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The Worrying 32 Billion Dollar Wonder Drug

Statins have been credited with life-prolonging - and life-threatening - properties. Victoria Lambert investigates

Tea, toast, marmalade, Daily Telegraph... and statin.

For many Britons, breakfast wouldn't be breakfast without these ingredients. And for some 3.4 million, the most important is that little pill.

Last week, the National Institute for Clinical Excellence (Nice) unveiled new guidelines stating that statins should be prescribed to people with a 20 per cent risk of developing heart disease. So we can expect them to appear on many more breakfast tables. In fact, new research suggests that as many as 14 million people aged 40 or over could be eligible to take them

Statins, which were introduced in the late 1980s, include the brands Zocor, Lipitor and Crestor, have been hailed as a wonder drug.

They lower cholesterol and, according to the British Heart Foundation, reduce the risk of dying from coronary heart disease by 25 per cent. Their use has also been associated with improved function of the endothelium (the lining of blood vessels), less plaque in the blood vessels, general anti-inflammatory action and even the prevention of blood clots.

Further studies are under way to establish how helpful they are in fighting dementia, cancer and cataracts.

But if your hand is moving closer to the tablets, hold fire. Because, despite global approbation, the murmurs that statins are not quite the Holy Grail are getting louder. And while many in the medical establishment are so confident of the benefits that they will not even countenance a debate, there are others who believe that these pills have been found wanting.

One such dissenter is Malcolm Kendrick, a Cheshire GP with a special interest in cholesterol and heart disease, and author of The Great Cholesterol Con (John Blake). Dr Kendrick believes that, for most people, statins are at best pointless and at worst highly dangerous. And he claims that those who prescribe them and those who take them are victims of clever global marketing.

He says the marketing budget for Crestor, for example, was $1 billion for one year alone. This hype, combined with our desire to find a drug that could make us live forever, has won over even the most sceptical. And of course there have been numerous studies and trials to back the claims being made.

According to Dr Kendrick, the results have been presented in a "very oblique way".

"I'm not saying the data is wrong. But a major trial in western Scotland showed that a man who had suffered a mild heart attack had a 96.8 per cent chance of being alive after taking statins for five years. If he was on a placebo, that fell to just 95.9 per cent. So you might live a few days longer if you take statins for five years than if you don't. And this was in a high-risk population."

A recent report in the Lancet supports Dr Kendrick's claim. It found that in men who did not already have heart disease, and in all women, there was no evidence that taking statins increased their life by a single day. So for the vast majority, although statins may change what's written on your death certificate (you will be less likely to die of heart disease), it won't change the date.

"Statins seem to lower cholesterol - but then no one has proven that this [their impact on cholesterol] is what reduces the risk of heart disease," says Dr Kendrick. "There is a whole host of other effects that could explain how they work."

Figures provided by the Medical Research Council show that if a man took statins for 30 years - and this is theoretical, since no one has been on them that long - he might get another nine months of life.

But Dr Kendrick calculates that the figures are over-generous: "I make it closer to two months," he says. "And if you're a woman? No extra months, weeks, days, or hours; statins are absolutely pointless." The reason for this is not known.

Dr Kendrick is not alone in his doubts. Although he says the British Heart Foundation considers him a maverick, the International Network of Cholesterol Sceptics - whose members include cardiologists, neurologists and biochemists - supports him.

They are concerned that statins are a colossal waste of money; sales reached $32 billion globally last year, and in their cost to the NHS, when calculated with the twice-yearly appointments and blood tests, could be £5 billion annually, if the Nice guidelines are implemented.

But more importantly, these doctors fear that regular statin takers are putting themselves at risk from numerous side effects, some potentially fatal. "If you give statins to anyone they will suffer minor muscle damage," says Dr Kendrick.

"But it is the elderly and frail who are affected significantly. In my own patients, I have found muscle damage to be a common side effect, which manifests as muscle pains and weakness."

The problem is more serious if the patient develops rhabdomyolysis (muscle wastage that can lead to kidney failure). According to Dr Kendrick, drawing on figures from the US Food and Drug Administration, there have been a total of 416 deaths between 1997 and 2004 directly attributable to simvastatin (Zocor) alone.

Other side effects of statins include amnesia, cognitive problems, irritability and impotence. The World Health Organisation is examining reports that taking the drugs can lead to amyotrophic lateral dystrophy, a devastating neurological condition which rapidly progresses to death.

So what should you do, hands still hovering - now rather nervously - over that packet of statins?

"If you tell your GP of your concern, he or she will most likely dismiss it," says Dr Kendrick. "But we should be questioning the research and asking hard questions about the role played by the pharmaceutical industry in promoting these drugs."

However, a spokesman for the British Heart Foundation said: "Statins are not only effective in saving lives, but are also easily tolerated by the majority of people."

© Copyright 2007 Telegraph Media Group Limited. All Rights Reserved.

Article Glossary:

Cholesterol: A soft, waxy substance. The body makes enough cholesterol to meet its needs. Cholesterol is used in the manufacture of hormones, bile acid, and vitamin D. It is present in all parts of the body, including the nervous system, muscle, skin, liver, intestines, and heart.

Statins: statins lower *LDL-cholesterol levels, and they lower LDL-cholesterol more than other types of drugs. Statins inhibit an enzyme called *HMG-CoA reductase that controls the rate of cholesterol production in the body. These drugs lower cholesterol by slowing down the production of cholesterol and by increasing the liver's ability to remove the LDL-cholesterol already in the blood.

*LDL-cholesterol: A form of cholesterol that circulates in the blood. Commonly called “bad” cholesterol. High LDL is said to increase the risk of heart disease.

*HMG-CoA reductase: a liver enzyme that is responsible for producing cholesterol.