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How to design a study to fail, and create bad PR for Ivermectin: Plus a lesson in white lies from the Wall Street Journal

Ivermectin

Late last week a large prospective “study” showed that ivermectin was useless so it got headline reporting at the Wall Street Journal, unlike the other 80 controlled studies the newspaper ignored. This study is not even a peer reviewed paper, nor is it even news — The TOGETHER Trial announced results way back in August  last year, but haven’t officially published the paper yet.

It’s a case of PR now, details later.

Thanks to the FLCCC we know some of the reasons the trial was never likely to succeed. And given that several groups involved in the trial were also big clients of Pfizer, it was a very convenient failure. Bear in mind, “fail” is relative — despite all the handicaps below, the Relative Risk of dying of Covid with low dose ivermectin was still 0.82 (0.44-1.52). Meaning they found a 20% lower mortality rate, but it wasn’t statistically significant when done with a low, late dose in the wrong way, with the wrong type of trial, with the wrong type of participants.

How to design a study to fail:

Early Treatment of COVID-19 with Repurposed Therapies: The TOGETHER Adaptive Platform Trial

Click to enlarge.

      1. Give the control group a head start.  It helps to begin collecting data on the control group weeks earlier when there is a less deadly variant around. That way more of the control group “do well” which makes the test group less likely to outdo them.
      2. Give people ivermectin on an empty stomach so it is not absorbed well. It works against worms, but lowers the effective antiviral dose to about one fifth of the current clinical treatment protocol.
      3. Limit the trial to three days, just in case all the other handicaps weren’t enough.
      4. Start the treatment late — maybe as late as 8 days after symptoms start. It’s not clear exactly how late the treatments ended up being on average. We just have to wait for the paper, eh?
      5. Use a randomized control trial in a community that already knows how useful ivermectin is.  That way the really sick people will rule themselves out of the trial, because they won’t want the useless placebo. By comparing groups that are already low risk, ivermectin is less likely to shine. RCT trials work best in communities where the drug is not normally known or used.
      6. Ivermectin was so widely known in Minas Gerais, Brazil that some of the control group may have been using ivermectin before they started the trial. No one asked. Nevermind if they were the lucky ones who actually got the right dose at the right time, we can call them “controls”.
      7. Use vague primary outcomes like “events” that are subject to bias and exaggeration.
      8. Rule out sick people (if they haven’t already ruled themselves out first) by only including patients with an “expected stay of less than 5 days. “
      9. Tweak the protocol in the middle of the experiment:  “we hypothesize that younger patients will benefit more than older patients.” Perhaps the results weren’t going well enough?

The illustrious Wall Street Journal swallowed the junk study whole and didn’t interview any of the experts who could have explained why the trial was a waste of time.  (Unless the purpose was not to discover if Ivermectin was useful but to get rich selling more expensive and risky drugs, in which case the TOGETHER trial was just what Pfizer needed.)

Wall Street Journal Logo

Ivermectin Didn’t Reduce Covid-19 Hospitalizations in Largest Trial to Date

Patients who got the antiparasitic drug didn’t fare better than those who received a placebo

Sarah Toy, Wall Street Journal

“There was no indication that ivermectin is clinically useful,” said Edward Mills, one of the study’s lead researchers and a professor of health sciences at Canada’s McMaster University in Hamilton, Ontario.

It’s all in how you phrase things:

“This is the first large, prospective study that should really help put to rest ivermectin and not give any credibility to the use of it for Covid-19,” said Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine…

It’s not the first trial of Ivermectin, not the largest trial, it’s the first large trial that should put people off ivermectin. 

Even liars leave clues:

But *most* studies showing positive effects had significant limitations such as small sample sizes or poorly defined outcomes, according to the NIH.

“Most” indeed, meaning 51% or more. Not all studies had significant limitations but we don’t need to mention the ones that were bigger and better, right? Like the trial in Itajaí, Brazil with 159,000 people that showed a bizarrely low infrequent dose of Ivermectin could halve hospitalization rates and reduce deaths by 70% if it was used preventatively.

Would you like a conflict of interest with that?

The TOGETHER Trial is supported by the Bill and Melinda Gates Foundation [INV-019641]. Gates is a well known investor in medical treatments and vaccines. Imagine how much money they might not make if a cheap safe alternative was found. The lead investigator Edward Mills, got funding from FastGrants, which includes money from facebook founder Mark Zuckerberg among others. Zuckerberg has invested $100 million in “Coronavirus cures”.  And on other days, some of the groups associated with the trial, with names like MMS Holdings and Cytel Inc, earn their money by doing work that helps Pfizer get drugs approved.

Comments under The Wall Street Journal are hotly polarized between people who quote other studies and dosages of ivermectin, and people who make smug remarks about  “the Horse Pill loving, anti-science, Joe Rogan listening clientele often found in these comments”.

Where is decent research going to come from?

The FLCCC calls for better trials:

Trials of generic medicines that are funded and influenced by profit-driven pharmaceutical companies will always fail. We need to create an independent, well-funded government body dedicated to conducting well-designed trials and transparent research studies of repurposed generic treatments – not only for COVID-19, but for all diseases that may have safe and affordable remedies. The use of independent research is our only hope of understanding how these medicines can best be used to help patients.

Sadly, as we well know, there is no such thing as an Independent government funded research body. They are all dependent on Big Government funding. They might start out fine but they all end up captured. 

More than anything we just need free speech. If doctors could say what they thought, Health Ministers, Prime Ministers, Presidents and Science Advisors could be shamed into the oblivion they so rightly deserved for the unnecessary deaths, suffering and pain they have caused.

Let the people choose their doctors, and let the doctors choose the medicines, and a real free market on a level playing field will solve the rest.

 

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UPDATED: The wonder drug that disappeared

My repeat Go-To summary of Ivermectin

If you only email friends one link — make it this story. It’s the biggest medical scandal since 1850— Why is a cheap safe drug being actively surpressed– because it threatens the Emergency Use Authorisations for all experimental vaccines, an industry worth around $100 billion. The Australian TGA admitted it banned the safe drug because people might not get vaxxed. Pfizer and other companies would be crazy, nutso, bonkers, and doing their shareholders a disservice if they did not lobby, cajole, scare, smear and call in all their favours to make sure there would never be a cheap safe alternative.

In desperation, some Americans are going to court to get rulings to order doctors to use Ivermectin on their loved ones. One family hired a helicopter to take their mother away from intensive care in a hospital that refused to give Ivermectin and saved her.

Ivermectin is so safe doctors fed it to primary school children to treat lice in Canberra. It has been used to virtually eliminate Covid in Japan, Uttar Pradesh, and in Indonesia where it cut Covid by 98% at the same time cases in Australia grew 500% with Lock-n-Vax. There are also success stories from Peru, Brazil, and Mexico.

For peer reviewed studies read: The BIG Ivermectin Review: It may prevent 86% of Covid cases. In vitro, Ivermectin reduces viral loads 5000 fold in 48 hours. There are no less than 73 studies involving 56,000 people that show improvements in over 80% when used prophylactically, 67% when used early and even as many as 40% with late-started treatment. There are 20 known mechanisms of action: IVM binds to ACE2, the spike, and TMPSSR2, it is a zinc ionophore, it binds to a protease the virus needs, prevents key viral proteins getting into the cell nucleus which would normally allow the virus to shut down interferon signalling to warn neighboring cells. It’s anti-inflammatory, it blocks the NF-κB pathway, which will reduce Akt/mTOR signalling, which inhibits PAK1 which reduces STAT3 and IL-6. STAT3 induces C-reactive protein (or CRP). It’s impossible for Covid to mutate around all these mechanisms at once. No leaky vaccine should be given without an anti-viral because it risks the mutation of a nastier virus that escapes our immunity. Read the horror of Marek’s disease in chickens. 50 years of leaky vaccines created a disease worse than Ebola.  It’s 100% fatal in ten days for unvaccinated chickens.

The FDA and others will say there is little evidence of success so far, but that’s a scandal in itself. Why are there no large trials? And why are other drugs like Remdesivir approved with only one trial and iffy results? Ivermectin is so safe some 3.7 billion doses have already been used around the world. The inventors won a Nobel Prize for its discovery in 2015. By July last year there were already signs Ivermectin could save as many as 50%Why were large trials not started then? The UK trial was designed to fail from the start.

Why are all the vaccine contracts secret? Say hello Serf to your new Head of State, Mr Pfizer?

Image of Ivermectin tablets from TDT

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