Nice find, I knew this study was bunk.. Can you help me understand , is this study the same as the previous one from the TOGETHER trial? It seems there are multiple ones from this same trial, but I might just be confused here..
Hm, I recall finding a possible terminology-driven reason behind the lower "per protocol" number, let me look at the paper again...
*edit: OK, right. The issue was the range of dose durations for the protocol group, not all of which were meant to be compared to the ivermectin 3 day course. "The placebos that were used in the trial involved regimens of 1, 3, 10, or 14 days in duration, according to the various comparator groups in the trial at the time of randomization."
So only the 288 3-day placebo-takers are in the "per protocol analysis" set. And, among the remaining 391, there would be a presumed 1.5% capture to the overall 100% adherence rate for the day 1 group (8.1 x (391/(3x679)), assuming even distribution between 1, 10, and 14) and some type of loss for the longer course groups due to recovery or other (the math would have to weight for days, and would only be a guess anyway). So, the lower adherence could be partially driven by that.
Ed Mills, the study's organizer wrote what you noted in a response to some queries he received. He noted essentially what you detailed and that this "per protocol" comment was required by NEJM. Though this also means that the study was further under powered and even more confusing. The study was problematic for other reasons. The ivermectin arm was under dosed, and IVM was given alone not with any other part of the protocol. Mills, given his ties to BMGF and Pfizer, himself was a problematic organizer for this trial.
"The Digger" in several posts in his substack goes into the problems you noted and other issues with the trial in several posts including these following posts:
Right, I would say the not with protocol thing is the most important. In my opinion doctors should just go with what they believe works and all this obsession on RCTs is just intentional rigging of the field to begin with. *edit: One thing I would note is that Together was really slow to publish after the Mills' video presentation on August 6 2021, which seems weird if the entire thing was a work of specific intentional sabotage rather than a generically flawed RCT.
Thanks that's a good post, and further illustrates that "per protocol" meant that this study was really just a mess. So either they have one method in the investigative arm and one in the control arm, or they have the same number of protocols and demographic mix in both arms. The better design would have been to have multiple days in both arms. Thus they should have had 1 day ivm vs 1 day placebo, 3 day ivm vs 3 day placebo, 5 day ivm vs 5 day placebo, and 8 day ivm vs 8 day placebo. They should have also given these various days of IVM and the placebo in the context of the entire treatment strategy (eg. I-MASK protocol w. zinc, vit C & D, melatonin, etc) as well as with food.
Funny, just noticed your edit...I got a chance to speak with Dr. Kory face to face for about 10 minutes about this study, and he pretty much believed (as you would suspect) that the trial was set-up to fail. When you look at how this trial and a prior one published in JAMA were publicized, that sort of seems to be the case. Get a poorly designed and executed study into a major journal and then have all the legacy media outlets reference that study as the indisputable "science" that "proves" that an off patent repurposed drug doesn't work. Therefore, we need new on patent drugs and vaccines to "save" us from the deadly virus as defined by all the fear porn. This insures that pharma will be able to get lucrative government contracts for wealthy nations where those wealthy nations pay 40 to 60 times production costs for drugs and vaccines that tax payers originally funded the development of.
Maybe they were just waiting for the peer review and publication to occur in a major journal, since so many people seem to think that peer review is the end all be all especially when it occurs in a major journal like NEJM, JAMA , Nature or Lancet.
A bit of a weird question James but do you know anything about High omega 6 diets, resulting in glutathione depletion, as one of the factors that are making children more likely to be hurt by heavy metal toxicity.
It would mean that we aren't just hurting more children by giving them more toxic metals and at younger ages. We are actually creating children that are less and less able to clear out those toxic metals.
What this means is what was a "safe" dose of Mercury or Alluminium* to a child in the 1850's (a dose that would harm 1 in a million kids) would be more dangerous to a child in the 1950's (1 in 10,000) and even more dangerous to a child born after the 1980's (1 in 10)
Seed oils were introduced into our diet around 1870's but there was a massive increase in the 1950's and 1970's.
We also started feeding babies Soy milk. So they were getting a bigger blast of omega 6 from an earlier age. Omega 6 in the diet does seem to concentrate in mothers milk so depending on her diet breast milk could be high in Linolaic Acid.
*Not that I'm saying there is such a thing as a safe dose!
Mercola writes about this. The issue isn't just omega 6 but specifically oxidized omega 6. Raw nuts are shown to be healthy in general, for example. Oxidized omega 3 is even worse. Nobody should ever fry with seed or nut oils.
Within 7 days? Why so long? Why not within 24 hours?
I've known people who were ill with covid then got better by the 3rd day. By the time that person got treatment in this study they could have already been 4 days out from feeling better again.
"We have a new cancer drug! But we have to give it to people who have been in remission for a decade"
They're so desperate to cover them themselves retroactively for blocking us from using Ivermectin that they'll publish anything. When I was training (a million years ago) we revered the New England Journal of Medicine, and Lancet. They were like gods to us. I don't know if they've just gone way down hill due to politics, or if they were always bad and we just didn't realize it at the time. It's really scary.
Thank you for pointing out a major flaw in this study.
Also, the potential conflicts of interests are troubling. For example, the corresponding author Craig Rayner lists funding from the Gates Foundation and under "not related to ivermectin": the Australian government, Pfizer, Astrazeneca, etc. Other authors indicate financial relationships from organizations such as Fast Grants and Rainwater Charitable Foundation that may be preferentially selecting researchers favorable to Big Pharma and not repurposed drugs - this is outside of my wheelhouse so cannot comment.
Nice find, I knew this study was bunk.. Can you help me understand , is this study the same as the previous one from the TOGETHER trial? It seems there are multiple ones from this same trial, but I might just be confused here..
Hm, I recall finding a possible terminology-driven reason behind the lower "per protocol" number, let me look at the paper again...
*edit: OK, right. The issue was the range of dose durations for the protocol group, not all of which were meant to be compared to the ivermectin 3 day course. "The placebos that were used in the trial involved regimens of 1, 3, 10, or 14 days in duration, according to the various comparator groups in the trial at the time of randomization."
So only the 288 3-day placebo-takers are in the "per protocol analysis" set. And, among the remaining 391, there would be a presumed 1.5% capture to the overall 100% adherence rate for the day 1 group (8.1 x (391/(3x679)), assuming even distribution between 1, 10, and 14) and some type of loss for the longer course groups due to recovery or other (the math would have to weight for days, and would only be a guess anyway). So, the lower adherence could be partially driven by that.
Ed Mills, the study's organizer wrote what you noted in a response to some queries he received. He noted essentially what you detailed and that this "per protocol" comment was required by NEJM. Though this also means that the study was further under powered and even more confusing. The study was problematic for other reasons. The ivermectin arm was under dosed, and IVM was given alone not with any other part of the protocol. Mills, given his ties to BMGF and Pfizer, himself was a problematic organizer for this trial.
"The Digger" in several posts in his substack goes into the problems you noted and other issues with the trial in several posts including these following posts:
https://philharper.substack.com/p/a-closer-look-at-the-drop-out-issue?s=r
https://philharper.substack.com/p/death-count-altered-in-the-together?s=r
https://philharper.substack.com/p/who-ran-the-negative-press-campaign?s=r
###
Thanks, I'll take a look - Modern Discontent also did a nice overview of the flaws https://moderndiscontent.substack.com/p/does-anyone-bother-reading-studies
Right, I would say the not with protocol thing is the most important. In my opinion doctors should just go with what they believe works and all this obsession on RCTs is just intentional rigging of the field to begin with. *edit: One thing I would note is that Together was really slow to publish after the Mills' video presentation on August 6 2021, which seems weird if the entire thing was a work of specific intentional sabotage rather than a generically flawed RCT.
Thanks that's a good post, and further illustrates that "per protocol" meant that this study was really just a mess. So either they have one method in the investigative arm and one in the control arm, or they have the same number of protocols and demographic mix in both arms. The better design would have been to have multiple days in both arms. Thus they should have had 1 day ivm vs 1 day placebo, 3 day ivm vs 3 day placebo, 5 day ivm vs 5 day placebo, and 8 day ivm vs 8 day placebo. They should have also given these various days of IVM and the placebo in the context of the entire treatment strategy (eg. I-MASK protocol w. zinc, vit C & D, melatonin, etc) as well as with food.
Funny, just noticed your edit...I got a chance to speak with Dr. Kory face to face for about 10 minutes about this study, and he pretty much believed (as you would suspect) that the trial was set-up to fail. When you look at how this trial and a prior one published in JAMA were publicized, that sort of seems to be the case. Get a poorly designed and executed study into a major journal and then have all the legacy media outlets reference that study as the indisputable "science" that "proves" that an off patent repurposed drug doesn't work. Therefore, we need new on patent drugs and vaccines to "save" us from the deadly virus as defined by all the fear porn. This insures that pharma will be able to get lucrative government contracts for wealthy nations where those wealthy nations pay 40 to 60 times production costs for drugs and vaccines that tax payers originally funded the development of.
Right, that would be the normal assumption. But if this weapon was ready back in August (https://rethinkingclinicaltrials.org/news/august-6-2021-early-treatment-of-covid-19-with-repurposed-therapies-the-together-adaptive-platform-trial-edward-mills-phd-frcp/) it seems weird that it wasn't fired off at the height of the media attacks, in fact it arrived after the FLCCC shuffled their recommendations in light of Omicron. But who knows.
Maybe they were just waiting for the peer review and publication to occur in a major journal, since so many people seem to think that peer review is the end all be all especially when it occurs in a major journal like NEJM, JAMA , Nature or Lancet.
A bit of a weird question James but do you know anything about High omega 6 diets, resulting in glutathione depletion, as one of the factors that are making children more likely to be hurt by heavy metal toxicity.
It would mean that we aren't just hurting more children by giving them more toxic metals and at younger ages. We are actually creating children that are less and less able to clear out those toxic metals.
What this means is what was a "safe" dose of Mercury or Alluminium* to a child in the 1850's (a dose that would harm 1 in a million kids) would be more dangerous to a child in the 1950's (1 in 10,000) and even more dangerous to a child born after the 1980's (1 in 10)
Seed oils were introduced into our diet around 1870's but there was a massive increase in the 1950's and 1970's.
We also started feeding babies Soy milk. So they were getting a bigger blast of omega 6 from an earlier age. Omega 6 in the diet does seem to concentrate in mothers milk so depending on her diet breast milk could be high in Linolaic Acid.
*Not that I'm saying there is such a thing as a safe dose!
Mercola writes about this. The issue isn't just omega 6 but specifically oxidized omega 6. Raw nuts are shown to be healthy in general, for example. Oxidized omega 3 is even worse. Nobody should ever fry with seed or nut oils.
Thank you for this analysis. This study was promoted as part of a coordinated propaganda campaign with major newspapers, news outlets.
Within 7 days? Why so long? Why not within 24 hours?
I've known people who were ill with covid then got better by the 3rd day. By the time that person got treatment in this study they could have already been 4 days out from feeling better again.
"We have a new cancer drug! But we have to give it to people who have been in remission for a decade"
Uhh ok?
They're so desperate to cover them themselves retroactively for blocking us from using Ivermectin that they'll publish anything. When I was training (a million years ago) we revered the New England Journal of Medicine, and Lancet. They were like gods to us. I don't know if they've just gone way down hill due to politics, or if they were always bad and we just didn't realize it at the time. It's really scary.
Good points! Also, dose and duration were messed up. Also, no zinc, etc. Crap study,
Early treatment is key. 72 hours is the magic window.
A study from Peru by Accinelli, et. al., made it clear about the treatment window.
https://www.sciencedirect.com/science/article/pii/S1477893921002040
Where in the original post's study are the statistics for time from symptom onset to first treatment?
Without those statistics, the study from the New England Journal of Misinformation is worthless.
Thank you for pointing out a major flaw in this study.
Also, the potential conflicts of interests are troubling. For example, the corresponding author Craig Rayner lists funding from the Gates Foundation and under "not related to ivermectin": the Australian government, Pfizer, Astrazeneca, etc. Other authors indicate financial relationships from organizations such as Fast Grants and Rainwater Charitable Foundation that may be preferentially selecting researchers favorable to Big Pharma and not repurposed drugs - this is outside of my wheelhouse so cannot comment.
https://www.nejm.org/doi/suppl/10.1056/NEJMoa2115869/suppl_file/nejmoa2115869_disclosures.pdf
Where were the RCTs on the faccines?!
James Lyons-Weiler is like those "meddling kids" of Scooby Doo. Thanks for taking the mask off this latest scam!
🤣🤣🤣
They won't stop.
Ivermectin became suspicious after it was permitted:
https://rayhorvaththesource.substack.com/p/further-considerations-about-ivermectin