Statin cheerleader Sir Rory Collins plans to examine himself. It could prove painful

By Jerome Burne

Professor Sir Rory Collins, the austere director of the institute in Oxford that produce much of the evidence supporting the increasing use of cholesterol –lowering statins, is in hot water once more. Last week he declared that he intended to investigate himself.

What needed investigating was his own admission a few months ago that his unit – the CTT (Cholesterol Trialists Collaboration) – hadn’t actually done any research to establish the level of damaging side-effects of the drugs even though he had been claiming for over a decade that they were negligible. Senior medical figures, such as the editor of the BMJ, are outraged.

Regular readers may remember that at the time of that admission, HealthInsightUK posted a blog giving the background to the revelation, pointing out that for years various critics had been claiming that proper data on statin side-effects was missing.

This is an important issue. Something like 12 million people in the UK take these drugs, NICE recently approved a major expansion of the number eligible for a prescription and doctors are paid for prescribing them. But if risk from side-outweighs the benefits the whole project is pointless and dangerous.

Fox and hen house; bank CEO and tax evasion

In the circumstances, allowing Sir Rory to conduct the investigation is like Lord Green offering to uncover what was known about HSBC’s Swiss tax avoidance schemes or nodding through a plan by Fred Goodwin to review the Royal Bank of Scotland’s mergers and acquisitions policies. For a more detailed and less flamboyant account of the ongoing issue of CTT and its lack of transparency see this week’s BMJ.

But this is not just about foxes being allowed to check on the hen houses it’s yet another example, of how our system of evidence based medicine that is supposed to be giving doctors and patients reliable guidance is capable of generating total confusion.

Of course we need to know the risks but ideally without the sticky fingers of vested interests smearing the results. The truth is that as far as the commercial side of cholesterol lowering is concerned, statins are so yesterday. When they were expensive patent-protected drugs there was a strong incentive to keep estimates of their side effects frequency low. But now they are all off patent and so very cheap, powerful forces have a strong interest in pushing up estimates of their risk.

That’s because waiting in the wings is a new class of far more potent, patented and so far more expensive, cholesterol lowering drugs known technically as PCSK9 inhibitors. They work by making the liver pull more cholesterol out of the bloodstream. A simple way to explain why we need them is to point out that they avoid one of the serious problems affecting statins.

Who knew so many were statin intolerant?

This, believe it or not, is that statins caused side-effects in lots of people. It’s been named “statin intolerance” but it means the same thing. Experts have been estimating the percentage of patients suffering from “statin intolerance” at between 10% and 20%. This is a far cry from the level of 1% that Sir Rory had been claiming at various times.

In fact Patrick Moriarty of the University of Kansas Medical Centre put it even higher in a paper he presented at the American Heart Association (AHA) meeting in Chicago in Nov last year. “Statin intolerance is one of the most common causes of an inability to reach goals in patients who need lipid lowering therapy,” he said. ‘It affects up to 25% of all statin-treated patients.’

And the side effect rate might be even higher. An American organisation called “Statin Usage” (funded by pharmaceutical company and The National Lipid Association) recently ran a big survey to find out why patients stop taking statins – described as “one of the biggest barriers to treatment”. The answer was because of side-effects at a level far higher than claimed by those concerned about “statin intolerance”. Sixty two percent said they stopped because of side-effects and 52% who didn’t refill their prescription, did so because of side-effects.

These wildly varying estimates are a long way from the Promised Land of hard data where it is possible to make informed choices. What’s more the story gets even more tangled and absurd. The cholesterol hypothesis that all this statin prescribing is based on is looking as if it could be a house of straw.

Elephant in cholesterol-lowering room

The industry and the medical profession have for years resolutely turned a stone deaf ear to voices pointing out the elephant in the cholesterol-lowering room. There are plenty of sensible careful studies that fail to find a connection between raised cholesterol and risk of heart disease.

This conclusion is virtually unthinkable since it would not only mean that two decades of statin prescriptions has been largely pointless (statins also lower inflammation, which may be beneficial in some cases), but that the new PCSK9 drugs, confidently expected to be multi-billion dollar sellers, will have to be taken off the table. The only thing these drugs do for sure is lower cholesterol.

For years it was only a few mavericks who pointed out that cholesterol did all sorts of valuable things in the body such as generating vitamin D, building the walls of all cells and making sex hormones ,so driving levels ever lower was probably not a good idea.

But recently the idea has been gaining traction in the mainstream press. Last week Matt Ridley, popular science writer and a member of the House of Lords, wrote a piece for the Times in which he made the point that not only was cholesterol essential but that new research had found high cholesterol was linked with living longer.

High cholesterol not an enemy but a friend

The research he referred to was a massive 100+ page report published in the Annals of Nutrition and Metabolism which analysed data from several large Japanese studies. The conclusion was that “cholesterol is not an enemy but a friend.” Having higher levels of cholesterol meant that not only were you less likely to die from heart disease but you were less likely to die from cancer, infection and liver diseases. In the case of liver disease providing your cholesterol was high enough: “serious liver disease does not develop”.

And there are various smaller studies that indicate that something similar is going on. Here is an article published just last week in Critical Care Medicine which investigated the cholesterol levels in 724 heart attack patients.

It found that those with a very low LDL cholesterol level (below 1.6mmol/l) had a 65% INCREASED risk of death compared with those with a level over 1.6. The effect of high or low triglycerides (fats in the blood) was even more dramatic. A 405% increase in risk of death for those with a level below1.24 mmol/L compared to those above that. And if you had low levels of both, your risk of death went up ten times.

In a sane system the fact that the evidence for statins is still so confused and contradictory after twenty years would make for extreme caution before allowing a another cholesterol drug onto the market, especially when it comes with a price tag of $7,000 to $12,000 a year.

But the marketing drums that drown out inconvenient evidence, as the statin saga shows, are already beating.

A new wonder drug with no side-effects

A recent cheerleading article in the UK press claimed that the new drugs can cut the risk of heart attacks by 50% and that one of them (evolocumab) is a ‘new wonder heart drug that has no side-effects’. A company executive is quoted as saying: ‘Overall safety “is very, very encouraging”.

But that ‘halving’ of risk means that the heart attack rate went from 1% to around 0.5% . This standard trick for turning a minor benefit into a major one was widely used to promote statins . As for safety the ‘no side-effects’ claim is a porky that is all too familiar from cholesterol lowering drugs. This one comes from trials that rarely lasted more than 24 weeks; just one ran for a year.

More sober assessments of evolocumab have pointed out that: ‘Neurocognitive problems, such as mental confusion or trouble paying attention, were seen in some of the study participants.’

So Sir Rory’s investigation of himself promises to be uncomfortable. His options are either to discover that he was making claims with no evidence base or that he is going to go head to head with a major marketing claim of several new multi-billion dollar drugs. Hot water indeed.

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.

32 Comments

  • There you go again, Jerome, talking commonsense. You think “intolerance” means something to avoid. But diabetes is carbohydrate intolerance. You don’t see health agencies recommending reduction carbohydrate for people with diabetes.

    • Editorial

      Yes their resistance to the bleeding obvious is remarkable. You might be interested in the behind-the-scenes post on SACN that Hannah Sutter did here about 18 months ago when the committee were still on their gentle 8 year meander to a decision that things were pretty much fine as they were.

  • Excellent article once again Jerome. At what point, if ever, will the public awaken and realise that the entire system of medical research is a complete and utter disaster area. Where is Hercules when you need the augean stables cleared?

    • That’s the thing- – “john citizen” has taken little care in questioning the stuff he is fed by the medical, nutritional and pharmacog propagandists. As in politics, you get the government you deserve.

  • “Last week Matt Ridley, popular science writer and a member of the House of Lords, wrote a piece for the Times in which he made the point that not only was cholesterol essential but that new research had found high cholesterol was linked with living longer”.

    It is… well, let’s call it “interesting”… to note that the virtually unanimous health advice of all Western governments, nutritionists, nutrition scientists, doctors, and nurses for the past 45 years has been, not only wrong, but the exact opposite of the truth.

    Can such a thing happen by accident? I don’t know which is more discouraging: to believe it can, or that it can’t.

    • Editorial

      A start would be to move from waiting till people got ill to treat them with drugs to focusing on keeping them well.
      Obstacles include the need for far greater government involvement in health and a readiness to research treatments that weren’t going to be highly profitable.
      Developing alternatives to the costly RCT as the only way to testing treatments will also be needed,
      All big asks. However the alternative will be an inexorable rise in lifestyle diseases and their associated costs.
      Its a kind of medical global warming. The problem requires an impossible rethink but the alternative is even worse.

  • Unfortunately, human nature is such that lay people tend to go on believing even the most discredited of official stories… until it is replaced by a much more credible one. It’s exactly the same phenomenon described by Thomas S Kuhn in his book “The Structure of Scientific Revolutions”, published just over 50 years ago. Scientists, he pointed out, do not abandon even the most discredited paradigm until they hear of a new and better one. It seems that human minds always need a story to hang on to, even if they are fairly sure it’s untrue.

  • Potentially decreased resistance to some virus infections could be a side effect from the PCSK9 inhibitors. PCSK9 inhibitors work by decreasing the level of functional PCSK9, this in turn leads to higher numbers of operational LDL receptors. These LDL receptors remove LDL from the blood and so produce the lower blood LDL levels.

    Unfortunately some viruses like the rhinovirus use LDL receptors to gain entry into cells. I believe that during such a virus infection the body produces PCSK9 in order to prevent the spread of the virus. People being treated by PCSK9 inhibitors will have less resistance to these viruses, the hepatitis C virus also uses a similar cell entry method.
    Some of the PCSK9 trials have been reporting that cold and flu symptoms /infections seems to be a side effect of the PCSK9 inhibitors.

    Another potential side effect is reduced ability for the liver to repair itself.
    http://onlinelibrary.wiley.com/doi/10.1002/hep.22354/pdf
    So in the case of a hepatitis C infection a PCSK9 inhibitor might be the last thing one would want. Indeed I believe some researchers are advocating the use of PCSK9 to treat hepatitis C.

  • For many years the good people of Pharma-Isle have lived a good life on the bounty of cholesterol lowering statins. It enable them to prosper and continue their work for the benefit of all of humanity.
    The PCSK9 inhibitor seeds have been sown and the trees are growing but the fruits are a long way from ripening.
    There is but one course of action. But only a very special sacrifice will satisfy the Wicker Man of Pharma-Isle

  • Mass prescribing of yet more unnecessary medicines will eventually break the NHS. It would be interesting to know how much could be saved by changing diet instead of prescribing drugs for type 2 diabetes, and thereby preventing at least some of the more costly complications.

    Having read Doctoring Data (Malcolm Kendrick), I am rapidly reaching the conclusion that the only driver for all businesses (pharma, big food, supermarkets) is the profit margin. End of. Platitudes regarding health etc are as worthwhile as Chamberlain’s piece of paper from Nazi Gernany.

    • And people wonder why I’ve no time for the NHS. I’m sick, I have been denied NHS treatment because I refuse to subscribe to their LFHC BS. All this “Save Our NHS” stuff does my head in – the thing that gets me the most mad, aside from statins (my father is in his 70s, and he lost his best mate 4 years ago to “liver failure caused by diabetes”, but his pal wasn’t diabetic – until they got him on statins. M was the picture of health – well, as healthy as one can be on an NHS diet. I STRONGLY suspect statins did for him. Shame there’s no way I can prove it).

      My biggest beef with the NHS (aside from its beef with beef – I’m sure everyone here is well-educated enough to know that red meat doesn’t cause cancer) is its weight loss advice. It’s been advocating a calorie-restricted LFHC diet for DECADES, and yet the collective national waistline keeps on expanding – I keep waiting for the obvious epiphany, but I guess there’s just too much pressure from Big Pharma (I refuse to believe that NICE (an ironic acronym if ever there was one) is wholly independent from BP) to keep pushing the anti-obesity pills, glucose-inhibitors, et al.

      I learnt the truth by simply going against the grain – literally. I dumped grains and I lost weight. I increased my fat intake and I lost MORE weight. Basically, doing the opposite of what I was told caused me to lose weight. Now I’m sick, and the NHS says that’s MY fault – or I’m told I’m faking it (I’m autistic, and apparently autistic people are prone to Munchausen’s, according to this little sector of NHS fucktardery). I’ve a drawer full of prescriptions for antidepressants (well, they’re Big Pharma’s third most lucrative product line) and laxatives and, obviously, I won’t have any filled.

      What the NHS is doing to the people of this country is, literally, sickening. I get so frustrated when I hear of people who’ve tried so many times to lose weight saying that they’re “not meant to be slim”, the NHS has the country so brainwashed and indoctrinated that people blame themselves and think themselves failures, rather than blame NHS doctrine.

      This may be a product of my ‘autistic brain’, but I think the NHS almost fits the definition of a cult; it has its doctrine (NHS Choices), and its ‘priests’ (GPs). It recruits new ‘priests’ via seminaries (med schools) who learn its doctrine. As many here may know, nutrition isn’t thought of as important at all (I’m a subscriber to Hippocrates’s adage that “all disease begins in the gut”, which is why I try to eat to my defined genetic and evolutionary dietary blueprint as possible).

      People think I’ve an issue with socialised healthcare – I don’t; what I DO have a problem with is socialised healthcare which isn’t run in the interests of the nation’s health; if the NHS was to embrace a LCHF dietary policy, and quit prescribing useless drugs that do so much harm for very little – if any – good, it would save BILLIONS, so the question has to be asked, why doesn’t it…? Who’s pulling the (purse) strings…?

  • Thanks again for another very clear and excellent article!

    I am still a little unclear how many statin ‘side effects’ are actually simply consequences of lowering blood cholesterol – and therefore an inevitable consequence of this kind of intervention whether using statins, PCSK9 inhibitors, or fibrates, etc!

    I understand that PCSK9 inhibitors require frequent injections and are hugely expensive! I am guessing that only very wealthy hypochondriacs will be treated!

    • Editorial

      Some of statins effects are due to what is involved in lowering cholesterol -blocking a pathway that also makes the important enzyme CoQ10, for instance – and some may be the result of having low cholesterol – such as the “brain fog” some people report.Unsurprisingly the amount of research into why certain side-effects happen is minimal.

      PCSK9 are certainly likely to have more serious versions of any side effects due to low cholesterol – it comes with report of cognitive problems – but because it affects a different pathway in the liver it doesn’t (as far as I know) block CoQ10 production. However as another post here pointed out, the effect it has on LDL receptors in the liver may well lead to greater vulnerability to viral infections.

      The first people to get it will those with genetically driven high cholesterol who, it is claimed, can’t get their cholesterol “low enough” with statins; also people with “statin intolerance” as mentioned in the article. The plan I believe is to gradually expand use by adding it to existing statin prescriptions to get cholesterol really low. This is a strategy that has already been tried with a drug called ezetimibe which was also very effective at lowering cholesterol further. However during the whole time it was licenced no trial ever showed it had any effect on patients’ risk of having a cardiovascular problem.

  • Matt Ridley is also sceptical that Global Warming is actually likely to be dangerous.

    http://www.rationaloptimist.com/blog/my-life-as-a-climate-lukewarmer.aspx

    That article is very well worth reading because it absolutely mirrors what has been happening in medical science.

    I think the awful truth is that modern science has been undermined on a broad front.

    • Here’s a thought- – There has been little or science, modern or otherwise, in the matter of treating population-wide human ailments, or preventing them, for several decades. There is an exception- -the sciences of communication and propaganda, in which technology and mass hypnosis have performed exceptionally.

  • “The effect of high or low triglycerides (fats in the blood) was even more dramatic. A 405% increase in risk of death for those with a level below1.24 mmol/L compared to those above that.” This surprises me. On a low-carb diet, triglycerides go way down while HDL goes up and there is usually a great improvement in health.

    • Editorial

      Yes I was also puzzled but I have simply reported what the abstract said. Afraid haven’t had time to try to chase it up, query authors, look at original etc

  • A general rant.

    As a medical neuroscience student, I have had the ‘privilege’ to be sharing modules with medical students. I was enlightened and deflated by the understanding that text books feeding of physiological, anatomical and medication knowledge leave NO room and time for critical thinking of treatment protocol beyond standard medication. what we are left with is a proud, intelligent group of people discussing health issues whilst thinking that they have a comprehensive understanding but in actual fact a rather limited insight. Most of whom genuinely caring and trying to do the right thing. Without addressing this I am afraid that those who have the biggest power to change things, the NHS doctors, continue to support the status quo…. ignoring real protocol changing scientific data, not on purpose but by extensions of time constrains, and simply because for most of them it is and unkown-unknown. The challenge is not finding enough data to warrant change but getting it to those that need it. Platforms such as HealthInsights are an essential tool in this challenge and I thank you for that!

  • my GP advised me yesterday that nothing but statins will bring down my 7.2 cholesterol level…i eat fairly healthy most of the time and take moderate exercise …he said no matter how much exercise or how healthy i eat my cholesterol is the way im made, probably passed on by my parents…i find this hard to believe…i dont want to take the statins…Sot sure what to do…

    • Editorial

      As a journalist I’m not in any position to give specific clinical advice, only to report on what research is discovering. First point to consider is whether raised cholesterol is actually unhealthy. A big study from Japan recently reported that raised cholesterol in older people was actually linked to living longer. Dr Malcolm Kendrick has written about that specifically in a recent post on his blog – just google him – and there is a lot more there about the tenuous links between raised cholesterol and heart health.

      You could also look at the extensive research done on why cholesterol is not a risk factor by Justin Smith at http://www.statinnation.net. As to what more you could do, I would suggest that rather than worrying about a single biomarker – cholesterol level – you keep yourself healthy overall. Stay at a reasonable weight and don’t base your diet round a heavy intake of carbohydrates, Zoe Harcombe on eating whole food is very good on this approach. You could even look at the book I wrote a few years ago with Patrick Holford 10 secrets of healthy ageing.
      Remember that while doctors and drugs are great in a crisis they are generally not helpful when it comes to staying healthy.

    • Just my personal observation, but if someone gives you a single-value cholesterol reading in the year 2015, you might wonder about their ‘up-to-date-ness’.It’s like asking about a football(soccer) match score and being told “the score is 5″, when really the score is 4-1, or 2-3, or 5-0. There is little or no meaningful info in the single-value score you were given. If you had been given LDL values, HDL values, triglyceride values, and HDL/triglyceride ratio it would be more meaningful, but the rate at which the medical profession is revising their interpretations of those numbers is a lesson in itself. Do what “EDITORIAL” suggests, read Kendricks and Harcombe, and Peter Attia, Uffe Ravnskov. And don’t worry abt cholesterol unless the numbers start falling inexplicably.

    • San,

      It just so happens that another blog contains the details of a number of surveys into the relationship between cholesterol levels and “all cause mortality”:
      http://vernerwheelock.com/?p=838
      I’d suggest you print that off, study the tables, and then take it with you the next time you visit your doctor!

      The extraordinary truth is that medical science seems to perform these studies and then ignore the results!

      Some time ago I agreed with my doctor that there was no point in wasting NHS resources assaying my cholesterol levels because I was never going to take a statin again whatever the level.

      • Hi David.#1 Following vernerwheelock.com does yield a treasure trove of info.
        #2 About having cholesterol tested- – a point to consider- – if the numbers inexplicably drop, beware that something is going wrong in your body.

  • It seems to me that when I read Professor Sir Rory Collins’ extensive qualifications and awards the only thing lacking is one day’s experience as a medical doctor with actual patients.

  • As a GP in Australia, who goes against the grain by encouraging patients to stop statins, and stop worrying about lipid levels, I would be grateful if you could mention some of the well designed and conducted trials showing no correlation between cholesterol and cardiac disease.
    Any more evidence I can present to my patients can only strengthen my case when they are swithering about stopping a statin

    • Editorial

      For anyone else who is interested I could forward an email to you that I have sent to Dr Barr containing a number of papers/newspaper reports (usually with enough info to find the original paper).

  • The New cholesterol guidelines for Longevity (2010) Harumi Okuyama

    Cholesterol and statins: Sham science and bad medicine – Amazon.com
    https://www.amazon.com/Cholesterol-statins-Sham-science…ebook/…/B00IU0SZUO
    This is what Michel de Lorgeril brilliantly demonstrates with this new book. … Michel de Lorgeril, Everything on spacedoc.com is ment for the public and very readable
    Okuyama H, Langsjoen PH, Hamazaki T, Ogushi Y, Hama R, Kobayashi T, Uchino H. Statins stimulate atherosclerosis and heart failure: pharmacological mechanisms
    Expert Rev Clin Pharmaco 2015 Mar;8(2):189-99.
    I am a ritired internist . My husband has muscle weakness without CK elevation that most studies ignore as statin complication.NB pharmacologic sequel of statins. To some extend provoked by three operation in short time, with proximal weakness in his feet , both tight that progressed

  • Sir Rory is of course a complete crackpot – anyone with at least half a brain knows that. Sadly, very few commentators blame the complacent and ignorant consumer for allowing themselves to be grossly misled. Once you know that cholesterol is an essential compound that is present in every human cell – and is also present in our brain (well most people’s anyway)then this precious substance should be treated with great reverence. To take a drug that interferes with the primal forces of Nature, i.e. poisoning the liver so it generates less of this life giving fat, is something that even a 5 year old child would understand. Sir Professor Rory Collins is a very dangerous individual. However, people who have a string of academic qualifications after their name manage to blind even intelligent folk with their corrupt, non-scientific rubbish.

    • Editorial

      Yes indeed. He was also an author on a very ‘authoritative’ study ‘proving’ that B vitamins were of no benefit in preventing/slowing cognitive decline. The trial was designed to disprove a very careful and hugely promising RCT (a rarity in nutritonal approach to Alzheimer’s). Sir R’s team got the result by ignoring all the key parameters of the original trial – heath of the patient group, dose and a crucial blood marker. There is a post on it on the site

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