A magic pill is being hailed as a panacea for all our ills. So why shouldn't everyone be taking statins?

Published on 04/07/2009 19:54

If people think it will eliminate the risk of a heart attack, they will just carry on smoking and eating an unhealthy diet and not taking any exercise.

ALLAN Hawke was hillwalking in Austria when he experienced a strange discomfort in his chest and an unusual breathlessness that took him by surprise. There were no severe chest pains but it worried him enough to cut his holiday short. When he returned to Scotland, he was told he had suffered a minor heart attack and put on several drugs – one of which was a statin.

Now – four years on – he is as active as he ever was: the 68-year-old not only walks in the hills, he plays tennis every week. "It was a shock to me, at first, to discover I would have to be on these tablets for the rest of my life," said Hawke, who enjoyed a healthy lifestyle but had a family history of heart disease. "But certainly – after a six-month recovery period – I was back to doing everything I did before and there has been no recurrence of the symptoms."

Hawke is one of a staggering six million people in the UK now taking statins – drugs which reduce the risk of cardiovascular disease by lowering the "bad", clot-inducing cholesterol (LDL) produced by the liver.

Heralded by some as "wonder drugs", statins are believed to prevent 10,000 deaths in the UK every year. And their benefits are not confined to a reduction in heart attacks: there have been suggestions they could also be effective in the treatment of diabetes, osteoporosis, rheumatoid arthritis and colorectal cancer, and that they may slow smoking-induced damage to the lungs.

Now their impact on the country's health could be extended further. Last week, a report, published in the British Medical Journal, suggested that, even in healthy people, using statins would cut the risk of a heart attack or stroke by 30 per cent. The research, a review of ten large-scale studies, involved 70,000 people without established cardiovascular problems, but with associated risk factors. It found that using statins reduced their chance of dying through any cause by 12 per cent.

Publication has renewed calls for statins to be offered to an even greater number of people. Indeed, Professor Roger Boyle, the heart disease "tsar" for England and Wales, believes they should be offered to everyone over the age of 55 – almost doubling the numbers on the drugs.

Side-effects are said to be minimal and, best of all, compared with most drugs, statins are cheap, with some working out at a mere 7p per person per day.

But although the proposal strikes a chord in Scotland – particularly the West – which has long had the worst heart attack rate in Europe, the concept of medicalising the healthy is a long way from gaining universal acceptance. Amid all the acclaim for statins, a few sceptics are making their voices heard. Dr Malcolm Kendrick, author of The Great Cholesterol Con, believes the benefits of statins are being vastly over-stated and their potential side-effects downplayed. There are others too, within the pro-statin camp, who fear prescribing them en masse will lead them to be viewed as an alternative to leading a healthy lifestyle.

So are statins magic bullets with the potential to overturn the country's poor record on heart disease? Or has their popularity more to do with the power of pharmaceutical companies to promote the benefits of their products than their potential advantages to patients? And would offering them to millions of low-risk over-50s be a sensible precaution or a gross over-reaction?

Despite the controversy over their effectiveness, statins are not new drugs. The first, Iovastatin, was licensed for use in 1987. Since then, a raft of trials, including the famous West of Scotland Coronary Prevention (WOSCOP) trial, have demonstrated that the drugs reduce the risk of heart attacks and strokes, both in patients with established cardiovascular problems and in patients whose lifestyles or genetic make-up places them at higher risk.

Guidelines issued by SIGN (the Scottish Intercollegiate Guidelines Network) in Scotland and NICE (the National Institute for Clinical Excellence) in England and Wales now state that GPs should prescribe statins for anyone over 40 with a 20 per cent risk of a heart attack or stroke in the next ten years.

Risk factors that indicate they should be taken include poor diet, raised cholesterol or blood pressure or a family history of heart disease. In Scotland, however, social deprivation is considered a risk factor in itself, meaning that, north of the Border, someone could be prescribed statins on the basis of little more than their postcode.

In addition, since 2005, one statin, simuvastatin, has been available in very low doses over the counter to those over 40 with a lower risk factor.

This means between six and eight million people are now taking statins in the UK. In Scotland, the figure stands at 600,000: 40 per cent of men over 50 and 25 per cent of women of the same age. But, as the Joint British Societies is expected to issue new advice within the next year, the threshold for prescription may be lowered again and the number of people being offered the drugs could rise even further.

Last year, both Professor Boyle, who himself takes a statin, and heart expert Professor Malcolm Law endorsed the idea of offering statins to everyone over the age of 55.

But in Scotland, at least, there is a degree of resistance to such a radical approach. "There is nothing wrong necessarily with the principle of medicalising healthy people," said Ellen Mason, a cardiac nurse with the British Heart Foundation, who agrees statins are a vital tool in the fight against heart disease. "If you look at the immunisation of children – that's what it involves and most people would agree that's beneficial. But the thing is, you have to be sure the health benefits outweigh the risks for everyone who is taking them."

Statins are known to have some side-effects – a decrease in mental power and depression in some and muscle weakness in others.

In rare cases, muscles can leak protein that may build up in the kidneys, causing a serious condition called rhabdomyolysis.

But David Clark, the chief executive of the Chest Heart and Stroke Scotland charity, who was involved in drawing up the current guidelines, said statins are enormously effective if targeted correctly.

But he worries even more widespread prescribing would undermine efforts to improve people's health through lifestyle changes.

"If people think there is a magic pill they can take which will eliminate the risk of a heart attack, then, being the human beings they are, they will just carry on smoking and eating an unhealthy diet and not taking any exercise. But statins don't eliminate the risk, they just reduce it," he said.

The position of statin-doubters like Professor Kendrick is far more entrenched. He has become a thorn in the medical establishment's side by continuing to maintain that raised cholesterol does not contribute to heart disease, a position he backs up by pointing out that, in Europe, the country with the highest cholesterol level, Switzerland, has the second lowest level of heart disease.

Kendrick believes statins do reduce the number of heart attacks in those with established cardiovascular disease – although by a different mechanism than lowering cholesterol – but points out the decrease highlighted in studies is always expressed in relative rather than absolute terms, and is therefore misleading.

With so many eminent experts having staked their careers on the dangers of cholesterol, and the weight of the pharmaceutical industry behind statins, Kendrick believes it is difficult for GPs to express their reservations. But he said the "statin-aholics'" pursuit of the "Holy Grail" of low cholesterol is harmful as it carries its own health risks.

"The amount of benefit derived from statins has been hyped to a ridiculous degree," said Kendrick. "I think in 20 years' time society will look back and ask if the medical profession was affected by some kind of statin flu.

"Ordinary people buy into them because they are afraid of dying and if they are told this will reduce their chances of dying without any side-effects then they will want to give it a try, but they are effectively being poisoned."

Kendrick is not the only dissenter. Professor Beatrice Golomb of the University of California, San Diego, believes muscle pains, mood swings and memory loss are common with statin drugs.

"There's a multi-billion-dollar industry ensuring that you hear all the good things about statins," she has said.

Mass medication with "wonder drugs" has never been accepted widely by a British public rightly sceptical of the long-term safety and the abuse of civil liberties. Thousands of people dose themselves with a daily aspirin believing that it will help prevent a stroke or heart attack. However, there is now increasing evidence that unless you have already had a heart attack or stroke, taking regular aspirin is likely to do you more harm than good, such as the risk of developing a bleeding stomach ulcer.

Mass fluoridation of Scotland's water supplies has always been resisted on civil liberties grounds despite the country's appalling dental health record.

Given Scotland's heart disease track record, however, and the bulk of the medical profession being very much in favour, the statin revolution is likely to continue.

Indeed, the most heated controversy in the next year is likely to centre not on the pros and cons of statins themselves, but on the famous polypill – a five-in-one pill that combines statins with aspirin and three drugs aimed at lowering blood pressure.

Although previous studies have suggested it would be effective in cutting deaths from heart disease, a recent report in The Lancet suggested a large trial with longer follow-up was needed to assess its feasibility. This, combined with a reluctance by pharmaceutical companies to develop a product which would not yield big profits, has dampened enthusiasm in the short term.

But the convenience, and dramatically reduced cost to the NHS, of taking one tablet instead of five means the prospect of a future generation of OAPs all popping a polypill at bedtime is no longer the stuff of science fiction.

In the meantime, Allan Hawke will continue taking his daily statins. He knows there is a debate over whether or not keeping cholesterol down is the be all and end all, but said that he, like everyone else, is at the mercy of the doctors.

"I think there have been some side- effects but I'm not a medical expert. The hospital consultant told me this is what I should do, and I am taking his word for it."