How senior medics use strong arm tactics to close down the debate on statin side effects

By Jerome Burne

One of the alarming and intriguing things about the cholesterol lowering drugs statins is the vigour and ferocity with which supporters defend them. It’s alarming because it makes it almost impossible for both doctors and patients to get accurate information about their risks and benefits. Intriguing because it is so unscientific.

In fact, even though these drugs have been around for 24 years and prescriptions are still being written in their billions, we still don’t know for sure how well they work or how safe they are.

Researchers who suggest that they may not be as safe as routinely claimed have been accused of killing patients by frightening them into stopping taking the drugs given to cut their risk of heart disease. And it is not just researchers who are attacked; the integrity of a top journal has recently been questioned too.

At the end of last month Professor Peter Weissberg medical director of the British Heart Foundation made the remarkable allegation that critical articles about statins had been published in The BMJ (British Medical Journal) two years earlier had not really been intended to report on scientific research but simply with the aim of selling more copies.

Arch statin defender infuriated

He claimed that the journal was not interested in objective reporting. ‘The best way for them to sell copies, he told a newspaper ‘is by creating a bit of controversy,’

Regular readers will be aware that there has been a long running debate about the effectiveness and safety of these drugs. On the one side is the majority of the medical establishment which claims that nearly 30 large trials have shown that these drugs save thousands every year from dying of heart disease and that the side-effects such as muscle pain, a certain mental fogginess or cataracts are usually mild and only affect a small percentage of patients.  

On the other are doctors and researchers who claim that the trials run by drug companies are unreliable, that large numbers of people have to take statins for one to benefit and that the side-effects are far more serious and common than admitted. A raised risk of diabetes, detected recently, is a particular concern.

This debate first received widespread media attention two years ago when The BMJ published two features on the higher rate of side effects. This infuriated arch statin defender Professor Sir Rory Collins of Oxford University who pointed out both papers contained an error of a couple of percentage points and demanded they be withdrawn.  The BMJ published a correction but didn’t withdraw them when a committee concluded it wasn’t necessary.  

An additional 2000 heart attacks and strokes

Sir Rory then went on a media offensive and claimed in print and on the airwaves that thousands would die if such research kept ‘creating misleading levels of uncertainty’. This was widely seen as highly over-dramatic way of correcting an error.

The pro-statin camp seemed to receive a fillip two weeks ago when a new study, also published in the BMJ,  found that the widespread coverage of the raised side effect risk two years reported two ago – had coincided with over 200,000 patients stopping taking statins for a while.

The researchers at the London School of Hygiene and Tropical Medicine calculated that this could have resulted in an additional 2000 heart attacks and strokes over the next ten years.

The paper made no attempt to consider what benefits might have followed from stopping statins and so avoiding side effects. In effect it effectively assumed that statins are perfectly safe and effective – precisely what was being disputed. The study report also ignored the irony that the controversy Professor Weissman was complaining about was entirely due to the media blitz about the BMJ articles conducted by fellow statin supporter Sir Rory Collins.

Mixing up correlation with causation

If you didn’t know any of this background you might think that the London School study represented something of a vindication for the pro statin lobby in general and for Sir Rory Collins’ warning in particular. Sir Rory certainly appeared to see it in this light. When it came out he was reported as calling on the BMJ to: ‘stop hiding behind the spurious argument that debate is warranted’ and to ‘take responsibility for the harm it has caused.’

The claim that calling for debate over the safety of statins was spurious and unwarranted would be unexceptional in a faith based system but this is supposed to be about the science. While Sir Rory is scrupulous and unforgiving about an error of a few percentage points by his opponents, he appears happy to casually brush aside one of the pillars of evidence based medicine in defence of his own position. The pillar is the principle that correlation does not equal causation. In other words when two things appear together – such as firemen and fires – you can’t assume one caused the other.

This is precisely the objection that Sir Rory and others have used to question the evidence from observational trials of statins which find that patients report many more side-effects than the low rate that is officially claimed. They claim that only randomised controlled trials give you certainty about causation.

Yet the London School study is also an observational study. It looked at the period when the media reports on statin side effects were most frequent. Then it looked at the rate patients discontinued statins in the period. But Sir Rory assumes that one caused the other.  As Gary Switzer, an expert in health care journalism wrote last week in an editorial on this latest study in the BMJ: ‘The authors provide no patient survey data to support the belief that people stopped because of news reports.’

Stopping statins less risky than taking them?

Presumably the hope behind the publication of the London School paper was that it would strongly discourage newspapers from writing about statin risks on the grounds that thousands would die as a result. But the main effect has been to raise yet more doubts about the benefits and risks of these drugs.

To begin with there was the formula that the London School used to calculate the number of deaths that would result from statin withdrawal. According to leading statin sceptic and Cheshire GP Dr Malcom Kendrick, the way heart attack risks are commonly calculated is highly unreliable.

‘Using an updated formula the number of heart attacks and stroke you’d expect over ten years from 200,000 people stopping statins is actually about 500,’he says.  Now one of the things about balancing risks and benefits is that when the benefits go down the risks of side effects stays the same. What this means is the benefit from stopping goes up.  

Kendrick illustrates what this means as far as your chances of developing one of statins’ most serious side effects – diabetes.  A reliable estimate of the diabetes risk is that for every 150 people on statins one person will develop it.’ he says.  ‘Using that rate to calculate the benefits from stopping statins reveals that there could be 4000 fewer case of diabetes if 200,000 people stopped taking them.’ Suddenly the claims that warning about the dangers of statins is killing people seems highly misleading

Statin supporters never actually tested their claims

But the irresponsibility of the statin establishment’s use of strong-arm tactics to close down any debate on side-effects doesn’t stop there.  Two years ago Professor Collins claimed that reported side-effects such as joint pain and memory loss affected only a few percent of patients – not closer to 20 per cent as the articles The BMJ had just published were suggesting.

But as Dr Fiona Godlee, the editor of the BMJ has pointed out, there are serious problems with the evidence that Professor Collins relies on to dismiss this higher rate. Neither Sir Rory and his team nor any independent researchers has ever conducted any analysis of the rate of such side effects.

That’s because all the data from the trials on statins are not available for independent scrutiny, Dr Godlee said in response to the London School study. Statins have been subject to nearly 30 major trials run by drug companies and the  full results – all the records of how patients responded, which is what you need for a proper assessment of side-effects – are held by an institution called the Cholesterol Treatment Trialists (CTT)  in  Oxford headed by Professor Collins. No independent researcher has ever seen any of this data.

‘This situation should shock people,’ said Dr Godlee. ‘It continues to shock me.’ Last year she was informed by CTT that not only had no outsider seen the data but that the Trialists themselves had never analysed the data for side-effects either. The CTT’s explanation was that this was not part of the original agreement that they had made with the pharmaceutical companies to hold all their data in 1995.

This makes it hard to understand how Professor Collins and the big heart disease charities were able to be so confident that statin side effects were not such a serious issue or that the benefit of taking the drugs always outweighed the risks.

This attitude among senior medical figures – that research and data that challenges an official position should not be engaged with but dismissed  -is clearly not in the interests of patients. It could have serious repercussions very soon.
A new and more powerful cholesterol lowering drug has recently been given the green light by NICE. What will happen when studies come out indicating that side-effects are more serious than originally thought? Will that too be dismissed as ‘a spurious argument that debate is warranted?’

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.

11 Comments

  • Never,never give up your passion for life

    HSE GAS SURGEON AFTER DRUG CLAIM
    A leading vascular surgeon whose research review concluded that cholesterol-lowering medicines may do more harm than good for many otherwise healthy people
    Sherif Sultan ,a senior medic at University College Hospital Calway,reviewed a range of studies of statins and found the lack of evidence to show they should be given as a mean of prevention to healthy people with high cholesterol but no heart disease.He claims the HSE directed him not to liaise with media in respect of his research in his capacity as a HSE consultant 6 October 2013.

    Cholesterol is vital for health
    According to Professor Ross Hall, cholesterol is a requirement of every cell and we cannot live without it.It is the building block of sex hormones cholesterol also helps to make bile acids for digestion. There is no harm in foods stuff who contain natural cholesterol find out for yourself don’t wait for a magic formula. Food can make you or break you ;people are so steeped in their rotten habits of eating that they think there is some mysterious potion that will benefit all of their physical miseries.No one can banish your ailment.Health building requires individual discipline.
    Philosopher Nietzsche:He who has a why to live can do anything.What makes you feel authentic?

  • A very good article. What an unnecessary health mess we have. How much money would the NHS save if we stopped prescribing statins and told diabetics to avoid carbohydrates and to eat a diet high in natural fats? That’s a lot of money that could be spent on real health care.

    Archie, thank you for the link. I’m glad Mr Sultan has not been gassed, merely gagged.

  • Archie Robertson,Thank you for your humanity.I am glad too he was only gagged not gassed…I don’t get myself worth from my mistakes.The hope of humanity lies in the prevention of degenerative and mental disease, not in the care of their symptoms. My Cholesterol was a little high now I manage to bring down to perfect levels without any medication food is my medicine.
    While professionals have to study for many years to get their credential,on occasion their different personalities might get in the way or at times they get it wrong.We have a right to know and questions everything.Difficulties are things that show a person what they are.

  • Editorial

    I was sent this comment by Gregory Stoloff, director of the care oncology Clinic in London who agreed I could post it here.

    At the Care Oncology Clinic we use statins in combination with three other off-patent drugs to treat cancer. They are effective because they affect both the way tumours use glucose and the response of the immune system to them. What we have observed is that statins are also worth giving to people with cardiovascular risk but not for the official reasons. The way we do it uses a far lower dose and is not concerned with cholesterol.

    The benefit of statins on heart attack risk comes not from their effect on cholesterol but from the way they lower inflammation. It is possible to take statins for just one week every quarter and still get the anti-inflammatory benefits (plus a slight cholesterol lowering) without experiencing any of the statin side effects.

  • Statins (and the absurd diet-cholesterol-heart hypothesis) is the goose that lays the golden eggs, funding cardiology conferences, medical trips, and academic departments, as well as making huge profits for manufacturers. It currently cost almost £1M to prevent one death buy using statins: the vast majority of those taking statins daily for years on end will not benefit.

  • Why not invest 1 M to prevent illness ? a course in mindfulness will be more beneficial
    John Kabat-Zinn,an author of mindfulness ,it describes it as simply the art of consciousness.

    Western science
    Many physicians who consider themselves grounded in western science will see mindfulness-based programmes for mental health disorders as being faddish says Dr Gregory Lewis Fricchione.On a more positive note ,mindfulness is being taught in medical schools in the USA,and researchers have begun to investigate the effect of mindfulness interventions of conditions such as cancer stroke,multiple sclerosis ,pain anxiety and depression (Irish time 3 November ).

    The now fashionable practice of combining antidepressant medication with cognitive behaviour therapy Member of the caring professions,such as psychiatrist psychologist health physicians,unwittingly end up taking the referral from a dysfunctional organisation which removes their bullies from the ranks.The facts are psychiatric drugs cause serious adverse reactions including hallucinations ,psychosis,hostility ,life treating diabetes heart irregularities
    stroke and death .I am aware of people prescribe psychotropic drugs for may years it is unacceptable behaviour and something has to be done. Twelve of the recent school shooters were on withdrawing from psychiatric drugs.It is all preventable but profits are more important than humans.It’s about basic human rights

    No system can cure disease.No person can cure of your ailment.The human body is self-repairing and self healing.You break a bone the doctor sets the bone and puts it into the cast.The broken bone knits together again;after a number of weeks.The internal healing forces that are within every human body.
    Conclusion
    One of society’s greatest shortcomings has been the failure to teach children about justice .It is the failure that to tech empowerment,about understanding and attitudes that drive equality and justice.The more clearly we see the reality of the world ,the better equipped we are to deal with the world.

  • In response to Editorial 15 july 2016

    Statins: “but from the way they lower inflammation”

    My understanding is that inflammation is the consequence of healing. It happens because there is something wrong and is the healing process. Therefore, lowering inflammation stops the healing process BUT does not treat the underlying (root cause) condition.

    Question: How does lowering inflammation treat the cause of inflammation?

    • Editorial

      Yes b/w, good/bad thinking about body processes does make for confusion. – classic example being good/bad cholesterol. There is no such thing as bad cholesterol otherwise the body wouldn’t make it constantly and it wouldn’t be the feed-stock for hormones, among lots of other useful substances. In the case of inflammation my very basic understanding is that pretty well any sort of stress to the body ranging from a good work-out to an infection stimulates inflammation because it is associated. as you say, with a range of useful things such as healing. In fact without a degree of inflammation we would all rapidly fall ill. The likes of exercise and infection only push up inflammation for a fairly short time and then it falls back. What causes a problem is constant low grade inflammation which is generated by, among other things, high levels of omega 6 fatty acids and an increase in belly fat. Both of which are conditions for which there is an obvious solution. So some inflammation is good but and the type that can cause problems can be dropped by various life=style measures.

  • It has been suggested that if the awful “fraudulent” US standard diet or UK eat well plate was reversed to something along the lines of Mediterranean diet / LCHF diet then Obama Care could be closed down and the NHS would have billions available for real disease prevention and research (like Ebola or Zika)

  • Define the problem first rather than fighting the symptoms.
    Mediterranean diet can only help so much!
    Problems are part of life in this world keep in mind that emotional wholeness is a process which involves changing habits of thinking ,or acting that takes some time.I don’t know very much about Obama intentions .Ebola or Zika is just another preventable diseases.
    We all know why you get high Cholesterol doesn’t come from the thin air.If we have anxiety does not mean that there is something wrong with us it may mean making changes in our environment or the job that we do(Dr Thomas Szasz professor of psychiatry).
    You must take care of yourself finding yourself is the first part of that taking care.Do things that make you feel good.Be with people who make you feel good.Eat things that make your body feel good.Go at a pace that makes you feel good.
    The unaware life is not worth living.

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