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expert reaction to study on the impact of statins-related media coverage on the use of statins

Publishing in the BMJ a group of researchers have reported an association between media coverage of statins and changes in initiation of statins use.

All our previous output on this subject can be seen here.

 

Prof. Sir Rory Collins, Co-Director of Oxford University’s Clinical Trial Service Unit and Professor of Medicine & Epidemiology, said:

“Matthews and colleagues have found evidence of harm to public health associated with the British Medical Journal’s publication of exaggerated claims about side-effect rates with statin therapy in October 2013. Following the publication of those claims, there was an increase in the numbers of individuals who stopped their statin therapy, including people who had had heart attacks and strokes previously, and so were at particularly high risk of having another one. In addition, fewer people were assessed by their doctors to determine whether they were at sufficiently high risk of heart attacks and strokes to be offered statin therapy. Immediately after the BMJ published its misleading reports, there also appear to have been reductions in the numbers of high-risk individuals in whom statin therapy was started.

“These findings are consistent with the report produced by the Picker Institute for the British Heart Foundation which found that media coverage of the misleading claims in the October 2013 BMJ papers was followed by an increased reticence among doctors to discuss the use of statins with their patients and to prescribe them, and with a reduced willingness by patients to continue taking their prescribed statin therapy.

“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.”

 

Prof. Kevin McConway, Emeritus Professor of Applied Statistics, The Open University, said:

“This is a good, careful study, clearly reported. It presents good evidence that patients taking statins were more likely to stop statin therapy in the six months after controversial media coverage about the drug. The researchers can’t be completely certain that this change was caused by the media coverage, and not to something else that might have happened about the same time. But their control analyses on glaucoma drugs and on a different time period do lend considerable weight to the idea that the publicity caused the change in behaviour. I’m convinced by it.

“In a way, though, this is hardly surprising. The research report reviews other studies that found evidence of media influence on patients taking statins in Denmark, Australia, Turkey and the Netherlands, as well as evidence of how media coverage affected the behaviour of patients in relation to several other diseases and treatments. But those who admire (or

bemoan) the power of the press might almost be a little disappointed that the effect in this study wasn’t higher. It certainly didn’t approach the doubling of new self-referral rates for breast screening in Australia after Kylie Minogue’s breast cancer. In this statin study, before the media controversy, out of 100 people taking statins for primary prevention – that is, they had not had a previous  heart attack, stroke, or other cardiovascular disease event – around 8 did not get a new statin prescription when their old one ran out. In the first six months, this did go up, to about 9 out of 100. For secondary prevention (people on statins who had had previous cardiovascular disease), the corresponding figures were around 6 in 100 not getting a new prescription before the media controversy, and about 7 in 100 after it. Yes, more people stopped afterwards, but not all that many more. To separate out this fairly small signal from the noise, the researchers needed lots of data and appropriately sophisticated statistical methods – they had both, which is a strength of the study., but the effects are still pretty small.

“The researchers make it clear that their estimate of the number of additional cardiovascular events, because of the media controversy, is based on several assumptions. They report that there will be at least 2000 such extra cardiovascular events in the UK in the next 10 years. Different assumptions would produce different estimates – this figure is bound to be rather uncertain, and in the research report the researchers also quote a figure of over 6000 as a ‘pessimistic’ estimate . But it’s also worth remembering that cardiovascular disease is unfortunately pretty common. In 2013-14, there were about 1.7 million occasions when people were treated as inpatients in NHS hospitals in the UK for cardiovascular disease. At that rate, that’s about 17 million in the next 10 years. That figure will include some double counting where the same patient is treated several times, but it’s still very much larger than 2000 or even 6000. Being affected personally by one of the 2000 or more extra events is of course something I wouldn’t wish on anyone, but a few thousand extra events aren’t going to have any major impact on the overall picture of cardiovascular disease.”

 

Prof. Jane Armitage, Professor of Clinical Trials and Epidemiology & Honorary Consultant in Public Health Medicine, Clinical Trial Service Unit & Epidemiological Studies Unit, University of Oxford, said:

“Debate is helpful if based on accurate information but the statin controversy hit the news because of 2 papers published by the British Medical Journal which stated that statins caused side-effects in a much higher proportion of people than the ‘gold standard’ randomised trials show. This UK study of statin prescribing in General Practice is observational and so, although based on very large numbers and carefully conducted,  we cannot be sure the impact of the media stories caused people to stop their statin but the timing fits.  It is in line with similar Danish and Australian studies  showing such media controversy is followed by people stopping their statin treatment.

“The adverse impact of this on public health is important to quantify as is attempted in this paper.”

 

Impact of statin-related media coverage on the use of statins: an interrupted time series analysis using UK primary care data’ by Matthews et al. published in BMJ on Tuesday 28th June. 

 

Declared interests

Prof. Sir Rory Collins: Rory Collins has obtained research grants from pharmaceutical companies (including makers of statins) for scientific research that is covered by University of Oxford contracts which protect its independence. He has a long-standing policy of not accepting any honoraria, consultancy or other payments directly or indirectly from industry, except for reimbursement of travel expenses to attend scientific meetings. He has a patent for a genetic test for statin-related myopathy, but does not benefit personally from it.

Prof. Kevin McConway: None

Prof. Jane Armitage: “I have coordinated academic led studies of the use of statins in high-risk people which have shown their benefits. These studies have received funding from Pharmaceutical companies including Merck who make simvastatin but have been conducted and reported independently of the funders. I abide by the departmental policy of not accepting personal payments or honoraria from Industry other than the receipt of reasonable expenses and travel costs to attend meetings.”

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