Millions of patients are being misled about the pros and cons of statins, experts claimed last night.
Accusing the medical establishment of perpetuating a ‘great cholesterol con’, they questioned whether statin pills are as effective as claimed.
The group of doctors, from Britain, the US, France and Ireland, said the very theory on which statins are based – that lowering ‘bad’ LDL cholesterol cuts heart disease – is ‘fundamentally flawed’.
Doctors say the theory on which statins are based – that lowering ‘bad’ cholesterol cuts heart disease – is ‘fundamentally flawed’ and there is no evidence that this is correct for over 60s
Writing in the Prescriber medical journal, they said the side-effects of statins may be far more common than major studies suggest – and called for companies and academics to publish their raw data so others could independently analyse the results.
Others last night dismissed their claims – and said the evidence that statins save lives is ‘overwhelming’.
Most cardiologists think cholesterol-busting statin pills are a cheap, safe and effective way of preventing heart attacks and strokes among an ageing and increasingly obese population.
But many others are uneasy about prescribing drugs to patients ‘just in case’ they have heart problems later on. And authors of the new piece, led by London cardiologist Dr Aseem Malhotra, question whether they are even as effective as thought, claiming the ‘cholesterol con’ has led to ‘overmedication’ of millions.
Instead, they say, clinicians should focus on diet and lifestyle.
The authors, including Dr John Abramson, of Harvard Medical School, cite research published earlier this year which found no link between high LDL-cholesterol levels and heart deaths among over-60s.
In the article entitled The Great Cholesterol Con, they wrote: ‘A lack of an association between LDL cholesterol and cardiovascular disease in those over 60 years from a recent systematic review suggests that the conventional cholesterol hypothesis is fundamentally flawed.’
Dr Malhotra said last night: ‘Decades of misinformation on cholesterol and the gross exaggeration of statin benefits with downplaying of side effects has likely led to the overmedication of millions.’
He added: ‘It’s time to enter a new era for full independent access to all clinical trials data so doctors can make decisions on treatments with patients with full transparency about true benefits and risks. Until then let’s open our eyes and stop buying into the great cholesterol con.’
A row over the benefits and risks of statins have escalated since a major review in The Lancet in September concluded they were safe and their benefits far outweighed any harm.
Dr Aseem Malhotra misinformation has likely led to the overmedication of millions of patients
That study, led by Oxford University, was intended to be the final word on statins. But just a week later, rival journal the BMJ cast doubt on the assertions by claiming ‘adverse’ side effects were far more common than the study implied. Dr Malhotra, advisor to the National Obesity Forum, last night said the argument could be ended if all raw data was published openly.
He was backed by Sir Richard Thompson, the Queen’s former personal physician, who said: ‘For hundreds of years physicians have clung to outdated and ineffective treatments. Could statins be now the latest star to fall? Have patients and the public been misled over them for many years?’
ARGUMENTS FOR AND AGAINST STATINS
The case for:
For those who have suffered a heart attack or a stroke, statins are proven to slash the chances of a second one.
They are thought to save 7,000 Britons’ lives a year.
Many doctors recommend statins as a preventative drug to protect millions who have not yet shown symptoms but have a small chance of a heart attack in the next decade.
They cost the NHS less than £2 a month per patient.
Oxford statins expert Professor Sir Rory Collins claims taking statins for five years increases side-effects by less than 1 per cent – and that just five in 10,000 suffer muscular pain as a result.
Backers of statins claim that patients incorrectly blame any back pain or muscle ache on the drugs, when in fact most side-effects have a different cause entirely.
The case against:
Many doctors are uneasy with what they call ‘over-medicalisation’ of the middle- aged – doling out statins ‘just in case’ they have problems later.
New rules set out in 2014 mean virtually all over 40s – up to 17million people in total – are eligible for a prescription, irrespective of symptoms.
The vast majority of those who take statins would never suffer a heart attack or stroke. A 2013 Harvard study calculated that for every 140 low-risk patients who take statins for five years, only one major heart event would be prevented.
The latest paper on side-effects in April’s JAMA medical journal said that between 5 per cent and 20 per cent of people who take statins stop owing to muscle pain.
Some doctors question whether reducing ‘bad’ cholesterol protects against heart disease at all. A study of 68,000 people this year found no link between high LDL-cholesterol and heart deaths among over-60s.
But others said the benefits of statins are ‘well-proven’. Some estimate the daily pills – which cost the NHS around £2 a month – prevent at least 80,000 heart attacks and strokes in Britain each year.
NHS watchdog NICE advises all adults with a 10 per cent chance of developing heart disease in the next decade be considered for statins – meaning up to 17million are eligible. In reality, between 6million and 10million are thought to take them.
Professor Mark Baker of NICE, said last night: ‘NICE’s guidance on the risk assessment and reduction of heart disease and strokes, including lipid modification, is based on the overwhelming body of evidence supporting the use of statins, even in people at relatively low risk.’
Professor Sir Nilesh Samani, medical director at the British Heart Foundation, said Dr Malhotra’s paper ‘risks confusing patients about the benefits and safety of their statins’.
He added: ‘It is imperative that patients who have been prescribed statins, especially after a cardiovascular event, continue to take them and if they have any concerns to talk to their doctor.’