Massive statin trial that aims to silence all the critics. The iron fist in an evidence-based glove.

By Jerome Burne

Last week a massive piece of research extolling the benefits of statins was published in the Lancet. Its headline message was that the benefits of statins are hugely underestimated and far outweigh any harm. It had found that only 2 people per hundred suffer side effects while 15 people per hundred avoid strokes and heart attacks.

It came garlanded with the full majesty of the medical profession. Thirty pages long with 28 authors, 300 references and a declaration of interests that filled 44 lines of small type and mentioned more than 20 of the largest pharmaceutical companies. This juggernaut was designed to bury the widely publicised doubts about the effectiveness and safety of these drugs already prescribed to 6 million people.

‘This study will give patients and doctors the confidence in statins as a life-saving medication,’ declared the Chief Executive of the charity Heart UK.

So that’s that then. All those worries about large numbers stopping taking the drugs because of side-effects, links with diabetes and cataracts, studies showing that hundreds of healthy people with a small risk of heart disease have to take them for one to benefit, all laid to rest. Or are they?

Bizarre history of statins for all

This hasn’t come out of nowhere; it arrives with a long and frequently bizarre history. The lead researcher – Professor Sir Rory Collins – has been publishing papers saying much the same thing for decades. Six years ago one of his papers, also published in the Lancet, was the basis for a change to NICE guidelines which recommended a doubling of the number of people eligible for statins because they were so safe and effective.

But this latest recitation of the benefits is unlikely to settle the many doubts about statins because, like all the others, it totally ignores the reasons why many researchers and clinicians don’t trust Professor Collins’ research. It’s all based on data from trials run by pharmaceutical companies which no researchers other than he and his team in Oxford are allowed to see.

Everyone now agrees that keeping the full results from trials secret makes them unscientific and unreliable. Dodgy statistics and unfavourable results that have been concealed regularly emerge whenever hidden data is finally examined. Despite repeated requests, the institute Collins heads – the CCT in Oxford – resolutely refuses to let the light in on the dark matter in his vaults. Instead he repeatedly accuses his critics of killing people by casting doubts on statin’s effectiveness.

Alarmingly this ‘killing patients’ defence seems to have been taken up by the Lancet, whose editorial makes the case that research challenging medical orthodoxy should be checked especially carefully and possibly not published. Authoritarian support for the status quo is common in politics and religion. It’s not supposed to be part of science. A far stronger case could be made for not publishing research based on hidden data.

Effectiveness of statins not evidence based

If you are looking for a short explanation of why the latest Lancet paper, despite its heavyweight support, is not the final word, you could stop now. But if you’d like to know more about the other side of the statin propaganda picture, please read on.

An important criticism that deserves a full response – rather than special attention because it is rocking the boat – comes from the well-respected statin critic Dr Michel de Lorgeril of TIMC-IMAG CNRS UMR 5525, Laboratoire Cœur et Nutrition, Université Joseph Fourier, Grenoble, France.

Last year he carried out a review of statin trials which, he concluded: ‘Strongly suggests that statins are not effective for cardiovascular prevention……a complete reassessment is mandatory. Until then, physicians should be aware that the present claims about the efficacy and safety of statins are not evidence based.’ (Read the article)

To come to this conclusion, he divided statin trials into two groups – those done before and after 2005. That’s because in 2005 new, stricter regulations were introduced in America and the EU changing the way randomised controlled trials (RCTs) were to be done. (All the big commercial trials supporting statin use and held by CTT are RCTs)

The change had been prompted by the discovery that a range of published trials, such as those of the painkilling drugs Vioxx and Celebrex, had downplayed or concealed dangerous side-effects. ‘The implication (of the changed regulations) was that previous drug assessment procedures were not satisfactory,’ writes Lorgeril.

Diabetes link with statins took 30 years to emerge

So his team looked at the statins trials done since the new requirements for greater transparency. There were four of them, all involving rosuvastatin, and they ‘unambiguously showed that the statin was not effective in secondary prevention, while the results are highly debatable in primary prevention,’ he writes in the Journal of Controversies in Biomedical Research in a paper entitled ‘Can We Evaluate the Real Efficacy and Safety of Cholesterol-Lowering with Statins?’

One of these trials – presented as a great success at the time – was known as Jupiter and it revealed, for the first time, that statins raised the risk for diabetes. Lorgeril pointed out that, the failure of the large number of statin trials to pick up this serious risk for 30 years clearly revealed ‘a high level of bias in reporting harmful outcomes in (pre-2005) commercial trials.’ So what other omissions or distortions are lurking there?

Lorgeril concludes that ‘the only possible interpretation of the data is that ‘statins do not protect diabetics’, and that ‘there is no question about their diabetogenic effect’. The great bulk of the trials held by CTT were done before the 2005 regulatory upgrade.

But in addition to serious doubts about the reliability of CTT’s data, there is also well-informed disagreement about how many people (usually out of a hundred) have to take a statin for one to benefit or to be harmed. (Known as numbers needed to treat (NNT) and numbers needed to harm (NNH).

The latest Lancet trial claims a very favourable balance between the NNTs and NNHs. A far less rosy picture emerges from a recent analysis available on a website called theNNT.com, run by Professor David Newman, director of clinical research at Mt. Sinai School of Medicine in New York, together with doctors at St. Luke’s-Roosevelt Hospital Center in New York City.

Greater chance of developing diabetes than avoiding CHD

This calculated the NNT and NNH of statins taken for five years by people who hadn’t had a heart attack but who were at high risk – most had conditions such as high blood pressure and/or diabetes or smoked. [Link] Their risk of a heart attack (25% over the next 10 years) was much higher than the risk level that NICE decided should make people eligible (10% over ten years). That means that you would expect them to show up as getting more benefit than the lower risk NICE group. This is not what they found.

  • NNT: Lives saved – 0
    • Preventing a heart attack – 1/104
    • Preventing a stroke – 1/154
  • NNH: Developed diabetes – 1/100
    • Muscle damage – 1/10.

In other words, you are more likely to develop diabetes if you take a statin for five years than you are to avoid a heart attack, while your risk of muscle damage is far greater than the Lancet paper claims

Neither Newman nor Lorgeril would claim their studies are the final word but they are clearly serious, informed and thoughtful criticisms of the Lancet’s heavyweight claim of infallibility. Until they are properly taken into account and until Sir Rory massive collection of secret trial data has been independently assessed, the confusion and uncertainty around statins will remain.

Collins, however, has made it very clear that he belongs to the ‘never apologise, never explain’ school of argument. When he attacked the BMJ two years ago for running two articles critical of his claims about the low-level of side effects, he made no attempt to answer them. Instead he persistently demanded they be withdrawn. The committee set up to decide on the matter found that there was no basis for withdrawal. In fact, the panel was critical of Collins for refusing to submit a published response to the articles:

Not interested in scientific dialogue

‘The panel noted with concern that despite the Editor’s repeated requests that Rory Collins should put his criticisms in writing as a rapid response, a letter to the editor or as a stand-alone article, all his submissions were clearly marked ‘Not for Publication’. The panel considered this unlikely to promote open scientific dialogue in the tradition of the BMJ.’ Two years on Collins is still not promoting dialogue, preferring to debate by fiat.

As for apologies, his behaviour over side-effects would have drawn an abject one from most people but not Collins. Some months after the committee’s decision it emerged that, amazingly, he and his team had never actually conducted an analysis of his secret data to find the level of side-effects they had reported. Rather than apologies for failing to gather evidence for a claim that is absolutely central to widespread statin use, he offered to run a belated trial himself.

Why on earth has the Lancet, long a champion of evidence based medicine, chosen to ally itself with the idiosyncratic form of eminence based medicine that relies on hidden data and a refusal to engage in normal scientific dialogue? It’s hard to see how this latest report gives patients or doctors confidence about anything to do with statins.

As if that wasn’t enough the one question that every patient wants to know about statins is never even mentioned in the Lancet paper.’ ‘If I take these drugs for five years doc, how much longer will live? Statin research claims to ‘save lives’ but as long-term statin critic Dr Malcolm Kendrick points out, since we all die eventually, all any drug can do is to prolong it.

Live 5 to 20 days longer taking statins

A recent study in the BMJ provided an answer. (doi:10.1136/bmjopen-2014-007118) Death was postponed between 5 and 19 days in primary prevention trials and between 10 and 27 days in secondary prevention trials!

So the Lancet paper certainly hasn’t made all the uncertainty disappear but it has revealed a nasty iron fist clenched beneath its evidence based glove. The editorial refers to: research papers that are ‘more high risk to public health than others’ which therefore ‘deserve extra vigilance ….and should be ‘subjected to rigorous and extensive challenge … If publication is agreed, it should be managed with exquisite care.’ In other words, it might be better if some papers that risk rocking the orthodox boat were quietly disappeared. For more on this see Dr Kendrick’s latest blog.  

Such an overtly authoritarian line only makes sense if the criticism is wrong and the public policy is soundly based. But who decides that? Massive analyses like the latest Lancet have become so complex that only a few people can properly analyse them. This is not a problem unique to medicine. It’s an inevitable part of the growth of ‘big data’ which has been analysed in a new book by mathematician Cathy O’Neil: Weapons of Math Destruction: How big data increases inequality and threatens democracy. The tools for analysing this data gain their authority from appearing objective and scientific but, as O’Neil points out, they are based on choices made by fallible humans.

‘Like gods these mathematical models are opaque,’ she writes ‘their workings invisible to all but the highest priests in their domain: mathematicians and computer scientists.’ O’Neil was talking specifically about the sort of algorithms increasingly used in industry and financial services. She might have added ‘bio-medical statisticians’.

Just how comfortable are you having the very high statistical priest Sir Rory Collins holding the health of your heart in his calculator?

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.

23 Comments

  • I was put on Lipitor in March 2015. After taking them for 10 days, I started having muscle pain. On the 14th day I was in agony with shoulder and neck pain. In the evening I had such a strange feeling of pressure in my head and then a very bad nosebleed. So I didn’t take the statin that night.In the morning I could barely move and had such a feeling of malaise.My whole body had cramped up and the cramp didn’t pass…I stayed like this for about a month and during this period I had difficulty in finishing a sentence or finding the right words.By now the pain was going and my muscles were really weak and I felt my head was too heavy for my body. Then I started getting pains in my feet and hands, really awful stabbing pains. This is a year and a half ago after 14 tablets. I now feel much better but still have muscle pain in my thighs and think I have some permanent damage……….Statins are poison and Rory Collins is a liar and should take them himself and then do research.Disgusting.

    • Valerie, I think he does take them and it might explain why he makes so little sense. I’m glad you’re recovering. My brother got better quickly but not everone is so lucky. I tell his story to anyone I know on statins and I hope others do the same. Word of mouth has to help to tell us the truth because the drugs industry won’t.

  • Excellent article. Nice should refuse to accept ‘evidence’ based on hidden data. Ensuring that people sitting on committees have no link to the pharmaceutical industry should be next. Remove the medics who take the pharma buck and then want to make health policy.

    My brother was losing his memory because of statins, a problem that quickly disappeared when he stopped taking them. Dr Mark Porter, The Times columnist, reported the same problem. Almost everyone I speak to on statins has had some problem that goes away when they bin these drugs. Since side effects are so rare, according to Sir Rory, I can only assume that for some extraordinary reason everyone suffering problems lives near me. The media that so credulously reported this story might be embarrassed when the full truth finally emerges.

  • Good article, thank you.

    You didn’t even mention the link between statin use and increased incidence of Alzheimer’s disease (and even the acute onset of amnesia among healthy adults). Cholesterol is an essential building block for the brain — that’s why, even when cholesterol intake is reduced, the body manufactures it instead.

    For more information on these and other insidious side effects of statin use, I’d recommend the book “The Cholesterol Myth”. It was an eye opener.

    Thanks.

  • As a complete layman who has survived a serious heart attack and is trying to find his way through this mess that is statin therapy I must say that my overwhelming instinct (after months of research and reading) is that statins will eventually be shown to be useless as a CVD prreventative measure and any benefit they might have will be related to properties other than cholesterol lowering. Rory Collins is due for a fall with a very hard landing.

  • Misleading research is determined to produce sound statistical work that they choose to be economical with the truth,and they choose problems easy to analyse,but profound triviality
    Why cholesterol occur in the developed world?To some extent lifestyle factors play contributory roles.CHD IS THE RESULT OF THE WRONG HABITS That is why we have to take responsibility.
    The prevention of unnecessary illness.The key to long-term good health lies with the concept of prevention.This does not mean your a lost course if you already have a problem focus on preventing while you seek to cure it .Take pride in preventing getting sick and knowing that your immune system is strengthened by the way you choose to live your life .It takes courage to stand up and develop new eating habits and try to take responsibility.
    Despite all the magic technology,The don’t have cures for many conditions that affects us :
    High CHD ,heart disease ,high blood pressure asthma, arthritis,Medicine can help us manage illness.We have to be realistic food can make or break us.We have to face the reality of life and stop live in a dream world. If you have high cholesterol visit your local library ,and your local gym more often .I am not going to lecture you about nutrition. THERE ARE NO MIRACLE CURES… EXCEPT THE MIRACLE CURES THAT NATURE PERFORMS
    The body does not appreciate being overtaxed you have to build on your exercise plan day by day,so that increasingly becomes a pleasure something you and your body look forward to and need,even crave as you get healthier.
    For our health’s sake, we have to begin looking at quantities we eat,and the amount of time leave between meals.Best wishes

  • Great article. Thank you for this and all the others on this site. Surely if Rory Collins wants to settle the question of the safety and benefits of statins the best way to do it is open up access to the data to independent reviewers. Instead of accusing critics of statins of killing people by warning them off these drugs,the irresponsible ones are Collins and Co who are sitting on data which could prove one way or another the safety and efficacy of statins. That they choose to review themselves suggests to me that they are not as confident of a clean bill of health for statins from independent reviewers as they claim. Anyone would think that they had something to hide.

    • Editorial

      Indeed

      • This is evidence that again, the rich people and their sycophants and political prostitutes in “respectable positions” STILL believe that people will respect them just because of a title, position, wealth, or false authority.

        The world is moving beyond that stage. You can be a billionaire and i’ll show you how you are infantile and causing every remediable problem on the planet. You can be a “powerful” politician – and i’ll point out how you are breaking the law, and ALL your power is derived by the consent of the governed.

        All these self-important…….turds…….. have made many decisions over the years – choices which have harmed humanity. Not ONE of these so-called powerful people has made decisions that have directly kept you alive for the last ???? number of years.

        Farmers HAVE. Without them – you (and the rich) would die. So who’s the important ones in society? The farmers – not the Rothschilds.

  • A study in the 90s showed that when 200 corpses were autopsied – every single one of them – killed by myocardial infarction – had a selenium deficiency.

    About 200 more – listed as “cause of death – cholesterol” found that in reality – over 90% were killed by high homocysteine levels. In other words – B vitamin deficiencies.

    We KNOW that the body NEEDS cholesterol to survive. Period. Makes your hormones, makes your D3 from LDL cholesterol in your skin. Prevents Alzheimers -which people are REVERSING with medium chain triglyceride fats, no vegetable oil fats, and reduced carbohydrates. This forces the body to fuel itself on ketones instead of glycogen and glucose – with about 6X greater efficiency…

  • Health power is moving out of our doctors’office,clinics ,and hospitals.We need to keep ourselves up to date on the later discoveries about fitness diet,stress and priorities.When we choose to work with the health professional,we must do so as healthy active consumers,not passive patients.
    You can achieve positive wellness by following Dr .Cooper’s integrated medically sound program for better living or Unislim recipe,Patrick Holford &Fiona McDonal Joyce cookbook what make you motivate?Health and fitness will bring positive wellness and deep personal satisfaction.
    The disease is not just a matter of chance ,destiny or fate .An overwhelming body of scientific evidence indicate that most of the today’s illness ,have their roots in inactivity,poor lifestyle habits,failure to develop and follow a complete balanced health and fitness program.
    You can and should take matters into your own hands .Health ,fitness is up to you start tody .
    In short, you, not your doctor determines whether you will achieve positive wellness or whether you will face high bills and meet premature aging and death.Follow health and fitness
    Best wishes

    • Editorial

      Not at all sure that is the solution to ME/CFS. Broad-brush injunctions to eat well and the rest certainly make it less likely you will get it ill and maybe enough to make you better if you got ill in the first place because you weren’t living in a healthy way. But if you have an organic disorder -say rickets or an inability to convert T4 thyroid or haemachromatosis – eating well as such won’t change it. It is probably a necessary condition for recover but maybe not a sufficient one.

  • Statins! I believe they were responsible for the immune system disease I now have …Eosinophallatic Faciittis

    • Editorial

      sounds horrible – can you supply more details? Did this show up in some of the commercial trials or is it one of the imagined conditions that people report when the know they are taking the drugs

      • Doesn’t sound very accurate to state that “imagined conditions” of people are so …… what am i looking for? You imply no validity whether you intend to do so or not.

        There is the placebo effect in which actual healing takes place with no “medical cause”, and there is the nocebo effect too. Our minds both measure things happening in our bodies which NO MD can ever figure out. This is why MDs ask you how you feel, when did Xsymptom start? etc. Because they DON’T know and you DO.

        • Editorial

          mmm this is where it gets tricky.Pretty well every condition has a psychological element – feel worse when stressed, angry unhappy better when a warm authority figure tells you all will be well. And it may well be that patients with a range of disorders could benefit from CBT along with graded exercise, whatever else is going on.

          What distinguishes those with CFS/ME is that they are treated by psychiatrists whose speciality is mental disorders and we do, justifiably or not, make a distinction between disorders of the mind and of the body- blame Descartes. And if you are told the origin of your all too physical symptoms are in your mind that is pretty close to saying they have an imaginary component.

          Puzzled by what your emphatic CAPS indicate. It’s self-evident that your reports on how you feel are more authoritative than those of an outside observer but why does it need capitalising?

          • The emphasis on “NO MD” can figure out the conditions felt by a patient should be somewhat obvious.

            It is important to realize that they ask the symptom questions and get a feel for the patient’s general health, perhaps symptomatic timelines, etc – because the physician DOES NOT (mirror post) know these facts, feelings, observations, symptoms, etc – and the patient does.

            Therefore the phrase “imagined conditions” implies that there is no reason for the people to feel things when this may well not be the case at all.

  • Medical Nemesis:Illich 1976 was critical of the whole medical industry bureaucracy and highlighted the perverse role of medicine in creating illness and injury through inappropriate and incompetent interventions.Positive self -esteem is not sufficient in itself,Self-knowledge is power nobody can take away from you.Seek information question everything.Greed leads to unscrupulous practice.
    http://www.medicinenet.com/eosinophilic_esophagitis/article.htm

  • if anybody proposed that Collins’ title is withdrawn I would support it

  • ALL DATA (emphasis deliberate) must be revealed in full for ALL TRIALS, else there will always be a suspicion of misleading or fraud. this because health trials credibility has been destroyed and this is the only way to regain credibility.

    When a court order forces CCT to reveal ALL statin data we may find that it has been manipulated or changed or massaged in some way. his credibility is so destroyed!!!

  • You should remove Newman from this post and from the website. See the news from earlier in 2016…

    • Editorial

      Hmm intersting ethical point “A”. Your are of course refering to the rather unsavoury incident involving Newman and inappropriate sexual behaviour with a patient in hospital. That would certainly be a reason not to have him running your scout troop but I’m not convinced that it invalidates careful and sound research on an important topic done with a number of other scientists.

  • I’m really pleased I started looking into Statins. Ive been on them for about 8 years originally for raised Cholesterol. Three years ago I was diagnosed with Angina and had a stent fitted. So I continued with my Statin now with aspirin and Ramipril. Ive not had any side effects unless chronic pain in my left eye for the last two years has been one. However, after following the alternative views on Statins Ive stopped mine. To help my health I have stopped drininking and increased my excercise to 6 hours per week and try to eat as well as possible. Its scary to come off them but I believe its for my best. Thanks for the information

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