Statins: Why Doctors Should Put Down Their Prescription Pads

| January 21, 2011 | Comments (19)

Normally I write to you each Tuesday, but this week is an exception. The latest statin-related research findings are simply too important, I think, to wait until next week, which is why I’m getting this report to you today.

A new review study, published this week, assessed the evidence regarding the effectiveness and safety of statin drugs in essentially healthy people. This was a big story for anyone with an interest in cholesterol and drug therapy, and it culminated in me giving my take on the review and other pertinent cholesterol-related matters on Channel 4 news here in the UK (see video below).

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The review in question was published by the researchers from the Cochrane Collaboration[1]. This international collective of researchers prides itself of conducting systematic, unbiased reviews of treatments. The point of this review, the researchers claimed, was to assess the risks and benefits of statin treatment in what is known as the ‘primary prevention’ setting. This essentially means giving statins to individuals who exhibit no evidence of arterial disease and have no history of a heart attack and/or stroke. In so-called ‘secondary prevention’, statins are given to people with known arterial disease and/or a history of heart attack and/or stroke.

This distinction is important because individuals in the secondary prevention category are at generally high risk of further problems, and potentially stand to benefit most from statin therapy. On the other hand, individuals in the primary prevention category are at generally low risk of cardiovascular disease issues (such as heart attack and stroke), and may therefore not benefit much from a strategy or treatment intended to prevent cardiovascular disease. This primary prevention category is particularly important when one considers that the vast majority of people taking statins are in this category, and if the pharmaceutical industry and some of its hired hands in the scientific and medical community have their way, increasing numbers of people will be taking statins in the future.

In the recent Cochrane review, 14 trials were analysed. They reported, having amassed the evidence, that overall risk of death was reduced by 17 per cent, and overall risk of fatal and non-fatal cardiovascular events such as heart attacks and strokes were reduced by 30 per cent. On face value, these results look pretty good. However, the devil turns out to be in the detail.

To begin with, the researchers allowed studies in which up to 10 per cent of participants were in the secondary prevention category. What this basically means is that their assessment of the data was not really focused on the primary prevention setting. What’s required is an analysis of purely primary prevention data. The Cochrane researchers did not manage this, but other researchers have. A meta-analysis of data from individuals in the primary prevention category was published just last year in the Archives of Internal Medicine [2].

This study was a meta-analysis (amassing of several similar studies) of 11 trials that included data on more than 65,000 people. An accompanying editorial [3] described this meta-analysis as “to date the cleanest and most complete meta-analysis of pharmacological lipid lowering for primary prevention.” Cleanest, because the reviewed studies included primary prevention individuals only. The reason why this is important is highlighted by the authors in the following passage: “Limiting the analysis to patients without existing coronary disease is critical because studies that include both groups of patients may appear to show benefit for all patients, when all the benefit accrues to those with existing disease.”

This huge and relevant study showed that statin use is NOT associated with a reduced risk of mortality in the primary prevention setting.

The Cochrane authors do mention this study, but it’s somewhat buried in the discussion. It is not mentioned at all in the introduction of their review in which they list more than one review, like theirs, that allowed secondary prevention data to corrupt the primary prevention data.

The Cochrane authors have also largely confined themselves to assessment of ‘relative risk’. However, it is well accepted that a more useful judge of the true effectiveness of a treatment is absolute risk reduction (if risk if low, relative reductions in risk translate to very small real reductions in risk) as well as ‘number need to treat’ (e.g. how many people need to be treated for one year to prevent one heart attack– generally, ‘numbers needed to treat’ in primary prevention are high)

However, there are, I think, many good things about this Cochrane review. It highlights many of the deficiencies in the evidence-base regarding statin therapy. Here are a few highlights:

  • Of the 14 studies reviewed, four of them were not double-blind in design (double-blind studies, where neither the researchers not the participants know whether they are taking the active drug or placebo are considered the ‘gold standard’ for good clinical research).
  • Eleven of the 14 studies recruited individuals who, while perhaps not having a history of cardiovascular disease, nonetheless had what would traditionally be regarded as at least one major risk factor for cardiovascular disease such as high blood pressure or diabetes.
  • Two major trials were stopped prematurely. This is a cause for concern as it may lead to “an over-estimation of treatment effects…” according to the authors of the Cochrane review.
  • All but one of the studies was industry-funded. According to the authors, “It is now established that published pharmaceutical industry-sponsored trials are more likely than non-industry-funded trials to report results and conclusions that favour drug over placebo due to biased reporting and/or interpretation of trial results.”
  • The study participants were ostensibly white, male and middle-aged (average age 57), and the authors of the Cochrane review question the appropriateness of this data in, say, older individuals and women.
  • There was no evidence of significant adverse effects, though about half of the studies did not even report adverse effects.
  • There was little or no significant evidence on the cost-effectiveness of statins in primary prevention.
  • There was little or no significant evidence on the effects of statins on quality of life.

The authors conclude:

“This current systematic review highlights the shortcomings in the published trials and we recommend that caution should be taken in prescribing statins for primary prevention among people at low cardiovascular risk.”

While I have my reservations about this review, I do think it is highly commendable that some researchers (at least) have a mind to review the data on statins with a degree of objectivity. While statins are vigorously promoted by many doctors and researchers, it is good to see some academics urging caution. It’s a good thing that they are presenting the other side to statins because this is a story that is rarely heard, but one that needs to be heard if individuals are going to make truly informed choices about whether they take a statin or not.

Next week, as promised, I’ll be exploring the evidence linking relatively low cholesterol levels with worse health outcomes, including an increased risk of death from cancer.

Here’s to a healthy heart

Dr John Briffa
for The Cholesterol Truth
Dr. John Briffa


Bear in mind all the material in this email alert is provided for information purposes only. We are not addressing anyone’s personal situation. Please consult with your own physician before acting on any recommendations contained herein.


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References:

1. Taylor F, et al. Statins for the primary prevention of cardiovascular disease. Cochrane Database of Systematic Reviews 2011, Issue 1. Art. No.: CD004816. DOI: 10.1002/14651858.CD004816.pub4.

2. Ray KK, et al. Statins and all-cause mortality in high-risk primary prevention: a meta-analysis of 11 randomized controlled trials involving 65 229 participants. Arch Intern Med. 2010;170(12):1024-1031

3. Green LA. Cholesterol-Lowering Therapy for Primary Prevention – Still Much We Don’t Know. Arch Intern Med. 2010;170(12):1007-1008.


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Category: Latest Cholesterol News, Statin Controversy, Statin Drugs Side Effects, What Doctors Don't Tell You

Comments (19)

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  1. Christine Watson says:

    I truly believe statins will prove to be one of the biggest drug scandals of our time!

  2. ian horwell says:

    I took statins for four years ,,until four years ago.stopped taking due to leg cramps etc.recently found out i have high blood sugar,,any connection do you think?

  3. Kate Stevenson says:

    My father (aged 73 and strong like an ox) began to take statins in February of this year. He is now in a hospital, muscles wasting away, nausea, constipation and a suspected infection of his gall bladder or liver. He has now been advised to stop taking the statins (and thankfully has been cleared of any cancer risk). Can anybody assure me that there is a way of rebuilding muscle tissue, that there is a way for my strong father to get through this? Thanks, Kate

  4. m morgan says:

    Since being on Simvastin I notice lost of muscle tone and bulk in my arms. I have started to exercise with weights to try to remedy this. Am I right to suspect it is the drug rather than the normal ageing process that is responsible for this? In other respects people tell me I look young for my age and I am not over or under weight – my arms look older than the rest of me!

  5. Sherry Hagood says:

    I’ve been on Simvastatin for about two years, and I thought that it and a good diet and exercise could help me keep my cholesterol level down. I have high blood pressure that is controlled by diet and two drugs. I am feeling better than I have in a long time. I am stable. My doctor told me to take my cholesterol at night before I went to bed, for that’s when it works best.

  6. brett curry says:

    Hello, my name is Brett Curry. I have just recently lost my father to a battle with Amyotrophic Lateral Sclerosis, which we believe to have been a direct correlation with his new use of the statin drug, Lipitor. My father was always an ideal example of physical fitness. He was diagnosed 2 years ago and given a prognosis of only a year and a half to live. Since his prognosis, I have become increasingly interested in the statin drug debate. I am currently constructing a research paper about the direct links between these statin drugs and neurological disorders. Any insight you could give me would be greatly appreciated. Thank you.

  7. Theresa Van Dorp says:

    Dr. John Briffa Reading your information on the websight I havea question. Am I doing my mother more harmby asking her to take the b6, b12, and folicafter she has had the 5 stents put into her which are not working that good. I give her the pomogranate pills and juice and the the b viyamins for the homosystien I do not know what else to do. I have read the b vitamins may make the person who has stents may be a bad thing.Please let me know. I only want to help her..Sheis not the ordinary person who has had an operation, She has had now 5 stents, never beforesick, but now has been on coumidan 2 yearsnow and getting very weeker. What can I do to help her. I have given up on the doctors becausethey wait for another surgury. I do not like of couse to see my mother suffer and would like alternitives medices. This I believe we can only do now because she will not or does not want to go to surgery again. And we know it will be very hard if,she can handle itSincerely,Theresa Van Dorp

  8. Derek says:

    Having major health complications with Statins…. which will be taken further. Any professional opinions expressed should declare all their past and present connections with statin trials and which Pharma Company was or is paying their fees !!

  9. Charles Atkinson says:

    I had a T.I. A. in May 2001 was put on AtorvaStatin & then onto SimvaStatin because of pains & cramps in the backs of my legs. These were better as I did not get the previous symptons.However, in March of 2006 I began suffering from Angina Was admitted to Hospital in mid June 2006, and told I wasa ‘hair’s breadth’ from having a ‘massive’ heart attackaccording to the ECG readings. But not knowing aboutthese findings then, I did not connect the 2. After having a Stent (angioplasty) at this time and being dis-charged, (feeling unbelievably well) I might add, in mymedication list I was back on AtorvaStatin !! After arguing my way off these at my GP’s when I hadheard enough to make me doubt Statins Since then I haveBeen taking one 1200mg Soya Lecithin cap; morn & night and am maintaining a Cholesterol level of 4.3–4.8 and I and my GP are happy and I have no side effects.Obviously, this won’t work for everyone but it’s worth a try I think

  10. Cholesterol Truth says:

    Many of you commented on the fact that statins destroy CoQ10… and that is right on the money!To find out more about CoQ10, the essential heart nutrient that sparks life and energy into every part of your body and that helps prevent heart attacks and strokes by stopping cholesterol blocking arteries, check out this link…

  11. Mike says:

    I agree with Arthur. It’s time patients hit back at their doctors with the facts and that is: Statins destroy CoQ10 which in turn causes so many side effects.As far as I’m concerned: The Risks outweigh the benefits – if there are any at all.

  12. Linda says:

    Statins made me very ill… it lowered my cholesterol, but destroyed the rest of me… muscle pain, fatigue, headcahes, memory loss, depression… I can carry on… This was all because it depleted the coq10 in my body! If you ask me (and probably anyone else that’s ever been given the drug), STATINS ARE POISON!Thanks for the info on this blog.

  13. Cholesterol Truth says:

    It’s great to see all these comments from our readers. Thank you for sharing your experience with the rest of the world. If you would like to read more about the side effects of statins and how they affect people (like many of those reading our posts and articles) follow this link to our affiliate website, http://www.thehealthierlife.co.uk: Crestor : The Super Strong Statin Drughttp://www.thehealthierlife.co.uk/natural-health-articles/heart-disease/crest…

  14. Heather says:

    I was prescribed statins 4 years ago, just because my cholesterol levels had risen slightly–to 4.3– and my doctor said that I would NEVER have to worry about my cholesterol levels in the future. Within a couple of weeks I had pain in all the muscles in my buttocks, which steadily got worse and so severe that I could not put any kind of pressure on them. I could not bend over; I could not climb steps; I had to sit on blown up cushions and there were times when I slept in 3 different beds in one night!I took myself off them, to see what would happen, and there was an immediate improvement, so I went back to the Dr and told him. I still get pain if I overuse these muscles and would NEVER take these pills again.

  15. Arthur Brunet says:

    I started in 10 milligrams at first then they urged 20 milligrams and soon up to 80 milligrams a day. At 10 milligrams I had bad calf pain and at 80 I could not walk at all from the pain. I have since refused to take any statin drug as I have no trust in them. My doctors get angry until I tell them these drugs lower coq10 levels in the heart which we need to survive and on that they shut up and walk out.

  16. Jeff says:

    My father was on statins until recently. Had lots of side-effects including muscle weakness, came off, took some CoQ10 and essentially doubled his walking speed overnight.

  17. Ken Brown says:

    The worst part of this whole process is that the side effects of taking statin drugs have been purposely witheld from GP’s and the general public. G.P’s are still saying that only 1 in 10,000 people experience side effects when the actual figure is more like 1 in 2. Statin users who have died from liver disease, kidney disease and suicide, etc, have only helped to make the figures look good for statins. Yes, the amount of statin users dying from heart disease may well be slightly less but that is only because those other deaths have not been correctly attributed to statins. Independent tests have proved that statin use does not improve the overall survival rate. There are better and safer alternatives, avoid statins (they are poison afterall) like the plague.

  18. DetoxSpecialist says:

    Very interesting report John. Isn’t it about time more doctors looked at the real reason cholesterol is high in the first place?

  19. JEFF STRUDWICK says:

    I WAS ON STATINS BUT CAME OFF THEM BECAUSE THEY MADE MY LEGS WEAK +HARD TO WALK

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