Increasingly people are questioning whether it’s worth taking statins, the cholesterol-lowering drugs that are supposed to cut your risk of developing heart disease. We think they are a really bad idea, unless you’ve already got heart disease, and have explained why (Guided tour round statin wonderland) and (I’ve never been wrong so fast or so right).
Unfortunately those making public health policy aren’t listening – yet. In fact the latest plan is to prescribe them to millions more. Last week the National Institute for Health and Care Excellence (NICE) published proposals for a new set of new guidelines that will mean yet more perfectly healthy people will be advised to take a heavyweight statin for life. (Full report)
Two of our contributors, who actually understand statin statistics, take a hard look at the key claims supposedly underpinning statin use. Dr Malcolm Kendrick unravels the fallacies behind the endlessly repeated claim that “statins save lives”, while Zoe Harcombe explains why lowering cholesterol is actually harmful rather than protective and shines a light on the vested interests that maintain these illusions.
Dr Malcolm Kendrick writes…
The claim behind this latest push to get everyone on these pills is based on the notion that we statin sceptics have got our sums wrong.
It comes from a group called the Cholesterol Treatment Trialists Collaboration (CTT) in Oxford who carried out a meta-analysis of all the statin trials in primary prevention (people taking statins who had not previously had a stroke or heart attack). Their conclusion was that they were beneficial and that lowering the bar for getting a statin would save thousands of lives.
It should, perhaps, be pointed out that the CTT group is part of the Clinical Trials Service Unit (CTSU) in Oxford, which has been paid hundreds of millions of pounds over the years to carry out research on behalf of pharmaceutical companies who manufacture statins.
Is their analysis wrong? Well, I am not going into this in any statistical detail – for that way most certainly lies madness. (For a much fuller analysis see: Statin trials: exaggerating benefits and ignoring the harm). Also, if you start looking at the statistics, you will completely lose sight of the bigger picture. And the bigger picture is this.
Statins do not save lives; they can only (at best) extend life.
The massive benefits claimed for statins
However, the benefits of statins are almost universally presented as being ‘life-saving’. For instance, just over ten years ago the CTSU put out a press release about the results of a big trial, using statins on people who had already had a heart attack.
“Around a third of all heart attacks and strokes can be avoided in people at risk of vascular disease by using statin drugs to lower blood cholesterol levels – irrespective of the person’s age or sex, and even if their cholesterol levels do not seem high.”
Headlines like this greeted the report, presented at the American Heart Association’s Scientific Sessions in 2001.
“Life-saver: World’s largest cholesterol-lowering trial reveals massive benefits for high-risk patients”
This was no media generated hype. It reflected the enthusiasm of the lead researcher Professor Rory Collins, now Sir Rory Edwards Collins, Professor of Medicine and Epidemiology at the Clinical Trial Service Unit. “Statins are the new aspirin,” he declared. “This is a stunning result, with massive public health implications.
Saving 50,000 lives a year
“We’ve found that cholesterol-lowering treatment can protect a far wider range of people than was previously thought, and that it can prevent strokes as well as heart attacks.
“In this trial, 10 thousand people were on a statin. If now an extra 10 million high-risk people worldwide go onto statin treatment, this would save about 50,000 lives each year – that’s a thousand a week.” (Source)
As you can see, it is claimed that 50,000 lives would be saved each year. If, that is, ten million extra people took statins.
When people take a ‘preventative’ medication, they do so in an attempt to live longer. So the question everyone needs to ask is: How much longer will you live if you take a statin?
Not saving lives after all
Would fifty thousand lives actually be ‘saved?’ No, of course not. What they should have said is the following. If ten million people (at very high risk of cardiovascular disease) took a statin, fifty thousand more people would be alive at the end of the year. [The figure is actually forty thousand, but fifty thousand sounds much better].
This, according to their figures, is true. However it would be rather more accurate to state their results in another way:
If ten million people (or any amount of people) took a statin, 0.5% more would be alive at the end of the year. However, the other 99.5% will have gained no benefit whatsoever. Or, one in two hundred people benefitted from taking the statin.
But, of course, this does not mean that this 0.5% of people then lived forever. Statins did not make them immortal. No, this 0.5% of people can only have had their lives extended… a bit. How big a bit? Well, I have been looking at this with statisticians from the Medical Research Clinical trials unit in London, and it seems that the figure is around three months.
No benefit for 99%
So, we can change the headlines from the CTSU press release – to this:
If a very high risk group of patients take a statin for a year. One in two hundred will live for an extra three months. The other one hundred and ninety nine will die on exactly the same day as they would have done anyway.
Now, just imagine what the result will be in primary prevention, where the underlying risk is far, far, smaller. Then imagine whether you think it is worth taking a statin or not. Then imagine if the CTSU, paid hundreds of millions by pharmaceutical companies, may have allowed a smidge of bias to creep into their work.
Zoe Harcombe writes…
The justification for the new guidelines is very simple. The lower people’s cholesterol levels, the lower their risk of developing heart disease. Unfortunately this is simply not true.
Over 10 years ago, a study (CHEST) was started to see if people having heart attacks had higher cholesterol levels. CHEST (Reference: Myocardial Infarction in Young Adults) started small but the results were so unexpected that it was significantly extended within a few years. To begin with researchers checked cholesterol levels of 183 people arriving in hospital having had a heart attack. The results, published in 2001, found that 68% had below average LDL cholesterol.
This lead to a much bigger study, published in 2009, involving 231,986 hospitalizations for heart disease, across 541 hospitals in America. LDL levels were recorded in 136,905 cases. (Ref.: Lipid levels in patients hospitalized with coronary artery disease) This time the results showed that half the patients had an LDL level lower than 100 mg/dL (UK equivalent 2.59 mmol/) while fewer than a quarter were higher than the American average of 130 mg/dL (3.36 mmol/l in the UK).
Higher cholesterol is safer
CHEST thus showed that 75% of people who were admitted to hospital having a heart attack had cholesterol that was lower than normal.
You might think that a logical conclusion from these results would be that having a higher LDL levels would make you far less likely to arrive at “Accident & Emergency” while having a heart attack.
However the official response to this evidence in the statin wonderland was to call for even more people to have their cholesterol lowered: “These findings may provide further support for recent guideline revisions with even lower LDL goals.”
Astonishingly this recommendation still carries weight as it is the idea behind the NICE guideline proposals. An obvious place to start to try to understand why anyone thought this was a good idea is to see if those involved have any conflict of interests.
Where the interests lie
Unforgivably these are not declared in the report even though NICE claims to be a body producing “evidence based guidance … created by independent and unbiased advisory committees.” So I started searching. My results revealed an absolute scandal.
First up is the Chair, Dr Anthony S. Wierzbicki. He used to be a HEART UK trustee, a body which calls itself the cholesterol charity but it is actually the mouthpiece of the statin and polyunsaturated spread manufacturers.
No doubt Mr HEART UK resigned as a trustee before heading up the group looking at statin guidelines in the UK, but his hand has been clearly declared.
The connections of the rest of the members were found in a set of meeting minutes from September 2012, when the Guideline Development Group first got together and shared their conflicts with each other. They make for quite a read.
A long list of drug companies
Alan Rees declares himself an ex-chair of HEART UK. Dermot Neely declares himself a current trustee and board member of HEART UK. He hasn’t even bothered resigning.
The companies for which the Group members declare interests (many companies appear time and time again, as repeated conflicts for group members) are Aergerion Pharmaceuticals; Amgen; Astra Zeneca (they have funded one of the Development Group members!); Bayer; Boehringer Ingelheim; Genzyme Corporation; Merck, Sharp & Dohme, Pfizer; Roche and Sanofi-Aventis.
The Chair alone, in addition to his previous leadership at HEART UK, declares interests in Amgen; Genzyme Corporation; Merck, Sharp & Dohme; Pfizer and Sanofi-Aventis.
A truly independent and unbiased bunch.
Find out if you “need” a statin
The NICE document makes seven recommendations – they are on P. 40 of the full report.
Here I want to concentrate on what they could mean in practise. If they are adopted they will classify people who are by any normal standards fit and healthy as being at risk of heart disease who need to be treated with a high dose statin. Studies have shown that the higher the dose of a statin, the more likely you are to suffer side-effects.
The crucial recommendation (No. 5) says this:
Offer high-intensity statin treatment for the primary prevention of CVD to people who have a 10% or greater 10-year risk of developing CVD. Estimate the level of risk using the QRISK2 assessment tool.
You can find the QRISK2 assessment here. Put in your own details and see what your own need for high-intensity statin treatment is.
I put in details for a healthy male, 63 years old, white (white people have less heart disease), non-smoker, no diabetes, no close relative has suffered even angina before the age of 60, no kidney disease, no atrial fibrillation, no BP treatment, no arthritis, 4.4 mmol/l total cholesterol, 1.3 mmol/l HDL [these are dream figures for cholesterol haters], below normal systolic blood pressure (120 mm Hg), normal height (175cm), normal weight (80kg). Then you press “Calculate Risk” and our Mr perfectly healthy has a risk factor of 10.1% and therefore must be highly intensely statinated.
Senior statin supporters have been attempting to confront the sheer illogicality of the new proposals head on. Writing in the Daily Mail, Professor Colin Baigent (conflict of interests include Astra Zeneca, Merck, Sharp & Dohme, GSK and Johnson & Johnson) commented:
“While the idea of prescribing statins to people who appear to be at low risk of a heart attack or stroke may seem illogical, consider this statistic: more than half of the deaths from coronary disease in this country occur in people who have had no previous problems of this kind.” (Article)
This is highly misleading. In fact those that Baigent describes as being in the ‘low risk group’ are, as the CHEST study showed, people in the low cholesterol group who suffer substantially more heart attacks. The genuinely low risk group are the ones with above average cholesterol.
We could try pointing out to NICE
- their staggering conflicts and
- their upside-down logic.
But there’s no point. The government knows that people with higher cholesterol are more at risk of heart disease. It doesn’t matter what the evidence says.
It reminds me of a quotation from my obesity book, origin unknown: “My mind is made up; don’t confuse me with the facts.”