Sometimes you read a thing quickly, and then you have to read it again to make sure you read it right. Yesterday I was sent a copy of a ‘Patient page’ from the Journal of the American Medical Association (JAMA). The page was from the April 3rd 2013 edition, pp 1419. It is stamped ‘JAMA – copy for your patients’. JAMA is one of the highest impact medical journals in the world.
This patient page states that:
‘One question involves disagreement about whether the statin side effects are merely uncomfortable or actually pose significant health risks. The other question is whether reducing bad cholesterol will actually help you live longer than you otherwise would. Some of this disagreement involves how physicians interpret the results of studies. However, a 2010 analysis combined the results of 11 studies and found that taking statins did not lower the death rate for people who did not have heart disease. If your physician recommends taking a statin, talk to him or her about the risks and benefits for your individual situation.’
For many years I have been ridiculed by colleagues for saying that, if you do not already have established heart disease, statins do not increase your life expectancy. By which I mean that they don’t’ actually work. ‘Don’t be ridiculous.’ Is what they exclaim to me. I usually reply that the evidence is pretty clear, and always has been. But I know that they don’t believe me.
Recently, without warning, one of the most influential medical journals in the world turned round and confirmed it. JAMA has stated in black and white that if you do not have established heart disease e.g. angina, previous heart attack, you will not live any longer if you take a statin.
Frankly, I think JAMA will now come under ever increasing bombardment from the ‘experts’ and will end up retracting this statement. In fact, I am willing to bet that they will – having now seen some of the outraged letters sent in. However from time to time the truth – like a small grass shoot growing through a concrete pavement – will emerge. As it did in April.
(I should add, at this point, that around 95% of people who take statins do not have established heart disease.)
However, wrapped up in this issue, is an inevitable argument. I know this argument well, for I have heard it a thousand times. ‘Ah, but it is not just death we are talking about here…. statins prevent non-fatal heart attacks and non-fatal strokes and suchlike. These are terrible things that damage the quality of your life. Medicine is not only about getting people to live longer, it is also about quality of life. Preventing a non-fatal stroke is extremely important, and statins do this.’ In other words, statins don’t make you live longer, but they do provide other, very significant benefits, by preventing Serious Adverse Events (SEAs).
This is a good argument. At least it would be if it were true. However, we have no idea about whether it is true or not. For the simple reasons that the data on SEAs is almost entirely hidden from view. Data on SEAs are considered so commercially sensitive that, in most jurisdictions, pharmaceutical companies won’t release them (and don’t have to release them), even if you ask nicely*.
Before moving onto that issue, I know that I need to explain I am talking about here in a little more detail, and clear up a bit of confusion with the nomenclature. For in the area of adverse events/effects, we have two terms that sound very similar, but mean very different things.
Firstly, there are drug related adverse effects. These are often called ‘side-effects’. But side effects can be good, or bad. For example Viagra was developed as an angina drug but it was found to create enhanced erections, as a side-effect. [You can decide if this is a beneficial side-effect or not]. Viagra also causes headaches. This is also a side-effect, but it would be more accurate to call it a drug related adverse effect.
Drug related adverse effects = negative/unpleasant ‘side-effects’ of a drug
A Serious Adverse Event (SEA) may sound similar to a drug related adverse effect, but it means something completely different. An SEA is a significantly bad thing that a drug might prevent e.g. non-fatal heart attack. Or, it could be something that the drug causes e.g. rhabodmyolysis (muscle breakdown), followed by kidney failure. Which is something that is known to be caused by statins.
SEAs can therefore be good, or bad. Depending on whether they are caused by, or prevented by, the drug. This means that there is absolutely no point in presenting figures on SEAs prevented by statins, without knowing if they caused an equal number of SEAs at the same time.
Completely unsurprisingly, whilst we are bombarded with statistics about how many SEAs are prevented by statins, we have very little idea about how many SEAs are caused by statins. Because in most countries, these data are not released. Its’ commercially sensitive dontcha know. [Damned right it’s commercially sensitive. If the public saw these data they would stop taking half their meds overnight.]
There have, however, been glimpses of SEAs with statins – when the data escaped from the clutches of the pharmaceutical companies. When the Cochrane collaboration fist looked at primary prevention studies, two of the five major studies did report ‘negative’ SEAs (although they did not say what the SEAs were, and still won’t). In these two trials AFCPAS and PROSPER, the SEAs were:
Statin arm: 44.2%
Placebo arm: 43.9%
‘In the 2 trials where serious adverse events are reported, the 1.8% absolute reduction in myocardial infarction and stroke should be reflected by a similar absolute reduction in total serious adverse events; myocardial infarction and stroke are, by definition, serious adverse events. However, this is not the case; serious adverse events are similar in the statin group, 44.2%, and the control group, 43.9% This is consistent with the possibility that unrecognized serious adverse events are increased by statin therapy and that the magnitude of the increase is similar to the magnitude of the reduction in cardiovascular serious adverse events in these populations.’ (read more…)
In short there were slightly more SEAs in those taking statins than in those taking placebo. Slightly more harm than good.
So what do we now know? We know that if you do not have established heart disease, and you take a statin, you will:
- not live any longer
- not avoid major Serious Adverse Events
Which means that there is no possible improvement in either the quality, or the quantity, of life. On the other hand there is a good chance that you will suffer from significant adverse effects e.g. muscle pain, joint pain, impotence, stomach upset, rashes etc. etc. On balance therefore we can state that, if you do not have established heart disease, statins provide no benefits on any important outcome. All they can do is to give you adverse effects. ‘Oh boy, that sounds like a great deal doc. Can’t wait, can’t wait, can I get them now?’
*Please see petition that I just put up on my blog. This petition arrived coincidentally as I was writing this article. At present the European Medicines Agency (EMA), will provide SEA data if requested (with huge persistence). The UK authorities will not release these data, nor will the FDA in the states. A recent move by the pharmaceutical industry is now threatening that the EMA will be forced to hide SEAs. ‘Six months ago two US pharmaceutical companies AbbVie and InterMune took a legal action against EMA that has closed down access to all trial data for all drugs for all doctors and researchers anywhere in the world.’
Closed down all access to all trial data for all drugs for all doctors and researchers anywhere in the world.
That statement is worth repeating. Be afraid, be very afraid indeed. And sign the petition please. Oh, and write to your MEP, as I am now doing.
Dr. Malcolm Kendrick 
The Ugly Side of Statins. Systemic Appraisal of the Contemporary Un-Known Unknowns” Sherif Sultan Niamh Hynes
Is quite interesting reading but doesn’t seem to have had much publicity. I wonder why?
Thank you s much for posting this article. I can almost weep. My husband may well be damaging rather than improving his health. I have had Dr. Kendrick’s book for years and Dr. Graveline’s book. But I cannot get my husband to take any of this on board. Fortunately he has gone back to eating cholesterol rich foods as we follow a GAPS-like diet, but if the metabolic pathway is blocked by the statin he may not be getting the benefit. His Primary Care Physician is so cavalier about prescription drugs. My husband is an obedient patient!
HSE gags surgeon after cholesterol drug claims
Surgeon’s research review concluded cholesterol-lowering medicines may do more harm than good
This is why it’s slow and difficult to get consensus medical opinion to change.
Yes, I have been following this. ‘Burn the unbeliever’ is the appropriate response, I suppose.
Reblogged this on mydiabetesandme and commented:
Because this is really that important.
i am and have suffered from taking statins and now i am trying to repair the damage myself as no medical person believes statins have caused my problems
I think I am very lucky that my doctor believed me, as I didn’t expect that, bearing in mind it seems not to be the norm. Right now I too am working on my own to repair the damage , as I don’t want to be offered more medication to fix it. That’s if it is all fixable. It’s so sad that the world is so corrupt and profit driven. “Never mind the patients, let’s just make lots of money”.
Certainly we must fight to preserve what right of access to results remains.
I knew my GP would not accept the truth about statins for some people….statins have screwed my life up…what’s left of it…..I did not ask my GP about stopping them, I just stopped. The pharmacist at the dispensary questioned me …..my GP has never questioned me. 6 months after stopping them and taking pomegranate juice I now feel almost normal. The more people talking about the adverse effects the better…..I have my say given any opportunity.
Dr. Kendrick,
Again may thanks for reiterating what you have been saying for years. I also believe that the JAMA statement will be retracted, and I also believe that the patient statement will never be made available to the patient here in the US! I may even make a point of asking fortdhe pateint statement, if I ever go back to see a US doctor. But, another point.
Besides the issue of established heart disease, another rationale is purported in order to get people to take statins–family history of heart disease. So, if your mum or dad had established heart disease and you do NOT have heart disease, why should you take statins?
If the JAMA statement ever gets out, the same thing will happen as happened when the new recommendations regarding the PSA were made public. Doctors will discuss the issue on public forum–especially those that are not accessed by the majority of the population, and the advestizing promoting statins, PSA, or any other refuted money earner will be gratly increased on via the most popular media. The status quo will remain, to the relief of the drug companies and the doctors.
Watch this space, but it may be like watching paint dry!!
Macolm, here in Canada I believe the cholesterol scam is served (intentionally) by inadequate disclosure by the labs that do bloods.
As I am sure you are aware, LDL cholesterol is calculated, not actually measured, using the Friedewald equation. The formula has a significant error factor when triglycerides are < 100 (Canada). For example, on one of my bloods the LDL was 'high' but my TGs were very low (good). When I recalculated LDL using the Iranian formula it came out about 35% lower (I can't remember the actual number).
In addition, calculated LDL does not differentiate particle size which, as a rule, is inversely proportional to TGs in that as TGs fall, LDL particle size increases.
At one time, blood requisitions used to state 'LDL calculated'. A few years ago, the word 'calculated' was deleted. Who is served by not disclosing vital information about LDL such as the error factor, the fact that it is calculated and not actually measured and that it does not reflect particle size? I am confident that you know the answer.
Keep up the good work. It is much appreciated and brings a ray of hope, only if a small one.
You make a good point. We get a figure e.g. 5.5, or whatever, and believe that this is accurate. Lipid measurement is a guess, followed by an equation or sorts. What, exactly, is an LDL, or an IDL. How can one differentiate. VLDLs become IDLs, become LDLs, and your guess is a good as mine when one turns into another.
“When I use a word,” Humpty Dumpty said in rather a scornful tone, “it means just what I choose it to mean — neither more nor less.”
“The question is,” said Alice, “whether you can make words mean so many different things.”
“The question is,” said Humpty Dumpty, “which is to be master – that’s all.”
There are some important questions I need to be asking, thanks for making me aware. For something less serious, pay me a visit.
I work as a HCA in a hospice and after my GP told me my cholesterol was ? 8. I asked what 8 meant, that’s very high my doctor said. I could not get a straight answer as to what is 8? I told the staff nurses and doctors at the hospice, 8. They all said get on statins now or you will have CHD, or stroke because cholesterol is very bad for you! So what can Joe Bloggs in the street do when so many doctors and nurses have been brainwashed?
well said i cant get through to any of them i have never been so ill for my 49 years of life since taking statins i will never take another ever if i did i would end up in a wheelchair and round the twist
I had a similar reaction from my GP: when he told me I need to take statins because my cholesterol level was 10 – I refused, and he said “if you don’t take statins, you will suffer severe heart disease within the next ten years”
Where is the published scientific justification for ‘tampering’ with definitions of ‘normality’? if a serum cholesterol score of 9 was normal 15 years ago, who has presented the population of the Western world with the science that proves the ‘normal’ of 9 has had to be changed? The same applies to the BMI index which has been reduced without any medical explanation. If the ‘normal’ of the past is wrong, who is responsible for mis-informing us or promoting incomplete medical research? Either way, someone is taking away our right to know what evidence-base is being used to plant and then shift the goal-posts so regularly and across so many health issues.
Normality…. what an interesting concept. I decree that everyone over two meters tall is abnormal and should be shortened. Might be interesting to see what happens. On a less dadaist note, I think you will find that money plays a very large role in redefining normal. The less normal people there are, the more money to be made.
Interesting reading as I am about to be told I need to take satins, ?Question. who will listen to me if its a question of shall I or shall I not, I feel like not @ 80 years & never taking this medication do I need it now. Selina
No
i was put on statins at age of 46 took them on and off for 2 years and now i am suffering
i am now following my b12 ,folate ,iron ,vitamin D and calcium if my b12 had been tested before maybe i would not have had to go through what i have now my body is suffering http://www.B12awareness.org http://www.b12deficiency.info/asse... check these 2 out please
There’s another way of looking at this. Now that most statins have gone off patent protection (at least in the US), the pharmaceutical companies need to decrease demand for them and increase demand for PCSK9 inhibitors that are coming out. JAMA is the perfect first step in persuading doctors that statins aren’t the best drugs for CVD prevention but that this new class of drugs are.
Here we go again.
I suspect you are probably right
Dr Kendrick
After 6 years of taking simvastatin I stopped when confronted by negative media. Your “The Great Cholesterol Con” reinfored my determination. Under pressue from my GP I have now been seen by a Lipid specialist and a cardiologist and I have heterozygotic FH.
My thyroid function and liver function are normal, fasting blood sugar 5.6, Stress test passed with flying colours, However, my CT coronary angiogram gave a calcification score of 254. “none of the plaques are causing more than 25% stenosis, and no significant abnormalities were identified”. I consider myself to be a healthy 64 year old, Should I relent and take stains as I am being urged to do? Regards
Mike W.
I had missed this new poison. Thanks for raising the issue, ‘forewarned is forearmed’ as they say.
A summary of the new money spinner is exposed at http://articles.mercola.com/sites/articles/archive/2013/07/29/pcsk9-cholesterol-drug.aspx
Hi, I have asked this elsewhere but didn’t get a response.
If you can’t have a cholesterol level (as you say in your book) why does someone with FH have such a high reading and this insignificant?
Also, when putting over the ‘Cholesterol Myth’ to others and they respond by stating the Framingham Study proved the links, what did this study actually prove?
Thanks
Are you sure? 😛
http://www.express.co.uk/news/uk/413679/Give-statins-to-healthy-Scots-now
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Dear Malcolm,
I accompanied my husband to the doctor today for his health check. Usually I leave the room but today I stayed to ask some questions. My husband is a very intelligent man, but he prefers to believe his doctor has his best interests at heart.
I asked him about Central Arterial Systolic Pressure measurement. He fumbled a bit. He did not know what I was talking about. I told him that one study showed the there was the equivalent of a 30mmHg difference between aortic and brachial systolic pressure.He assumed that the difference was an underestimation and was surprised when I told him it was an overestimation. He is a very smart man and inclined to read the research, so I do hope that he will follow through. BIG implications!
Before I left, I handed him the JAMA statement regarding statins. He said that the government here in the US was to be making some recommendations regarding Blood Pressure and Cholesterol but they had changed their minds because these are two extremely controversial issues. YOU BETCHA!
He did say the the government was supposed to be rescinding the recommendation for PSA as a screening tool for prostate cancer. I have heard nothing of this, but I can report that local news in pushing more widespread use of statins (last night), very early intervention by radiation and five year treatment with Tamoxifen for women who have something that is not quite cancer (they are calling it something else). This report was last week and flies in the face of the review showing that 18 women are treated unnecessarily in order that the one woman who has cancer is found and treated! (Last week’s news) remember I am in one of the foremost cancer treatment cities in the world, Houston Texas. PSA is still being touted as an essential test for all men.
No doubt “the government” will stand down on that issue too.
I recently refused a colorectal examination, requesting the FOB test first. This request was refused, so I got my own FOB test and did it myself.
My philosophy? If it is not happening in Scotland, it is not happening here. While the UK is imperfect, its recommendations are much more moderate on many issues. US healthcare is very, very aggressive. I thank god I came here because it wakened me up to the issues.
Sorry about the length of this post, and thanks for everything you are doing to effect change.
Glynis
Dear Dr. Kendrick – thank you for posting this critically important information.
However, there is another side to this issue that I’d like some greater clarity on: What about people who HAVE had a heart attack? Does taking statins provide them with any significant health benefits that couldn’t be achieved through other, more “natural” means?
I had a major MI just over 2 years ago (at the ripe old age of 47) but I stopped taking statins about 6 months ago becuase I was noticing serious negative side effects. For the past 3 months I have started following a low carb high fat diet with intermittant fasting as my wife and I have read and seen a lot of info about how beneficial this approach could be. But we still have a question about whether or not some sort of statin prescription would be beneficial for me as well…
I cannot give individual medical advice over the internet. Sorry
Okay – understood. Thank you for taking the time to respond.
What about in general terms though? Have statins been proven (or disproven) – in general – to have a positive impact upon the cardiac health of those who have had an MI?
In general terms statins have been proven to reduce CV and overall mortality in men who have had an MI. The absolute benefit is not great, but it is there. In general, if you get no adverse effects from your statins, probably worth taking. If you get adverse effects, then the harm to benefit ratio quite quickly moves over to harm. This is a general reply
You keep saying ‘in men’. In general, what about a woman who has had an MI. Statins or no statins? I am confused reading your book – in chapter 7 you say 2 things in a row that appear to contradict each other about women.
You are perhaps confusing CV mortality with overall mortality
Perhaps I am confusing CV mortality with overall mortality BUT am still wanting info on women who have had cardiovascular event and the use of statins (good or bad) – in general that is.
Reduction in CV deaths. No reduction in overall mortality.
hi i went on statins due to a genetic type 3 hyperlipidemia ,i am/was very healthy until the statins
i went on 3 different ones but my leg muscles started to change shape and trouble with my upper arms my left mostly but i also was very low . i have found that my b12 level i have raised from 300 to 600 and now i feel so much better,my vitamin d had dropped to just 17 with vitamind and calcium these are higher,i also eat for 7-8 hours a day intermittent fasting and my levels are now kept under control with just these rather than damaging my whole body with statins .
coq10 gets ruined with statins ,vitamin d gets ruined including your muscles and you mentally ,how are doctors helping us ?
Without giving specific medical advice, what does the medical literature say about statins for those who have had a heart attack and an angioplasty?
My understanding is that is such cases the issue isn’t lowering cholesterol so much as it is lower inflammation of the arteries. Does the medical literature convincingly support this use of statins? Does it indicate that statins are better than no statins in preventing another heart attack?
Cholestrol
The medical science is doing advance research and they are
conducting variety of experiments on human beings. About 40 yrs
back they found out Cholesterol as the main culprit to cause
heart attack. Since then they started giving us medicines and
advised diet control. Now we can see that, the rate of heart
attack is increasing day by day. This itself is a proof that their
prediction is wrong. Doctors from all over the world has
difference of opinion on this issue. If at all.. still if the doctor
community feels CHOLESTROL as villan, Why should a
patient be given STATIN drugs which damages our liver,
when cholestrol melting vitamins (VIT E) are readily available
in market.
Kevin’s question is interesting, Dr. Is it possible to answer it in general terms–in terms of empirical findings or in terms of the rationale Dr.’s have for prescribing it, and then comment on whether this reason is plausible or strongly supported or not?
It is supported. I wouldn’t say strongly. Frankly, I never would take statins, but I think the benefits (if they truly do exist, and are not biased and manipulated by the industry) are so small as to be not worth bothering about. I prefer to enjoy my life. But for others a small extension may be seen as worthwhile. I only to try and represent the facts (as far as I know them to be true). It is up to others to decide what they should do.
Re your comment to Lawrence: “In general, if you get no adverse effects from your statins, probably worth taking.”
Are all adverse effects noticeable? Could there not be dangerous adverse effects that take place without being noticeable, at least not before they have done significant harm?
Also, why are they then worth taking? Is it merely because of a rather small difference in mortality rates from another heart attack? In short, a statistical reason, rather than a well-established and well-understood biological reason?
Yup
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Dr. Kendrick,
I have come across this site after researching a cause to my husband’s debilitating muscle weakness not to mention the agony and numbness and tingling he experiences on waking which quite literally makes him cry. He is a mere 42 years old with a history of familial hypertension, high blood pressure and high cholesterol. He has taken simvistatin for a number of years, he came off the for about 6 months and saw some improvements but after another very high reading his Doctor said that she very strongly advised he needed to go back to them once again. He has a very physical, manual job that he, until very recently, pushed himself through but now is off sick (not paid) with not only the effects of the statins but also severe depression. I know that you cannot give medical advice but what I am trying to get my head around is the sort of information we should be asking his GP for. We are only now researching and discovering what you all already know but have an appointment in the morning. Trying to get our heads around CK levels and B12 and vitamin D. Can you advise what sort of questions should we be asking at this point, given that here too we are encouraged to follow the gospel of the GP!
Thank you in advance !
Tina,
I cannot give patient specific advice on the Internet. I would advise you went to http://www.spacedoc.net
I cannot thank you enough – I have familiar hypercholesterolemia and was put on statins on my 18th birthday I’m 46 now and dumped it as I was taking up to 12 pain pills a day just to have a sort of quality of life – no more! Why prolong a limited life…I’m responsibly single and childless – it stops here!
Have any of ur relatives had cardiovascular incidents at a young age?
Hi Mary,
Yes that’s why they called it familial, my uncles died at ages 23, 34 and 55 (after a quadruple bypass and heart transplant prolonged his already poor quality life!), my last uncle made it to 65. Interestingly enough, mum was diagnosed when she turned 38 she is now 73 and my auntie has so far made it to 80 (she had 3 bypasses in her life) both on statins and unfortunately living very poor quality lives with muscle aches and all the other horrible side effects from statins.
I’m a thin, fit. 56 yo wf nurse. I’ve had 2 episodes of stable angina in the past 12 mos. I don’t smoke and I eat a light, healthy diet. I exetcise. TGs are fine. HDL 49 and LDL 190. Blood pressure is normal. I DO NOT want to take a statin. Am I being stupid. I just think of all my pioneer relatives that lived well into their 80s. How many of them had high LDLs? I just don’t know what or who to believe. My doctor is on three different bp meds plus a statin. He has too much muscle pain to exercise. So, what’s a petson to do?
Thank u for any response.
Mary
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