It’s about time some people were straight with the statistics on statins

Yesterday, the National Institute for Health and Care Excellence (NICE) published draft proposals concerning the use of statins for the prevention of cardiovascular disease. Previously, NICE advised doctors to recommend treatment in those with a calculated 10-year risk of cardiovascular disease of 20 per cent or more. Now, NICE is proposing that this threshold will be reduced to 10 per cent.

I have not read the draft proposals, but I have read this piece in the Daily Mail penned by Professor Colin Baigent, a vocal promoter of statins and part of the Cholesterol Treatment Trialists (CTT) collaboration which has produced reviews that are frothing in their enthusiastic for statins.

In the piece in the Daily Mail, Professor Baigent is unequivocal in his support of statins: the benefits clearly outweigh any risks, even in those at relatively low risk of developing cardiovascular disease. The risks of statins, are utterly downplayed.

His comments essentially parrot the findings of his own research. Back in 2012, his group published a meta-analysis (grouping together of similar studies) of statin trials [1]. Part of this meta-analysis involved assessing the impact of statin therapy in individuals deemed to be at relatively low risk of cardiovascular events such as heart attacks and strokes. One of the stand-out findings of this study is that statins led to a statistically significant reduction in risk of ‘major vascular events’. This was even true for individuals at less than 10 per cent risk of such events over a 5-year period. This led to the suggestion that statins used might be widened to even people at low risk of cardiovascular problems. Let’s have a look at these results in a little more depth.

First of all, ‘major vascular events’ is a ‘catch-all’ term that encompasses many different potential outcomes including fatal and non-fatal heart attacks and strokes and ‘revascularisation’ procedures (such as placing tubes called stents in the coronary arteries). When a lot of different outcomes are grouped together, it makes it much more likely that a statistically significant results will emerge.

When the outcomes are narrowed a little, the results are less impressive. For example, when we look at risk of death from any vascular event (a heart attack or stroke), we find that statins did not reduce risk in individuals deemed to be at low risk (<10 per cent over 5 years). This, by the way, was even true for those who had known vascular disease.

The ‘positive’ findings from this study have, as is often the case, been expressed as relative reductions in risk. The risk of vascular events overall was 21 per cent lower for each 1 mmol/l (39 mg/ml) reduction in levels of low density lipoprotein cholesterol (LDL-C). This, by the way, is a theoretical risk reduction, based on mathematical modelling of the data. In reality, though, there is not a clear association between the degree of cholesterol reduction in trials and the clinical benefit derived from this. Thus, ‘promising’ certain reductions in risk with specific reductions in cholesterol is potentially very misleading.

And besides, even if statins and cholesterol reduction do lead to ‘significant’ reductions in risk of cardiovascular events, when overall risk is low, then a relative risk reduction might not amount to much in real terms.

We’re told by the authors this meta-analysis that treating with statins prevented 11 major vascular events for every 1000 people treated for a period of 5 years. Put another way, 91 people would need to be treated for 5 years to prevent one major vascular event. Or in other words, only about 1 per cent of people treated with statins for 5 years will benefit (and about 99 per cent won’t).

Professor Baigent and his colleagues give us some soothing reassurances about the fact that the benefits of statins vastly outweighing the risks of adverse events such as myopapthy (muscle pain and weakness). They quote of the excess incidence of myopathy as 0.5 cases per 1000 people over 5 years. However, the source they quote is based on diagnosing myopathy once the marker for muscle damage (creatine kinase) is at least ten times the upper limit of normal. Many individuals will have significant pain and weakness with much lower levels of creatine kinase. Statins are also linked with adverse effects on the liver and kidneys, and increase risk of diabetes too. Overall, adverse effects of statins affect about 20 per cent of people who take them.

The numbers of people who need to be treated with statinsfor one to benefit are big, and many more people with have adverse effects than who benefit. These are the facts, and it’s about time people some people were straight with them.

References:

1. Cholesterol Treatment Trialists’ (CTT) Collaborators. The effects of lowering LDL cholesterol with statin therapy in people at low risk of vascular disease: meta-analysis of individual data from 27 randomised trials. The Lancet epub 17th May 2012

43 Responses to It’s about time some people were straight with the statistics on statins

  1. NM 14 February 2014 at 9:03 am #

    And the 1-in-100 benefit is probably quite unrealistic, too. The trials that produce these data are invariably industry-funded, and adverse trials are routinely hidden and remain unpublished. Furthermore, the trials that are published are often highly skewed to paint the intervention in a good light (by fiddling with the entry and exit criteria, trial length, by sneaking in some covariancy and so on). It is very difficult to trust this sort of data at all, especially where the margin of significance is so razor thin.

    I wish the above were the ramblings of a mad conspiracy theory, but pharmaceutical companies have been revealed as mendacious and tendentious by the revelations of court cases they’ve lost and huge fines they’ve been forced to pay. Dr Goldacre’s book “Bad Pharma” reveals this in all its gory inglory, as does the related AllTrials project.

    That the AllTrials project has to exist at all is a scandal that pretty much invalidates anything that industry shills like Baigent say.

  2. Mike 14 February 2014 at 11:41 am #

    My 80 year old mother (who is as fit as a fiddle) was prescribed statins because her cholesterol was high. She immediately started feeling joint and muscle pains. Thanks to the knowledge sites like this are spreading I suggested she stop taking the statins and the pains stopped straightaway and frankly I think high cholesterol in old age in beneficial rather than hazardous. I won’t be taking them.

  3. SH 14 February 2014 at 5:06 pm #

    The cardiologist who saw my wife recently said that she has a 10% risk of cardiovascular disease because she is a woman…so presumably all women will be recommended to take statins from here on……bonkers !

  4. LLM 14 February 2014 at 5:20 pm #

    It was iinteresting to hear the BBC two mornings ago on Breakfast News explain to the public what statin drugs actually are………..

    “..statins are drugs which lower cholesterol and other fats in the blood…

    I did email BBC asking them why they were giving out misinformation regarding statins. Needless to say I got no reply.

  5. Sheulee 14 February 2014 at 5:33 pm #

    Oh good grief. Nice.

  6. Jennifer 14 February 2014 at 5:35 pm #

    As always, a sensible response, Dr Briffa. I just cannot get my head round these numbers of people being medicated, usually for life, without any valid reason. The example from Mike, above, of his fit 80 year old mother is a case in point.

    On a forum yesterday, the majority of people were making similar points and asserting that they would definitely not be taking statins. I referred the few who were being cynical as, of course, doctors always know best, to your blog!

  7. Trevor 14 February 2014 at 5:42 pm #

    So how much are the pharmaceutical companies paying Professor Baigent to promote statins to this extent?

  8. Rosie 14 February 2014 at 5:44 pm #

    Thanks again Dr Briffa,
    Because of your diligence in health matters it informs ordinary people like us to be on the ball when it comes to our health. We regularly speak your name to other people like us so that they too can take care of themselves.
    Much gratitude and thanks once more

  9. Joseph DelGrosso 14 February 2014 at 6:00 pm #

    I never understand why these lopsided statistics get parroted. Why can’t authors of these papers just set the numbers straight, and lay out clearly RR, AR, and NNT. Both statistical and clinical significant are important to making decisions based on the data, and generally clinicians don’t go to the trouble to dissect the data.

    Thanks for breaking this down for us.

  10. linda 14 February 2014 at 6:02 pm #

    try taking b12 1,000ug a day this helps repair the damage due to statins and also opti-omega 3 1,000 capsules are helping my muscle problems . try and get your vitamin d3 level checked also

  11. Fiona 14 February 2014 at 6:09 pm #

    I’ve mentioned this new blog from Dr Briffa on that of Dr Malcolm Kendrick, ‘A sorry little patient tale’, where over 100 comments deal with experiences using statins.

  12. Soul 14 February 2014 at 6:10 pm #

    I was standing in line at the health store the other week when a guy, about my age I’d guess, began complaining to the store clerk of muscle pain. He said it was due to taking a statin. He had tried a few ideas to rid himself of the muscle aches, but the ideas had not panned out. He was looking to discover if the store had some pills to offer that might be new to him for the pains.

    I thought of speaking up, offering advice about what I did when I began to experience aches from taking a statin, I changed my diet, took a few supplements etc. but in the end kept quite. I’ve gotten to know the store clerk and mentioned something to her, and she said yeah she doesn’t know why people take statins but we all need to reach our own conclusions. All so true.

    It isn’t the first time I’ve heard of others experiencing aches from statins. One fellow in particular, a friend of the family and a retired general in the armed forces claims that the statin he took caused such crippling pain that he was disabled, nearly “killed” by the medication. Quite a claim.

    And made me wonder too, why people are all to often are not more curious about the medications they take, questioning risk to benefits that can be obtained. When I experienced muscle/joint pains from a statin I decided it was time to do some research, see if there were alternatives for heart disease prevention. The information wasn’t to difficult to find. For some curious reason it seems many are less willing to take greater control of their health. Some will even go to great lengths to follow doctors directives, questioning little.

    I think too a subject you have brought up in previous post before can be problematic. Many physicians feel they need to follow the standard prescribed care mentioned by officials. It is easier to go with the flow, than to risk ones career by going against the current.

    In the back of my mind I’m reminded of Claus Kohnlein’s book called Virus Mania. Interesting reading, mainly about the disease AIDs, but also on methods for treating other virus diseases. Claus can be seen in a documentary film called House of Numbers. The film can be viewed on YouTube at:

    http://www.youtube.com/watch?v=BwgmzbnckII

    In his book, Dr. Kohnlein makes an interesting mention about one of the main medications given for the treatment of AIDS. He mentions that tennis player Aurther Ashe and musician Freddie Mercury seemed to be aware that the medication AZT was deadly and was behind their declining health. Yet, both felt it best to follow prevailing wisdom and continue taking AZT. Around the same time basketball star Magic Johnson thought different, at least it is believed so. It was said in the book on page 142 and 144 that privately Johnson has mentioned to others while on a trip to Florida that he didn’t take AZT for long. It was causing to much pain, ruining his health. He has been asked if he takes other AIDs medication, but hasn’t provided answers, at least to the author.

  13. Susan 14 February 2014 at 6:25 pm #

    The Guardian on Wednesday published a more balanced report with criticism of blanket prescribing of statins than the one in the Mail (I presume – as I dont read that newspaper) What was the issue re side effects and kidneys?

  14. Janet Alton 14 February 2014 at 6:49 pm #

    Women don’t benefit from taking statins. It was shown by meta-analysis in 2007 and again in 2012. And you’re so right Mike – not only do elderly people not benefit from statins over the age of about 70, but they positively do need their cholesterol, and statin therapy can be very detrimental. Here’s some evidence, from VERY respected journals):

    J Abramson and J M Wright (20-26 January, 2007). Are lipid-lowering guidelines evidence-based? Lancet. 369 (9557): 168-169. (Answer: no, not really)

    Gutierrez J, et al. Statin Therapy in the Prevention of Recurrent Cardiovascular Events: A Sex-Based Meta-analysis. Arch Intern Med. 2012;172(12):909-919

    Mangin D, et al. Preventive health care in elderly people needs rethinking. BMJ 2007;335:285-287

    In any case, eating an apple a day has been shown to offer roughly the same protection against heart disease as taking a statin:

    Briggs ADM, Mizdrak A, Scarborough P. A statin a day keeps the doctor away: comparative proverb assessment modelling study. BMJ 2013;347:f7267

    So let’s all forget about statins and just eat apples!

    • Stephen Rhodes 16 February 2014 at 5:54 pm #

      Remember too that prescribing statins to women of childbearing age is extremely dangerous as they are a Category X drug – they are teratogenic like thalidomide.

  15. Vanessa Schaffeler 14 February 2014 at 7:06 pm #

    The side effects that involve memory and cognitive problems must be vastly underreported – just speaking to friends and colleagues it has come to my attention that many people have found issues with their memory since starting statins that they put down to ‘getting older’. Once they thought about it more, the link between the problem and beginning statins became more obvious.

    Many people also don’t realise that these problems can take months or years to appear, as the body starts to suffer from lack of cholesterol where it is needed. The new FDA guidelines in the USA actually mention this –

    (see here – http://www.fda.gov/Drugs/DrugSafety/ucm293101.htm

    “There have been rare post-marketing reports of cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with statin use. These reported symptoms are generally not serious and reversible upon statin discontinuation, with variable times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks).”

    I think that the reference to ‘rare post-marketing reports’ of this nature is because many doctors don’t realise there is a link and, as I mentioned above. patients themselves don’t make the connection.

    • Helen Wenley 15 February 2014 at 1:11 am #

      I agree with you. My husband suffered brain fade and severe muscle pain when he took statins. Even though he told his doctor about these symptoms, the doctor ignored him.

  16. rs711 14 February 2014 at 8:53 pm #

    Either this researcher is gravely incompetent, unaware of basic statistics (relative vs absolute risks) & medical literature…or he/they is/are dangerously, purposely deceptive. Or both.

    Thank you for continuing to spend time & energy debunking these charlatans with sound science. Maybe recognition & public thanks will never come, maybe…however,I hope you find some measure of satisfaction in applying the scientific method with integrity and helping ‘many’ people – I applaud you Dr.Briffa.

    Raphael Sirtoli

  17. Nina 14 February 2014 at 10:46 pm #

    Nice to see people with feet on the ground commenting on the Mail article.

  18. Jennie 14 February 2014 at 11:00 pm #

    Re SH

    If your wife was told she had a 10% risk of having cardiovascular disease
    Then presumably she has a 90% chance of NOT having it!?

    • Gregory Barton 15 February 2014 at 1:25 am #

      … or, if she takes the statin, a 9.9% risk of having cardiovascular disease, plus the added bonus of all sorts of potential side effects which cannot be quantified.

    • SH 15 February 2014 at 10:48 am #

      Re Jennie ..Statistics are tricky things and it seems that they are mostly used against the public by the pharmaceutical industry. I don’t think having a 10% risk of CD means you have a 90% risk of not having it…..but I get your drift! The American Heart Association claim that 30% of women are ‘living with CDV’. I have read enough about cholesterol and statins to stay well away from them although unfortunately my wife’s father does what his GP says and he takes them. He is in his eighties and I doubt that the deterioration I notice in him is purely because of his age.

  19. Alexander Cranford 14 February 2014 at 11:48 pm #

    I have often wondered if there is a placebo effect from taking statins.
    Have you all seen the (Australian) ABC two part program on The Heart of the Matter? Part 1 is about the lack of evidence against saturated fat and part 2 on the general ineffectiveness of statins. Click on where is says MP4.

    http://www.abc.net.au/catalyst/stories/3876219.htm

    http://www.abc.net.au/catalyst/stories/3881441.htm

    • Liz 15 February 2014 at 10:02 am #

      I watched these two programes the other day, they made me cry. I get so cross and so sad about what is going on. Why can’t they be shown here in the UK? All we get is the crappy Horizon debacle.

  20. Helen Wenley 15 February 2014 at 1:09 am #

    In the book “Grain Brain” Dr Perlmutter explains why we need cholesterol for brain health. My husband stopped taking statins because of the side effects – major muscle pain. It is far better to change our diet – and I recommend Dr Steven Gundry’s book “Diet Evolution” to those who wish to live a long healthy life.

    • Jennie McGinlay 15 February 2014 at 7:47 pm #

      Change our diet – exactly! I have no problem with being prescribed drugs if I get ill, but Statins are being recommended as a preventative measure – why on earth should that be necessary? If we eat healthily, we don’t need preventative drugs.

  21. John Walker 15 February 2014 at 7:54 am #

    What is also important in the UK, is the appalling waste of NHS money. Or am I the only Senior Citizen who has given way to my Doctor’s badgering and takes home statins, which I immediately throw away?

    • Maggie 15 February 2014 at 10:36 am #

      I wouldn’t have thought so, I think many people must take home the statins prescription and throw it away just to keep badgering gp’s off their back (including my husband!).

      • John Walker 15 February 2014 at 11:21 am #

        Hmm… Maggie, my Doctor follows up the fate of her prescriptions so I can’t do that. Never mind eh? :)

        • linda 17 February 2014 at 4:30 pm #

          i was told i would be on statins for life but i manage my high cholesterol and high triglyceride with just b12s 1000ug a day vitamin d and opti omega 1,000
          my levels have come down from 12.1 to 5.8

  22. David Manovitch 15 February 2014 at 11:14 am #

    Doctors are ‘addicted’ to prescribing drugs and manipulating biochemical parameters. They decreasingly view patients as people but chemical soups to be readjusted to theoretical standards. Doctors pay scant attention to the promotion of health, and are only comfortable ‘attacking’ disease, the concept of which they are ever expanding. The public are only too willing to swallow the medicine rather than promote their own health.

    Declaration of interest: I am a doctor.

    • Christine Whitehead 15 February 2014 at 7:02 pm #

      Good point, well made. Shame there aren’t more doctors like you.

  23. John Walker 15 February 2014 at 11:18 am #

    Thanks Liz. Indeed these films should be shown on British TV. IMHO, the Horizon programme mentioned, and many of the celebrity chef programmes are in contravention of the advertising standards legislation. As are the manufacturers of dozens of Yoghurt varieties, cereals, etc, etc.. We all know the culprits, but trying to get others to see the truth is like banging your head against a brick-wall. Just like Liz I become incensed when I come across this rubbish. I don’t cry, but I have to bite my tongue to stop myself ‘bawling’ at the television; thus angering my better-half, who prefers to believe the hype, because how can so many people be wrong? .

    • Marie 23 February 2014 at 5:11 am #

      Ask her if she believes the world is flat as well. Afterall, most of the people on earth believed that for many many years… how could so many people be wrong??

    • Jennifer 25 April 2014 at 6:54 pm #

      Yes John, I can well understand your frustration. Since the beginning of time, most people have been wrong about most things – fact!

      A relevant quote I love is:

      The trouble with people is not so much with their ignorance as with their knowing so many things that are not so!! William Alanson White.

  24. Janet B 15 February 2014 at 11:28 am #

    When I stopped taking the statin almost a year ago now, my HbA1c plummeted. Strangely, adopting a low carb diet has had SOME effect but not as dramatic as stopping the statin. I feel so well now.
    Thank you Dr. Briffa, for all your good work in this and some many other areas. Thank you.

  25. Carol Sayer 15 February 2014 at 11:48 am #

    My personal story is, I have stopped taking statins for about 9 months, due to doing my own research and not liking what I found. I had been on stains since having a stent procedure about 6 years ago.
    I was happy to take whatever the medics gave me and grateful to be here.
    In 2011 whilst still taking statins, and on a low fat high carb diet very slim and with cholesterol low under or around total of 4,6 ( I had a heart attack ) and was put on even stronger statins.
    Again I was grateful to have overcome this and still be around.
    Since I stopped the statins myself, changed my diet to low carb high fat, yes my cholesterol has elevated to 7.1 total But I feel that my body has found it’s own level and I’m happy with that, I just need to make sure that it’s the LDL that’s not the higher of the two.
    Unfortunately I have not pleased the medics, and was told my chol. level is “sky high, and I have obviously inherated the gene FH ” this did panic me a bit, as I hoped for support and not condemnation.
    But through my diet my aim is to make sure I reduce inflammation in the artery wall which I have learned to be the real cause of heart disease, I stay clear of any processed foods, and enjoy the real foods from nature and not manufactured rubbish, so I hope I am now on the right track.

    • Marie 23 February 2014 at 5:16 am #

      You ARE on the right track, no fear, and it is likely that your cholesterol levels will drop from here, many who switch to a low carb diet have an initial raise in cholesterol levels before they drop, which makes the docs happy :).

  26. Stephen Rhodes 16 February 2014 at 6:09 pm #

    May I make a plea that people watch this 35 minute Youtube of a discussion with Dr Stephanie Seneff about cholesterol where she explains how she has pulled together diverse research on how cholesterol (and vitamin D) works in the body by being sulfated (sulphated on this side of the pond) and how the widespread use of statins has become the largest cause of avoidable death in the US in recent years.

    She has also compiled considerable data on the side effects of statins by data-mining the sites that invite comment from those taking drugs, which has enable her to unequivocally defend that the widespread debilitating side effects of taking statins are real and unique for any mass medication.

    http://www.youtube.com/watch?v=_hbNSHPco0g#t=15

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