Dr Kendrick has been warning about the almost total lack of effectiveness of statin drugs to prevent heart disease for over a decade, during which time the number of prescriptions written for these drugs in England alone has more than doubled from from 25 million to over 50 million. So much for his ability to affect public policy. However, last month it seemed that the official view had finally caught up with him. [Editor]
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,’ they exclaim. I usually reply that the evidence is pretty clear and always has been. But I know that they don’t believe me.
However now one of the most influential medical journals in the world had turned round and confirmed it. JAMA has stated in black and white that if you do not have established heart disease, e.g. angina or a previous heart attack, you will not live any longer if you take a statin. I should add, at this point, that around 95% of people who take statins do not have established heart disease.
Surely statins improve quality of life
But statin supporters have another arguement up their sleeve. ‘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 arguement. At least it would be if it were true. However, we have no idea about whether it is 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.
But first I need to clear up a bit of confusion over two the meaning of two related terms “adverse events” and side effects which are often talked about as if they are the same but which can 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.
The side effects that are normally kept hidden
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. It’s commercially sensitive dontcha know. [Damned right it’s commercially sensitive. If the public saw this 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 first looked at primary prevention studies (involving people who hadn’t had a heart attack but had a raised risk of one), 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 called AFCPAS and PROSPER, the SEAs were:
Statin arm: 44.2%
Placebo arm: 43.9%
This is an alarming finding for anyone convinced of the safety of statins. This is how the journal describes the result: ‘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 other words what you would expect if there was a reduction in the number of of heart attacks and strokes in the group getting the statin, is that there should be an equal reduction in the number of serious adverse events over all. But the number of SEAs was almost the same in the placebo group meaning that as well as reducing some SEAs the statins were also causing some new ones.
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 from taking a statin 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?’