by Pierre Kory, Pierre Kory’s Medical Musings:
The New England Journal of Medicine published the fraudulent TOGETHER trial, designed and conducted to launch anti-ivermectin headlines across every major media outlet across the world.
In part I of my post on the TOGETHER trial of ivermectin, I presented the context of this trial within Big Pharma’s decades-long Disinformation campaign against “science inconvenient to their interests.” I argued that no science has ever been a greater threat to Pharma than the massive efficacy data of the generic drug ivermectin in COVID-19. I detailed how they have long deployed “studies designed or conducted to fail” and/or “studies manipulated to show positive results.” They do both. Repeatedly. They then publish these studies in a small number of captured high-impact scientific journals which influence the captured media and then are recommended for or against by captured health agencies.
TRUTH LIVES on at https://sgtreport.tv/
Note that the importance of the wording of the conclusion in a trial’s abstract, published in a high-impact journal, cannot be overstated. Only a small minority of physicians read and think critically about the full study manuscript. Even less read the full study abstract. Sadly, the overwhelming majority simply read the abstract’s conclusion. In this manner, and particularly in the case of the TOGETHER trial, they can baselessly and erroneously convince the vast majority of doctors and citizens that ivermectin is ineffective. In the case of ivermectin, they did this via less than a handful of severely flawed “Big RCT’s” despite the overwhelming mountain of valid OCT’s and RCT’s and the success of health ministry program success in COVID. The TOGETHER trial on ivermectin was never going to be a positive trial. Ever. That was a foregone conclusion.
So what I want to do here is break down exactly how they accomplished this feat, using the most brazenly fraudulent conduct of any trial I have studied. This is NOT to say that I have never witnessed fraudulent studies, but this trial displays an unprecedented number of targeted tactics designed to deny, suppress, and distort the evidence of efficacy.
First off, this trial was designed and conducted by researchers employed by companies with deep ties to Big Pharma (Pfizer specifically) and/or the Bill and Melinda Gates Foundation (BMGF). Recall the latter essentially defends and represents the intellectual property rights and goals of the entire vaccination industry). The Pharma associations by study investigators are so common that it association is not automatically an indictment (but should be).
Please realize that the numerous connections to Pfizer are particularly troubling here. Pfizer’s Paxlovid is a direct competitor to ivermectin. Paxlovid stands to make many tens of billions of dollars around the world with no upper limit as the pandemic promises to rage on. Paxlovid is composed of a formulation with a single mechanism shared with ivermectin. Yet, somehow it has important drug interactions with almost every class of medicine known. Ivermectin on the other hand, has many more anti-viral and anti-inflammatory mechanisms, yet has almost no drug interactions. It is one of, if not the safest and most inexpensive and widely available medicines in history. Just sayin’. Note that one TOGETHER trial investigator, Craig Rayner, works for a company that works for Pfizer. What is fascinating is that he published the world’s first “anti-ivermectin” letter way back in June of 2020 after the landmark Monash University in-vitro study found that ivermectin eradicated SARS-CoV2 in a cell culture model. Note that he did so.. before a single clinical trial had been done in COVID. Interesting no? Probably just a coincidence.
Further, the over a dozen markedly positive trials supporting ivermectin in prevention against COVID-19 make the drug a direct competitor to the vaccines. The 65+ trials showing efficacy in treatment would remove the EUA for the vaccines (if “science” was functioning). Thus, ivermectin is a direct threat to the entire COVID-19 vaccine industry as well. So, to be clear, ivermectin has the largest Big Pharma market forces arrayed against it than any other generic medicine in history. The below chart summarizes the prevention trials (which include multiple RCT’s forthose of you who are RCT fundamentalist church members). This impressive chart is why the captured WHO, in their last guideline document on ivermectin, simply stated, “we did not review trials of ivermectin in the prevention of COVID-19.” How convenient. This is also a new “play” in the Disinformation playbook which I will call “The Ignore.” When inconvenient science like the below pops up, just ignore it.
Beyond the many concerns I myself identified in the TOGETHER trial and among its investigators, this post also relies on the work of a large network of colleagues and experts. They uncovered even more concerning flaws than I would have been able to do alone. I find their work unparalleled in meticulousness, depth and importance. At the top of those doing “deep dives” (please visit their linked Substacks) are the polymaths Alexandros Marinos and Phil Harper, but the list also includes PhD’s in statistics (David Wiseman) and epidemiology (Harvey Risch), and expert clinicians or researchers (Flavio Cadegiani, Jackie Stone, David Scheim) among others. Also at the top is the expert scientist group c19early.com, as they have the most comprehensive (yet far more concise) list of identified issues here. Reading their take on the trial is shocking, yet their conclusion is too mild for what they found, i.e. “these results are unreliable.” Read their more concise explanations of the 47, yes 47, major concerns, with many being what I call “fatal flaws.” I will go through quite a few of them below before I will stop with exhaustion and disgust. Here is the list from ivmmeta.com:
Many major issues including multiple impossible numbers, blinding failure, randomization failure, and many protocol violations, as detailed below
Protocol issues: blinding failure unequal randomization, significant confounding unknown onset patients included widespread community use DSMC not independent extreme conflicts of interest vaccine inclusion changes analysis company works closely with Pfizer designed by Cytel Δ viral load not reported per-protocol conflict vs. fluvoxamine multiple conflicting randomization protocols conflicting dosing plasma concentration below known effective primary outcome easy to game conflicting target enrollment futility threshold inconsistent subgroup analysis missing analysis missing outcomes mid-trial protocol changes imputation protocol violation single-dose recruiting continued after change funding list incorrect SAP after trial start single dose results not reported placebo unspecified
Data issues: unexplained delay no response to data request 3 different death counts patient count mismatch conflicting placebo arm counts unknown onset results dramatically better low active arm side-effects incorrect conclusion conflicting comorbidity counts conflicting adverse event counts screening to treatment delay missing age information mean delay likely excluding unknown onset two different per-protocol counts 3-dose placebo much more effective dominated by Gamma variant, no discussion
The deep Big Pharma/BMGF ties of the main study investigators are not a barrier to publication in Big Journals (if anything they’re a boon). However, many of the other flaws are so profound that, if sanity and ethics reigned, the study would never (should never?) have been accepted by a major journal. But lets go anyway:
- The investigators knowingly conducted the trial in an area where ivermectin use was rampant, yet they did not explicitly exclude patients taking ivermectin from the control group. This was done despite all the other ivermectin trials having had this as an exclusion criteria. Excluding patients already on a medicine from an RCT that is studying the medicine is Research Trial Design 101. Solely on this basis, this study should have been dead in the water upon arrival to NEJM. Fraud or incompetence? You choose. That same question should also apply to all issues following. One investigators defense was “but we carefully screened for ivermectin use.” I am sure you did, but please explain why it was not made an explicit exclusion criteria? Indefensible. Full stop. Again, not subtle folks. The biggest “tell” of fraud. I mean, how can you show efficacy when both groups have access to the same drug? Palm to forehead. See below from Alexandro Marinos’s brilliant thread on this topic:
To paraphrase Alexandro’s words, we really do not have to go farther to call foul on this trial. It’s what is called a fatal flaw (or fatal fraud). The consequence of not specifically and primarily identifying people on ivermectin is that they run the welcome risk of comparing those taking ivermectin… with many/most/all in the control group who were also taking ivermectin. It is hard to prove that a medicine is better than itself. It’s almost as if they wanted the control group to take ivermectin. But here’s the thing, they don’t need everyone in the control group to be on ivermectin in order to bury the efficacy signal, they only need enough to.. avoid a statistically significant benefit. Mission accomplished. Indeed, the reality of this trial is that, in the duplicitous words of the Principal Investigator Ed Mills, “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.” Yet while he said this privately, what he said to the newspapers was ,“there was no indication that ivermectin is clinically useful.” He wrote the conclusion as “treatment with ivermectin did not result in a lower incidence of medical admission to a hospital due to progression of Covid-19.” Yet, buried in the supplementary appendix is the result of a complex statistical method (Bayesian analysis), which most statisticians consider to be the most robust at determining efficacy. That analysis found a 79.4% probability of the superiority of ivermectin. Shocking I know.