In contrast to the TIME article on this study (which we reviewed), and some others, the Reuters piece is appropriately skeptical and far more business-oriented, paying substantial detail to costs, harms, and regulatory challenges and cautions. It is skimpier than than the TIME article on some of the biological novelty of the new drug, but overall does a better job of informing readers and professionals of the slow slog many novel drugs must take before they are demonstrated safe, effective and affordable for those who may benefit.
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 took pains to do so.
This article does a great job of noting the cost and pricing issues inherent in the drug company’s efforts to develop, test and market novel biologicals. The headlong rush to “personalized” medicine, pharmacogenetic approaches to treatment, limited resources even in wealthy nations with gold-plated insurance policies, and the opacity of drug industry research costs make it imperative to explain to the public the realities of medicine’s pricing system.
The thoughtful reader will understand that the benefits are modest, as indicated by the well-written headline and carefully worded opening sentence. However, missing from the story was a discussion of the study findings in absolute terms.
The story says the study that “heart-attack survivors on one of three doses of canakinumab were 15 percent less likely to suffer another major cardiac event than those on a placebo.”
What does this mean in absolute numbers? The way researchers measured it was in events per 100 person-years, and the “events” were non-fatal heart attack, non-fatal stroke, or death from a cardiovascular reason. 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.
From the get-go, readers are told there are risks to keep in mind. This was entirely absent from the TIME story we reviewed.
That said, we wish this Reuters story had discussed the harms more in-depth–how frequent were they? How severe?
This was a randomized, placebo controlled clinical trial with a large number of patients. The story doesn’t explain this, nor any of the study’s limitations.
This story, which is more of a “business of medicine” story, uses a drug industry analyst source to good effect, and included commentary from the study’s accompanying editorial.
Both this story and the TIME story don’t mention that there are many effective and less expensive alternatives to secondary cardiac disease prevention, such as smoking cessation, aspirin, statins, blood pressure control, etc.
The lede graph says “Novartis will seek regulatory approval” for the drug’s use against heart disease, “though some experts fear fatal infection risks and a high price may overshadow the medicine’s limited scientific benefits.” At least for now.
The story 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.
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