This news report about a significant clinical trial on statins and heart disease fails to look skeptically at the claims of the self-interested researchers. Rather than pushing back against the exaggerated claims of efficacy, safety, and imminent transformation of treatment protocols, the report magnifies them.
The report’s failures are largely due to emphasis rather than omission. The caveats are noted, but buried or otherwise minimized. For example:
In all, 16 paragraphs make positive statements about the results. Four paragraphs call the findings into question.
The story also fails to parse facts about CRP. The study looked at people with presumably safe cholesterol levels but high CRP levels. Because the drugs reduced both cholesterol and CRP, the results are silent on whether the benefits are related to a reduction in CRP. Yet the reporter allows the lead author–who holds a patent on the CRP test used in the study–to make this assertion.
Given the obvious financial interests of the researchers and their sponsors, and the extravagant predictions of population-wide benefits, the reporter should have made an extra effort to find disinterested sources who could put the news in context.
This would not have been difficult. The article cites an editorial in the same issue of the journal urging cautious interpretation of the results. The reporter could have at least used that editorial or an interview with the writer to inject a balance that was missing from this overly enthusiastic report.
The story reports the per-dose cost of the tested drug, $3.45 per day, and of generic statins, about $1 per day.
The reporter should be commened for reporting the estimated cost to the public of treating the expanded population group that might benefit from using the drug: $9 billion annually.
The story also reports the cost of a CRP test, which could identify people who may benefit from statins, at $80.
The reporter emphasizes in the lede the relative risk reduction of heart attacks or stroke in the treatment group. It would have been very useful to put this in perspective by immediately stating that the risk of a serious cardiac event in the treatment group was 1.8 percent, compared to .9 percent in the placebo group.
Later in the piece the report states that 120 patients would need to be treated with statins for two years to prevent one event. This is a useful, if late, addition.
The piece does not put the study’s reported 20 percent reduction of relative risk of death in perspective by using absolute risk figures.
The story fails to make clear one of the study’s major shortcomings: While the study subjects had moderate cholesterol and elevated CRP, the statins drove down both LDL cholesterol and CRP. Whether any of the risk reduction was due to the reduction in CRP levels is unknown. The self-interested researcher’s implications notwithstanding, this study was not designed to even test this hypothesis.
The story briefly mentions the increase of newly reported cases of diabetes in the group taking the statins, but does so in a minimizing way.
The story fails to mention that the study ended before long-term risks could be assessed. It fails to mention the unknown long-term risks of maintaining LDL cholesterol below 55 mg/dl, the level achieved by half the patients in the treatment group.
It also fails to mention the fact that Crestor is known to have a worse risk profile than other statins. This failure is peculiar, given the fact that the author of the current news article wrote an excellent piece about the elevated risks of Crestor for the same newspaper in 2005.
The story does not make clear the many limitations of the study (of which more appear below). The result is a story that appears far more credible and definitive than it is.
The story carelessly makes generalizations about the prevalence and severity of heart disease that don’t apply to the studied population. This has the effect of implying the findings, and the proffered treatment, apply to a much larger population than they do.
The age of the participants while noted briefly should have been stated as a caveat. The median age of participants was 66 years. The ten year chances of a heart attack in the patient population under study is 14% in the men and 7% in women.
In addition, 41% of those enrolled had evidence of metabolic syndrome. Nearly 7,400 of the 18,000 participants would be viewed as having a relatively high risk of a cardiovascular event with this diagnosis–not as "healthy" patients, as the researchers imply. The story should have caught this.
The article reports the study was funded by AstraZeneca, the maker of Crestor, and that Paul Ridker, the lead researcher, has received consulting fees from the company. It reports that he holds patents on tests for C-reactive protein.
But this understates the conflicts of interest in the study and in the sources chosen.
Nine of the study authors have received support from AstraZeneca and other drug companies. The "potential conflicts of interest" disclosure in the journal article takes up 17 lines of very small type.
The story quotes sources from two groups that are funded partly by the pharmaceutical industry: the American Heart Association and the American College of Cardiology.
The author should have sought commentary from experts who question the role of C-reactive protein in heart disease, and those who recommended prudent, targeted use of statins. There are many such experts.
Nonetheless, the story meets our stated guidelines for this criterion, showing how liberal they can be.
The story fails to mention that diet and exercise–along with smoking cessation–are the first lines of treatment to reduce risk of cardiovascular disease–and CRP levels.
The statin drug used in the study, Crestor, is on the market. The story indicates that other statins, which may have similar effects, are available as well.
The study is significant in that it appears to show that statin therapy may benefit a previously unrecognized population of patients. The study conclusions are therefore novel and presented as such.
There are several press releases associated with the study, but the article does not appear to draw excessively from any of them.