UNCERTAINTY over cholesterol-lowering statin drugs is “probably killing more people than had been harmed as a result of the paper on the MMR vaccine”, according to a leading medical researcher.
Professor Sir Rory Collins, of Oxford University, has claimed unjustified concerns over the treatment is putting lives at risk and harming the reputation of medical science.
He hit out at articles published in the British Medical Journal (BMJ), which he said were creating a situation similar to the controversy over the MMR vaccine.
“It is a serious disservice to British and international medicine,” he said, adding that unfounded concerns were probably killing more people than had suffered as a result of research on the measles, mumps and rubella vaccine written by Andrew Wakefield.
He objected to articles by John Abramson from Harvard medical school and UK cardiologist Aseem Malhotra, who both claimed statins caused harmful side-effects and did not cut death rates.
He said claims that around a fifth of people suffer disabling side affects due to statins were not backed by original research referenced in the papers published by the journal.
“Statins are given to people at elevated risk of heart attacks and strokes - if people at elevated risk stop taking their statins or don’t start taking their statins then they will have unnecessary heart attacks and strokes, there will be unnecessary deaths from vascular causes,” he said.
But BMJ editor Dr Fiona Godlee defended the articles, adding that some studies play down possible side-effects.
“The randomised control trial data is notoriously poor at reporting adverse events,” she said. “So I think it’s extremely important that the public understand when we’re talking about extending statins to people at low risk, that the balance between benefits and harms becomes much more important.”
The drugs are already offered to around a tenth of the population who are predicted to have a one-in-five chance of developing heart disease over the next decade. Risk factors include age, sex and whether a person smokes or is overweight.
But a consultation on guidelines is currently under way after the National Institute for Health and Care Excellence (Nice) in England suggested the treatment should be opened up to people with as low as a one in 10 risk.
The Nice recommendation follows a study led by Prof Collins and could result in an additional five million patients being prescribed the drug. Doctors will need to “make a judgement” about the risks to people who have a lower than 10 per cent risk of developing cardiovascular disease and advise them appropriately, the draft guidelines say.
Prof Collins has also came under fire for not releasing the drug company trial information that formed the basis of his research.
Ms Godley said: “It’s no longer sufficient to make widespread extension of drug treatments on the basis of data that is not widely available for scrutiny.”
That view was echoed by Dr Mike Knapton, a GP and associate medical director of the British Heart Foundation, who said such public spats were “not helpful” as they undermine public confidence.
He said releasing the information would reassure both the public and medical professionals and should be done in the interests of “transparency and openness”.
The doctor, who takes the drug himself, said: “It’s not helpful professors having these ding-dongs in the public arena. My patients and me are going to have to sit there on Monday morning and think what we’re going to do. We need to make some sense of this rather than these inflammatory comments on both sides.
“I’ve never in my experience come across a drug that doesn’t have side effects in some people. All drugs have side effects and statins are no exception.
He pointed out that cholesterol can be lowered and the risk of heart attack and stroke cut by making lifestyle changes.
“I don’t think we’re going to be recommending statins to the whole population. At the end of the day choosing to take a statin is no different to choosing to stop smoking or choosing to eat a healthier diet,” he said.
This week will see the publication of new advice on preventing cardiovascular disease from the Joint British Societies (JBS), which includes the British Cardiac Society, British Hypertension Society, Diabetes UK, Heart UK, Primary Care Cardiovascular Society, Stroke Association and British Heart foundation.
The guidelines will do away with the current 20 per cent risk threshold and offer a web tool for calculating the likelihood of a person developing cardiovascular disease over their lifetime. Existing JBS guidelines have been in force since 2005.
The NHS currently spends around £450 million a year on statins. If the draft recommendations get the go-ahead, this bill will jump dramatically, although the cost of the drugs has fallen significantly since they were first licenced in the 1980s.