Many people stopped taking statins in the period immediately following intense media coverage of a bitter controversy over the drugs, found a study published in the BMJ, raising questions about the role and responsibility of researchers, editors, and journalists when tackling topics with potentially life-affecting consequences.
The authors calculated that the bad-news statin discontinuations may result in more than 2,000 additional cardiovascular events over the next 10 years. The study was broadly consistent with previous research finding that negative media coverage of statins and other drugs can lead some people to discontinue their prescriptions, at least temporarily.
The finding, according to one leading opponent of the original articles, demonstrates the potential harms caused by irresponsible publications. But an accompanying editorial by a veteran healthcare journalist and media critic offered a strikingly different perspective. It pointed out that the overwhelming amount of healthcare coverage in the media is highly positive and uncritical, likely driving many more people to take drugs than stop taking drugs.
The U.K. researchers used a large primary care database to detect changes in the number of people initiating or discontinuing statin therapy before and immediately after the media controversy, which occurred in response to the 2013 publication of two papers published in the BMJ that were highly critical of statins. They found no difference in the number of people initiating treatment before and after the controversy. But people already taking statins were significantly more likely to stop taking the drugs, both for primary prevention (odds ratio 1.11, 95% CI 1.05-1.18) and for secondary prevention (OR 1.12, 95% CI 1.04-1.21).
The researchers found that older age and and longer length of time taking statins were associated with an increased likelihood of discontinuing the drugs. In a negative control analysis, the researchers found no similar changes during the study period in prescriptions for glaucoma treatment.
The authors estimated that more than 200,000 people in the U.K. alone stopped taking a statin in the period after the controversy began. Assuming that two-thirds of the patients would restart statin treatment, they calculated an additional 2,173 cardiovascular events in the next 10 years.
Public Debate and Public Health
Cholesterol trialist Rory Collins, MBBS, of Oxford University, was the first to report problems in the original 2013 papers and was a highly vocal advocate for their retraction. He offered the following comment on the new paper:
"Matthews and colleagues demonstrate the harm caused to public health in the U.K. by the BMJ's publication of exaggerated claims about side-effect rates with statin therapy in October 2013. Individuals who had previously had heart attacks and strokes, and so would be at particularly high risk of having another one, were found to have stopped their statin therapy. In addition, doctors stopped assessing whether their patients 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 indicates that media coverage of the misleading claims in the October 2013 BMJ papers resulted in greater reticence among doctors to discuss the use of statins with their patients and to prescribe them, and 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. Instead of hiding behind the spurious argument that 'debate' is warranted despite having misrepresented the evidence, the BMJ should now take responsibility for the harm that it has caused to public health and correct the scientific record by retracting the statin papers that it published in October 2013."
Fiona Godlee, MBBChir, editor-in-chief of the BMJ, defended the decision to publish the original papers: "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."
Broader Media Concerns
In the accompanying editorial, Gary Schwitzer offered a different perspective on the controversy, suggesting that the negative consequences of the study may be exaggerated. Even if media coverage did cause people to stop taking statins, he asked, "Is that such a bad thing? As Montori and others have said, 'Informed patients may choose not to follow a guideline that does not incorporate their preferences.'" Schwitzer added: "What do we know about patients' preferences in this case? Perhaps news stories inspired patients to question trade-offs in ways they never did when they started taking statins because they had not been fully informed."
Schwitzer, who has been monitoring media coverage of health subjects for many years as the publisher of Health News Review, also raised a broader point about media coverage of health stories and the much more widespread problem of uncritical acceptance of medical studies by the media. He points out that media coverage in this case was an exception to the rule, since more typically journalists "emphasize or exaggerate potential benefits while minimizing or ignoring potential harms."
"We rarely see journalism about overdiagnosis, overtreatment, or shared decision making. Few stories clearly communicate the trade-offs involved in medical decisions. Far more stories fawningly promote more use of more interventions, evidence be damned. Journalism that exposes the public to ongoing controversies in science should be nurtured, not branded as negative," Schwitzer wrote.
Taking a position in the middle, Harlan Krumholz, MD, of Yale University, commented that it is "no surprise that public dialog about risks and benefits might influence patient behavior. The question is whether the information was accurate and accessible – and whether the decisions were improved based on patient preferences and goals. Knowing that behavior changed does not tell us much about whether patients were better off or not."