately, there isn’t. And I’m involved with a couple of different coalitions that are starting to build websites, particularly for helping inform students like university students that are returning to class so that university administrators or others can use these as resources and point people to them so that they can become informed themselves.


    In the interim, there’s the WHO site website for vaccines. For COVID, there’s one that the CDC maintains. There’s the NIH recommendations for drugs, but all of these are kind of lagging. They’re not right out at the front edge of the latest information. Understandably, they have to pass through a bureaucratic filter. And they often don’t link to the primary data, and people are just crazy hungry for information right now. So hopefully, that’ll come to pass over time.


    Mr. Jekielek: And some people may be concerned that some of these very, very official sites might be following the kind of, I guess, like approach that you’ve been describing in this episode. So they may be wondering, where can I look to be-


    Dr. Malone: That’s exactly right. And many people were coming to my LinkedIn and Twitter feeds seeking that level of information and seemed to have been trusting me as a neutral arbiter of that information. Unfortunately, that’s getting shut down. So I was trying to do it through that vehicle, but I no longer have that channel. And so I really grateful for you in Epoch for making it possible to reach people through this video medium, which many find more useful than reading a dry peer-reviewed academic paper. I don’t know what the answer is right now in a time when people are increasingly distrusting official public health.


    Mr. Jekielek: Well, on that note. And we’ll definitely have you back again soon, Dr. Robert Malone, such a pleasure to have you on.


    Dr. Malone: Thank you very much.

    Quote from Fm1

    With our group from the DoD (Department of Defense), we attempted to include an ivermectin included arm in the trial that we have pending with the agency as an IND right now, but the FDA raised so many objections and asked us to do some fundamental studies about demonstrating the mechanism of action of ivermectin that the Department of Defense decided that it just wasn’t worth the delay in time to get the trial started. And so they dropped the ivermectin arm.

    This clearly proves that whole FDA is bribed ergo corrupt. The mechanism of action of Ivermectin is exactly known. So this was a fake paper argument only.

    Quote from Fm1

    So there’s some great kind of epidemiologic studies or data coming out of India where Indian States had been on ivermectin. The incidents of attack rate of disease was low. Then they withdrew it for political reasons. There was a change in regime. It went up. Then they reimplemented it. It went back down again. So that’s pretty strong evidence.

    Ivermectin works at least 1000x better than any vaccines. In view of deaths. 100'000x better.

    Quote from Fm1

    The RNA vaccines obviously have gotten a lot of attention. They’re remarkable. The adenovirus vectored vaccines probably produce more protein over a longer period of time. They came out fairly early and were identified as associated with coagulation problems. Those coagulation problems are now being seen more with the RNA vaccines.

    They have the spike protein in common. IF injected by dilettantes it will kill you - best case - within minutes. There are many cases in the 10' range.

    Quote from Fm1

    So long COVID, COVID, and some of these vaccine adverse events seem to have some overlap. And there are physicians that are claiming that they can actually do laboratory tests and show that they’re having similar profiles in terms of laboratory abnormalities with these genetic vaccine, genetic COVID vaccine-related syndromes, and long COVID.

    So vaccination (can) produces the same symptoms as long Covid.


    Big Pharma mafia:: Vaccines can help to cure long Covid. Any more questions?

    Switzerland::


    We had a spontaneous jump from about 100 cases/day to 250 so a factor of 2.5. But it stays at this level again. Hospitals/deaths are declining or stable on very low level despite we have 60..70% Delta now.


    All German/US/UK/FR journals /TV stations still publish fake news a about vaccine efficiency and vaccine target (85% of total population) needed.

    The fascist method now is fully implemented. You get a "C" in your passport if you had the vaccine same in WWII where you got a "J".

    People with "C" - here the complementary meaning of "J" - get freedom albeit they carry the same risk to infect an other person. Especially for the Pfizer vaccine where it even could be worse.

    Be aware of this! In the whole west the fascists are back. Just for your memory. Before WWII the big capital (pharma was in there too: Amphetamines, Zyclone B paraceptamol etc.) joined the fascists.

    The ivermectin story

    A modern morality tale..long and twisted.. twisting still

    "

    The parties against and in favor of ivermectin remained in deeply conflicting positions, presenting opposite conclusions on the existing research. The WHO, along with regulatory agencies and national
    governments of high-income countries, appeared to aim at preserving the value of existing investments
    in vaccine and investigational therapeutics development, as well as questioning the efficacy and safety of
    repurposed medicines.
    Criticism towards excessive influence of Bill Gates in the WHO emerged during the period, as the
    largest funder of the WHO appeared to be a group of vaccine promotion and intellectual property
    rights enforcement oriented organizations founded by Gates. There was a noticeable centralization of
    power, with the pandemic response largely directed by a few public-private partnerships working on
    commercializable technologies."


    The WHO, the philanthropic entity Bill and ?Melinda? Gates Foundation, the public-private partnership Gavi ,

    The Vaccine Alliance, and the philanthropic-commercial entity CEPI appeared to be strongly
    interconnected with each other and with high-income nation states.


    Major financial investments and commitments likely created propensities for various biases and a vulnerability to the sunk cost fallacy [.

    A haphazard or ideological commitment solely to vaccines (95% of government spending) may
    have overlooked considerations of cost-effectiveness and feasibility, such as vaccines likely being more
    expensive and more vulnerable to viral variants than repurposed medicines,

    their long-term safety being unclear, and vaccines likely requiring constant redevelopment and revaccinations,

    in addition to not being suitable for self-administration and requiring refrigerated delivery systems.


    With regard to the sunk cost fallacy, it would be more economical for the governments to reconsider the vaccine and investigative pharmaceuticals dominated pandemic policy and at least adjunct it with broad-spectrum repurposed medicines.


    https://www.researchgate.net/p…4qwuSdI7tVnXs7gSTg&_iepl=

    Quote from Curbina

    Fatal mRNA Covid vaccine related thrombocytopenia case reported.

    This is based on an old Pfizer sponsored hit piece discussed long ago. If you you subdivide the blood cloth, then you find an effect that you don't see in RNA vaccines - great for Pfizer/Moderna. So they push this. But there are two other cloth types you only see with NRA vaccines and of course this is what Pfizer (& Moderna) tries to hide.

    The reaction to Pfizer cloths can be dramatic a quick. As said in the link some pages back of a Japanese that died within 10 minutes. Same for an US doctor among the first vaccinated.

    So your link is a bit medical and propaganda. Difficult for uninvolved to see who sponsored who as the authors simply lie when they say we have no relation/conflicts as in fact their institute has tons of relations...

    Meet the inventor of MRNA vaccines



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    https://blogs.sciencemag.org/p…or-and-what-it-maybe-isnt


    I good detailed backgrounder on why maybe mRNA (which everyone is jumping on) is not a great way to deliver therapies (as opposed to vaccines - where it has proven amazingly efefctive).

    https://blogs.sciencemag.org/p…or-and-what-it-maybe-isnt


    A comment on Robert Malone's views.


    I liked them, overall, because there is a lot of thoughtful speculation. I think he has an agenda (= a preconceived opinion) which is that the US is maybe not properly evaluating evidence on risk vs reward of vaccines in young people (adolescents) because of the high overall benefit to society in having them vaccinated - so it is easiest just to be vague about risks. He may be right, or wrong.


    https://journals.plos.org/plos…1371/journal.pmed.1003656


    interesting paper . Comparing those vaccinated with those who were infected with early wave COVID. Both have a long-term antibody response. But the natural antibody response is much more specific to the original variant than the vaccine response, and therefore does not so much help against delta.


    That puts into even more stark relief the dilemma. While we have a large reservoir of unvaccinated young people, capable of being reinfected by the next variant, we will continue to have a high endemic COVID rate. Why does that matter, if no-one is dying? The problem (well one problem) is that we will go on breeding new variants which will eventually escape the vaccine well. Thus far the new variants have also proved more lethal - we would be in troble if that continued though of course it may well not.


    I disagree with Malone about the medical establishment being against repurposed drugs because they prevent vaccination. Maybe there are a few people with that idea. You will find people with any idea. I see more likely the concern that many people are vaccine hesitant and when given a non-working or not-much-working-drug will not get vaccinated because of it and then still contribute to hospital and death statistics.

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