Over 200,000 patients stop using statins due to controversy: study

Controversy surrounding cholesterol-lowering statin drugs led to more than 219,000 patients stopping their treatment over a six-month period, a new study  suggests.

As a result, around 2,000 people may suffer a cardiovascular event such as a heart attack or stroke, experts have predicted.

In October 2013, two articles were published in The British Medical Journal (BMJ) that questioned the value of extending the use of statins to healthy people at low risk of heart disease.

Then in February 2014 reporting on the issue rocketed after the National Institute for Health and Care Excellence (Nice) launched draft guidance suggesting larger proportions of the population should be prescribed the drugs in a bid to prevent cases of heart disease, heart attacks and strokes.

The next month, leading medical academic professor Sir Rory Collins criticised articles published in The BMJ.

Researchers looked to see whether this period of public debate affected the likelihood of patients taking statins.

After examining UK prescribing data, they looked at people aged 40 and over who stopped and started taking statins each month from January 2011 to March 2015.

They found that among patients who were taking the drug because they were deemed to have a high risk of developing disease in the next 10 years there was a 12 per cent increased likelihood of stopping statins in the six months following the period of public scrutiny.

And among patients taking statins for existing heart disease, there was an 11 per cent likelihood they would stop, according to the study which has been published in The BMJ.

Overall, they estimated that this figure equates to 219,000 people who stopped taking statins - and this could lead to over 2,000 extra cardiovascular events, such as heart attacks and strokes, over the next 10 years.

Study author professor Liam Smeeth from the London School of Hygiene & Tropical Medicine, said, "Our findings suggest that widespread coverage of health stories in the mainstream media can have an important, real-world impact on the behaviour of patients and doctors. This may have significant consequences for people's health."

Dr Fiona Godlee, editor in chief of The BMJ said, "It seems to me absolutely right that there is public debate about the benefits and harms of treatments.

"Patients may now be better aware of several things. First, that we have far less good information on the side effects of statins than on their benefits. Secondly, that for some people, especially those at lower risk of heart disease, the survival benefit from statins may not outweigh the negatives of taking a drug every day with all that this entails.

"And finally that the complete trial data on statins are not available for independent scrutiny. This should shock people. It continues to shock me."

But the medical director of the British Heart Foundation (BHF) suggested that The BMJ published controversial views in order to sell copies.

Professor Peter Weissberg said, "Over the last decade or so we have seen a shift in the way medical journals behave. Twenty to 25 years ago all of the main medical journals were wholly objective, they would publish data, they would publish objective editorials that looked at the balance, we now know that several of the leading medical journals have now got axes to grind. The BMJ for example have made it no secret that they do not like the medicalisation of the normal population, not just when it comes to statins but pregnant women and all sorts of walks of life, in the aged, in terminal care and the like.

"I think when you see reports coming out like this people are very quick to ask the doctors who have done the studies so 'Where are your conflicts of interest?  Are you paid for by the drug company? Are you biased, in other words, in your reporting?' and that's a very reasonable question to ask but there doesn't seem to be the counter question. That is 'so is this journal on a campaign?' and therefore liable to be biasing particularly its opinion pieces towards the story that they are trying to build up.

"I think it is important when looking at the opinion pieces, and that's what they are, and they are there to sell, they have to sell copy. And they sell copy best by creating a bit of controversy and will often use opinions of people who are well outside two standard deviations from the mean of medical opinion. Of course if they are quoted as a leader in a prominent medical journal, that gets a huge amount of traction."

Dr Godlee added, "I think it's both appropriate and necessary to question the growing tendency to medicalise healthy people. The BMJ strives at all times to do this in line with the evidence, while also calling for far greater accountability and openness than is currently the case.

"The article we published by John Abramson and colleagues was not an opinion piece. It was a critical analysis of the available evidence. It's main thrust was to question the extent of the benefit of statins in people at low risk of heart disease. This has not, to my mind, been adequately responded to by those promoting the wider use of statins."

Meanwhile, a separate study suggested that some GPs have a "lack of confidence" when responding to patients' concerns about the drugs.

The study, conducted by the Picker Institute on behalf of the BHF, conducted three focus groups with GPs as well as an online poll of family doctors and cardiologists.

The authors wrote, "GPs in the focus groups reported a lack of confidence when responding to patients' concerns about statins. They emphasized that they were generalists, not specialists, and that they struggled to keep up to date on the constantly changing landscape of research on the wide range of conditions relevant to their patient populations, particularly around complex issues such as statins."

But 37 per cent of the 625 GPs who responded to the online poll said they were "very confident" in understanding the risks and benefits of statins, three in five said they were "fairly confident", and 3 per cent said they were not confident.

Commenting on the latest BMJ study, Sir Rory, who is co-director of Oxford University's Clinical Trial Service Unit and professor of medicine and epidemiology, said, "Matthews and colleagues have estimated that between about 2,000 and 6,000 people will suffer life-threatening or fatal heart attacks and strokes due to these reductions in the use of statin therapy in Britain alone.

"The impact worldwide, given the international readership of The BMJ, may well be far greater. Instead of hiding behind the spurious argument that "debate" is warranted despite having misrepresented the evidence, The BMJ should now take responsibility for the likely harm that it has caused to public health and correct the scientific record by retracting the statin papers that it published in October 2013."