Statins Row – A Debate Over Drug Efficacy Or A Symptom Of NHS Sclerosis?

Letter from nine leading medical experts to Health Secretary Jeremy Hunt that questions NICE guideance on statins.

Letter from nine leading medical experts to Health Secretary Jeremy Hunt that questions NICE guidance on statins.

A row rumbling on within the medical profession in the UK has erupted into the news again this week over the role of statins – the blood cholesterol lowering drugs that can cut the risk of heart attacks and strokes.

By dramatically reducing cholesterol levels in the blood, statins can lower the risk of premature death for an individual and significantly cut the number of heart attacks and strokes within the population.

There are already around seven million people in England and Wales taking statins. The chances are that if you are over 50 in the UK then you will be on them. The National Institute for Health and Clinical Excellence for England and Wales – NICE – wants to extend their use to a further five million people deemed to have a greater than 20 per cent chance of a heart attack or stroke within the next decade. And it issued draft guidance to this effect back in February.

This week an influential group of medical professionals hit the headlines with a letter to NICE Chairman Professor David Haslam, and copied to government Health Secretary Jeremy Hunt, telling him that the NICE proposals are worrying because they stem from an over-dependence on research funded by the pharmaceutical industry. The doctors point to evidence from studies that were not funded by the pharmaceutical industry that statins increase the risk of diabetes in middle aged women.

Now, we need cholesterol. It is an essential chemical that helps our cells work properly and forms a key link in a number of chemical processes including the manufacture of vitamin D. It is a natural chemical that is made within our bodies; but we also get cholesterol from the fatty food we eat – particularly, butters, cheeses, milk and meat. The trouble is that too much cholesterol in the blood is associated with a hardening of the arteries – arteriosclerosis – that can reduce blood flow, increase blood pressure and trigger heart attacks and strokes. Statins inhibit an enzyme in the liver that is involved in the natural production of cholesterol and so they help to lower overall cholesterol levels.

Statins work – but how many should benefit and what are the risks?

And the fact is that they work – they do reduce excess blood cholesterol in most patients. It is also a fact that a low fat diet – cutting fat consumption – can also help reduce cholesterol levels. And recent research suggests that regularly eating apples will have a significant beneficial impact on cholesterol.

The evidence suggests that statins reduce the number of heart attacks and strokes among those taking the medication. But there is genuine uncertainty around exactly how many people would benefit and over the side effects and risks.

In 2013, a peer-reviewed research paper, by Dr John Abramson of the Harvard Medical School in Boston and colleagues, that was published in the prestigious British Medical Journal (BMJ), claimed that statins have no benefits for those at low risk of heart attack and stroke and that the side effects of statins – which include muscle symptoms, a risk of diabetes, liver inflammation, cataracts, decreased energy, sexual dysfunction, and fatigue – occur in approximately 18 per cent to 20 per cent of people treated with the drugs.

Not surprisingly, this story made the news. It also provoked a fierce row within medical circles. Subsequently, the BMJ withdrew the statement around side effects saying the actual risk “equates to up to 9% of the study population having possibly discontinued statin therapy as a consequence of statin related events, rather than the 18% cited” . However, the BMJ pointed out that the primary finding of Abramson’s research —that the data failed to show that statins reduced the overall risk of mortality among people with a less than 20 per cent risk of cardiovascular disease over the next 10 years— remained unchallenged.

So the debate within the medical profession is about where to draw a line between the undoubted benefits of statins to those at greatest risk of heart attack and stroke and the impact of side-effects on those who might otherwise be considered fit and healthy. This is a medical issue.

The trouble is that the near-monopoly state-owned National Health Service (NHS) that we have in Britain has established a process managed by NICE for centrally deciding what treatments should be available and which should not. This means that decisions about medical treatment can have less to do with the needs of individual patients and more to do with the priorities of politicians and the capacity of the NHS budget. Furthermore, the huge multi-billion pound NHS drug spend has become a big juicy opportunity to be tapped by the sales teams of pharmaceutical companies.

Is The NHS Drug Buying Bureaucracy Going The Same Way As Defence Equipment Contracting?

When budget spreadsheets rather than individual medical needs dictate medical priorities – and let’s be blunt, that is what NICE is all about – then we are on a slippery slope. Worse, since NICE is the gate-keeper to the NHS drug budget it has been set up as a target for pharmaceutical industry lobbying.

You don’t need to be a mathematician to realise that, even at pennies a pill, the potential profits to be had from selling lifetime courses of statins to a fifth of the UK population are enormous and therefore that the temptation within the pharmaceutical industry to influence and nudge the decision making process must be huge.

There are worrying parallels between what is happening in the NHS today and what has already happened in defence where large industrial vested interests barter with a government bureaucracy for the fattest slice of the cake. In defence, the interests of national security have come a poor second to the profits of equipment makers. We are running the same risk in the UK with NICE and the NHS.

The debate around the benefits of statins needs to be settled by the medical profession. The ethics of medicalising a potentially healthy slice of the population on the basis of risk needs to be discussed by our politicians. While the issue as to whether any particular individual patient should or should not be prescribed statins must remain a matter for that individual and his or her doctor.

My advice: let the medics argue it out and, in the meantime, eat loads of apples.

Sources

Read the letter from the medical professionals to NICE Chairman Professor David Haslam and Jeremy Hunt here.

Here is some research about the benefits of apples for cholesterol: Adam D M Briggs, Anja Mizdrak, Peter Scarborough. A statin a day keeps the doctor away: comparative proverb assessment modelling study. BMJ 2013;347:f7267 .

Here is the BMJ paper that caused the row: Abramson JD, Rosenberg HG, Jewell N, Wright JM. Should people at low risk of cardiovascular disease take a statin? BMJ; 2013; DOI:10.1136/bmj.f6123.

Here is the BMJ correction to the Abramson paper.

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