Introduction
This note is the first of three, on a topic that I have wanted to comprehensively cover for some time. Dr Malcolm Kendrick and I did a lot of work on all the statin trials for the defamation case that we brought against the Mail on Sunday. While the case was about defamation and not statins, it was critical to our defence to be able to show that the science was not settled in the cholesterol-heart-statin arena (science should never be settled). It was important to demonstrate that the benefits of statins were lower than claimed, that the potential harms were higher than claimed, and that a number of esteemed academics shared our view about overplayed benefits and underplayed harms. It was also important to demonstrate that heart disease is complex and multifactorial and that the ‘cholesterol causes heart disease’ narrative is far too simplistic and narrow. (It’s actually wrong, but we didn’t need to go that far).
The Clinical Trial Service Unit (CTSU) is an academic research unit within the Nuffield Department of Population Health at the University of Oxford. The Cholesterol Treatment Trialist (CTT) group is a collaboration led by researchers from the CTSU and other institutions. The CTT group produces meta-analyses of data from statin trials to assess the effects of cholesterol-lowering drugs on cardiovascular outcomes. (A meta-analysis pools together a number of trials on a particular topic).
Professor Sir Rory Collins is the head of the CTSU. Until he retired in 2023, Professor Colin Baigent was deputy director of the CTSU. Collins and Baigent were the two lead authors of the CTT meta-analyses. Collins and Baigent were integral to our lawsuit for two reasons: 1) the key evidence in favour of statins emanated from the CTT group and therefore it was their work that we needed to critique and 2) Collins and Baigent helped the Mail on Sunday journalist, Barney Calman, for weeks before the publication of the defamatory articles. Collins and Baigent were named numerous times in the Judgment of our case (Ref 1).
In parallel with writing other Monday notes, I have spent months pulling together all my notes on the statin trials and the CTT meta-analyses. This note is the first of three, which will summarise the work of the CTT collaboration and the main outputs from this research group. This first note will share, as background, a series of events from 2013-2014, which led to two interesting outcomes: 1) the CTSU was required to report the funds that had been received from the pharmaceutical industry and 2) the fact that the CTSU refuses to share data with other researchers was put on the record.
Zoe
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