Our Review Summary
This article, reporting on findings of a published paper on the experimental blood-thinning drug prasugrel, is an excellent example of a thorough, intelligent and disinterested report on study findings. Specifically:
- It makes clear that, while the findings can be interpreted favorably, FDA approval is not guaranteed
- It makes clear that the benefits and risks need to be carefully compared and are controversial. It does so using both study data and commentary from a number of knowledable experts. In each case the relationship of the source to the study, both professional and financial, is made clear.
- The article places the controverial findings in the context of market competition, which is the proper backdrop for a study of what is essentially a copycat drug.
It’s worth noting that this excellent five-star story was reported in fewer than 1,000 words. It was done by a medium-market newspaper, with a reporter filing under deadline on the road.
It’s also worth noting that this same newspaper announced 60 staff cuts this week. We hope it doesn’t affect future health care news coverage.
Criteria
Satisfactory
The article includes price information for the drug’s likely competitor, Plavix–about $4 per day, a significant cost for a drug that is taken daily, perhaps for a lifetime.
The article correctly indicates that the price of Plavix is likely to come down when it goes generic in four years.
The article properly includes speculation that the pricing of prasugrel may be a key factor in its adoption, should it be approved.
Satisfactory
The reporter includes considerable data about several key clinical endpoints of both benefits and harms, in two cases using both absolute numbers of patients and percentage increase or descrease.
The reporter gets extra points for including "number needed to treat"–the number of people who would have clinically significant outcomes for each 1,000 treated with the drug.
Satisfactory
The story is built around the question of the drugs’ risks vs. benefits. Data about harms are mentioned early and often, and described in detail. A direct comparision of the fatal bleeding rates for the two drugs would have been additionally useful.
Satisfactory
The New England Journal of Medicine article is based on results of a Phase III trial that appears to meet all the important criteria for significance: the study is prospective, the study group is large, the patients were randomized, the treatments double-blinded, the clinical endpoints signficant. While there is no placebo group, this was likely decided for ethical reasons, so all patients in the study would receive at least current best-practice treatment.
The article assigns proper crediblity to the study, which to appear in NEJM has received rigorous peer review.
Satisfactory
The article does nothing to exaggerate the risk of death or the consequences of heart attacks, strokes or cardiovascular disease deaths. It allows the outcome figures to speak for themselves.
Satisfactory
The article quotes five experts in cardiology from different institutions, providing greater balance and context than just one or two experts would. In each case the relationship of the souce to the study and/or its funders is revealed. The considerable conflicts of interest of the investigators are made very clear.
Satisfactory
The article makes clear that prasugrel is being developed as an option to Plavix, and that Plavix with aspirin is currently best-practice treatment.
Satisfactory
The article makes clear that the drug prasugrel is not FDA approved and that its approval is uncertain.
Satisfactory
The article makes clear that this is a drug that is very similar to Plavix, and that it may be marginally more effective. No claims of novelty are made.
Satisfactory
The companies’ joint press release, an enthusiastic announcement about the drug’s benefits, bears little resemblance to this story.
Total Score: 10 of 10 Satisfactory
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