The False, Sinister, and Duplicitous Statements of the TOGETHER Ivermectin Trial Investigators

This is my third and last post on the fraudulent TOGETHER trial and it’s investigators as I am just done with it. I hope that the my global network of colleagues trying to expose this fraudulence have better success than I had so far.

Anyway, in Part 1, I introduced the trial in the context of a decades-long Disinformation war waged by Big Pharma (using tactics pioneered and perfected by Big Tobacco) against generic, repurposed drugs like ivermectin. In Part 2, I detailed the most brazen of a multitude (47 to be exact) of actions consistent with the aim of producing a “negative trial”, with these actions committed in both the design and conduct of the TOGETHER trial, by a group of the most deeply Pharma-conflicted study investigators of any trial in the pandemic. They brought out the superstars for this one.

I have long wondered how the investigator’s conduct can be so blatant and obvious. I only recently concluded that it is because… they don’t have to be subtle. It just doesn’t matter. The newspaper headlines are out across the world and the NIH has quietly changed its recommendation from neutral to now “against the use of ivermectin outside a clinical trial.” Which leaves us arguing over the bomb fragments of a massive detonation of what could have been world-changing and life-saving Public Health policy.

I remind all, again, that my accusations of fraud could be easily refuted or clarified, simply by an open sharing of the patient-level data by these investigators. That they refuse, even with their own outside colleagues, despite promising repeatedly to do so, is to me, damning and definitive evidence of massive fraud. What is hilarious is that instead of sharing with the public, they instead claim to have parked the data behind an organization called ICODA… funded by Bill Gates. See below. What is even more telling.. is that on the ICODA website, the trial is not even listed. Again, not subtle.

Now, to the point of this third post. In the past year, I have been privy to comments uttered or written both publicly and semi-privately by several investigators of the TOGETHER trial. I will present them here. I believe they add another pillar of evidence supporting the conclusion of fraud as they lend disturbing insight into the people who designed and conducted the trial. Liars at a minimum. You be the judge for whatever else you think they are. So buckle your seatbelts because it gets weird, disturbing, and infuriating.

First, who are these investigators? From the C19early.com group:
Possibly the largest financial conflict of interest of any trial to date. Disclosed conflicts of interest include: Pfizer, Merck, Bill & Melinda Gates Foundation, Australian Government, Medicines Development for Global Health, Novaquest, Regeneron, AstraZeneca, Daichi Sankyo, Commonwealth Science and Research Organization, and Card Research. Many conflicts of interest appear unreported. For example, Unitaid is a sponsor [Harper, togethertrial.com (B)].
Analysis done by a company that receives payment from and works closely with Pfizer. All analyses were done by Cytel. Cytel is a statistical modelling company that helps pharmaceutical companies get approval — they work very closely with Pfizer [cytel.com]. Cytel’s software and services are used by the top 30 pharmaceutical companies [cytel.com (B)].

A co-principal investigator (Ed Mills) works for Cytel and the Gates Foundation [empendium.com]: “The majority of the time I work for a company called Cytel, where I design clinical trials, predominantly for the Bill & Melinda Gates Foundation”.
The first author (Gilmar Reis) runs a company that survives on contracts from pharmaceutical companies. His research company has never done a trial on any generic drug. Note that, per the c19early.com group, “independent investigators without conflicts of interest) tried to participate in the trial but were denied [odysee.com (B)]. “The independent, non-conflicted investigator who was denied participation in the trial was none other than the FLCCC’s Dr. Flavio Cadegiani. I wonder if it was his integrity, ethics, professionalism, humanity and intelligence that disqualified him? Or was it the fact he was treating the COVID gamma variant with double the dose of ivermectin for three times as long as the study’s protocol? Again, from the c19early.com group:
The Gates Foundation is a founding partner of GAVI, which took out Google ads telling people not to use ivermectin [twitter.com (V)], and a major funder of Unitaid, which (my words here)… modified the results of the Hill meta analysis in a way that prevented adoption [c19ivermectin.com, c19ivermectin.com (B), twitter.com (C)].
Associated with MMS Holdings. The trial is associated with MMS Holdings [dcricollab.dcri.duke.edu], whose mission includes helping pharmaceutical companies get approval and designing scientific studies that help them get approval. One of their clients is Pfizer [mmsholdings.com].
Certara. One of the senior investigators was Dr. Craig Rayner, President of Integrated Drug Development at Certara – another company with a similar mission to MMS Holdings. They state on their website that: “Since 2014, our customers have received over 90% of new drug and biologic approvals by the FDA.” One of their clients is Pfizer [certara.com]. Craig Rayner has had previous financial relationships with: Bill & Melinda Gates Foundation ✔ Medicines Development for Global Health ✔ Novaquest ✔ Regeneron ✔Merck ✔ Astrazeneca ✔Pfizer ✔ Daichi Sankyo ✔ Commonwealth Science and Research Organization ✔
I wonder what all these investigators’ prospects are for future pharmaceutical company contracts if they blow up a 100 billion dollar market for COVID-19 vaccines and pharmaceuticals by proving the preventive and therapeutic efficacy of a generic drug?

I should remind myself here that some supporters have told me to be careful because I am “poking the 100 billion dollar bear” with these posts. It’s not that I am brave in that way, but rather that I think they would have taken me out long ago and that now it no longer matters because Big Pharma just doesn’t give a shit anymore about ivermectin. They already won the battle, the TOGETHER trial was just the final blow – no advanced health economy in the world recommends it. The NIH just reversed the “neutral” recommendation that Paul Marik and myself got them to make. To see just how wickedly effective this Disinformation campaign was, check out this recent editorial in the Annals of Emergency Medicine. One of the top-rated journals in that field, regurgitating propaganda with zero awareness. If they ever start wondering why everyone I meet is terrified about going to an establishment doctor or hospital, I will point them to this editorial.

OK, so let’s review the lies, attacks, and duplicitous statements made by some of these folks, in particular those of Ed Mills, David Boulware and Craig Rayner.

Let’s start with the duplicitous statements about the trial conclusions, uttered by Ed Mills and David Boulware. I don’t want to spend too much time on this as the brilliant journalist/filmmaker Phil Harper already nailed them for these in his substack called “The Digger,” where he argued that their statements are 100% in-line with a public relations campaign against ivermectin. Although this characterization is completely unsurprising to me, what I find intriguing is that their private, conflicting, positive statements supporting ivermectin (i.e. duplicitous) just might reflect a conscience. However weak or remote it may reside in their soul. Or it could just be they are trying to feign some sort of intellectual honesty among their academic colleagues to preserve their professional reputations. Yeah, let’s go with that one.

Let’s start with what Ed Mills told a colleague named Marc Rendell, an exchange published by Steve Kirsch in his substack post on the TOGETHER trial (I will tell you that this is the very last correspondence between Ed Mills and Marc Rendell, given that all subsequent emails from Rendell to Mills have gone unanswered). Hmm. Anyway:

Here’s the reply from Ed Mills to Marc Rendell on April 3, 2022:
Hi Marc

I hope you are well. Thank you for your email. You have been the only person courteous enough to ask the questions.

I don’t understand the psychology of the ivermectin advocates. They fail to see the positive in this study and just focus on it not being overwhelmingly positive. I actually think it is quite positive.

I presented this a couple weeks ago at the NIH Collaboratory Rounds and, if they listened, I advocate that actually, there is a clear signal that IVM works in COVID patients, just that our study didn’t achieve significance. In particular, there was a 17% reduction in hospitalizations that would be significant if more patients were added. I really don’t view our study as negative and, also in that talk, you will hear me retract previous statements where I had been previously negative. I think if we had continued randomizing a few hundred more patients, it would have likely been significant.
The idea that Mills might have a conscience also stems from another exchange after his NIH presentation. Frank Harrell, a Professor of Biostatistics asked Mills, “When you have a confidence interval that goes all the way down to a 30% reduction in relative risk, the question of whether the trial was stopped too early in light of the political ramifications of needing to demonstrate that the efficacy is really unimpressive, it really could be raised as a logical question…. ”

“Any reaction to that?” asked the host.

“I totally agree with Frank,” Mills said.

What? He “totally agrees” with a statement suggesting that stopping the trial early could have been the result of political motivations? He is the Principal Investigator! Wow, he must have been given truth serum before that presentation because this is what he and Boulware told the newspapers instead:
“Ivermectin did not result in a lower incidence of medical admission to a hospital,” Edward Mills in TOGETHER paper, March 30th 2022.

Here is the headline that statement generated:

Also, he said this to another newspaper:
“There was no indication that ivermectin is clinically useful”, Edward Mills quote March 18th 2022

In the New York Times: “There’s really no sign of any benefit,” said Dr. David Boulware, an infectious-disease expert at the University of Minnesota.
I guess David wasn’t paying attention during the NIH presentation. “No sign of ANY benefit?” Maybe he and Mills should get their stories straight. Or not. Seems it was best for them to tell the papers one thing and the exact opposite to the academic community.

Boulware goes even further to try to destroy ivermectin. In that same article, the NY Times quotes him as follows, “Now that people can dive into the details and the data, hopefully that will steer the majority of doctors away from ivermectin towards other therapies,” Dr. Boulware said.

Umm, diving into the details and the data actually finds that there are tons of evidence to show they buried, hid, and manipulated the evidence of efficacy to show their non-statistically significant evidence of benefit. My colleagues (chief among them being Alexandros Marinos whose posts on the TOGETHER trial are a masterwork) have done deep dives into the data by scouring the published manuscripts, protocols, and presentations of all the repurposed medicines studied in the TOGETHER trial. Their conclusion, based on the blatantly withheld data along with the to-date-unrefuted evidence of manipulation of multiple control groups in violation of the study protocol, is that the investigators are hiding the finding of a massive benefit of ivermectin. Boulware’s invitation to “dive into the details and the data” is a farce. What data David? You mean the data you are having Gates hide for you behind ICODA?

Now, lets examine the numerous statements that Ed Mills has given in defending the 3-day dose used in the trial.

What follows is that Ed Mills, a year ago, wrote that they changed the protocol from one day only (I laugh each time I read that) to three days only, and that this decision was based on Andrew Hill’s work because he had shown a “dose-response” in his early pre-print posted on January 19th, 2021 (i.e. “dose-response” means that the higher the dose, the more potent the benefit).

To wit, see his email below to Steve Kirsch and Filipe Rafaele in March of 2021, two deeply researched observers and/or funders of therapeutic trials (Kirsch) in COVID. Note that I am cc’ed on a number of these emails). I have redacted all email addresses but in this one below, Mill’s email was literally one ending with @cytel.com. Hilarious.
From: Edward Mills <>
Sent: Saturday, March 6, 2021 4:48 PM
To: Steve Kirsch
Cc: filipe rafaeli Pierre Kory Patrick Collison
Subject: Re: IVM under dosing in Brazil trial
We are doing three days of dosing. The original protocol had one day of dosing, which was used back in January, when we submitted this for approvals at the ethics and national bodies. It then changed to three days of dosing after an amendment based on emerging trials from Andrew Hill’s synthesis. I have already explained that on several occasions.  Thats what is being administered. Clinicaltrials.gov  needs to be updated. Clinicaltrials.gov is not a protocol, its a registry. Gates funded the first part of this trial, when we evaluated HCQ and lopinavir vs placebo

Editorial interlude (PK): Of course Gates did – HCQ was actually the “OG” (original gangster) of repurposed drugs in COVID, and man did they murder that drug using a submachine gun of fraudulent trials). Back to Mills:

Thats why they are on the website. Again, this has been clearly explained in the past.
We will do an interim analysis after 800 patients. We aren’t making any changes until then.

Ed

Anyway, back to the emails. Filipe replies:
On Mar 15, 2021, at 11:00 AM, filipe rafaeli <> wrote:
Hello Edward,

Nine days ago, you said: “There will be an updated protocol on the website in the next few days that is far more elaborate”. https://clinicaltrials.gov/ct2/show/NCT04727424?cond=Covid19&intr=ivermectin&draw=6&rank=49. In the website, it is still saying that is single dose: “Drug: Ivermectin Tablets – 06 mg oral tablet: Three tablets if weight 40 – 60 kg, single dose; Four tablets if weight > 60 kg, single dose”. Do you have any news about this?

Filipe
Ed Mills writes back.
Em ter., 16 de mar. de 2021 às 02:35, Edward Mills < escreveu:
I have come across your previous articles and I abhor your views on everything.     Your admiration for Josef Mengele is disgusting.

I have no sympathies for nazis, under any circumstances. Never, ever. These were people that were killed, I knew them and I knew their families.  Your views disgust me. I suggest no-one else on this email thread supports you either, Please, never contact me again. Your hate will not win.
Fuck you
 Ed

Whoa. Crazy town. Filipe goes on to school him below. Note how at the end, in his post-script, Filipe predicts the exact nonsense that Ed will pull in his hydroxychloroquine trial.

Em ter., 16 de mar. de 2021 às 03:54, filipe rafaeli <> escreveu:
Edward,

If you understood, after reading the entire article, that I am an admirer of Mengele, you are either illiterate or cognitively impaired.

I have no admiration for Mengele. I am a Latin American leftist. I am a socialist. Here I know what fascism is. Here I know what dictatorship is. I am an anti-fascist. My grandfather was arrested during the Brazilian dictatorship (64-85). By the fascist military with machine guns. I have friends who were tortured.

Do you want to know why I mentioned Mengele? Because I remembered him.

I remembered Mengele when I read “studies” by “scientists” with hydroxychloroquine and ivermectin.

I remembered Mengele when I saw “scientists” administering low dose or overdose. “It doesn’t work.”

I remembered Mengele when I saw “scientists” giving medicines at the time of extreme unction. “It doesn’t work.”

I remembered Mengele seeing “studies” that stopped when they were partially positive, before statistical significance. “It doesn’t work.”

I remembered Mengele when a fake study was published which justified stopping several studies with HCQ when they were partially positive. And after the hoax was revealed, I remembered Mengele again because those studies were not resumed.

I remembered Mengele when Kory and Marik’s study was censored after peer review.

All by coincidence, of course.

And I always remember Mengele every time I see a “scientist” seeking power, positions, and money instead of saving lives.

Read the entire article, word for word, twice, and do your work.

PS: I am curious about the result with your HCQ study. I saw that you are very excited.
– I hope it is not too small (Impossible to achieve statistical significance this way)
– I hope it is not “early treatment” after 5 – 7 days of symptom.
– I hope it is not in patients outside the risk group.
– I hope it wasn’t at too low a dose (Impossible to achieve statistical significance this way).

Filipe

After Mill’s HCQ trial gets published in JAMA, Filipe wrote again. Check it out:

Date: sáb., 24 de abr. de 2021 às 17:26
Subject: Re: IVM under dosing in Brazil trial
To: Edward Mills < Cc: Steve Kirsch, Pierre Kory

Hi Edward,

I have just read your article carefully. https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2779044
You should probably be receiving effusive congratulations. You will have a brilliant career.
Risk of death reduced by 66%.
Risk of hospitalization reduced by 24%.
But it was not statistically significant (it doesn’t work).

Too bad.
[Remember that] on March 16, I played Nostradamus here:

Oh dear, unfortunately it was *finished early*. It was too small, 200 patients! So it was not statistically significant.
Oh dear, unfortunately *more than 80%* of people were
randomized after 5 days of symptom onset.
Oh dear, unfortunately *it was in monotherapy*.

Comment by covid crusher:
“Do not expect the authors to point out that those hospitalization results are entirely and remarkably consistent with the other 4, all identically underpowered, HCQ outpatient RCTs, homogenously pointing to 30%-ish hospitalization benefit”.

My congratulations, Edward. History will be very kind to all the scientists working on this pandemic. I am now waiting for your study with ivermectin. For sure it will be a success!

Filipe

Before we move on, I recommend you read Filipe’s brilliant summary of the “murder” of HCQ in 2020 from his substack “Pandemia”.

 

Pandemia

Yes, hydroxychloroquine is scientifically proven against COVID-19

“He was capable of being so kind to the children, to have them become fond of him”, reported a witness about this man, with a shy smile, from the photograph. With a degree in medicine and a doctorate in anthropology, he was a famous scientist, productive and internationally renowned…

Read more

a year ago · 15 likes · 15 comments · Filipe Rafaeli

 

Now let’s get back to Mills and his other, conflicting statements about how he chose the 3 day dosing. This next one is a brilliant lie and it occurs at the end of a disturbing email exchange with a Canadian pastor (name/email redacted) who had been following ivermectin and was trying to educate his congregation about it.

On Mar 7, 2022, at 6:01 AM, the Canadian Pastor wrote:

Hello Dr Mills,

You may have heard of the interview from Dr Tess Lawrie with Dr Andrew Hill and the suppression of the Ivermectin back in January 2021.

https://rumble.com/vwfia3-a-letter-to-andrew-hill-dr-tess-lawrie-oracle-films.html

Unitaid was the shadow author of Hill’s conclusions.

I hope that in some way the truth of this coverup will come to light.  To think again that hundreds of thousands of lives could have been saved.

XXXX (Pastor)

On Mon, Mar 7, 2022 at 10:19 AM Mills, Edward <> wrote:

Can you please stop emailing me? You have no right to study details any more than anyone else does.

The Pastor replies:

On Mar 7, 2022, at 10:37 AM, XXX> wrote:

I will Dr Mills. Not sure what you meant by having no right to study the details. It doesn’t make sense.  If this Together Trial has been in the same vein as Dr Andrew Hill and the suppression of truth then you and the team are responsible.  If people would step forward and tell the truth.

Ed Mills suddenly attacks the Pastor.

On Mar 7, 2022, at 10:39 AM, Mills, Edward <> wrote:

Fuck off. Pray to your stupid god for insights.

The Pastor sends Ed Mills Alexandros Marino’s post on the TOGETHER trial.

On Mar 20, 2022, at 5:16 PM, XXXX wrote:

The Pastor writes again to Mills.

On Mar 22, 2021 at 7:58 AM XXXX wrote:

Hi Dr Mills,

Thank you for taking on the together trial study at McMaster. We’ve been praying for this and looking forward to hearing results. Dr Carvallo’s study with great results appears on NIH’s website with no results to show.  It seems that the doctors who are finding the results are forced underground to give their findings.  Hoping this is not the case here.

The Pastor again writes to Mills.

On , Mar 22, 2021 at 8:39 AM <XXX > wrote:

Hi Dr Mills,

Dr Carvallo from Argentina forwarded to me his studies/articles. I thought you may be interested. As a Christian, I’m praying that lives will be saved versus needlessly dying.

Ed Mills writes back, and just starts making shit up. Check it out.

From: Ed Mills <(this email was an MTEK sciences email address! See Alexandros Marinos substack here for his deep dive on MTEK’s conflicts of interest).
Date: Mar 22, 2022 at 8:45 PM
Subject: Re: Study
To: XXX

Thank you for your email. We appreciate your interest in clinical trials relevant to COVID and we hope that together, we can identify cheap and effective interventions that can safely help patients in the outpatient setting.

As you are likely aware, this is the largest placebo-controlled clinical trial for COVID. We have successfully identified 11 different interventions in the trial and identified two that are effective – fluvoxamine and peginterferon lambda. We did not find important benefits from ritonavir-lopinavir, hydroxycholoroquine, doxasozin, ivermectin (low and high dose), metformin, or placebo. We are currently evaluating fluvoxamine plus budesonide and fluoxetine plus budesonide versus matching placebos.

For those interested in ivermectin, we greatly appreciate your interest in this important human drug. We appreciate the feedback received by entities such as the FLCCC, early treatment for COVID group, and the thought leaders in those networks. In particular, champions such as Dr. Pierre Kory  have frequently commented on our trial and we particularly appreciate their advice.  They helped advise on the choice of drug dosage, duration, and concomitant medication use. Without their help, perhaps our findings would have been uncertain.  Thanks to FLCCC and the Early Treatment for COVID group we successfully chose their recommended dose, duration and follow-up. Thank you to those entities for your leadership in this area. Without their important questioning of so many pharmaceutical led trials, we would have uncertain evidence. We appreciate the endorsement now of groups such as FLCCC and look forward to working with them closely in the future.  We agree with them that as, as the evidence seems to no longer support ivermectin, other options are, thankfully looking applicable.

All manuscripts will be published in the future in peer-reviewed manuscripts and will be freely available. We cannot provide preprints of the manuscripts or respond to individual requests for data from trials until they are made public. Data may occasionally be made available via academic presentations.

We are grateful for your support of the trials.

The TOGETHER Trialists Collaboration

The largest placebo-controlled trial of COVID in the world.

Glory to Satan.

“Fuck you?” “Glory to Satan?” “Fuck off?” “Go pray to your stupid God?” Calling someone a Mengele sympathizer? These comments are disturbing enough but the gratuitous nonsense about him working with the FLCCC is both hilarious and a 100% falsehood. I have never spoken to him or been consulted on anything to do with the TOGETHER trial or it’s investigators. That guy is hallucinating..and lying. I was asked about dosing by David Boulware, a TOGETHER trial author, way after the trial protocol had been set. Note this is the same Boulware that David Wiseman, with me as co-author, wrote a Letter to the Editor of JAMA about, busting him for false data reporting regarding the dates of (late) delivery of HCQ in his trial. The Letter didn’t get published. Shocker. So we published it on a pre-print server instead. We also attacked the TOGETHER hydroxychloroquine trial, for essentially the same stuff they pulled with ivermectin. It again wasn’t accepted as a Letter, however, they did allow it as a comment under the on-line JAMA publication (go to comments, can find it as the 2nd one down). They all use the same tired playbook. Over and over.. and no-one in academia notices.

Why Mills would write that fantasy about working with the FLCCC to a random pastor is beyond me. Complete and total fabrication. Note that the definition of liar is someone who tells a lie. He even makes it sound like we were invited to and participated in a nuanced committee discussion of dosing strategies. I have never talked to Ed Mills in my life. I have only observed him from afar as I have been privy to way more of his anti-ivermectin comments than I am including here, out of respect to some of my colleagues desire for confidentiality. What is even more hilarious, is that he must have forgotten the relentless attacks on the FLCCC and ivermectin that he spewed in this interview from June 14, 2021 in the Halifax Examiner. In summary, he says that the journal that our comprehensive review paper was published in was “low quality” (it is not), and that the FLCCC “overcalled the importance of our paper,” and, ”that group is actually making it much more difficult to make the science be believed because they’re overcalling the importance of what they’re doing. They should just leave the science to the scientists and allow the clinical trials to complete”. I love it, we should leave the “science to the scientists?”

Let’s talk about Science. The FLCCC’s Paul Marik, Umberto Meduri, Joseph Varon, Jose Iglesias and myself have collectively done research over decades, conducted many trials, and have published over 1,500 peer-reviewed papers in medical journals. But we should leave the science to him? Does that remind anyone of Fauci saying “I am Science?”Also in that interview he said that papers such as ours are “easy to write,” but “good science (what he does) is harder to do.” I don’t think he knows the hundreds of hours of research, scouring of databases, pre-print servers, and reading of papers that went into our review paper. He then invents that the FLCCC has “a well understood agenda promoting ivermectin, and no amount of evidence is likely to change their mind.” Well understood agenda? WTF? If my agenda was to destroy my career. then mission accomplished Ed. I am really good at what I set my mind to apparently.

Now, let’s go to Mill’s third lie about dosing, written right in the damn manuscript, showing that the study is not worth the paper it is printed on. In the sixth paragraph of the manuscript posted on the New England Journal of Medicine website, he again lies, “On the basis of feedback from advocacy groups, we modified the protocol to specify 3 days of administration of ivermectin.”

This statement is consistent with what he told the pastor, i.e. the FLCCC “advocacy group” informed the dosing. I have already stated above that this is false, but it also conflicts with what he told Filipe Rafaele and Steve Kirsch long ago (also above), about how Andy Hill’s work prompted them to change the dosing. It also conflicts with what is the actual truth, which is that the group that got Mills to change the duration of dosing was actually… one of the funders of the trial. Calling them an “advocacy group” is an insult, but let’s say that was who he was referring to in that sentence. Why didn’t he just write the truth, which was “on the basis of feedback from the trial funders?”

I will tell you why. He wanted to be able to defend the dosing decision by saying it is what the FLCCC recommended. This guy lies like a rug. But I am sure he is telling the truth about the rest of the trial. I mean, it was probably just that one little white lie.

Unfortunately he is not a very good liar. My email exchange on dosing with Boulware occurred on May 13th of 2021. Way after the TOGETHER dosing was set. And nowhere do I say it should be limited to just 3 days in an RCT, or that there should be some fraudulent, totally invented 90kg weight limit to the dosing which is one of their most brazen dose-limiting tactics. See my email exchange with Boulware in May, 2021:

From: David Boulware <>
Date: Thursday, May 13, 2021 at 8:19 AM
To: Pierre Kory <>
Subject: Re: Positive Mongolia study on fluoxetine (Prozac) for COVID

Pierre,

What’s a reasonable dose for ivermectin for early mild disease?

RCTs are testing 400 mcg/kg/day x 3 days.

Reasonable?  Too low? Too high?

David

On May 27, 2021, at 8:46 PM, Pierre Kory <> wrote:

400mcg for 3 days is totally reasonable.. but I would go 5 if they did not have a sufficient response/resolution by day 3 . My issue with RCT’s is that they treat too late by definition in almost all acute illness models – for every day later you treat, you need to be more aggressive. So 400mcg is fine for me as a doc when a patient calls me or I get word someone is sick.. but by the time a sick patient is enrolled in an RCT who knows

Other issue is I believe any further placebo controlled RCT’s are unethical – but understand others don’t see the world  that way.. not a surprise – Pierre

Pierre Kory, MD, MPA

President & Chief Medical Officer

Front-Line Covid-19 Critical Care Alliance

So, both Mills and Boulware try to defend the TOGETHER trial dosing by misrepresenting this email exchange. See these tweets below where Boulware actually claims that they received my input in February of 2021. Another blatant lie? Or perhaps he just innocently “misremembered?”

He not only misrepresents what I actually wrote which was that 400mcg/kg for 3 days was perfectly reasonable if I myself was treating them early… and that for a late treating RCT, “who knows what the right dose is” – clearly implying it would have to be higher. He also omits the part about treating for 5 days if not recovered by the 3rd day. He also avoids mentioning that his question to me was posed pre-delta variant in the U.S. We changed our dosing for Delta not long after that email, and even at the time of the email, our dosing was already 0.3mg/kg for 5 days! Also, the U.S dosing had no relation to what Brazilian early treatment docs were doing during the gamma variant, which was already the predominant variant in Brazil when the TOGETHER trial switched their dosing. Note that Gamma was a variant 4 times as fatal with way higher viral loads.

They also ignore the fact that in the same email I tell them that more placebo-controlled trials were unethical. And again, nowhere do I suggest they should put in a 90kg weight limit which would result in a large under-dosing of all overweight (highest risk) patients in the trial. Whatever. Here is Boulware peddling even more nonsense on Twitter just last month.

Oh, and before we move on, let’s just finish with a doozy of a recent attack by Ed Mills on the Pastor. Apparently the Pastor had been tweeting about the Together Trial, asking when results would be coming and also suggesting that the results wouldn’t be accurate. The tweets are not that offensive or accusatory at all actually ( I am not posting to preserve anonymity of the pastor) but here comes Mills out of nowhere, like 6 months after the last tweet, citing a stupid article about how “well-intentioned” researchers like Mills are getting abused on social media. Too funny.

Mills, Edward <>

Fri, Mar 25, 10:21 PM

You are one of these fuckers Pastor. You are a disgusting human being.  Should I tell your congregation? You fucking asshole.  https://www.science.org/content/article/overwhelmed-hate-covid-19-scientists-face-avalanche-abuse-survey-shows

The Pastor Replies.

Thu, Apr 14, 9:36 AM to Edward

Wow, to whom should I relay this disgusting email from a professional?  Tracking with Phil Harper’s detailed description of all that has gone on. .

This next issue is another doozy. Colleen Aldous, a colleague of mine who is a nationally renowned scientist and ivermectin expert in South Africa, wrote to Mills after the NEJM publication. Here is what she wrote:
I have two questions that I cannot work out from the paper and wonder if you can answer them.
There are four sample size numbers provided for the placebo group, 679 ITT, 675 modified ITT, 288 per the protocol and lastly, 587 who stayed per protocol. What is the difference in the make-up of the per-protocol group and the group who stayed per protocol? Were the 299 that make the difference from the other protocols of the TOGETHER trial, as it is implied they were not necessarily the three-day placebo group?
The placebo group mortality is 24. When I work out the RRR I get the same answer as offered in the paper if I use the ITT number. However, it is not clear to me where the 24 deaths actually come from. How many of the 24 reported deaths in the placebo group occurred among the 288 patients who stayed per-protocol? It is reported how many of the placebo group’s hospitalisations occurred in the per-protocol group but not the mortality.
Here is Mills’s answer:
Hello
Question 1. The 288 are patients who received the identical 3-day placebo. Because this is a platform trial there are multiple placeboes used, proportionately equivalent to the number of active arms at any time.
Question 2. I’m not interested in this question as its not the correct way to interpret the outcome.
Regards Ed
Mills’s response to Question 1 is brazenly incomplete, given that it doesn’t answer Professor Aldous’s question. At all. For you non-data geeks, the opaqueness of the control group Colleen is referring to has bothered many an analyst of the TOGETHER trial’s shenanigans. Not one TOGETHER investigator has presented the data that can answer her question fully. It’s because Colleen is “over the target” and Mills knows it, so he tries to blow her off with a half answer, essentially pretending to not understand what she is really asking, i.e. the exact numbers of 3 day placebo patients that started and the final number that stayed per-protocol and how many died in the 3 day “per-protocol” placebo group. He is basically skirting the issue by implying that 288 patients were assigned 3 day placebos.. and thus, 288 patients were 100% compliant. This is so over-the-top absurd given that no randomized controlled rial EVER has had no drop-out in any assigned group. Like I said.. over the target.

Beyond this absurdity above, what is even more damning is that Ed Mills just flat-out refuses to answer the 2nd question. Busted again. The published NEJM paper offers a per-protocol analysis of hospitalization by reference to the 288-person (3-day) placebo group.  But Mills is somehow saying that the exact same analysis would  be incorrect for mortality.  Bottom line: he refuses to answer the simple question of how many of the 24 reported placebo deaths occurred in the 288-person per-protocol group.

God this post is never ending. Unfortunately, there is even more. We still have to look at Mill’s statement as to why the trial suddenly ended when it did. Just like the above in regards to how he chose the dosing, he again makes three different statements in regards to the decision to stop the trial in his recent NIH presentation. He is the dumbest liar ever. Let’s move on:

First, from the C19early.com group which called out the TOGETHER investigators for stopping the trial at a time that was not pre-set by their published and Ethics Board Approved protocol:

Please understand, the non-independence of the DSMC is an outrageous violation of research practice and ethics. From Alex Marinos’s brilliant substack on this issue, there were two scientists tasked with evaluating the TOGETHER protocol before the study commenced, and who openly objected to the appointed chair of the DSMC. Again, this objection was lodged prior to the trial, due to the proposed Chair having deep and long-standing professional and financial relationships with the study investigators. The investigators, instead of removing their conflicted colleague, just made him a non-voting member. Good to have some eyes and ears at the head of the committee apparently.

Now, lets get back to Mill’s statements as to why they stopped the trial when they did.

Remember that Mills, above, stupidly admitted to Marc Rendell, “In particular, there was a 17% reduction in hospitalizations that would be significant if more patients were added.”

Here are the reasons he gives as to why the trial was stopped when it was.

“I don’t call the shots when to stop the trial, the Data Safety Monitoring Committee (DSMC) decides”

Not true, because later he says:

“The DSMC makes a recommendation to the steering committee” (which Mills is on).

At another point he says they stopped the trial because “they ran out of funding,” and bizarrely mentions that the trial was “funded by a 32-year-old billionaire.” There are a number of problems with this statement. First, what does the billionaire’s age have to do with anything? And how a billionaire whose main philanthropic goal is to fund trials rapidly in COVID (his organization is literally called Fast Grants) yet could have limited resources beggars the mind. Also, his statement deliberately hides the fact that the other funding organization was the massive Rainwater Foundation, and that they have said they would have given more money to finish the trial if the investigators had asked. Busted.

And then here is the best statement as to why he ended the trial:

“We were being abused by the community, I lost interest because of attacks we were receiving.”

You ended the trial because you “lost interest?” Whatever Mills.

Now, let’s move on to another investigator named Craig Rayner. I already mentioned him in Part 2 but I did not explicitly call attention to his conflicts. Shall we review them? Again, from c19early.com:

Not only is he one of the most Pharma-conflicted investigators, but he is also on record as the first researcher in the world to publish a Letter to the Editor in June of 2020 calling for caution in thinking ivermectin could be effective in COVID, reacting to what must have been very unsettling to him and his Pharma sponsors – the enthusiastic global response to a wickedly positive in-vitro study at Monash University in Australia. His letter essentially launched the first of many anti-ivermectin narratives across media and medical journals. This narrative appeared in major newspapers across the world for over a year. The media kept stating that standard doses of ivermectin could never achieve the tissue concentrations used in a test-tube experiment of monkey kidney cells. The idea that effective concentrations found in an in-vitro cell culture using monkey kidney cells directly relate to live human dosing has been repeatedly shown to be unreliable.. at best. But this is what they do.

Although Rayner did not know this in June of 2020, there is NO way the investigators were unaware that by January 2021, Paul Marik, Andrew Hill and myself had presented to the NIH the results of an updated (at the time unpublished) experiment from Leon Caly and Kylie Wagstaff (authors of the original study from Monash University) that showed standard dosing did in fact achieve effective concentrations in lung and fat tissue. In fact, the aforementioned “narrative” was peppered throughout Andy’s manipulated-by-Unitaid (err, BMGF) pre-print, two weeks after we presented these data to the NIH. Those manuscript statements are what caused Paul and I to initially suspect scientific misconduct was occurring because we knew Andy had in his possession the results of Caly and Wagstaff’s updated experiment, yet he refused to include it in his paper (one can always reference unpublished work as “unpublished work” or as “personal communication” with an expert..especially in a pandemic costing millions of lives). Andy chose to do neither and we were furious at him because we knew he was deliberately perpetuating a harmful and inaccurate narrative.

I also note that 16 months later.. that updated experiment from Monash University has still not been published. Curious no? I would ask Caly and Wagstaff myself but I already know the answer. Careers dependent on continued grant funding make folks shy away from publishing inconvenient science. Hey Kylie, Leon, if I got this wrong and the reality is that you have been trying to publish but keep getting rejected, then I retract (hah!) my insinuation. I know you to be good people.. but even the good people get cowed in this game. Still would be nice to get a little help out here.

THE END.

I just want to say how much I appreciate all the subscribers to my substack, and especially the paid ones. Your support is so greatly appreciated.

P.S I am getting professional help (hah!) to write a book about what I have personally witnessed and learned during the Pandemic war on ivermectin. Pre-order here for: