Media Scrutiny Over Risks and Benefits of Statins Impacts Patient Use

High-profile media reports suggesting statins are associated with an increased risk of adverse events resulted in a transient increase in the proportion of primary- and secondary-prevention patients stopping their LDL cholesterol-lowering therapy in the United Kingdom, according to a new study.

Interestingly, primary- and secondary-prevention patients taking statins for a longer duration—more than 1 year of continuous prescription—were more likely to stop statin therapy following the period of intense media exposure compared with those on the drugs for a shorter time period. The increased likelihood of stopping was also more pronounced in older patients, say researchers.

“We found no evidence that the media coverage was linked to any change in the proportion of newly-eligible patients starting statin therapy, but we did find an 11% to 12% increase in the likelihood of people who’d already been taking statins stopping their therapy,” lead investigator Anthony Matthews, MD (London School of Hygiene and Tropical Medicine, England), told TCTMD. “We also found that the increase [in stopping] was only for a short period of time. After 6 months, the proportion of people stopping statins returned to levels similar to before the media coverage.”

Speaking with TCTMD, Naveed Sattar, MD (University of Glasgow, Scotland), said he has encountered patients reluctant to start statin therapy based on concerns about side effects. Although not involved in the current analysis, Sattar, the lead author of a large meta-analysis documenting the risk of diabetes with statin therapy, said there are a small proportion of patients who are wary of treatment because of what they’ve heard or read in the news.

“The reality is that when people read things in the newspapers and there’s a quote from an official-sounding individual, they often take this to mean the findings must be robust,” said Sattar. “It’s difficult for them—they don’t have the privilege that physicians and clinical academics have in knowing the literature inside and out, in knowing the level of quality evidence for certain facts, and in knowing which facts are dubious. I can make a good value judgement based on the quality of research in front of me but the public doesn’t have that same ability.”

Results of the study were published June 28, 2016, in the BMJ. 

Media Scrutiny Arose in the BMJ

Previous studies have suggested that the media can influence patient behavior when it comes to statin therapy. As reported by TCTMD, a Danish study showed that statin discontinuation was linked with negative statin-related news in the media, as well as with higher risks of MI and cardiovascular death. Studies in Australia, Turkey, and France have also shown an association between media reports about statin side effects and patient use.

To TCTMD, Matthews said the media scrutiny over the side effects of statins was heightened based on two articles published in 2013 in the BMJ.

In the first, John Abramson, MD (Harvard Medical School, Boston, MA), and colleagues questioned whether people at low risk of cardiovascular disease should take a statin. He also stated that statin side effects occur in 18% to 20% of patients, a rate challenged by other researchers and subsequently identified as an “error of interpretation” by the journal, which revised the language to refer not to established side effects but rather “statin-related clinical events that may be interpreted as adverse reactions by patients or their clinicians.” In the second paper, Aseem Malhotra, MD (Croydon University Hospital, London), debated the role of saturated fat in heart disease and stated that the “government’s obsession with levels of total cholesterol” has led to the “overmedication of millions of people with statins.” He also cited the same percentage of statin-related side effects.

Matthews said the debate over statins gained further attention with impending changes from the UK National Institute of Health and Care Excellence (NICE). In 2014, NICE expanded eligibility criteria for primary prevention to patients with a 10-year risk of cardiovascular disease ≥ 10% (as opposed to previous criteria of treating patients with a 10-year cardiovascular risk ≥ 20%).

In the 6-month period following the BMJ papers, the researchers said there was a period of increased media coverage in the United Kingdom regarding the risks and benefits of statins, including one article in the Express stating, “Millions Face Terrible Side Effects as [Statin] Prescription Escalates.” Other articles were less reactionary, but there was open discussion in the media about the potential risks of statin therapy. In one article, Rory Collins, FMedSci (University of Oxford, England), stated that he feared physicians suspicious of statins create a misleading environment about the drug’s benefits and risks. In the article, Abramson is quoted, accusing Collins of “fear-mongering.”

While Abramson and colleagues focused on the risks and benefits in patients with low cardiovascular risk, Matthews said the concern was that people at high risk would fail to start therapy, or stop their statin, based on the public debate. In their study, they identified a “media exposure” period of October 2013—when the BMJ first published the statin papers by Abramson and colleagues and Malhotra—and March 2014, a point in which the search term “statin side effects” declined in popularity on Google. During the study period, they identified 88,010 statin-eligible individuals (primary-prevention patients with a 10-year risk of cardiovascular disease ≥ 20%) and 28,593 individuals who had a cardiovascular event (secondary-prevention patients).

Regarding the findings, there was no evidence of any change in statin initiation between the period prior to the negative media exposure and the exposure period. This was true for patients treated with statins for primary prevention and those with existing cardiovascular disease. After the exposure period, there also was no change in the number of patients who started statins for primary and secondary prevention compared with the exposure period.

The analysis did show that patients were more likely to stop taking statins after the 6-month period of negative news compared with prior to the exposure period. This increase in statin cessation in the postexposure period was observed in primary- and secondary-prevention patients. For example, in the period after being exposed to negative media reports about statins, there was an 11% increase in the risk of statin cessation among primary-prevention patients and a 12% increase in risk of cessation among secondary-prevention patients (compared with the period prior to media exposure).

Overall, the researchers estimate 218,971 patients in the UK stopped taking a statin in the 6 months after the negative media coverage. If one-third of individuals failed to restart statin therapy—a restart estimate used in previous studies—at least 2,173 cardiovascular events within the subsequent 10 years could be attributed to the absence of statin coverage. Matthews told TCTMD these numbers are “not set in stone,” but rather an attempt simply to estimate the clinical implications of stopping treatment.

In an editorial, journalist Gary Schwitzer (University of Minnesota School of Public Health, Minneapolis) questions whether stopping statins could be attributed to the news reports, noting that not all the stories were negative. The 6-month period of media debate, and the resulting stories cited by the authors, are a “slim sample” on which to base conclusions. “We should not rush to judge the media’s role in this episode,” writes Schwitzer. “The authors provide no patient survey data to support the belief that that people stopped because of the news reports.”

To TCTMD, Matthews agreed, saying the observational study does not prove causality. He added that the study is not intended to “blame” the media, but instead meant to emphasize the important role researchers, universities, and the media play in communicating information accurately. While there is a minority of physicians and researchers who don’t see a benefit of statins in certain populations, the overwhelming majority of physicians believe the drugs are effective in secondary prevention, as well as in patients at high risk for cardiovascular events. Such views of the scientific community should be conveyed to the public, said Matthews.  

For Sattar, while the media does have a role in presenting information to the public, stories sound better if they’re sensationalized, or are given a certain twist. For example, he noted that statins have been linked with cataracts in some observational studies, but the nuance of such an “association” is often overlooked and causality is implied. These stories frequently ignore the quality of the evidence and the limitations in the data. “We see this all the time,” said Sattar.

Patients Will Listen as Long as You’re Not a Dictator    

Last month, the Cholesterol Treatment Trialists’ (CTT) collaboration—the Oxford-based group that has been pooling randomized clinical trials of statin therapy since 1995—announced the launch of a new meta-analysis to assess the relative and absolute risk of adverse events with statin therapy. The analysis is a response to a wide range of observational studies, including many picked up by the media, suggesting statins are associated with an increased risk of muscle pain/weakness, cognitive impairment, cataracts, and other side effects. At the time, Colin Baigent, BMBCh (University of Oxford, England), one of the principal CTT investigators, told TCTMD there is increasing evidence the reports influence prescribing patterns and patient behavior.

For Schwitzer, who runs a US-based project to review media messages about healthcare interventions, the 10-year data of several thousand stories suggest the media “emphasize or exaggerate potential benefits while minimizing or ignoring potential harms.” He said that if news stories generate new questions and complete conversations between patients and physicians on the risk/benefit tradeoff, personal preferences, and values, “this is an outcome to embrace.” 

To TCTMD, Sattar said that while patients will frequently highlight concerns about statin therapy, his role as a physician is to simply present the data and to allow patients to make an informed decision without any value judgements on his part. Once he reassures them of the “unequivocal” quality and quantity of data, and the fact that he gains nothing financially by prescribing statins, many come around to therapy. For the truly reluctant—such as those who might be preoccupied with the small, but real, risk of diabetes mellitus with statin therapy—he’ll walk them through the potential risk-versus-benefit trade-off.

“The vast majority, when they hear what I’m telling them, say, ‘OK, I didn’t realize that, doc,’” said Sattar. “So the way we convey this message to patients is really important. It’s not about dictating what they should do, but instead giving them the evidence in an objective manner.”

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