Unitaid rep appears in another decision against Ivermectin

...where have we seen this name before?

In my last post, I went through the strange and yet familiar process that a UK regulatory body called ‘NICE’ used to recommend against Ivermectin. One key component of the process is the ‘MAGIC app’, which is used to present findings to clinicians and patients. The other component is a systematic review of the data which isn’t published in the normal manner. Used together, it allows data to be presented to decision-makers in a way that makes regulatory decisions predictable. It’s a useful tool if you want decisions to go ‘your’ way. If you haven’t yet read the post, it will illuminate this article a little better if you read it first, but it’s not vital.

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So we’re examining the UK NICE decision to recommend against Ivermectin. The process they used is very similar to the process that the World Health Organisation used. In fact, it’s almost identical. But is there a concrete commonality we can point to which might account for some of that similarity?

Rather helpfully, NICE give us a ‘register of interests’ document on the page detailing their decision. To be fair to NICE, it’s much more extensive than most other documents of this type, but their prudence in putting it together shouldn’t distract us from what’s inside.

To my total surprise, Professor Andrew Owen is right there on the NICE therapeutic subpanel. It lists him as a member since March 2022. Previous readers of The Digger will be familiar with Professor Andrew Owen, but for those fresh to the story, Andrew Owen is a recipient of Unitaid funding via The University of Liverpool and a private company called Tandem Nano. Unitaid had ‘a say’ in the research conclusions of a critical research paper on Ivermectin. Inside that very paper, Andrew Owen’s name appeared in the metadata despite no mention of him in the listed authors. As ever, read the full series for details.

The NICE COVID guideline register of interests shows Professor Andrew Owen as a member since March 2022.

Finding Professor Andrew Owen is a member of a UK regulatory panel which also decided against Ivermectin means that he and his sponsor, Unitaid, have now appeared at four critical moments for Ivermectin. Each moment assisted in keeping Ivermectin off the market as a treatment option for Covid-19. It’s important to note that the decision against Ivermectin was made by NICE in December 2021, but Andrew Owen is reported as appearing on the panel in March 2022.

It’s now worth revisiting some previous things I’ve reported on to bring some more clarity. I will now refer to the Andrew Hill paper, which was likely edited by Unitaid, as the “Unitaid paper”.

Foi2021 00242 Ivermectin Foi Response

235KB ∙ PDF file

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Three weeks after the Unitaid paper’s publication, it found its way onto the desk of the UK ‘Covid Therapeutics Advisory Panel’. Their role was to funnel promising repurposed therapeutics into well funded public medical trials. It has become clearer that CTAP were in possession of the Unitaid edited paper thanks to an FOI document I received some weeks ago. I have posted it above.

The document details the decisions that CTAP made in recommending certain drugs for further study. It’s very useful because it contains additional information which isn’t included in CTAP’s public declaration of the process which they shared months later.

Based on this document, we can see that on the 11th of January 2021, “CTAP awaited the WHO analysis” on Ivermectin. The Andrew Hill Ivermectin paper was at that time known as the WHO’s Ivermectin study. It looks like the panel tasked with recommending which drugs to study for COVID efficacy were eagerly awaiting the Andrew Hill “Unitaid edited” paper.

Taken from the FOI document 2021-00242 posted above

In the same FOI document, we can see that CTAP was presented with a document called “Ivermectin meta-analysis Jan 9 DRAFT FOR REVIEW” on the 10th of February 2021. It’s almost certain that this document was the ‘Unitaid edited’ paper. Why? Because it’s the only meta-analysis from that period that fits the description. Tess Lawrie published a ‘rapid review’ paper on January 3rd. I’ve confirmed that no version of this paper had the name cited in the CTAP document. The Bryant et al study didn’t appear until March 2021. The Kory paper was from months earlier, and more recent versions just do not fit.

A document called “Ivermectin meta-analysis Jan 9 DRAFT FOR REVIEW” was reviewed by CTAP on 10/02/2021

The naming convention, “Ivermectin meta-analysis” perfectly matches the Andrew Hill ‘Unitaid edited’ paper, which was being shared in various forms in January 2021. Below is a version of the paper from Jan 14th 2021. The filename was “Ivermectin meta-analysis”.

So I’m confident that the document which CTAP had on February 10th 2021 was the Andrew Hill ‘Unitaid edited’ paper. Why is that significant? Because that Unitaid edited paper found a 75% reduction in mortality for patients using Ivermectin. That paper literally said there was a “clear need… for additional, higher-quality and larger-scale clinical trials, warranted to investigate the use of ivermectin further”. The paper also said “Ivermectin should be validated in larger appropriately controlled randomized trials”.

This was CTAP’s exact role.

We were in an emergency. They were “horizon scanning”, looking for promising drugs to quickly funnel into well-funded trials. They’re given a meta-analysis which showed a drug with incredible promise, it screamed “investigate this drug further”, and what did CTAP do?

CTAP decision on Ivermectin taken from FOI-2021-0024. PDF posted above.

They recommend against studying Ivermectin further!

They argue that the paper they were presented with “supported the panels original recommendation not to prioritise Ivermectin.” But the paper did no such thing. It literally demanded Ivermectin be studied further in randomized control trials, which the CTAP panel was in a position to make a reality.

We know that some weakening alterations were inserted into the paper between January 14th and January 19th. If we imagine a version of the paper from just five days earlier, presumably in a similar weakened state, it would still be very difficult to recommend against studying Ivermectin further. So how can such a decision manifest? Had the editing of the paper been so effective that it elicited this perfect ‘no’ response from CTAP?! Or was there something more going on?

What happened?

One of Unitaid’s representatives was sitting on the CTAP panel which made that decision. It was Professor Andrew Owen. The same person who I linked to the editing of the paper in the first place was sitting on the CTAP panel reviewing the very paper he likely edited. We only know he was on the panel because it’s still listed on his University of Liverpool bio. An FOI request to see the full list of experts who sat on the panel was denied and is currently awaiting review.

Bio of Professor Andrew Owen shows he sat on the CTAP panel which recommended against studying Ivermectin. Even after the panel read a research paper which he himself is credibly alleged to have ghostwritten.

Jump forward one month to the 31st of March, this time it’s the World Health Organisation putting together their guidelines on COVID therapies. A half baked review of the evidence is done. It is not published in the normal way. The findings are presented to a panel using the Magic App. The result? They too recommend against Ivermectin. Who was it preparing the evidence base from which this decision is made? It’s Unitaid representative Professor Andrew Owen.

It’s now December 2021, this time it’s NICE, a UK regulatory body, making its own recommendations on which treatments to use for COVID. Another half-baked review of the evidence is done. It is not published in the normal way. The findings are presented to a panel using the Magic App. The result? They too recommend against Ivermectin. By March of 2022, Unitaid representative Professor Andrew Owen is listed as part of the ‘Therapeutic subpanel’ which formulated that decision.

At the critical junctions in the UK and International regulatory process, Unitaid had a representative right there. Why? Why are Unitaid involved in the sponsoring of the research all the way through to the regulatory decisions against the drug?

I’ve been doing a little digging on that too…

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