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

by Jerome Burne

Should a professional body, however eminent, be allowed to keep information about the safety of products they are supplying to public hidden so no one else can run tests on them?

That is the question raised by HealthInsightUK’s finding that a large and respected organisation whose job it is to analyses the findings of statin trials – The Cholesterol Treatment Trialists’ (CTT) Collaboration in Oxford – has an agreement to keep secret much of the information contained in its huge database which holds results from 27 trials of these drugs, nearly each of which was run by a drug company.

Questions about the secrecy of the CTT have been put in the spotlight following the recent recommendation by NICE to change the guidelines on statins. If the proposals are accepted, millions more healthy people in the UK who have no sign of heart disease will be prescribed these drugs. A key part of the evidence supporting this proposal was a study by CTT published in the Lancet in 2012.

HealthInsightUK has also established that the CTT do not hold data on the side-effects of statins. A spokesman confirmed that they base their estimate of risk on the published results of trials conducted by the drug companies. He dismissed claims that side-effects such as muscle pain and depression were wide spread, saying they were only “hypotheses”.

Denied access to data

This could explain why the CTT has regularly reported a much lower rate of side-effects than trials run by independent researchers. Knowing the true rate of side-effects is particularly important with statins because many patients have to take them for one to benefit. If the estimate of side effects is too low the benefits may not outweigh the risks.

Concern about the secrecy surrounding CTT’s data is not new. Dr Jim Wright editor of the highly respected and independent journal Canadian Therapeutics Initiative which analyses drug studies has described how several years ago he had tried and failed to get access to statin data held by CTT.

“They had agreed someone from my team could have access to their data, although the researcher would have to go to Oxford to see it. However after travelling 6000 miles, they were told that the data was not available.”

This is just an anecdote but many others have since reported the same thing. The latest concern about access to CTT data was triggered last year when the Cochrane Collaboration – famed for its rigorous assessment of the benefit of drugs and other treatments – produced a report saying that statins should be more widely used on people without heart disease. The report was heavily based on the CTT Lancet study. Was it actually possible to check their findings?

Everyone wanted the data

A number of senior researchers approached by HealthInsight have supported Dr Wright’s claim that the data held by CTT hasn’t been available. Professor Rita Redberg cardiologist and editor of the journal JAMA Internal Medicine, has stated in an email that: “CTT will not make their data available to any colleagues and other researchers who wish to study risks and benefits of statins. The CTT data is not accessible publicly.”

“I have not requested access to the CTT data,’ says Dr David H. Newman, Director of Clinical Research, Mount Sinai School of Medicine, New York.

‘However, I’m not aware of anyone who has gained access to these data, which speaks volumes since everyone has wanted it. For the science to be considered even potentially credible, another independent group will have to replicate their analysis.”

Professor Harriet Rosenberg of the Health and Society Program at York University in Toronto commented that: “many scholars have asked the CTT for data without success” in a formal reply to the Cochrane review last year.

The response by the CTT when such individual claims are made is to say that anyone with a well formulated proposal can get access to their data. But emails seen byHeathinsightUK throw doubt on that. They were exchanged between one of CTT’s top researchers Professor Colin Baigent and an Australian TV journalist researching a story about statins.

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 “10 Secrets of Healthy Ageing” was written with nutritionist Patrick Holford. He blogs at “Body of Evidence” – jeromeburne.com. 2015: Finalist for 'Blogger of the Year' award from Medical Journalists' Association.
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8 Comments

  • 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:-
    http://www.lizscript.co.uk/glyn/paradox.pdf

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

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