London - Having reached the age of 72, Professor Klim McPherson was prepared to accept some deterioration in his physical capabilities. But when, earlier this year, he found he was struggling to bend over to tie up his shoelaces, he decided enough was enough.
And so it was that little more than a month ago, the Oxford don stopped taking the little orange tablets his doctor had prescribed him and which he had been swallowing before bedtime every night for the past three years.
To his great surprise, within seven days, the aches and pains that had so restricted his movements had almost entirely disappeared.
“I’d been finding it difficult getting down the stairs and had to negotiate them step by step,” says Professor McPherson, one of the country’s most eminent public health experts.
“As for reaching my laces, that was painful and uncomfortable. But now I can once again do all the things I couldn’t do before.”
The medication that Professor McPherson has chosen to go without is a statin called Simvastatin.
Like the seven million or so other Britons who take statins on a daily basis, the professor had been prescribed the drug to lower his cholesterol levels and so reduce the risk of heart attacks or strokes.
The National Health Service estimates the drugs, which can cost as little as £16 (about R300) for a 12-month course, save 7 000 lives a year.
The National Institute for Health and Care Excellence (Nice), the NHS watchdog, recently issued guidance that the drugs should in future be prescribed even more widely - in fact, to almost half of all adults.
“Cardiovascular disease (CVD) maims and kills people through coronary heart disease, peripheral arterial disease and stroke,” explained NICE’s Professor Mark Baker. “Together, these kill one in three of us. Our proposals are intended to prevent many lives being destroyed.”
A worthy aim, undoubtedly. However, to say that not everyone agrees with the role statins have to play in the future health of the nation would be something of an understatement.
NICE’s proposals have caused an unprecedented outbreak of warfare among the medical and scientific community.
On one side are those who wholeheartedly support the ever-widening use of statins. On the other are those who believe their side-effects have been massively underestimated.
This, some claim, is due to an over-reliance on research funded by the pharmaceutical industry, for whom statins have proved to be the single most profitable class of drug ever manufactured.
They argue that depression, cataracts, an increased risk of diabetes and the sort of muscle pains experienced by Professor McPherson could affect anywhere between 10 and 40 percent of statin users.
And, while they do not deny the benefits statins can bring to those at a high risk of heart disease, they warn against putting millions of healthy patients on pills for the rest of their lives.
At the centre of this battle is the patient, confused and unsure what to believe. It is a worrying state of affairs and one that some fear could have terrible consequences.
“There are some real concerns people will come off statins because of this and then a fatal heart attack will occur,” says Jules Payne, CEO of the charity HEART UK, which provides support, guidance and education services to healthcare professionals and people with concerns about cholesterol.
“We will lose people when the whole point of this is to keep people alive.”
Statins work by lowering levels of cholesterol, the fatty substance in the blood that clogs up arteries. They block the action of a certain enzyme in the liver which makes ‘bad’ cholesterol, called low-density lipoprotein.
While statins are routinely given to patients who have had heart attacks, angina or bypass surgery, they are also given to patients at risk of CVD. GPs calculate the level of risk by looking at factors such as smoking history, cholesterol levels, blood pressure and body mass index.
Doctors in this country used to prescribe statins only to those with a 30 percent risk of a heart attack within the next decade, but this was cut to a 20 percent risk in 2005.
As a result, Britain has become not just the statins ‘capital’ of Europe, but the second highest prescriber of the drug in the Western world, afterAustralia.
Under the new NICE guidance, the threshold would be lowered further still so that those who have a 10 percent risk will be offered statins.
NICE estimates that between five and ten million adults are currently taking the drugs, although 12.5 million are eligible. But under the new guidelines, another 4.5 million would qualify.
This means that 17 million adults - nearly half of the 37 million adults in Britain - would either be on statins or offered them.
Part of the reason for this change is that many statins are now out of patent, meaning that they can cost just a few pence a day. Preventing a heart attack in this way is obviously much cheaper for the NHS thantreating someone who has suffered one.
But some doctors are concerned. They warn that while the drugs themselves may be cheap, once the cost of extra GP appointments to prescribe and monitor patients is added in, the annual cost to the NHS could run into billions of pounds.
They also claim that by targeting a relatively low-risk section of the population, the plan could make minimal difference to the number of heart attacks and strokes while exposing millions more people to possible side-effects.
While some studies have shown that these affect just one in 10 000, some doctors and academics believe the problems they cause are much more widespread.
This fundamental disagreement was highlighted in May when the British Medical Journal was forced to withdraw claims published in an article stating that statins cause side-effects in one in five patients.
Leading the attack on the BMJ was Oxford University’s Professor Sir Rory Collins, who has led analysis of many statin trials, and who accused the paper’s authors of overstating the risks 20-fold. In so doing, he warned that patients could be discouraged from taking statins and their lives put at risk.
But still, the controversy rolls on. Critics of the ever-widening roll-out have claimed that the data driving the new NICE guidelines was largely funded by the pharmaceutical companies and has not been sufficiently scrutinised by independent researchers.
And they have also attacked the independence of NICE itself, pointing out that at least half of its 12-strong advisory panel of experts have direct financial ties to the pharmaceutical companies that manufacture statins.
NICE has since stated that none of the panel members stand to gain financially from the guidance and that all of the links were formally declared to NICE and published online.
Among the most vocal critics of the new statin strategy is Dr Malcolm Kendrick, a GP from Macclesfield who is also a member of the British Medical Association’s General Practitioner’s sub-committee.
He says that the official research is contradicted by what he and fellow medics see on a daily basis.
“If just one in 10 000 patients were really suffering side-effects as we are told is the case, then in all my clinical work I might expectto have seen one or two people with these problems,” says Dr Kendrick.
“Two weeks ago on a Monday morning the first three people who came to see me were complaining about the adverse affects of statins. They were mainly suffering from muscle aches and pains and one had quite bad stomach problems.
“Over New Year, another female patient went into hospital with severe stomach pains and nearly had an operation. She came to see me and I said statins can cause stomach pains, and she stopped and the pain went away. If she hadn’t, she would have had her abdomen opened up.
“These drugs are all damaging, and as you get older that damage gets all the more serious.
“You find that someone who can just about get out of a seat starts taking statins and then can’t get out of his seat; someone who used to be able to walk down to the shops now can’t.
“I say that statins won’t make you live 15 years longer - but they will make you feel 15 years older.”
Of course, real evidence is needed before an informed decision can be made. As a scientist, and in of spite his own personal experience, that is something that Professor McPherson acknowledges.
For this reason, he is among those calling for the existing data produced by the pharmaceutical companies to be tested independently before statins are offered more widely.
“I think NICE making these somewhat draconian rules on the basis of such an inadequate evidence basis is foolhardly,” he says.
Such criticisms have not gone down at all well with the supporters of statins. Sir Rory recently attacked the high-profile signatories (one of whom was Dr Kendrick) to an open letter calling on NICE to re-think its stance on the matter.
He said: “I’m concerned that the public as a whole and doctors as a whole are being misinformed.
“This has the potential to cause very large numbers of unnecessary deaths from heart attacks and strokes, and the people who put their names to that letter should be ashamed of themselves.”
It is a point taken up by Ms Payne, of HEART UK.
“I think the argument has been blown up out of all proportion,” she says. “Statins have been well-researched and documented in a large number of studies which demonstrate that they are, in fact, a very, very safe and cost-effective drug.
“The research is strong and robust and, yes, it may well be funded by pharmaceutical companies, but there are rules about these studies and there are many studies about their safety.”
She advises that if people are concerned about the statins they are taking and are experiencing side-effects, they should not just stop taking them but talk to their GP and consider alternative types.
“The message that has been completely lost in this argument is that nobody is shoving statins down people’s throats. It should be a partnership discussion between the GP and patient about their risk over the next ten years and how they feel about taking statins.”
Four years ago charity worker Steve Forster had just such a conversation with his doctor after tests showed his cholesterol levels were dangerously high.
Coupled with the fact that he weighed 15½ stone (about 98kg) and his mother had a history of heart disease, the 52-year-old was easily persuaded that something had to be done to improve his health.
“The doctor said I was a heart attack waiting to happen,” says Steve, who lives near Gateshead with wife Helen and their five children.
For the first year he tried to lower his cholesterol levels by changing his diet and exercising. But when that had only a marginal impact, he decided to start taking statins, which very quickly had the desired effect.
“When I was put on Simvastatin I was informed about the side-effects but I have not had any,” says Steve, who has also managed to lose 3 stone (19kg)
While he has the odd ache and pain, he believes they’re more down to getting old, rather than medication.
And, anyway, he has no doubts about the benefits of the drugs he is taking.
“On a daily basis I think that I could be dead and how I would have missed out on my children growing up,” he says.
“For me, the statins, combined with a change of lifestyle, have been a life-saver.” - Daily Mail