Statin drugs shown to be largely ineffective for the majority of people who take them, but why does this fact seem to have passed researchers by?

Over the last decade or two, it seems that increasing pressure has been put on us to have our cholesterol levels measured, and to do something about them if these turn out to be ‘raised’. Elevated cholesterol levels in the bloodstream is often said to be a potent risk factor for so-called ‘cardiovascular’ disease – something which can ultimately lead to unwanted and potentially fatal events such as heart attack and stroke.

From a conventional medical perspective, the mainstay treatment for reducing cholesterol are known as the ‘statins’ which include atorvastatin (Lipitor), rosuvastatin (Crestor) and simvastatin (Zocor). A huge stash of cash has been made out of these drugs, but is their life-saving reputation deserved?

Before we get delve into this subject in depth, we must first get clear on the two fundamental ways statins may be used the prevention of cardiovascular disease. One way is to prescribe statins to people who have no evidence of existing cardiovascular disease. This type of approach is described as ‘primary’ prevention. Statins can, of course, be used in individuals who have been diagnosed with cardiovascular disease. For instance, they may be known to have narrowing of the vessels around the heart (heart disease), or may even already have had an event such as a heart attack or stroke. Giving statins to such individuals is described as ‘secondary’ prevention.

What is the relevance of making this distinction? Well, individuals with a history of cardiovascular disease, compared to essentially healthy individuals, are at a much higher risk of cardiovascular complications such as heart attack and stroke. As a result, they are generally much more likely to benefit from whatever benefits statin drugs may have to offer.

Studies have found that in secondary prevention, statin drugs reduce the risk of death from cardiovascular events such as heart attacks and strokes. This translates, crucially, into a reduced risk of overall risk of death too. Scientists have generally assumed that these benefits also apply to the primary prevention setting, but do they?

In this week’s copy of the Lancet, an editorial examined this issue in some depth [1]. Its authors present the results of their own review of a total of 8 predominantly primary prevention trials [2]. This showed that statin therapy was NOT effective in reducing overall risk of death. The study found that risk of cardiovascular events such as heart attacks and strokes were reduced by statin therapy, but that this amounted to a real reduction to the tune of 1.5 per cent. What is more, 67 individuals would need to be treated for 5 years for just one ‘event’ to be prevented. One of the most startling findings of this review was that there was no apparent benefit seen in women (of any age) nor in men over the age of about 70.

These results are further weakened by the fact that 8.5 per cent of the individuals in these studies were actually in the secondary prevention category. To get a true picture of how ineffective statin therapy and primary prevention really is, it would be necessary to analyse pure primary prevention data separately. The authors of the Lancet review do not have access to this data, but they know some people who do.

The authors draw our attention to a group of scientists known as the Cholesterol Treatment Trialists’ (CTT) collaboration who in the past have assessed data from studies which include both primary and secondary prevention [3]. These scientists, the authors argue, have the data they need to calculate the effect of statin therapy in a purely primary setting. One wonders why they haven’t done this crucially important work.

Past events suggest this may have something to do with politics and money. Back in 2004, there was a significant lowering of what are regarded as acceptable levels of cholesterol, as recommended by a group known as the National Cholesterol Education Program (NCEP) expert panel in the USA. After its recommendations were made and taken up, it came out that 8 out of 9 members of the panel had financial links with drugs companies making statin drugs. The report’s publisher described the omission of these clear conflicts of interest as an oversight. I’ll say.

I suppose this wouldn’t matter too much if the recommendations to lower cholesterol upper limits were based on good science. The scientific basis for the recommendations made by the NCEP expert panel was in the Annals of Internal Medicine published in 2006. The authors of this review stated: In this review, we found no high-quality clinical evidence to support current treatment goals for [LDL] cholesterol. They went on to say that the recommended practice of adjusting statin dose to achieve recommended cholesterol levels was not scientifically proven to be beneficial or safe [4].

2004 was also the year that saw the decision to make the statin simvastastin (Zocor) available over-the-counter (OTC) in the UK. This decision seemed an odd one, bearing in mind that there is little, if any, evidence that statin therapy helps all but a small minority of the general population. Also, there has simply been no analysis at all of the likely effects of simvastatin use as an OTC medication. The Government body instrumental in the making of this decision – The Medicines and Healthcare Products Regulatory Agency (MHRA) – had previously stated that two-thirds of individuals who contributed to the consultation process had been in favour of making simvastatin OTC. That turned out to be a gross distortion of the truth ” the reality was that only about a third of individuals were in favour. The MHRA put this ‘mistake’ down to an administrative error.

Is it me, or is there something fishy going on here? What I find most curious is that in response to the Lancet editorial, which amounts to quite a damning appraisal of the basis for statin therapy, the mainstream media has reacted with deafening silence.

I think it’s great that researchers who are not in the pay of the pharmaceutical industry are prepared to ask hard questions about the presumed value of statin medication. But I also think it’s a shame that these researchers lack the funds needed to give such important work the airing it deserves.

References:

1. Abramson J, Wright JM. Are lipid-lowering guidelines evidence-based? Lancet 2007;369:168-169

2. Jauca C, Wright JM. Therapuetics letter: update on statin therapy. Int Soc Drug Bull Newsletter. 2003;17:7-9

3. Cholesterol Treatment Trialists’ (CTT) Collaborators. Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90-056 participants in 14 randomised trials of statins. Lancet 2005; 366: 1267-1278

4. Hayward RA, et al. Narrative review: lack of evidence for recommended low-density lipoprotein treatment targets: a solvable problem. Ann Int Med 2006;145:520-530

19 Responses to Statin drugs shown to be largely ineffective for the majority of people who take them, but why does this fact seem to have passed researchers by?

  1. Neil 22 January 2007 at 11:42 pm #

    I fear the bullshit concepts of ‘good’ and ‘bad’ cholesterol, of cholesterol ‘sticking’ to artery walls presents a simple and vivid picture that the public can readily grasp. This is tabloid presentation of serious science, and like the tabloids, is chock full of errors lies and misrepresentation.

    The good quality trials seem to be pretty equivocal about the mortality benefits even in secondary prevention let alone primary prevention. Its money, money, and reputations that drive the statination of the public. Too many people with reputations to lose have nailed their colours to the mast that says high cholesterol or high LDL is bad. To admit they were wrong would be to admit they have been misleading and mistreating the public for the past 20 years.

  2. Audrey 23 January 2007 at 11:53 am #

    New NICE guidelines were published last week recommending everybody with a reading greater than 6 mmols/l of cholesterol should be treated with statins.

    The majority of people with hypothyroidism have raised cholesterol and hypothyrodism is underdiagnosed. Again signs and/or symptoms are removed instead of looking at the whole person.

  3. John Briffa 23 January 2007 at 12:15 pm #

    Neil – thank you again for getting straight to the point and saying it like it is. Audrey, I\’ve looked at the NICE website and can\’t find anything about the guidelines you mention – can you help?
    John

  4. Audrey 23 January 2007 at 2:09 pm #

    When I read it properly I see it was entitled “The new NICE guidance on the use of statins in practice-Consideration for implementation” written by Dr Sarah Jarvis and Noel Wicks MRPharmS.
    Date of preparation December 2006 and (surprise, surprise) supported by Astra Zeneca.

    It may not be on the web yet. If you want me to post it to you by snail mail, I will.

    Audrey

  5. Carol 26 January 2007 at 11:40 am #

    This does not surprise me – nor the lack of coverage in the media. I\’ve previously worked in the medical industry and have first hand knowledge of how far the influence of the big pharma PR machine is spread. I\’m now on the \’other side\’ as nutritional therapist. I have moderate (familial) hyperlipidaemia and I have been subject to incredible and often aggresive pressure to take statins. As a woman, the Lancet review gives me more ammunition to resist this. Tocotrienols, plant sterols and the right diet plus exercise are more effective and far safer.

  6. Rowena Payne 26 January 2007 at 12:47 pm #

    Thank you! Having read the cholestrol article I am now FINALLY going to stop worrying about my cholestrol reading which is higher on the HDL side. Statins do not work on women, my diet is high fruit/veg and unprocessed and cannot be ‘tweaked’ any more, also I swim regularly which I enjoy. My grandfather and father died prematurely from strokes so I am mindful of looking after myself post 50. It will be good to ‘let go’ the worry!

  7. Kate 26 January 2007 at 1:38 pm #

    Hooray! Finally, I can stop having this sneaking worry about my cholesterol, which is nonresponsive to statins.
    The link between hypothryoid levels and high cholesterol readings is easily found on US sites. I went to my GP with this information and finally got treated after nearly 30 years of being refused thyroxine – despite all blood tests showing that I was hypothyroid (yes, with goitre and high tsh levels as well).
    Just so long as I stick to my low GI diet and live as active a life as I can, I know that there’s nothing more that I can do to lower my LDL.
    I’ve just changed my diet to a raw food base, with plenty of olive and omega 3 oils. I’m not giving up animal proteins as yet, but I feel fantastic on this regime.
    Again, thanks and keep spreading the word.

  8. Sue Knottenbelt 27 January 2007 at 12:38 pm #

    Interesting debate on this. I would be very interested to hear opinions on supplements that claim to reduce cholestrol…i have been using a product that was discussed in an article by dr susan clarke (observer or sunday times?) that claims to

    “support cardiovascular function and maintenance of cholesterol levels within normal ranges. …..a unique combination of Red Yeast Rice, Policosanols, Phytosterols, Coenzyme Q10, Chromium Polynicotinate, EPA, Artichoke Leaf Extract and Guggul. It is the most comprehensive formulation that supports the maintenance of HDLs, cholesterol, and Triglycerides within normal ranges. In clinical trials, Red Yeast Rice and Policosanols reduced elevated cholesterol levels by over 30% within eight weeks of use. Beware of other products containing Policosanols because only the ones derived from sugar cane have been evaluated clinically. Peak levels of cholesterol production occur between the hours of 4.00 am and 6.00am and hence follow the dosage regime exactly.”

    i have followed the regime for 3 months (though i see the recommended timing of dosgages has changed to load it more into those so called peak times) with no apparent impact on my cholestrol levels …though i havent yet had the full HDL analysis. i am a vegivore who eats fish once a week and has negigible dairy and maintains an active lifestyle…

    is there any evidence for the efficacy of these type of herbal products?

  9. Dr John Briffa 27 January 2007 at 12:45 pm #

    No evidence that I’m aware of. However, if reducing cholesterol is your aim, my question is: “Why bother?”: The studies show that taking dietary steps to reduce cholesterol does not save lives, even in individuals with diagnosed cardiovascular disease. Personally, I think the role of cholesterol in cardiovascular disease has beeN SERIOUSLY OVER-STATED.

  10. Janet Alton MNIMH 27 January 2007 at 5:11 pm #

    As a Medical Herbalist I wanted to comment on the herbs mentioned by Sue above. I use Guggul with patients only if they appear to need thyroid support and have blood sugar on the high side, because Guggul can address both, and achieving balance like this appears to reduce LDL cholesterol levels (it’s known, of course, that low thyroid activity causes blood cholesterol to rise, and I couldn’t agree more that hypothyroidism is seriously under-diagnosed). I don’t use Red Rice because you might as well use a statin – it inhibits the same enzyme. I do use Artichoke, however. Medical Herbalists reduce cholesterol by using herbs which benefit the liver – which is the organ which churns out 75% of the cholesterol in your body. Simple herbs like Artichoke, Milk thistle and Dandelion root improve liver function. No, I can’t produce clinical trial evidence for any of this, (well actually there are studies on Milk thistle) but as long as my patients benefit (and their blood tests show that they DO), I don’t let it bother me. I agree that the cholesterol myth has been preposterously over-hyped. I’m just as keen to reduce my patients’ homocysteine levels, and I watch with keen interest for somebody to invent a drug which does this, so that this becomes the next “must-have” treatment.

  11. Audrey 28 January 2007 at 1:09 pm #

    Maybe the pharmaceutical industry isn’t interested because we already know that folic acid and some B vitamins inhibit homocysteine.

  12. Ilona 28 January 2007 at 2:31 pm #

    As I approach the age of 60 and have recently been told (over the phone) that the results of a cholesterol test indicate I may have to take “a pill” to quote, I was very struck by this response to the debate about statins in the BMJ online correspondence pages, “subtle statin side effects nearly universal” 18 June 2006, from catey shanahan,
    Family Practice MD in the US.

    It seems to indicate the ageism underpinning attitudes and expectations re. health and well being of “the elderly”, where the author highlighted moderately unpleasant but debilitating symptoms that might be considered normal for people over 70 but could well be the result of prescribing statins.

  13. Ilona 28 January 2007 at 2:33 pm #

    The Url for the above post is
    http://www.bmj.com/cgi/eletters/332/7553/1330

  14. Janet Alton MNIMH 29 January 2007 at 3:47 pm #

    We know that Vitamin B6 lowers cholesterol, but it hasn’t stopped big pharma from coming up with statins! (OK, I admit that the dose given in the BNF is frighteningly high).

  15. Gregory 7 February 2007 at 5:10 pm #

    I have been looking for sites like this for a long time. Thank you!

  16. Jo 7 February 2009 at 4:14 pm #

    I have hypothyroidism and have been on lipitor and at one time triclor. My cholestrol levels are high and now after reading this site and others I realize how misguided our doctors can be with our medicines! I put on about 13 pounds with lipitor and due to the insurance company wanting the doctor to preauthorize the lipitor now I choose to not have her put me on a lower cost statin! I am going to go the natural avenue to help lower my levels and at the same time hopefully the gained weight will come off. Its really a sad thing that so many people are taking meds that are aiding in making them sicker in other areas! Thanks for this site!

  17. catherine 27 March 2009 at 10:35 pm #

    I have been taken lipitor 10 mg for about 3 years,now, I was told it was because I had a suspected TIA 2003, although I was not aware ofd this until 2007, they are supposed to lower my cholestrol which is now 3.5 it was 5.2. I feel awful on these tabs,have heavy generalised sweating periods constantly, which is so embarrassing,with having done very little effort, and feeling leaden , is it possible to stop taking these statins and keep my 3.2 cholestrol. I also take thyroxin for underactive thyroid, and have done for about 15 years. apparnrly I was told that this thyroid problem can lead to high cholestrol, although my GP never mention s this, can you help

  18. Molly 7 September 2011 at 1:16 am #

    I have recently been interested in researching the benefits of Milk Thistle. However, I am diabetic (throught pancreatic surgery, and am insulin dependent) and have been prescribed a statin (Lipitor) to control cholesterol levels(which is seems to have done). Would taking Milk Thistle as well as Lipitor be a benefit or counter beneficial?

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    [...] has long been known that many cholesterol drugs are of limited or negligible effectiveness. Statins are not effective at primary prevention and have a host of serious side effects. Fibrates are clinically worthless, having no impact on [...]

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