Dr. Edmund Fordham: Scientific Misconduct Uncovered in the TOGETHER Ivermectin Trial

Dr. Edmund Fordham is a physicist and engineer in the energy industry, a survivor of Stage 4 lymphoma, and a former Independent Parliamentary candidate. He works with EbMCsquared CiC as a Consumer Representative.

This is an edited segment from the weekly live General Assembly meeting on June 20, 2022. This presentation is also available on Rumble and on Odysee. The full General Assembly Meeting is available in the Newsroom. A transcript of this presentation can be found below.

Here’s what WCH members, staff, and coalition partners are saying about Dr. Fordham’s presentation:

Excellent job Edmund!“ – Sonia Elijah

„Wonderful research Edmund.“ – Fahrie Hassan

„Very important work. Thank you for your diligence.“ – Rima Laibow

„You don t have to follow the science, you just have to follow the money. there you will find all the answers…“ – Hector Carvallo

Transcript

Edmund Fordham
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[00:00:00]

Dr. Christof Plothe: Our next speaker is Dr. Edmund Fordham from the UK Scientific Misconduct uncovered in the TOGETHER Ivermectin trial.

Dr. Edmund Fordham is a physicist and engineer in the energy industry, a survivor of stage four lymphoma and a former independent parliamentary candidate. He works with EbMCSquared CIC as a consumer representative. So welcome and thank you very much for your time, Dr. Fordham it’s all yours.

Dr. Edmund Fordham: Okay. So I, I thought I would be a bit more specific in my, in my title. I [00:01:00] certainly do consider it as scientific misconduct. What I’m gonna be speaking about is the question of where is the promised data and it was promised for the TOGETHER Ivermectin trial.

And first of all, what is TOGETHER? If you, concentrate only on the mainstream media, it’s this Ivermectin trial which proved that Ivermec tin was basically no use for COVID, it’s a waste of resources. Wall Street Journal tells you it’s the biggest trial to date, and it didn’t do anything for the patients. Los Angeles Times went over the top saying no effect whatsoever, which is certainly not true. But they managed to work in a photograph of Donald Trump, who had nothing to do with Ivermectin throughout his entire presidency. So this is gloriously irrelevant. But that’s what the media is saying.

Now if you want a little bit more factual stuff, there is a slide presentation from the investigators. This was given in August last year, so it’s nearly a year old. It’s a trial conducted in one state in Brazil. It’s a platform trial with multiple drugs in it and it’s adaptive, which means that they allow themselves some latitude to change things over time.

And one of the things that’s interesting about the [00:02:00] date is that there was another seven and a half months goes by before there’s actually any publication in a full write up. So the 6th of August presentation is all we’ve got to go on or had until the the end of March. And I’m gonna show you just one slide from the slide deck from last August, because this actually does contain information and it makes clear that this is really a very complex structure in this trial, it’s showing the recruitment over time, into the various arms with half a dozen different repurposed drugs and a placebo arm. And what it doesn’t show you is that there are actually multiple placebos because to maintain blinding, they had to have you know, a one day placebo, a three day placebo, a 10 day placebo and so on.

And there are two different Ivermectin arms just to make things even more complicated because people complained about the doses being completely inadequate. So they paused it for a couple of weeks and changed the dosing scheme. So there’s a lot of complexity here in the data. And if you’re really persistent, like Alex Marinos whose Substack I’ve referenced here because they really are the [00:03:00] best articles that have been written about this so far. You’re gonna have to read them yourselves. It would take an all day presentation to go through the whole lot. But he actually picked off some numbers from this chart and that was kind of interesting because the 2020 numbers tally precisely with the published reports, the Ivermectin numbers don’t. In other words, there are missing patients and you’ve got 639 in the chart and in the reports, you’ve got 677.

So some of them got added at some point, and it’s not documented. There’s a hint that maybe the placebo arm includes patients recruited before the Ivermectin patients.

Why might that matter? Well, it was all in the middle of the Brazilian Gamma wave, the most aggressive variant of COVID we’ve seen so far, so

and it’s changing quite rapidly the whole situation, so if they were non contemporaneous, then there’s likely to be a bias between the control arm and the Ivermectin arm. So anyway, the, the paper finally comes out 30th of March just before April Fool’s Day. That’s online only. It makes it into print by 5th of May [00:04:00] and I have in my possession three different PDFs for the online version between 30th of March and 5th of April. And it’s incredibly tedious when you go through this, you’ve gotta pick through three different documents and decide which, which version you are working with. And they were all silent revisions without any kind of correction notice.

And here’s just one example that I was particularly offended by. Deaths were changed without any notice. Grade five adverse event by the way means that somebody died. And there was a conflict between table S6 in the supplementaries and table 3 in the paper. So this got put to the, one of the principal investigators who said that, hmm, maybe it’s COVID deaths in Table 3 at all-cause deaths in in Grade 5 . The smart people at this point will realize that this is completely impossible. That’s a kind of test question for you. We won’t go back to it. Doesn’t really matter because two days later they simply fixed it by changing the data. The PI’s memory did not serve him correctly, his colleague just changed the data to bring it into correspondence. [00:05:00]

Now this might be an innocent mistake but normally you’d have to put some kind of correction notice in saying, sorry, we made a mistake, here’s the correct result.

Many inquiries have been made directly to the PIs. This is one from our colleague Colleen Aldous in South Africa, put to Ed Mills, two questions on the placebo group and also on the deaths within the placebo group. The first question she does actually get some kind of an answer to, and it was sort of what we’d expected. Question two is basically asking for a number: How many of the 24 deaths occurred amongst the 288 per protocol placebo group?

So it may be, or maybe not be an important number, but it’s just a number. And he says, I’m not gonna answer this question because it’s not the correct way to look at the data. But all we’re asking for is a number. Now I get, a little bit annoyed at this kind of thing. Why might it be important? Well putting it into a meta analysis, which is what Tess Lawrie introduced me to, and this is from her recent SubStack article, [00:06:00] involves putting in basically four numbers for each of the trials that you are trying to pool. You need the total number that died in the treatment arm and in the placebo arm and you need the total number of patients in each arm. What are those four numbers? It shouldn’t be too much to ask. The deaths have been changed, so Tess‘ SubStack is actually wrong and the total control on size is not really answered. So by this stage, if you go to websites like ivmmeta.com, we’ve got a whole catalog of issues with this particular trial. And there are so many that one screenshot can’t take them. You’ve gotta go down another page. And then another page for all the 56 , issues that have been raised and the notes that had been written up about that.

Now, when you get to this stage of criticism of a high profile study like this, there’s really no option in my opinion, other than going back to square one, we’ve got to look at the patient level data to resolve these issues.

And was that a commitment they made? Certainly was, right back at the [00:07:00] registration stage of this clinical trial they said they were gonna share individual participant data. When they published the protocol there’s a clear commitment on written request that they will be making the final dataset available without contractual limitations. I have, by the way, requested that myself, I didn’t get a reply. There are two more in the published papers on fluvoxamine and metformin and as for Ivermectin, we’ve got a data sharing statement, which is part and parcel of the published paper in the New England Journal of Medicine, posted as they note on March 30. What do they promise? A complete de-identified patient data set immediately after publication, remember that’s 30th of March and it comes from a repository called ICODA, and it gives you a URL. And I checked out the URL and the URL was broken as of the 2nd of April. So I fired off an email to the official email address of the TOGETHER trial. I got an auto acknowledgement, so for sure they got it, but I’ve never had a reply.

And it’s a bit ironic to see that if you look in the fine print [00:08:00] of the published paper, they can be contacted at that email address, but I’m still waiting.

25th of May. I’d been part of the various discussions going on by email about the various issues with this trial. And I got a little bit exasperated because I thought you can’t resolve this, except by looking at the data. They promised the individual patient level data and they haven’t delivered. So we fired off an official letter to the editor of New England Journal with Flavio Cadegiani and Jose Iglasia of of FLCCC a nd we said, basically, you promised the data you haven’t delivered show us the data or retract the paper until you do. And that is still showing as with the editor. Meanwhile, I discovered that the ICODA organization , had actually got its website back to life so I was able to do a little bit of digging on who ICODA is. They’ve got a logo, that doesn’t take much, it’s said to be convened by a charity called Health Data Research UK, which is a newly registered charity that has yet to produce its full set of accounts. and[00:09:00] its funders are a clutch of what we might call the usual suspects.

If you do a little digging, it’s pretty clear that The Gates Foundation is the principle funder of the ICODA exercise. They have a registered address in prime central London real estate in the same block as The Wellcome Trust so the connections are fairly clear.

This is a slide I abstracted from ICODA because in case anybody thinks that the data might end up there in the end and then it’ll be okay, we’ll be able to take a look at it. I’m not so sure. They don’t allow downloading of the data. They give you a work bench and you’re supposed to use their software tools. And if you’ve got your own software tools there’s no guarantee that they’re going to allow them to be used. And it also controls what your objectives might be by using this famous word ‚appropriate‘ which basically means what we like even if it isn’t what you like.

So that I think is something that people may not have noticed so far so I’m just introducing it as a bit of a caution. But the website being alive, I did manage to send a web form [00:10:00] inquiry to ICODA, saying, well, there’s this paper in New England Journal, they’re talking about you, can you please advise if the promised de-identified patient dataset is held by ICODA and if so, please, how may I access it? And just a bit of a timeline. That was two days before the four day Jubilee holiday, which I knew was gonna be a bit of disruption to things. I actually tried to call them on Monday the 6th, and that’s a bit of amusement I’ll show shortly. But I did get a reply on the 7th of June. They did give a phone number. So picking up the phone, this is what you get you have.

So that kind of thing normally makes me really pretty suspicious because okay, they may be working remotely, but it’s not so hard to arrange call forwarding to a different number. And the interesting thing is that if you look at their contact form, now the number has gone. So somebody’s been a bit embarrassed about this.[00:11:00]

But the really remarkable thing is that the day, the next day I did actually get a reply. And this here basically is the bombshell. I mean, I was absolutely astonished and staggered by this. Not by the fact that ICODA does not hold the data, which I’d begun to suspect anyway, but that they were so immediate and they were so clear about it. So actually full marks to ICODA for this, they gave a straight answer to a straight question. Do you, do you hold the data? No, we don’t. And we’ve asked the authors to update their data sharing agreement.

So, I, I mean, this, I truly did not expect, I expected simply to get a no response. but it makes clear that, the statements that have been made by the TOGETHER team I’m afraid simply are not true. ICODA does not hold the data. What they say in the data sharing statement is that you can have the complete data said immediately on publication from ICODA, but it’s not there. So that clearly isn’t true. Moreover, my colleague David Scheim had an email from [00:12:00] co-author Dr. David Boulware, and he says quite clearly that data have been placed, past tense, with ICODA and you’ve gotta register and put in a project proposal.

So that clearly isn’t true either. So David Scheim was the one who broke this story at TrialSite News on the 9th of June. Having sent the day previously an open email from David, Colleen Aldous in South Africa and myself to the co-authors of the trial and to the journal with copies to various other science journalists and essentially saying, you’ve promised this data set where is it, and if you can’t provide it promptly, then you really ought to retract the study. And I for good measure sent a chaser email to the New England Journal because we’d sent our letter to the editor, which is still showing us pending and complained about these falsehoods in the data sharing statement.

Haven’t gonna reply yet. And as of yesterday, it was still showing as ‚with the editor‘ in these submission system at the New England Journal of Medicine. And of [00:13:00] course, World Council of Health have mirrored this story as of 12th of June, which is why I’m speaking to you now. And. That basically is the end of my story, because I think that this is something that’s very, very straightforward.

They have said you can have the full dataset, it will be with ICODA. It’s not with ICODA. We’ve got a situation where there are 56 itemized critiques on the ivmmeta website and counting. And I believe there is a paper in preparation, which is going to detail that more completely. They promised data sharing right back from the registration of the trial, said, you could have it on publication and they simply have not delivered.

The authors are no longer replying to questions. I haven’t had any reply from the journal and that ladies and gentlemen is where it lies. I have a big problem with a trial, as well-staffed, as well-funded and resourced as this, making very, very clear statements that they’re going to be open and transparent with their data and then it’s just not [00:14:00] delivered and moreover, the repository, the third party repository that they say will be holding it, then admits to us that we simply haven’t got it and we’re asking the authors to change their statements.

I think that this trial’s got a major credibility problem. I think they’ve got just the two options that we’ve suggested to them. They’ve really got to make full disclosure, just like they promised from the start, or back down. And quite how it is going to play out, I do not know. I can’t read the future. But there it is for the moment.

Dr. Christof Plothe: Well, thank you very much Dr. Fordham for this amazing presentation showing us the struggles of what a real, peer-review nowadays can consist of. I’m sure there will be quite a few questions about that.

Just a short note for all, all our views. Unfortunately, due to unknown technical problems, we had lost the sound of this and some parts of the last speakers, so we apologize for that. The, the recording of the meeting will be reloaded in the newsroom tonight, so anybody is still interested, can listen to it after the meeting. I hope we’ll be undurbed [00:15:00] from now on I’ll hand it over to Tess.

Dr. Tess Lawrie: Thank you so much for your tenacity and rigor, uh, in in trying to hold the, these investigators to account, it’s simply, you know, unbelievable ludicrous that their results get published by the media seven months ago.

And that they differ from the results that are in, you know, the, the data that are in the paper and that we, we get, no, we can get no accounting for, for the, the difference and that the, the investigators are not coming forward with the data, making the data available as promised is really as highly suspicious.

Do you have anything else up your sleeve that you think might coax them out of their silence?

Dr. Edmund Fordham: Well, that’s really a question for David Scheim. I mean, I know he’s made, various approaches, but it’s probably not my place to say, say what those are. I don’t think that David is, is going to let the matter drop. I’m pretty sure he won’t. [00:16:00] I’ve sort of reached the end of the road in a sense because, if somebody’s not replying to you, you know, they basically don’t want to talk to you. And the only means I know at that, at that point is to, is to go visit a lawyer and start filing some kind of litigation. So, you know, there, there it is. But the fact of the matter is that they’ve, they’ve promised the data set, they’ve given this illusion of transparency and they have not delivered upon their promises and they’re refusing to do so. And they’ve involved a third party who says we haven’t got the data.

Dr. Tess Lawrie: What is, I think what’s also astonishing is the silence of the journal because the, the New England Journal of Medicine is supposedly one of the most prestigious journals and for it to be absolutely silent and unaccountable and not responding and not processing the letters is, is very worrying. It just reminds me that in the, you know, the that in that 2015 meeting about global norms were sharing data and [00:17:00] research and health emergencies, that it was a World Health Organization meeting the NEM journal was represented at that meeting and in that meeting, they undertook and not to hinder the publication of manuscripts and data and, and so on, there were a whole lot of undertakings that that they were supposed to adhere to. So it is very concerning that not only are they not adhering to that, but that they seem to be somehow complicit in failing to divulge what’s actually going on with this paper and this study. Thanks very much. There’s many thanks for you to you in the chat something from Mark Trozzi, he says; is there a criminal aspect to this, it seems like fraud? I think we need to head, we need to head to the criminal arena rather than the civil legal arenas. I think that sounds more like a statement than a question. [00:18:00] Fari Hasan, many of the New England Journal of Medicine editorial board are, are, are majorly conflicted. So I’m not sure if there’s, any specific information you have Fari on the conflicts. But I think it would be of interest to this group to hear, if you, if you have any information on that.

What I can say about certainly our meta analysis is we are also just waiting for the data because we can’t update our meta analysis until we actually have those four numbers that Dr. Fordham and his colleagues are so tenaciously seeking.

Is there anything else you’d like to say, Dr. Fordham before we continue?

Dr. Edmund Fordham: Only that I suppose that the, the discussions that have gone on that are cataloged at ivmmeta and have been thrown around various email threads and on SubStack articles by people like Alex Marinos and Pierre Kory and so on, if you want to be ruthlessly [00:19:00] objective about this, there’s nothing for it other than to go back to the raw data. The whole situation reminds me very much of a, of a totally unrelated situation I encountered in my industry career, where I was asked to, basically troubleshoot an experiment, which was clearly delivering nonsensical results, even though all the lab techs who were involved with it were adamant that they’d done everything right.

And there was absolutely nothing for it for that, but to go back right to the, the the base level recordings and the calibrations of instruments and so on and redo everything from the ground up. And I think all of the questions and the, the speculations that have been made about it, can’t actually be answered unless you do something like that.

So I, I do, I do think it’s a situation where, I mean, I, I, you know, they, they, they’ve got to make full disclosure or else, you know, the, the real credibility of this is blown.

Dr. Tess Lawrie: I suppose as long as the media, as long as people don’t know about [00:20:00] it, as long as I suppose they feel well, there’s, you know, there’s not much noise, they seem to be just choosing to be quiet rather than… because the, the media’s not picking it up, they’re just not showing any interest, so somehow we need to get the media interested and involved. Right, thanks very much then, that was absolutely fascinating and we look forward to the next exciting episode of the TOGETHER trial .Christof back to you.

Dr. Christof Plothe: Well, thank you very much. Dr. Fordham for your really amazing work, just keeping in mind how simple it seems to be for the one site to withhold data, not to be able to interpret what is going on and the media reporting it as truth. And at the same time papers like, report, a pre-print of the WCH of self-reported outcomes, choices discrimination among the global COVID 19 and vaccinated cohort this week was just retracted without any real reason to do so. So, it’s very easy to get [00:21:00] some very disputable facts into the media was others are not even reported. So thank you very much for your very, very important work.

 

 

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