SOS: Sanity over Statins – CTT the house of statin secrets

The secret agreement

She asked him several times if researchers could get access to their data. At first he said that all proposals of a high scientific standard would be considered. But pushed further this is how he responded:

“The CTT secretariat has agreement with the principle investigators of the trials, and in those instances where trial data were provided directly by the drug manufacturers with the companies themselves, that individual trial data will not be released to third parties. Such an agreement was necessary in order that analyses of the totality of the available trial data could be conducted by the CTT Collaboration.”

In other words we’ve agreed that some data won’t be released. A little background to the CTT makes Baigent’s statement clearer and explains some of the other mysteries surrounding this very influential body staffed largely by epidemiologists and statisticians.

It was formed in 1994, right at the beginning of the statin era, with the idea of gathering together trials from all the different manufacturers so they could perform large scale analyses of benefits and risks, rather than building up an evidence base one study at a time. Baigent’s claim is that without agreeing to this confidentiality the CTT would never have been able to do their very large analyses.

Secret data no longer acceptable

Twenty years ago there wasn’t the same degree of skepticism about drug companies and their readiness to play fast and loose with data for commercial ends. Today there is a general feeling that relying on company trials without their data being open to third part scrutiny is unacceptable.

Professor Rosenberg in her response to the Cochrane review remarked that the CTT “rely heavily on industry-sponsored trials” and asked the authors whether because of this they had asked for any raw data from CTT. (Published articles about a trial are a brief summary of 100,000s pages if raw data which contain details of what happened to each individual patient.)

The reply from the lead researcher made it clear that like the others he believed that such an approach would have been a waste of time. “We are aware that attempts to obtain individual patient data from CTT does not appear to be feasible.’ He added that they didn’t need it for their systematic review.

No information on side effects

So there seems a pretty strong case for saying that for all practical purposes the drug company trials held by the CTT are not available for independent scrutiny.

The situation with side-effects appears to be even more unsatisfactory. CTT papers regularly find that those in the placebo group have about the same rate of side-effects as those getting the drug. The figure given in their most recent 2012 report puts the incidence of serious muscle damage, the main one mentioned, at about 1 in 10,000. But this is wildly at odds with the reports of individual physicians and independent clinical trials which find that as many as one in ten patients have problems.

In an attempt to discover how the gap can be so large Professor Rosenberg asked the authors of the Cochrane statin review whether the CTT actually held any side effect data. “It’s not clear if the AE (adverse events) data was withheld from the Cochrane reviewers,” she wrote “or were not collected in the original trials.”

Lead author of the review Dr Shah Ebrahim didn’t know either. “Full disclosure of all the adverse events by type and allocation from the RCTs is now really needed,” he replied “as the CTT does not seem to have these data.”

Jerome Burne

Jerome Burne

Jerome Burne is the editor of HealthInsightUK. He is an award-winning journalist who has been specialising in medicine and health for the last 10 years and now works mainly for the Daily Mail. His most recent book “The Hybrid Diet” was written with nutritionist Patrick Holford, published 2018. Award: 2015: Finalist for 'Blogger of the Year' Medical Journalists' Association.
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  • Couldn’t the Cochrane Collaboration force the issue by simply refusing to consider results produced from secret data when producing its recommendations?

    • Editorial

      That is certainly what another Cochrane group did when assessing Tamiflu and would would certainly seem logical to apply that same principle to statins. As mentioned in the piece though what the CTT doing is not actually illegal and infact follows “standard practice” so it would involve some sort of a standoff between the two organisations. I have no information about the internal politics that would involve.

  • I have found it troubling that when a newspaper like the Daily Mail through its correspondents, draws the attention of its readership to various health concerns, the newspaper concerned is pilloried in the media at large, and it always seems to be when it questions the veracity of en bloc medication of the general public, whether or not they show symptoms of illness. I would suggest that there is more to this than meets the eye. As an individual I would never take statins, whoever much my GP insists. I am fit, healthy, good weight and eat a healthy diet and take exercise. I have no health issues apart from a touch of arthritis (I am 60) for which I take supplements (Glucosamine and Omega 3) We, as individuals should be in charge of our health, not self appointed professionals with ulterior motives.

  • The Nobel Prize in Physiology or Medicine 1998 was awarded jointly to Robert F. Furchgott, Louis J. Ignarro and Ferid Murad “for their discoveries concerning nitric oxide as a signalling molecule in the cardiovascular system”.
    That statement alone was good enough for me -(a former Bradychardia, T.I.A & pacemaker recipient, who suffered chest & left-arm angina symptoms when exercising/walking fast)-to begin a recommended supplementing that involved taking twice a day a drink-powder that included 5grams of L-Arginine & L-Citrulline. These 2 amino-acids combined are more productive than is L-Arginine alone in producing Nitric Oxide. Within a few days I felt a seemingly miraculous benefit to my vascular system that in less than a week virtually eliminated all angina symptoms allowing me to double my walking pace in comfort. H.Recommend.

  • P.S What I meant to add –pertinent to the discussion on statins–was that I dropped my prescribed statin for L-Arginine combo supplement -and no regrets!

  • my views are expressed in an essay which goes to the heart of the failure.
    50 years ago we failed to recognise that sugar-damaged lipoproteins broke the lipid nutrition cycle leading to raised LDL due to receptor failure.
    It wasn’t overproduction in the liver, but a failure of damaged LDL to feed organs.
    Most stain adverse-effects relate to a lack of fatty nutrients reaching ldl receptors – ldl is glycated (AGE)
    Please read my essay:-

  • Glyn, I have read it, printed it and will begin to preach it. Thank you

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