The Playground

  • Recently, TrialSite reported that 120 children became ill from the Pfizer-BioNTech mRNA-based COVID-19 vaccine while at least three children died due to unfortunate responses to the vaccine. Now, news out of Vietnam raises more trouble as yet another child died after COVID-19 inoculation with BNT162b2. While still a rare event, the news is no less concerning.

    Oh this company loves the children. None died here from CoV-19 so far. Most that died world wide have been on chemo.

    May be Pfizer is more interested in Moms & Dads money than helping children...

  • So - this is a retrospective analysis using adjustment via propensity score, showing a very small effect.

    Such studies are notoriously unreliable, because you can never get exact adjustment, and small changes in the way you do the scoring are who you include/exclude will swing the results.


    I big effect in such a study would not be great evidence, but would be "well, worth looking more" quality.

  • Israel sees no change in seasonal cases due to vaccine & boosters:



    Average case count pre "vaccination" is the same as post vaccination...So this is one more argument that overall gene therapy (CoV-19 vaccines) have no effect at all.


    But cases have increase from alpha to gamma to delta by about 3x. So in reality we have something in the range of 2-4 for the vaccine protection depending on what you look.


    But the mortality decreased too - from alpha to delta - by a factor of 5 at least in most "non fat" countries...So it would be no surprise that at the end we will see only a marginal contribution from gene therapy...


    The other (long time side effects of gene therapy) story we will know in 10 years....

  • Conclusion: Prophylactic use of ivermectin showed significantly reduced COVID-19 infection rate, mortality rate and chance of dying from COVID-19 on a calculated population-level analysis, which controlled for all relevant confounding variables.

    This reduction in mortality will be an underestimation, because many people in the non ivermectin-prescribed group will still take the drug on the side, especially if they get sick. Or, they have taken it previously and it continues to have effect.

    In places like that region of Brazil where Ivermectin is readily available, it would be best that such studies include a blood test for the presence of ivermectin to correct for this very real possibility.

  • So - this is a retrospective analysis using adjustment via propensity score, showing a very small effect.

    Such studies are notoriously unreliable, because you can never get exact adjustment, and small changes in the way you do the scoring are who you include/exclude will swing the results.


    I big effect in such a study would not be great evidence, but would be "well, worth looking more" quality.

    It showed a reduction in infections of 7% in the Ivermectin group, which is small, but it also showed 48% < in mortality which is not.


    And while you claim these studies are unreliable, they had: "A total of 220,517 subjects were included in the analysis; 133,051 (60.3%) ivermectin users and 87,466 (39.7%) non-users." Having that many participants should compensate for some deficiencies I would think.


    And as Mark said, with so many prophylactic Ivm kits distributed around the city, there is a good chance many of those who were registered as *not* having a kit, got one from a friend or neighbor after getting sick.

  • University of Oxford PRINCIPLE Trial Puts Ivermectin Study Arm on Hold—Purported Supply Issues


    University of Oxford PRINCIPLE Trial Puts Ivermectin Study Arm on Hold—Purported Supply Issues
    TrialSite has chronicled the ivermectin studies, including the important PRINCIPLE trial led by the University of Oxford. Now, interestingly, the
    trialsitenews.com



    TrialSite has chronicled the ivermectin studies, including the important PRINCIPLE trial led by the University of Oxford. Now, interestingly, the prestigious Anglo-academic research center has announced the ivermectin arm of the study is on “hold” due to “temporary supply issues.”


    Marty Makary’s MedPage Today did some digging Ivermectin Arm of PRINCIPLE Trial Put on Hold | MedPage Today into the matter. Jennifer Henderson, an investigative writer, shared that Merck, a key producer of the generic typically available drug, didn’t comment to the medical news online media.


    Noteworthy, Ms. Henderson and MedPage Today interestingly first turned to Merck and the New Jersey-based pharmaceutical company’s point of view as a sort of appeal to an authority. Merck’s response could be interpreted as a signal of the drug’s fate as a possible COVID-19 treatment candidate: the company “concluded that the probability of ivermectin providing a potentially safe and efficacious treatment option for SARS-CoV-2 infection is low and has prioritized internal efforts towards the development of alternate candidates that provide a higher probability of success for the treatment of COVID-19.”


    As much as TrialSite has respect for Dr. Makary and MedPage Today, the media, unfortunately, doesn’t educate the reader about the contentious views and some could argue bias and possible conflict of interest associated with Merck and this generic drug in the context of COVID-19. The journalist doesn’t bother to mention Merck’s “skin in the game” for COVID-19 antivirals and how this could conflict with any interest in their own version of ivermectin.



    For example, while MedPage Today refers to Merck as a sort of authority getting their quote first, the reporter doesn’t share that Merck received $356 million in U.S. taxpayer money to develop branded antiviral candidates. All during the pandemic, TrialSite chronicled ivermectin-based studies while observing Merck’s actions closely.


    Readers can access articles such as the Feb 5 piece, “Merck Challenges Safety & Validity of All Ivermectin Studies for COVID-19, Despite having Donated Billions of Doses to Less-Developed World to Fight Parasites & Accumulating Positive Data.” Merck also received an initial commitment of $1.2 billion of taxpayer-originated funds to procure an investigational competitor, molnupiravir, which in all reality has shown mediocre results. Could there possibly be some conflict of interest?


    Regardless, TrialSite appreciates the MedPage Today’s Editor-in-Chief and their writer’s effort to keep the topic up for discussion.


    We have written extensively here that it is no secret that the drug development system hasn’t evolved to embrace and use low-cost therapies when the industry isn’t supportive. The University of California, Hastings College of the Law professor Robin Feldman, JD, has written about how this system works. A good example is the book titled, “Drugs, Money and Secret Handshakes: The Unstoppable Growth of Prescription Drug Prices.”


    TrialSite chronicled the heavy bias, as measured by the National Institutes of Health (NIH) and other federal agency influencers in directing billions of dollars of taxpayer-originated money into advanced, highly experimental research during the onset of a pandemic versus embracing pragmatic real-world probes into existing drugs. During the summer of 2020, TrialSite introduced high-powered initiatives to identify repurposed targets from real-world analyses including:


    UCSF (Quantitative Biosciences Institute (QBI)

    Sanford Burnham Prebys

    Scripps/Calbr

    TrialSite showcased some of the challenges NIH’s NCATS faced in meeting its mission to find low-cost, repurposed drugs.


    Ivermectin became a topic of great interest after the University of Monash made the striking find that the antiparasitic drug absolutely destroyed SARS-CoV-2 within 48 hours in a cell culture environment. Critics pointed to concentrated doses involved, however studies around the world commenced—thus far, at least 70 ivermectin studies have been completed—the overwhelming majority yielding positive data.


    The mainstream or corporate media only started covering the topic when some tracked studies fell short—ironically. The main focus was the Lopez-Media study, which was associated with some controversy and possible conflict of interest.


    Three influential studies for the U.S. and UK include the Together (study drug fell short while Fluvoxamine shined); COVID-OUT, ACTIV-6, and of course, PRINCIPLE. Critics such as Dr. Michael Goodkin have authored in TrialSite that the study drug was underdosed in Together, and also, unfortunately, for the other aforementioned studies. Dr. Michael Goodkin shared with TrialSite that given the underdosing per the protocol, it’s highly likely that these major studies’ data will disappoint ivermectin proponents.


    The PRINCIPLE trial site Join the PRINCIPLE Trial — PRINCIPLE Trial thus far has not communicated any cause behind the supply issue, according to MedPage Today. While traditionally a robust supply of ivermectin is available, the demand caused by off-label usage has been notable as prescriptions in the U.S. went from a few thousand per week pre-pandemic to nearly 90,000 per week during the pandemic. But this drug is straightforward to produce and there are multiple suppliers.


    Over the past year, TrialSite observed a possibly connected, seemingly orchestrated public relations propaganda campaign to delegitimize the drug and all those who supported further research or off-label usage. This smear campaign led directly to the U.S. Food and Drug Administration (FDA) as TrialSite’s Sonia Elijah covered in a Nov. 5 piece titled “FDA’s Smoking Gun: Disinformation Campaign Targeting Ivermectin.”


    While it needs some updating, the core underlying assumptions of the TrialSite ivermectin fact check piece are relevant.


    Producers of Ivermectin

    Several companies manufacture ivermectin. The drug referred to as the ‘Wonder Drug’ from Japan was the reason for two scientists winning the Nobel Prize. Merck brought the planet a real gift with the Mectizan program, where the company donates hundreds of millions of doses to fight off tropical-borne parasitic diseases, mostly in Africa and elsewhere.


    A subset of ivermectin producers of the product include the following:


    Producers Country of Origin

    Merck USA–Supplies world via various subsidiaries & brands

    Edenbridge Pharmaceuticals USA

    HuBei YuanChang Sai CHuang China

    Shandong Octagon Chemicals China

    Xi’an Tian Guangyuan Biotech Co., Ltd China

    Zhejiang Hisun Pharma China

    Shandong Qilu King-Phar China

    North China Pharma Group China

    Quimica Sintetica Spain

    Hovione Farmaciencia Portugal

    Winmark Bangladesh

    Delta Pharma Ltd. Bangladesh

    Valeant Pharmaceutical Intl. Canada (supplies to Mexico)

    Call to Action: Check out Ms. Henderson’s piece in MedPage Today. Ivermectin Arm of PRINCIPLE Trial Put on Hold | MedPage Today


    Ivermectin Arm of PRINCIPLE Trial Put on Hold
    Trial website cites supply issues
    www.medpagetoday.com

  • And while you claim these studies are unreliable, they had: "A total of 220,517 subjects were included in the analysis; 133,051 (60.3%) ivermectin users and 87,466 (39.7%) non-users." Having that many participants should compensate for some deficiencies I would think.

    Having more participants compensates for the known errors you get from small studies (when they say things like RR=0.6 - 1.2, that would narrow to RR = 0.81-0.88 or whatever just b=y having more participants.


    The various (unintentional and unavoidable) biasses are not affected by number of participants alas, which is why these retrospective studies are good for studying possible relationships, but not much good for determining whetehr a drug works (unless it is very very clear).

  • University of Oxford PRINCIPLE Trial Puts Ivermectin Study Arm on Hold—Purported Supply Issues

    Only TSN would add purported to this headline. It is a disgrace to so slur decent hard-working UK doctors.


    And worth thinking about supply issues: if not because of Brexit, COVID, or lorries (all an issue with UK supply chains), they may be due to FLCC & BIRD upping the demand for medical-grade ivermectin. Bad for anyone with worms, and for these trails!


    Kory (FLCC) is on record as saying that we should not have these trials, because the efficacy of ivermectin is proven. Talk about weasling out of validation!


    Don't check what I'm saying because I know I'm right....

  • Ivermectin in humans has never been use for worms... Only idiots repeat such unfounded claims...

    What do you think causes river blindness?


    Rivers?

    Onchocerciasis - Wikipedia en.wikipedia.org


    This is caused by a fly!!!


    Oof! The gauleiter of zurich thinks that people take ivermectin to kill the flies in their eyes!


    And like-bot Fm1 appears to agree! (I guess this is not surprising, when you consider that he believes vitamin D cures covid, based on him not having had a heart attack yet. :S )


    It would appear that neither dotard read the first line of the wikipedia article:


    “Onchocerciasis, also known as river blindness, is a disease caused by infection with the parasitic worm Onchocerca volvulus.


    Perhaps the mere picture of the fly on top of the wikipedia was enough evidence for them?


    Perhaps they are unable to understand that the worm infects both flies and humans?




    A REQUEST: can we get some more capable anti-vaxxers please?! Where’s Navid gone? At least he could spell properly. One of them actually wrote ‘Phizer’ twice yesterday! Unbelievable!

  • About that ivermectin shortage:


    Vet quality ivermectin is in very short supply in the UK - leading to likely slaughter of animals that can't be treated. The reason is people self-dosing on animal ivermectin.


    Ivermectin shortage because of false Covid claims may see animals sent to slaughter
    An ivermectin shortage linked to false claims that the drug can cure coronavirus could result in farm animals being sent to slaughter.
    www.independent.co.uk

  • Nice bit of data science on an argument a from not-capable antivaxxer Renz (I know - that is a tautology) that deaths from COVID-19 vaccine are higher than from Flu vaccine. This is his second attempt. The first one neglected background deaths. This new argument has a different mistake...


    Renz "Whisteblower" data from CMS falsely claims death rate higher for SARS-CoV-2 vaccine than flu
    Back in October, I write a blog post responding to the lawyer Renz's "whistleblower report" claiming that The USA government's Center for Medicare and Medicaid…
    www.covid-datascience.com

  • It showed a reduction in infections of 7% in the Ivermectin group, which is small, but it also showed 48% < in mortality which is not.

    One more fake study....Just look at Uttar Pradesh, Rajastan etc... The largest study ever done with 100 mio. people taking the Ziverdo Ivermectin combo.


    FUD and fear mongering reaches today new heights. Even science news emission like 3SAT nano spreads FUD that vaccines do work to stop Omicron.... Last chance to cash in on booster doses as Germany will order some ten more million they of of course will not need...

  • Italy:: No booster no work!


    President Draghi (Italy) is the biggest supporter of his friends owned Pfizer stake!!


    Teacher, nurses and many other now must undergo 3 gene therapy jabs to be able to go on working.... No booster no work!!


    Corona-Bestimmungen in Italien - Italien erweitert die Impfpflicht und schränkt die Einreise ein
    Mehr Berufsgruppen müssen sich impfen lassen und die Einreise ist nur mit Test oder Quarantäne möglich. Eine Übersicht.
    www.srf.ch


    This post edited to remove political and other comments. Alan

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