More Fraud Uncovered In The Lopez-Medina Ivermectin Trial Published In JAMA
Well after 100 doctors wrote an open letter to JAMA asking for a retraction based on the study's innumerable flaws, Alexandros Marinos uncovered more brazenly corrupt actions by study investigators.
Disclaimer: the below post is 100% plagiarized from a Twitter thread by the brilliant ivermectin study fraud detective Alexandros Marinos. His Substack called “Do Your Own Research” is amazing and I invite all to subscribe. This one is a doozy, and like a lot of his other discoveries of the manipulations of ivermectin trials by Pharma-conflicted investigators, they are the result of very close reading of the initial registered trial protocols. He then tracks all the changes in often numerous updated versions.
From Alexandros Marinos:
The story of Lopez-Medina
I've just been catching up on the most widely promoted ivermectin study of 2021, and (surprise!) it's a mind-blowing story. So let me put together the pieces for you. The trial took place in Cali, Colombia, between July and December 2021, and had 476 participants.
Clearly interest in ivermectin (which is available over the counter without prescription there) was going through the roof, at more than 10x normal rates of consumption.
The experimenters felt that if they said "we're doing a study on ivermectin" they'd get nobody since so many were taking it anyway. So they went as far as to mislead the participants, saying that the study was on "D11AX22 Molecule." This was also written on the consent forms.
The text above was a statement from Dr Lopez-Medina himself, after much speculation on the issue. He claims there was no ethical issue. I'm... not as sure. Even so, a ton of participants were found to have been taking ivermectin too recently, and had to be ejected. Every highlighted number below is patients dropping off because they were found to be possibly taking ivermectin.
The text above was a statement from Dr Lopez-Medina himself, after much speculation on the issue. He claims there was no ethical issue. I'm... not as sure.
Even so, a ton of participants were found to have been taking ivermectin too recently, and had to be ejected. Every highlighted number below is patients dropping off because they were found to be possibly taking ivermectin.
To everyone's surprise, the adverse events between placebo and treatment were identical, and very VERY suggestive of ivermectin use. Did I say everyone's? I meant no-one's.
This list of symptoms, by the way, is described in the study protocol as "symptoms that have historically been reported in subjects receiving ivermectin". Given the relatively high dose in this trial, it's *kinda strange* that they appear pretty much evenly across groups.
To make matters worse, a third-party group got access to the data and figured out that more than one person per household was allowed to take part in the study, but they were not randomized in the same group.
Ed note: Although I co-authored the above paper rejected by JAMA (shocker) I want to give full credit to this statistical sleuthing at the core of the paper to my expert colleague David Wiseman.
This means that two sick family members could have gotten sick, gotten in the trial, but somehow one ended up in treatment and one in placebo. But the investigators won't tell us what was in the placebo, only that it tasted similar.
"What was in the placebo" is not really the kind of question you want to be asking in these trials. There should be a straightforward answer. And for at least 15 days in the beginning of October 2020 it was. The placebo contained ivermectin. I'm not kidding. Apparently there was an error(?!), and all patients from that period were discarded. Mr Trial Pharmacist: you had 1 job. Keep treatment and placebo separate.
In the midst of all this chaos, the trial investigators noticed something strange. They were expecting about 20% of the placebo group to trigger the main endpoint. Instead it was being triggered by only 3.5%. The placebo group was... doing... super well.
So what do they do? Change the endpoint. Wait. The endpoint is selected together with study size to get a reasonable shot at hitting "statistical significance". If you change the endpoint, shouldn't you also redo the math and change the size of the trial?
According to Lopez-Medina, no. Even though ivermectin reduced duration of symptoms by 2 days in the newly selected endpoint, there weren't nearly enough patients to reach significance.
You won't be surprised to hear that many doctors were not happy with the conduct of the trial. Lots of them even signed a letter to the journal.
The press, of course, understood that this trial was a car crash and ignored it. Right? Not quite.
So what else went wrong? Due to the aforementioned issue with background usage, the investigators were pragmatic. "you can join if you haven't used ivermectin for 5 days" they said. The advocates found this to be very problematic. The proponents said 5 days should be enough.
Except this morning, I found out that in the clinical trials.gov pre-registration, the exclusion criteria didn't say 5 days... it said 48 hours without ivermectin was enough. In contradiction to what was published.
I think I found something about the Lopez-Medina ivermectin trial. Many ivermectin supporters have noted that it required patients not use ivermectin >=5 days prior to randomization. Local use of ivermectin was 10x normal. I just found that it was actually only >=48 hours prior.
According to the clinical trials.gov registry, it was changed from 48 hours to 5 days, which most people thought was on December 16, only 5 days before the end of the trial. Why would it be changed so late other than to cover up the extremely short gap?
Hmph. Very strange. In the paper itself, the time interval is 5 days for all revisions. Is this some kind of error? For the published paper to disagree with the registered protocol is not a good look at all.
Anything else? As Scott Alexander said, "...ivermectin boosterism and vaccine denialism are closely linked." Or as I like to say it "...vaccine boosterism and ivermectin denialism are closely linked." .
Ed note: Alex’s re-ordering of Alexanders statement mirrors my own take, a perspective that I was trying to “teach” Mr. Alex Berenson in our friendly “webinar debate” on ivermectin, but he refused to listen. Oh well. Be better Alex. I guess he trusts Scott Alexander on this issue more than me.
Don't tell me there's conflicts of interest now?
Sadly, I must. You see, at the same time that the organization of Dr. Lopez-Medina was running this trial, it was also running the Janssen vaccine trial for J&J.
In fact, Dr Eduardo Lopez-Medina himself, is a childhood infectious disease doctor with specialization in vaccines. Here's a Dengue vaccine candidate he worked on:
So you won't be shocked to see Sanofi, Janssen, GSK, Gilead, and others in the CoI statement, will you?
In the midst of all this, the paper writes: "preliminary reports of other RCTs of ivermectin as treatment for COVID-19 with positive results have not yet been published in peer-reviewed journals… ignoring 8 peer-reviewed RCTs with positive effects published prior to the paper.
To top things off, the team that did the re-analysis found that the 75 discarded patients, when compared with the placebo group, actually produce a "statistically significant" improvement on the new endpoint. Lopez-Medina confirmed their calculations.
Ed note - again, all credit to David Wiseman for the above finding.
Colombian trial flop, indeed.
Ed note: I hate, absolutely hate MedPage today. The worst. Total Pharma rag and read widely and gullibly by “system docs.”
Some local color - apparently Colombian left-populist, ex-rebel, opposition leader (now president-elect) was promoting ivermectin as Covid-19 cure in 2020. That was the politics issue Lopez-Medina was citing. I'm going to guess the establishment stayed neutral.
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P.S. I opened a tele-health clinic providing care not only in the prevention and treatment of acute COVID, but with a specialized focus on the study and treatment of both Long-Haul and Post-Vaccination injury syndromes. If anyone needs our help, feel free to visit our website at www.drpierrekory.com.
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