Healthwise
Claims about harmful side-effects have been retracted, but not everyone is convinced seven million Britons should be taking the cholesterol-lowering drug
6:30AM BST 16 May 2014
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Every night, about seven million Britons will take a statin before bed, perhaps chasing it down with a prayer that the cholesterol-lowering medication will do its job and prevent them from having a shattering heart attack in the dark of the night. Or perhaps they’ll be hoping that they will not be struck down with the side-effects so many associate with taking statins.
Most commonly, according to NHS Choices, these include muscle and joint pain, but also nose bleeds, a sore throat, runny or blocked nose, headache, nausea, constipation, diarrhoea, and flatulence; as many as one in 10 are said to be susceptible to a side-effect. Anecdotally, the most common moan from statin users appears to be “brain fog” – fuzzy thinking and memory loss.
Statins, it must be said, cause a unique emotional reaction as well. Other drugs that we now consider household staples – such as aspirin, antibiotics and diuretics – offer the possibility of some fairly grim side-effects, too, including bleeding in the stomach, rashes, dizziness and even impotence. Yet, in those cases, we often bin the information leaflet and run the risk, secure in our collective belief that treatment outweighs any corollary reactions.
But from the moment statins landed on our GPs’ prescribing pads, promising to lower mortality and morbidity rates in coronary heart disease, many of us have treated them with suspicion – much to the despair of those in the science community who consider statins to be lifesaving. Sir Roger Boyle, for example, the former national director for heart disease and stroke at the Department of Health, recommended a “blanket approach” in 2007, to give everyone above a certain age a daily dose of statins to “save lives, NHS funding and doctors’ time”.
So there has been a fairly warm response to the announcement yesterday by Fiona Godlee, editor-in-chief of the British Medical Journal, that a paper suggesting statins carry an 18-20 per cent risk of side‑effects is to be reassessed.
Prof Peter Weissberg, medical director of the British Heart Foundation, said: “Statins are an important weapon in the fight against heart disease and it is essential that trusted medical journals like the BMJ do not mislead the public. Patients should feel reassured by this move and should not stop taking their statin.”
Yesterday, Dr Godlee said the figure of 18-20 per cent included in the BMJ paper was based on data from an “uncontrolled observational study” and was incorrect. Speaking to BBC Radio 4’s Today programme, she said: “The BMJ and the authors have withdrawn the statements made in [the articles] that side-effects of statins were higher than we now think the evidence supports.”
Some experts don’t think the BMJ is going far enough. In March, Prof Sir Rory Collins, Professor of Medicine and Epidemiology and Co-Director of the University of Oxford’s Clinical Trial Service Unit and Epidemiological Studies Unit (CTSU), who has led global trials into statins, warned that these figures were dangerously misleading. “It is a serious disservice to British and international medicine,” he said. He claimed that the alarm caused would probably kill more people than had been harmed as a result of the MMR vaccine scare created by a now widely discredited paper in the Lancet written by Andrew Wakefield.
Although Dr Godlee has said that the remainder of the content of the articles is valid, she has also set up an independent expert panel to decide whether the BMJ needs to retract them completely, which is what Prof Collins now wants. “This is a serious misrepresentation of the scientific evidence and has a substantial public health impact,” he said.
A storm in a scientific tea-cup? If we weren’t talking about statins, you might well think so. But this is a row we can’t ignore. Not least because the use of statins is recommended to carry on rising. Draft guidance from the National Institute for Health and Care Excellence (Nice) in February suggested that the threshold for starting preventive treatment for heart disease, stroke or peripheral arterial disease should be halved from a 20 per cent risk of developing cardiovascular disease over 10 years to a 10 per cent risk. This would effectively double the number of people to whom statins are prescribed, bringing the total prescription cost alone (not including blood tests and biannual GP appointments) to just under £600 million.
Developing new drugs is an incredibly expensive and lengthy process: it costs about £1.2 billion and takes 12 years on average to develop and bring a new drug to market, according to the Association of the British Pharmaceutical Industry, and it will then get just 20 years of patent protection (although this can be extended occasionally for five years in the US and Europe).
This week’s mistake aside, peer-reviewed journals such as the BMJ play an important part in the scrutiny process that decides both whether those drugs are efficacious and whether they have undesirable side-effects. But some of the highly specialised medical journals cost a fortune to subscribe to. According to pharmacologist Prof David Colquhoun, access to 2,000 journals from publisher Elsevier costs University College London, his academic home, £1.38 million a year. This means that research published there can languish a little, especially if no one draws attention to it – which might suit a pharmaceutical company if the results aren’t so hot.
Prof Colquhoun points out that new “open access journals online” are a positive move. “Instead of just two referees looking at each piece, you get many minds and multiple comments underneath with some very incisive views, which can only be a good thing.”
It is worth noting, too, the increasing success of the All Trials campaign. This initiative, led by the journalist and scientist Dr Ben Goldacre, the BMJ, and the independent medical review body the Cochrane Collaboration, among others internationally, aims to get all clinical trials published and reported. It warns that currently around half of all clinical trials have not been published; some trials have not even been registered.
In the end, those millions who are using statins without obvious side-effects, and who see a significant lessening of their cholesterol levels, may say: what’s the problem?
Dr Malcolm McKendrick, a GP in Macclesfield and author of The Great Cholesterol Con, does not agree that statins are indisputably vital to all now. “For the vast majority of people, taking a statin will have zero impact on their life expectancy,” he says. “There have not been any trials carried out in the elderly, and there is no evidence any women will benefit from taking them.”
Dr Adam Fitzpatrick, a cardiologist and an expert in heart rhythm disorders at the Manchester Royal Infirmary, perhaps surprisingly, agrees. “Even if you have suffered heart disease and are male, the most benefit you can expect after taking statins for 20 years is an extra three months’ life, according to the research. That’s three months at the end, mind you, when you will probably be dying of cancer or have dementia. Is that really much of a gain?”
Dr Fitzpatrick also points out that the evidence for statins still doesn’t prove that they are responsible for fewer people dying of heart disease. “Saying statins save thousands of lives a year is just propaganda. The mortality rate for cardiovascular disease has been falling for 50 years anyway – and it reflects other factors, including quality of care and diagnosis, not to mention the number of people stopping smoking.
“We should be focusing on what the patient is complaining of. Our job is to tell them what it is caused by and reassure them, if that is appropriate. I see so many old ladies with atrial fibrillation who have been stuck on 80mg daily of the statin Lipitor and haven’t been able to move since due to muscle weakness. It is madness not to be tailoring care to those individuals.”
Dr McKendrick says that we could soon be hearing a lot more about side-effects. “When the new cholesterol-lowering drugs – monoclonal antibodies called PCSK9s – get through their trials, the pharma companies will need to create a market for them that doesn’t pitch them head-to-head with statins.”
Then, he suggests, we could suddenly find ourselves quizzed more closely by our GPs about muscle aches and brain fog, with the option, for those worried about side-effects, of taking these new drugs instead of statins.
These are drugs that will be in patent for 20 long, fertile years and which are far more expensive than statins ever were. With them will come a whole new set of possible side-effects – and, once again, patients may be left to weigh up the risks themselves.
