People with heart disease and cancer, along with physicians, are bombarded almost daily with the onslaught of novel, eye-poppingly expensive, and ever “promising” new ways to treat or prevent these life-threatening disorders. Because their benefits and potential harms are so often barely known, and because their impacts are frequently confined to “subsets” of patients in clinical trials, the overall result is a see-saw of hope and despair that journalists find challenging to report and put into context.
The anti-inflammatory effects of a Novartis drug called canakinumab is the latest case in point. TIME magazine’s description of clinical trial results, published in the New England Journal of Medicine, unfortunately fails to address the modest benefits, and the substantial risks and costs, of the drug. This is in contrast to a Reuters story on the same study that takes a far more cautious, cautionary and calibrated tone that better serves readers.
The anti-inflammatory scientific arc is littered with the consequences of less-than-stellar clinical results, overblown expectations and pharmaceutical industry high-stakes business gambles. That makes it especially important for news organizations to cover the subject area with the utmost care and context–this story didn’t meet that bar.
The story makes clear enough that far more must be done at the bench and bedside to bring this drug into first line use, even for subsets of people who already have had heart attacks or who have cancer. One reason is the $200,000 per year price tag already in place for the drug’s use in some rare autoimmune disorders tied to its anti-inflammatory effects. The pricing challenges are a substantial and enlightening part of the Reuters treatment of the study, which we also reviewed, but nowhere to be found in this TIME article.
The story states:
“After four years, the people who received the drug had a 15% lower chance of having a heart attack or stroke compared to people who didn’t get the drug.”
This is an error. The benefit only applied to second heart attacks, not strokes.
Also, what does 15% translate to in absolute numbers? This wasn’t explained, so we’ll elaborate here: The way researchers measured results was in “events per 100 person-years”, and the “events” were non-fatal heart attack, non-fatal stroke, or death from a cardiovascular-related cause. In the placebo group, there were 4.50 cardiac events per 100 person-years. In the group receiving 150 mg doses of canakinumab, there were 3.86 events per 100 person years. Of the various doses given (50, 150 and 300 milligrams), the 150 mg dose was the only statistically significant result, and it was only because of non-fatal heart attacks.
As noted in an editorial that accompanied the study, this was translated as a “modest” benefit. The story fails readers by not including that detail. For a comparison on how to write about the study results more responsibly, see the Reuters story.
Hardly a word about the real and unknown harms of the drug, which are more carefully outlined in a Reuters piece. The TIME article emphasizes the positive news–that anti-inflammatory drugs like the one described in the trial may well represent the future of substantial reductions in heart disease and cancer mortality. But there are caveats that needed much attention not paid in this story.
Readers can infer this data was from a relatively large randomized controlled trial, so we’ll give this a barely passing Satisfactory. Some discussion of the study’s limitations was needed, however.
No mongering here.
The story does not disclose that its primary source, Dr. Paul Ridker, has accepted consultancy & speakers fees from Novartis, the funder of the study.
The article does note that statin therapy also offers some anti-inflammatory effects that are possibly or probably responsible for prevention benefits in heart disease. But there are many effective and less expensive alternatives to secondary cardiac disease prevention that were not mentioned, such as smoking cessation, aspirin, statins, blood pressure control, etc.
The story makes clear that no one is suggesting the drug at present for routine use, and that at present the drug is not cleared for use in heart disease patients.
The TIME article, like the Reuters piece, does a pretty good job of explaining what is novel about the the drug’s effects and targeting.
The story does not appear to rely on the news release.