Great work Alex. I've just noticed that Edward Mills is the supervising author for this study but works for Cytel. He declares this on his form, and also his funding from the BMGF. But he doesn't declare his collaboration with Kristian Thorlund and Kyle Sheldrick in the pseudo-attack on molnupiravir (https://pubmed.ncbi.nlm.nih.gov/35294804/). At the same time the conflict form includes two dates of submission - 21st Nov 2021 and 24th Feb 2022. This happens if there have been late additions to the authorship, after it was first submitted. The additional authorship relates to Craig Rayner who appears to be the late arrival and has multiple conflicts including Pfizer and the Australian government. The conflicts document is here (https://www.nejm.org/doi/suppl/10.1056/NEJMoa2115869/suppl_file/nejmoa2115869_disclosures.pdf). He is the founder of Certara, an organisation that is putatively involved in finding repurposed drugs. I would hazard a guess that the only repurposed drugs they have found for anything would be very expensive patented drugs, but that would be cynical. The whole thing stinks
Whatever the reason, that would never happen in clinical medicine. It is bizarre. Rayner and Harari are very overpublished. I suspect they are synthesising data for ghost written publications
Thank you for all that hard work, I love your penetrating and evenhanded analyses. But keeping it simple - IVM should be given within the first few days - 4 at most, preferably sooner. This trial as I understand it allowed 7 days from symptom onset - 8 in some cases including drug transport. Doesn't that invalidate the trial right then and there?
I’m very grateful to the people that look controversy in the eye and make the effort to expose this stinky business. The information is empowering - I feel I can make better health choices for myself and my family, and have gained a deep understanding of why and how my GP might (unwittingly) be uninformed.
Bravo! The most important factor: there was no interest in controlling if the people in the placebo arm started taking IVM (and other treatments) off protocol, considering everyone knew IVM was THE cure, and that you needed at least 5 days of IVM. More here: http://bit.ly/research2000
What a lot of work Alexandria! I would have liked to have seen doctors from the FLCCC comment on this along with Laurie, Rose, Ritsch etc. I wish those I know who refuse to look at preventatives read this, but their minds are already only in step with the fda, cdc, NEJM and whoever else is against repurposed drugs and natural herd immunity.
I don’t know if anyone pointed this out yet, but Merck’s own literature suggests 2.5x serum amplification with meal. i think your data was incorrect. . Dr. Charusa thinks you get an additional 50% with some butter. Beer also amplifies
Point being PK is a huge miss on this trial. Pointing the finger FDA by Boulware and Mills doesn’t cut it. Hard stop. Hard fail. FOIA all communication for public inquiry between FDA and Boulware/Mills
Good point, I didn't know merck had this in their docs, that's super useful. I think the 2,5x increase is the same as the ~150% increase I described, said differently.
Why do you write "it’s unclear why they would choose a dose that was far less than the consensus recommendation at the time and for which absolutely no support of effectiveness existed." when the amended protocol specifies 400ug/kg/day for three days, which was clearly right in the heart of the FLCCC recommendation?
Two doses were only recommended if your symptoms stopped so I don't think it applies, though in fairness I did go back and check earlier protocols from December 2020 and they do recommend 2 doses at 200mcg. So I've clarified the language somewhat.
It's important to note that the criticism still stands however: the original TOGETHER protocol actually stopped scaling the dose at 60kg, meaning that the average dose being given would be far less than 400mcg, maybe even less than 250mcg. The FLCCC protocol never had weight limits. In addition, the FLCCC protocols tend to make sure the patient gets *at least* the dose defined. In the low-dose TOGETHER ivm protocol, while a 60kg patient would get 4 tablets of 6mg (which would in fact be 400mcg) a 59kg patient would be given 3 tablets, which is actually 305mcg/kg. You'd have to go down to 45kg to get back to 400mcg, and only under that would you have some dosing above 400mcg, but arguably a patient under 45kg would be a small minority in a trial with a median BMI of 30. On the other hand, a patient weighing 120kg would get the equivalent of 200mcg, and higher weights would get even lower per-kg doses.
What I generally don't understand is the stinginess with the dose. The drug's safety is not seriously contested, and if we want to truly answer once and for all if a drug works, why be stingy with the dose? Give a high dose without asterisks so we don't have to have these kinds of debates.
Several studies using ivermectin for either prophylaxis or treatment purposes have used the drug in a single dose, which ranges from 150-250 μg / kg.
Similar to the studies that used ivermectin as an antiparasitic, we chose to use the fixed dose scheme by weight range. Thus, patients weighing less than 60 kg will receive 12 mg of ivermectin, between 60 to 80 kg will receive the dose of 18 mg and patients weighing over 80 kg will receive the dose of 24 mg of ivermectin. This dose has been shown to be safe in these studies and in studies in patients with COVID-19.
The literature data regarding an extra dose are conflicting, and therefore in this study, we will choose to use the single dose.”
Personally, I don’t think they made the *right* original decision, but I understand where they were coming from in light of this explanation. I don’t think the original choice warrants criticism, and I respect the fact that they took further input from the advocate community and adapted. While it’s true that FLCCC bumped up the dosages as high as .4-.6mg/kg during delta, I seem to recall Kory admitting in a FLCCC webinar that was based more on hunch than any scientific evidence. And I was aware of other alt med doctors still prescribing only .2mg/kg around that time. So I can understand how the leaders of the trial tried to aim toward a reasonable middle ground. but do I wish they had used .4-.6mg/kg for 3+ days without limiting by weight and without instructing only to take on empty stomach? Yes I very much do.
`I did my own research and found that there is no new district disease and no evidence what so ever for a viral cause of the old diseases IT's interesting to see who are the ones supporting the uncontrolled, invalid virology experiments and continuing the virus narrative of the globalists. https://odysee.com/@drsambailey:c/Secrets-of-Virology-Control-Experiments:e
I do have one quibble, though it may just be confusion on my part. You share Steve Kirsch's quote of Dr. Mills above. Yes, that quote appears on Kirsch's page, but right before it Kirsch adds the disclaimer "The bold is mine." Thus, it's not at all clear that the bold statements were written by Dr. Mills -- only Kirsch knows -- and they're are certainly the most incredible portions of the quote.
I think "the bold is mine" is Steve's way of writing "emphasis mine", a standard way of noting you are emphasizing words in a direct quotation.
If it wasn't mills' quote, it would not be in quotes, and I would expect he would have said as much, given the gravity of the statements.
But really, the actual answer is that Steve just emphasized what he believed to be the important parts, and this was his way of declaring that. I find it hard to believe it's anything else.
But it's a worthwhile question and thank you for asking!
Don’t know but it wouldn’t surprise if he has? Apparently he has requested the IPD regarding the mortality anomalies, will be interesting to see if he actually gets the data and if so what he makes of it
Nobody outside the trial staff has gotten access to the data. And this particular person is the last person I would trust to be an independent arbiter.
It will be interesting to see if they give GMK or Kyle Sheldrick the IPD and not you...that would be a real cause for concern.
In regards to the paper, the anomalies you describe are perfectly ok if mentioned in the discussion and summarised in the abstract. However, both of these things failed to occur and certainly the paper does not justify banner headlines in major papers such as “Ivermectin has no effect whatsoever” etc.
In terms of moving forward, I don’t think you will get very far by yourself, not even if you wrote a letter to the editor go-signed by Kory, McCulloch, Phil Harper et al.
I think you need to reach out to someone who the NEJM finds indisputably credible, run your concerns past them and ask them to co-sign the letter to the editor. Not sure who this “indisputably credible” person is but that is your only hope.
They’ll ignore you until they’re legally bound not to.
Good luck, I admire your dedication and attention to detail
Phenomenal work.
Yes, phenomenal! Thanks so much!
Great work Alex. I've just noticed that Edward Mills is the supervising author for this study but works for Cytel. He declares this on his form, and also his funding from the BMGF. But he doesn't declare his collaboration with Kristian Thorlund and Kyle Sheldrick in the pseudo-attack on molnupiravir (https://pubmed.ncbi.nlm.nih.gov/35294804/). At the same time the conflict form includes two dates of submission - 21st Nov 2021 and 24th Feb 2022. This happens if there have been late additions to the authorship, after it was first submitted. The additional authorship relates to Craig Rayner who appears to be the late arrival and has multiple conflicts including Pfizer and the Australian government. The conflicts document is here (https://www.nejm.org/doi/suppl/10.1056/NEJMoa2115869/suppl_file/nejmoa2115869_disclosures.pdf). He is the founder of Certara, an organisation that is putatively involved in finding repurposed drugs. I would hazard a guess that the only repurposed drugs they have found for anything would be very expensive patented drugs, but that would be cynical. The whole thing stinks
Fascinating. It seems they changed who the corresponding author is from Mills to Rayner. Maybe Rayner took responsibility for the manuscript?
Whatever the reason, that would never happen in clinical medicine. It is bizarre. Rayner and Harari are very overpublished. I suspect they are synthesising data for ghost written publications
Follow the science?
I just see red flags everywhere, since March 2020
A little OT... enjoy ... addictive song
https://video.thesetruths.com/Su7rhdh/shoot-any-booster/
It has all the hallmarks of a ghost written article.
I don't know if it was still the case at the time of this trial, but I came across this when researching an early trial on HCQ: (https://revivethera.com/2020/03/revive-therapeutics-appoints-dr-david-boulware-md-as-scientific-advisor-for-infectious-diseases-including-covid-19/). The article that this was linked from indicated that Revive was, in March of 2020, repurposing one of their drugs to re-release for Covid-19.
Thank you for all that hard work, I love your penetrating and evenhanded analyses. But keeping it simple - IVM should be given within the first few days - 4 at most, preferably sooner. This trial as I understand it allowed 7 days from symptom onset - 8 in some cases including drug transport. Doesn't that invalidate the trial right then and there?
I’m very grateful to the people that look controversy in the eye and make the effort to expose this stinky business. The information is empowering - I feel I can make better health choices for myself and my family, and have gained a deep understanding of why and how my GP might (unwittingly) be uninformed.
Bravo! The most important factor: there was no interest in controlling if the people in the placebo arm started taking IVM (and other treatments) off protocol, considering everyone knew IVM was THE cure, and that you needed at least 5 days of IVM. More here: http://bit.ly/research2000
What a lot of work Alexandria! I would have liked to have seen doctors from the FLCCC comment on this along with Laurie, Rose, Ritsch etc. I wish those I know who refuse to look at preventatives read this, but their minds are already only in step with the fda, cdc, NEJM and whoever else is against repurposed drugs and natural herd immunity.
I don’t know if anyone pointed this out yet, but Merck’s own literature suggests 2.5x serum amplification with meal. i think your data was incorrect. . Dr. Charusa thinks you get an additional 50% with some butter. Beer also amplifies
Point being PK is a huge miss on this trial. Pointing the finger FDA by Boulware and Mills doesn’t cut it. Hard stop. Hard fail. FOIA all communication for public inquiry between FDA and Boulware/Mills
https://pbs.twimg.com/media/FCDvUTCWYAITiKo?format=jpg&name=large
Good point, I didn't know merck had this in their docs, that's super useful. I think the 2,5x increase is the same as the ~150% increase I described, said differently.
Many thanks, your efforts are so fully evident on dark horse with Bret
Thank you for your brilliant work Alexandros.
Thanks man, clear and comprehensible. You're doing great work.
This is phenomenal research and reporting!!!!
Why do you write "it’s unclear why they would choose a dose that was far less than the consensus recommendation at the time and for which absolutely no support of effectiveness existed." when the amended protocol specifies 400ug/kg/day for three days, which was clearly right in the heart of the FLCCC recommendation?
I think that particular comment was referring to the prior dose of 1x400mcg dose
Even that was within the FLCCC protocol dose, which was 200mcg/kg for 2-5 days.
Two doses were only recommended if your symptoms stopped so I don't think it applies, though in fairness I did go back and check earlier protocols from December 2020 and they do recommend 2 doses at 200mcg. So I've clarified the language somewhat.
It's important to note that the criticism still stands however: the original TOGETHER protocol actually stopped scaling the dose at 60kg, meaning that the average dose being given would be far less than 400mcg, maybe even less than 250mcg. The FLCCC protocol never had weight limits. In addition, the FLCCC protocols tend to make sure the patient gets *at least* the dose defined. In the low-dose TOGETHER ivm protocol, while a 60kg patient would get 4 tablets of 6mg (which would in fact be 400mcg) a 59kg patient would be given 3 tablets, which is actually 305mcg/kg. You'd have to go down to 45kg to get back to 400mcg, and only under that would you have some dosing above 400mcg, but arguably a patient under 45kg would be a small minority in a trial with a median BMI of 30. On the other hand, a patient weighing 120kg would get the equivalent of 200mcg, and higher weights would get even lower per-kg doses.
What I generally don't understand is the stinginess with the dose. The drug's safety is not seriously contested, and if we want to truly answer once and for all if a drug works, why be stingy with the dose? Give a high dose without asterisks so we don't have to have these kinds of debates.
As it turns out, they did provide some clarity on their original choice @ https://static1.squarespace.com/static/6112a257d1c1153666ccb987/t/620ebfe2b4812a71ede603a1/1645133795401/EN+-+Protocol_research_COVID19_AMB_02_Brazil_v1.0_17Dec2020.pdf :
“3.6.2 Ivermectin
Several studies using ivermectin for either prophylaxis or treatment purposes have used the drug in a single dose, which ranges from 150-250 μg / kg.
Similar to the studies that used ivermectin as an antiparasitic, we chose to use the fixed dose scheme by weight range. Thus, patients weighing less than 60 kg will receive 12 mg of ivermectin, between 60 to 80 kg will receive the dose of 18 mg and patients weighing over 80 kg will receive the dose of 24 mg of ivermectin. This dose has been shown to be safe in these studies and in studies in patients with COVID-19.
The literature data regarding an extra dose are conflicting, and therefore in this study, we will choose to use the single dose.”
Personally, I don’t think they made the *right* original decision, but I understand where they were coming from in light of this explanation. I don’t think the original choice warrants criticism, and I respect the fact that they took further input from the advocate community and adapted. While it’s true that FLCCC bumped up the dosages as high as .4-.6mg/kg during delta, I seem to recall Kory admitting in a FLCCC webinar that was based more on hunch than any scientific evidence. And I was aware of other alt med doctors still prescribing only .2mg/kg around that time. So I can understand how the leaders of the trial tried to aim toward a reasonable middle ground. but do I wish they had used .4-.6mg/kg for 3+ days without limiting by weight and without instructing only to take on empty stomach? Yes I very much do.
It's the weight limit that has no support in literature. The use of an antiparasitic dose for an antiviral use had been described, as thin as it is.
And I think it’s fair to focus the criticism on that issue more specifically
`I did my own research and found that there is no new district disease and no evidence what so ever for a viral cause of the old diseases IT's interesting to see who are the ones supporting the uncontrolled, invalid virology experiments and continuing the virus narrative of the globalists. https://odysee.com/@drsambailey:c/Secrets-of-Virology-Control-Experiments:e
The is NO evidence of a virus; lab or wet market or other wise https://georgiedonny.substack.com/p/seeing-is-believing
Jo
Hey, the monkey pox business has got me doing my own research on the original and worst vaccine- small pox https://georgiedonny.substack.com/p/lets-hope-the-monkey-pox-nonsense?s=w you may be interested. Thanks, Jo
Fascinating analysis.
I do have one quibble, though it may just be confusion on my part. You share Steve Kirsch's quote of Dr. Mills above. Yes, that quote appears on Kirsch's page, but right before it Kirsch adds the disclaimer "The bold is mine." Thus, it's not at all clear that the bold statements were written by Dr. Mills -- only Kirsch knows -- and they're are certainly the most incredible portions of the quote.
I think "the bold is mine" is Steve's way of writing "emphasis mine", a standard way of noting you are emphasizing words in a direct quotation.
If it wasn't mills' quote, it would not be in quotes, and I would expect he would have said as much, given the gravity of the statements.
But really, the actual answer is that Steve just emphasized what he believed to be the important parts, and this was his way of declaring that. I find it hard to believe it's anything else.
But it's a worthwhile question and thank you for asking!
Apparently an expert has concluded that nothing untoward happened in the Together Trial (except the mortality data!)
https://mobile.twitter.com/GidMK/status/1510862614452404226
Has this expert perhaps collaborated with people from the TOGETHER trial on anything recently?
Don’t know but it wouldn’t surprise if he has? Apparently he has requested the IPD regarding the mortality anomalies, will be interesting to see if he actually gets the data and if so what he makes of it
Nobody outside the trial staff has gotten access to the data. And this particular person is the last person I would trust to be an independent arbiter.
It will be interesting to see if they give GMK or Kyle Sheldrick the IPD and not you...that would be a real cause for concern.
In regards to the paper, the anomalies you describe are perfectly ok if mentioned in the discussion and summarised in the abstract. However, both of these things failed to occur and certainly the paper does not justify banner headlines in major papers such as “Ivermectin has no effect whatsoever” etc.
In terms of moving forward, I don’t think you will get very far by yourself, not even if you wrote a letter to the editor go-signed by Kory, McCulloch, Phil Harper et al.
I think you need to reach out to someone who the NEJM finds indisputably credible, run your concerns past them and ask them to co-sign the letter to the editor. Not sure who this “indisputably credible” person is but that is your only hope.
They’ll ignore you until they’re legally bound not to.
Good luck, I admire your dedication and attention to detail