Statins: BMJ investigates claims over side effects

Two articles claiming cholesterol-reducing statins may be unsafe are to be investigated and could be retracted by the British Medical Journal.

The authors have withdrawn figures suggesting up to 20% of users would suffer harmful side effects such as liver disease and kidney problems.

About 7m people in the UK at risk of heart disease are prescribed statins.

Experts fear the articles, which were widely reported in October, will have discouraged people from taking them.

British Medical Journal (BMJ) editor-in-chief Dr Fiona Godlee said it was publicising the withdrawal of the side-effects figures "so that patients who could benefit from statins are not wrongly deterred from starting or continuing treatment because of exaggerated concerns over side effects".

Analysis

By James Gallagher, BBC health and science reporter

No drug is completely safe, even paracetamol comes with side effects.

The real question is whether the benefits of statins, such as cutting the odds of a heart attack, outweigh the risks which include type-2 diabetes.

The drugs are currently given to patients at high risk of heart disease, often after a heart attack. These patients have the most to gain by lowering their cholesterol.

But there are now plans to prescribe statins to low risk patients too. They would face the same side effects, but for much smaller benefits.

This ongoing vitriolic debate over the merits of statins will not help the National Institute for Health and Care Excellence persuade millions of healthy people they should be taking statins for the rest of their lives.

Peer reviewed

In the UK statins are offered people who have a 20% chance of heart disease in the next decade and studies have also examined whether more people should be offered the drugs to prevent heart problems.

In October the BMJ published papers by Harvard Medical School's Dr John Abramson and UK cardiologist Dr Aseem Malhotra which claimed that side effects occur in 18-20% of statin users.

Dr Godlee said this figure was based on data from an "uncontrolled observational study" and was incorrect. However, it had not been picked up by the journal's editors or the experts who peer reviewed the work.

"The BMJ and the authors have withdrawn - not the articles - but the statements made in them that side effects of statins were higher than we now think the evidence supports," Dr Godlee told BBC Radio 4's Today programme.

However, she said the journal has now set up an independent expert panel to decide whether it needs to completely retract the articles.

Dr Godlee said she had established the panel because as editor she had an interest in not immediately retracting the work unless the case against them was clear.

'Very low risk'

Medical researcher Prof Sir Rory Collins, who raised doubts over the two papers in March, said the BMJ articles had "overestimated the side effects of statin therapy by more than 20 times".

He told the Today programme this was likely to have encouraged people to either stop taking statins or not to start treatments in the first place.

Asked if he believed statins were safe to take, Sir Rory said trials of more than 100,000 patients showed there was "a very very low risk of muscle problems" and a "small increase in diabetes".

"These are far outweighed in the high-risk patients and indeed even in the patients at lower risk... by reductions in the risks of heart attacks and strokes," he said.

'Extremely painful'

"I was prescribed Simvastatin about nine years ago following heart problems," says John Cakebread, from Kent.

"I stopped taking the medication six years later after researching the subject on the internet and finding out about side effects.

"I have now been left with peripheral neuropathy in the feet.

"This is extremely painful.

"My GP refuses to acknowledge this condition and that it could be caused by statins.

"He still wants me to take this medication, but I have refused."

Professor Peter Weissberg, medical director of the British Heart Foundation, said patients should feel "reassured" by the withdrawal of the claims and said people "should not stop taking their statin".

"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," he said.

Dr Tim Chico, honorary consultant cardiologist at the University of Sheffield, said the drugs were "one of the most well proven treatments doctors can use for any disease".

He said that he had to explain to patients "every day" that the adverse effects of statins are often overestimated.

"Statins save lives. This is beyond doubt," he said.

Medical experts have long debated whether the use of statins should be extended to people with a "low-risk" of heart disease.

A study by the University of Oxford in March 2012 concluded that people with a low-risk of heart problems would benefit from statins.

Dr Godlee said the BMJ would continue to debate "whether the use of statins should be extended to a vastly wider population of people at low risk of cardiovascular disease; and the role of saturated fat in heart disease".

The independent panel will be chaired by Dr Iona Heath, a former chairwoman of the Royal College of General Practitioners and a member of the BMJ's ethics committee.