On 5 February 2026, headlines appeared across international media stating that statins do not cause most side effects blamed on them.
These claims originated from a new paper published in The Lancet, authored by the Cholesterol Treatment Trialists Collaboration.
At first glance, the paper appears authoritative. It is a large meta analysis, it comes from Oxford affiliated researchers (dozens and dozens), and it uses the language of rigorous statistical correction (don’t they always?).
However, closer inspection raises serious concerns about data access, trial design, conflicts of interest, and a call for regulatory change that should alarm clinicians who care about informed consent and patient safety.
Who are the Cholesterol Treatment Trialists?
The Cholesterol Treatment Trialists Collaboration, usually referred to as the CTT, is coordinated by the Clinical Trial Service Unit at University of Oxford headed by Sir Rory Collins. Over the last twenty years, the CTT has published a series of influential meta analyses on statins, all in The Lancet.
The February 2026 paper is their seventh major publication.
Importantly, every prior CTT paper relied on largely the same pool of statin trials, the overwhelming majority of which were funded, run, or monitored by pharmaceutical manufacturers.
This is not a new concern.
An independent review commissioned by the BMJ in 2014 explicitly criticised the CTT for refusing to share individual participant data with other researchers.
Or put another way, we need to check Pharma/CTT are not lying about what the data actually says (they do have form on this, Vioxx and the deaths of 50k people is a good example).
“….called for the anonymised individual patient data from the clinical trials of statins to be made available for independent scrutiny.
This last is a key point. Currently only the drug companies, the trialists, and the Cholesterol Treatment Trialists (CTT) collaboration in Oxford have access to individual patient data from the statin trials.
As I understand it, even CTT does not have the data on adverse events, which were specifically excluded when the collaboration was established. Nor does CTT have the right to share data with third parties. The Cochrane review group did not have access to the individual patient data. It based its analysis on the published information, including the published CTT analysis. This is not acceptable.
As highlighted by the AllTrials campaign (alltrials.net), such debates will not be satisfactorily resolved in the public interest unless legitimate third parties are given access to the clinical study reports and the anonymised patient level data. At the very least this will allow greater understanding of the data’s limitations.
As a first next step towards this goal, I have written to the principal investigators of all the relevant clinical trials, asking them to make the data available or to explain why they will not. My letters and any replies I receive will be published at thebmj.com/statins”
Well, twelve years later, she is still waiting for access to the pharmacy sponsored data that shows statins are safe and more effective than the open access data does and observational studies.
Let me summarise that again:
The majority of data used in meta-analyses for guidance on statins for CVD is analysed only by the CTT, and Pharma/CTT refuse to allow anyone else access to the individual patient level data. So we have to believe the individual data is real, fair and accurate.
Again, they have form here, please re-read the about RIAT – Restoring Invisible & Abandoned Trial initiative.
They found when all the data was restored (after being removed/changed by Pharma), the drug in question actually increased your risk of death.
https://academyofchiropracticnutrition.com/a-new-cholesterol-drug-that-increases-your-risk-of-death/
Click it 👇️
Bear in mind this drug is still being sold on the original data.
Back to statins, this data access is important as that data consistently seems to show very little side-effects (relative to real world data & observation).
That refusal to release patient data was repeated again in the February 2026 paper.
The key to understanding this is the CTT trial data show essentially no, or very side effects in the statin vs placebo.
The latest paper states that trial data were provided to the CTT on the understanding that they would not be released to others. Requests for data must be made to the original trial custodians (Big Pharma).
This matters. Without access to raw participant level data, independent researchers cannot verify analytical choices, cannot test alternative interpretations, and cannot properly scrutinise harms.
The BMJ review panel stated clearly that ongoing uncertainty about statin risks and benefits would be reduced if such data were shared. Twelve years later, they still are not.
For clinicians, this means we are again being asked to accept the conclusions of the CTT and thus the pharma industry without indepedent analysis.
The paper states that the CTT Collaboration has not received industry grant funding. This claim sits uneasily beside publicly disclosed funding records showing that Oxford University and its Clinical Trial Service Unit have received hundreds of millions of pounds over the past two decades for commercially funded research.
The statins examined in the paper were manufactured by Pfizer, Novartis, Bristol Myers Squibb, AstraZeneca, and Merck. Author declarations of interest run to more than a page. Oxford University also maintains strategic research alliances with several of these companies.
The issue is not that collaboration exists. The issue is whether such relationships make it plausible that research critical of statins would emerge from this environment. On that question, clinicians are entitled to be sceptical.
What the paper actually did
The researchers began by extracting all adverse effect terms listed in official product documentation for five statins. They then examined 19 double blind statin versus placebo trials drawn from the familiar CTT pool.
Here is the first major concern. Of these 19 trials, the majority included run in periods (this is crucial).
In many cases, participants first received placebo or statin for several weeks before randomisation.
Anyone who reported problems, showed intolerance, or failed to meet biochemical targets could be excluded before the trial formally began.
This design feature essentially removes many of the patients with side-effects, so the final count of side effects is negliable – and let us be realistic, it is deliberate and frankly unethical.
Thisalone should make you realise just how utterly corrupted the whole system is.
You are part of a study on statins and in the run phase in phase, you complain of muscle pain, so they kick you out, or you stop taking the statin because of side effects, and they kick you out for noncompliance. And Viola, the study at the end, shows very little side effects (because you removed most people with issues at the start).
The largest trial in the analysis, the Heart Protection Study, excluded over one third of participants during the run in phase.
That is not a small methodological detail.
It fundamentally shapes the safety signal.
Rather than relying on peer reviewed adverse effect reporting from published trial papers, the CTT secretariat requested adverse event data directly from trial teams. These data were collected outside the peer review process and will not be shared.
The second major issue is how these adverse effects were categorised.
Instead of broad clinically meaningful categories such as gastrointestinal disorders, muscle symptoms, or metabolic effects, the paper split harms into 66 narrow subcategories.
Burping was given the same analytical weight as liver enzyme abnormalities. Diabetes was divided into high intensity and moderate intensity forms, an unusual distinction that reduced event counts within each category.
This fragmentation makes statistically significant findings less likely, especially when combined with aggressive statistical correction.
The authors applied a false discovery rate adjustment, arguing that it was necessary because of the large number of outcomes assessed. Yet this large number was created by the decision to split harms into dozens of small categories.
The 2016 protocol for this analysis promised that both corrected and uncorrected results would be presented. In the final paper, only corrected results appear. Without access to raw data or unadjusted findings, clinicians cannot assess whether the conclusions are robust or artefactual.
Only four adverse effects were highlighted as statistically significant. Yet two of the most clinically important statin harms, new onset diabetes and muscle damage, were omitted from the headline findings because they had been reported previously.
That omission is mind bendingly blatant in a paper devoted specifically to statin adverse effects. These are precisely the harms patients worry about and experience.
Even within the four admitted harms, liver dysfunction and fluid retention are not trivial findings. They must be weighed against the modest absolute benefit of statins, especially in primary prevention where mortality benefits remain unconvincing (under 1% on average, at least over 5 years).
The most troubling aspect of the paper is its conclusion. The authors call for rapid revision of statin labels and official patient information.
Currently, adverse effects listed in summaries of product characteristics and patient information leaflets are determined through a regulatory process involving trial data, post marketing surveillance, and national agencies such as the MHRA and EMA.
This system is imperfect and under reports harm (yellow card system itself believes only 10% of adverse events are reported, or put another way, adverse events may be 900% higher than we know), but it is at least independent of any single academic group.
The idea that an academic collaboration, closely linked to pharmaceutical manufacturers, using unpublished data it refuses to share (I could argue it is hiding data), could bypass this process and demand rapid revision is deeply concerning.
That is not neutral science, it is lobbying.
Many patients already feel unheard when they report statin side effects. They experience pressure to take these drugs, often without balanced discussion of risks. A paper that dismisses most adverse effects and is pushed within main stream media without critique, risks further eroding trust.
If this precedent stands, it opens the door for similar academic pharmaceutical collaborations to reshape patient information across medicine.
Today it is statins. Tomorrow it could be antidepressants, hormone therapies, or metabolic drugs.
As clinicians committed to informed consent and patient centred care, we should be alert to this shift.
This paper is not just another meta analysis. It is a test case for who controls the narrative around drug harms. And the outcome matters far beyond cholesterol.