The great statin deception

Statins are the world’s best-selling drugs. Designed to lower our levels of ‘bad’ LDL (low-density lipoprotein) cholesterol – the stuff that blocks arteries and causes heart disease – they are the ultimate just-in-case drug given even to healthy people when they’ve reached the age of 50 or so.

Not surprisingly, they are seen as life-savers. The UK’s drugs assessor, the National Institute for Health and Care Excellence (NICE), reckons the drugs could save 50,000 lives a year if every British male over the age of 60 and female over 65 took them regularly. Because of this enormous benefit, doctors in the UK are encouraged to start every 60-year-old on statins, whether or not there are heart problems or any risk of developing cardiovascular disease.

Yet the cost to the UK taxpayer is enormous. The bill for statins runs to around £450 million a year, which can be added to the drug’s worldwide revenues of around £20 billion ($35 billion). But if the drugs are saving that many lives every year, the cost is fully justified.

But are they?

The NICE estimates of lives saved seem to be wildly at odds with the evidence. Researchers from multiple centres across the UK reckon the drugs would save just 750 lives in the UK every year.1 They looked at death rates from coronary heart disease between 2000 and 2007, and noted that numbers had fallen by 38,000. However, just 1,800 could be directly attributable to statins; the vast majority were due to changes in lifestyle, such as improvements in diet and exercise.2

None were saved

But what does it even mean to save lives? Surprisingly, scientists seem to be vague about this; often a life is considered ‘saved’ when compared with someone else, usually a participant not given the drug being tested who died while the trial was being conducted. It’s a form of statistical juggling that has meaning within the tight logical framework of a scientific study – but has little to do with the
real world.

Danish researchers decided to take a closer look at this murky and ill-defined area, and came up with a very surprising discovery. Rather than looking for lives saved, they instead used a more precise measure: the average postponement of death. With this definition, the scientists were able to see exactly how long people lived after their lives were considered ‘saved’ – and the average was between just three and four days.

In other words, statins were extending life by an average of up to four days in people with a heart problem who were taking a statin. The greatest extension of life across the 11 studies they reanalyzed was 27 days in heart patients who took a statin for more than five years; at best, these statin patients were living nearly a month longer than someone not taking the drug.3

This very modest benefit has been seen in other trials. In one review, patients with heart disease had their risk of death reduced by just 1.2 per cent if they took a statin for five years,4 but even that benefit disappears in people who don’t have heart disease. For those with a less than 20 per cent chance of developing heart disease over the next 10 years, there is absolutely no benefit in taking a statin, a major Cochrane Collaboration analysis has concluded.5

Sugar pill anyone?

If they’re not helping us live longer, do statins at least offer protection from a heart attack or stroke that might leave us debilitated or destroy our quality of life? Again, the benefits are hard to see: the drugs achieve a one in 140 risk reduction for a non-fatal heart attack or stroke in people who have a low risk – which means less than 10 per cent – of heart disease over the next 10 years.5

Put another way, the drugs are no better than a placebo, or sugar pill, say the researchers from Cambridge University who reviewed 11 statin studies involving more than 65,000 people, half of whom were taking the drugs. Yes, those not taking a statin had higher levels of LDL cholesterol, yet similar numbers from both groups had died during the four years of the study, suggesting there is more to heart disease than ‘bad’ cholesterol and statin therapy.6

Two researchers from University College Hospital in Galway, Ireland, came to a similar conclusion when they took a fresh look at 55 studies that had previously been published. Instead of seeing benefits, they found that people taking statins weren’t living longer and were just as likely to develop heart disease as those not taking the drugs. Worse, women, diabetics and young people taking a statin were actually more likely to develop heart disease.7

The possibility that statins actually increase the risk of heart disease and death was beginning to emerge in the Illuminate trial – later described by researchers as medicine’s best-kept secret – before it was hurriedly closed down after participants started dying suddenly or developed cancer.8

Money speaks

How can this be when health regulators around the world, like the UK’s NICE, are so positive about the enormous benefits of statins? The studies they rely on to shape public-health policy are invariably funded by drug manufacturers, which have a vested commercial interest in achieving a very positive outcome.

To put it starkly, drug companies use “statistical deception” to exaggerate the benefits and downplay the risks of statins, say two researchers, who reckon the drugs help just 1 per cent of the population.

Researchers David Diamond, of the Veterans Hospital in Tampa, Florida, and independent researcher Dr Uffe Ravnskov ran the data again from some of the biggest statin trials and concluded that the drug-company funders had used statistical deception to create the illusion that statins are wonder drugs, when the reality is that their modest benefits are more than offset by “the numerous adverse effects of statin treatment”.9

In the UK, NICE’s decision to expand the group being prescribed a statin was partly influenced by the Cholesterol Treatment Trialists Collaboration (CTT) which, it was later revealed, was receiving substantial funding from drug companies; for example, Merck, one of the biggest manufacturers of statins, had donated £217 million.

When independent researchers like the Cochrane Collaboration and the NNT (Number Needed to Treat) group have reanalyzed the same data, but taken out the bias, the benefits invariably seem to disappear. Biases have included the exclusion of 36 per cent of participants because they had previously suffered an adverse reaction to the trial drug and their inclusion would have skewed the risk–reward balance and made the drug – in this case, simvastatin, marketed as Zocor – less attractive.10

Side-effects and adverse reactions are common among statin patients. One population-based survey – USAGE (Understanding Statin use in America and Gaps in Education) – has revealed that up to half the people taking statins stop within the first year, with 62 per cent citing some side-effect – such as muscle weakness, joint pain, nausea or ‘brain fog’ – as the reason.11

At best, statins may have some marginal benefit in those who already have heart disease – but they would do just as well, if not better, by eating a healthier diet – while no independent evidence even suggests that the world’s most successful drugs do a thing to benefit the rest of us.

Cholesterol: What’s your score?

Just as many know their blood-pressure reading, so they are familiar with their cholesterol ‘number’. The ideal score is 5 mmol/L (millimoles per litre of blood), which is made up of 1.3 mmol/L of HDL (high-density lipoprotein), the ‘good’ cholesterol, and 3.7 mmol/L of LDL cholesterol, although doctors like to see the HDL reading at 2 or higher.

The typical score in the UK is around 6.1, and any LDL reading above 4 will automatically trigger a prescription for a statin.

But your cholesterol score is mo
re the stuff of fashion than health. Go back 20 years and the healthy score was around 7, and this was lowered to 6.5 10 years ago before reaching today’s 5.

It’s predicted to fall again soon to 4 – currently the ideal score for anyone who has already suffered a heart attack – and cardiologists reckon it will then drop to just 2.5 over the next 10 years.

Just eat well

Eating a healthy diet and exercising regularly can prevent six times the number of deaths from heart disease as can a statin.

If statin drugs save 750 lives every year in the UK, as UK researchers suggest (see main story), then healthier lifestyle choices could save 4,600 lives.

This makes sense because up to 80 per cent of cardiovascular disease is caused by lifestyle choices, such as an unhealthy diet of junk food, smoking, drinking too much alcohol and being physically inactive.1

A bad diet seems to be the major cause of heart disease and, conversely, eating healthily has the greatest protective effect. In fact, eating just one apple a day has the same protective effect as a statin for preventing a heart attack in someone who is healthy.1 The Mediterranean diet, especially when supplemented with 30 g/day of nuts or 4 Tbsp of extra-virgin olive oil, can reduce the risk of a heart attack or stroke by a third.2

Intriguingly, these risk reductions are seen even in people with high levels of ‘bad’ LDL cholesterol; instead, it’s the levels of alpha-linoleic acid, polyphenols and omega-3 fatty acids – all mainly derived from vegetables and fruits – that matter.3

“Concentrating on LDL-lowering alone as an end in itself might be counterproductive. Indeed, insulin resistance may emerge as the single most important determinant of coronary artery disease,” says leading cardiologist Dr Aseem Malhotra, of Frimley Park Hospital in Surrey, UK.4

Stressing the negative

A bad diet may be the major cause of heart disease, followed closely by smoking and inactivity. But is there another cause? Dr Malcolm Kendrick, author of The Great Cholesterol Con (John Blake, 2007), reckons that stress and isolation are unrecognized causes, and ones that are growing with the rise of the nuclear family.

Although stress may be a good thing to help us overcome a challenge, the persistent kind, when we feel powerless and there’s no end in sight, can lead to heart disease, he believes. This can include working for a bullying boss, having long-term money worries and suffering from constant racist abuse,
he says.

Just eat well

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