Saturday, April 9, 2022

The TOGETHER Trial, designed to fail, actually showed ivermectin worked, by Steve Kirsch

 FULL  ARTICLE  HERE:

Carefully Selected Quotes,
by Ye Editor


"Here is what Peter McCullough wrote: “Dose too small and for too few days too late in course of illness.  Despite all of these deficiencies, this small underpowered trial still showed a signal of benefit and presumed acceptable safety.  Another paper supporting our use of IVM.”


... Ivermectin works and this study didn’t prove otherwise. The most important thing is this: The evidence, including this study, consistently shows that ivermectin works against COVID. ...

However, the media (including Alex Berenson) don’t want to look like they were wrong so they simply misinterpret the study results and hope you won’t read the study yourself.

... What the study showed is this:

    For the P.1 variant of the virus, giving a low dose of ivermectin (0.4mg/kg) for just 3 days starting up to 8 days days after first symptoms as a monotherapy (i.e., with no other drugs) results in a small effect that requires more patients in your study than you originally thought to prove it is statistically significant.

That doesn’t mean the drug didn’t work. It just means it was underpowered for the variant it was given against as a monotherapy for just 3 days.

It’s pretty clear that had the study enrolled more patients, ivermectin would have “worked” and the results would have been statistically significant. The author admits this.

Here are some key points everyone needs to know about the trial

    Patients waited up to 8 days after symptoms before starting treatment; the average was 3-4 days after symptoms. Basically, if you wait 8 days before treatment, your drug will fail:

    For the P.1 variant (aka gamma), it should be given it at 0.6mg/kg for patients not responding to the lower dose, not keeping it fixed at 0.4mg/kg

    You need to give it for as long as symptoms persist (and not stop after 3 days). This is especially important for the P.1 variant that was common at the time of the trial.

    Ivermectin is most effective in COMBINATION with other drugs (such as zinc), not alone. Nobody gives it alone.

    It’s really important to make sure you are running the placebo and ivermectin arms at the same time since the variants can change over time. Gamma was prevalent at ivermectin time which was a significant disadvantage and was not present for the placebo group. This puts the drug at a significant disadvantage.

... 450 people fled the trial in the control group and it was never mentioned (the IVM cohort had just 50 people drop out). This means the control people likely dropped from the trial when they realized they weren’t getting the drug.

    Why did it take 7 months to get the study published in the NEJM in a pandemic? In my opinion, the most interesting thing in the whole study is that people who have analyzed the data for the “unknown” group (those not in the 0 to 3 or 4 to 7 day before starting treatment) found that ivermectin had a 50% reduction in the primary endpoint (hospitalization). This is a huge benefit that was not noted in the NEJM paper. I wonder why?

    If ivermectin doesn’t work, why would it be superior in 12 of the 15 categories they looked at?  Also, it’s really bizarre that those who took it earlier fared worse than those who took it later (last two lines):

The key points are:

    Be careful not to generalize the result of a trial. A given trial means that drug X given with a delay Y and at a dose Z and duration A and…. is not statistically significant if there are only B people in the trial.

Changing one or more of these variables can turn a “not statistically significant result” into something that is statistically significant with a big effect size.

... Timing, dosing, duration, and combination of drugs all matter. Timing is the most important thing. If you delay for too long, a miracle drug can turn into a dud.

The study also PROVED that the New England Journal of Medicine, mainstream medical community, and the press are incapable of objectively interpreting the results of a study.

In today’s world, evaluation of studies is driven by agreement with the mainstream narrative, not by a critical look at what the study actually shows. If it agrees with the narrative, the study doesn’t have to be evaluated for flaws. That is not how science is supposed to work.

Here is what study senior author Ed Mills wrote in a private email to Marc Rendell (used with permission): ...


Here’s the message 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. ...
Best wishes
Ed"
...