TIME’s look at new heart drug overlooks high price and potentially fatal risks

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

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.

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

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.

Does the story adequately explain/quantify the harms of the intervention?

Not Satisfactory

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.

Does the story use independent sources and identify conflicts of interest?

Not Satisfactory

The story does not disclose that its primary source, Dr. Paul Ridker, has accepted consultancy & speakers fees from Novartis, the funder of the study.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

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.