Our Review Summary
This story reported on the results of a recently published study that found a new anti-clotting medication (which is not yet FDA approved) had better outcomes than the currently available medication used to treat people with acute coronary syndrome. We are troubled by journalistic predictions that FDA "approval seems likely" based on this study. Give the data and set the crystal ball aside. Such predictions sound more like marketing than journalism.
Why This Matters
While predicting that FDA approval is likely, the story never gives a cost estimate. How much will it cost to get a 1.1% reduction in death?
Criteria
Not Satisfactory
There was no discussion of costs, although the story did mention that the twice a day dosing of the drug would be required. If the drug is as close to FDA approval as indicated in the story, it would suggest that the company has some idea about its pricing.
Satisfactory
The story highlighted the potential benefits of this drug over the current medication as reducing overall death rates by 1.1%
Satisfactory
The story did discuss the main harm – the difference in bleeding – and that since ticagrelor must be taken twice a day, missing a dose can be very dangerous since the drug wears off so quickly.
Not Satisfactory
The story did not provide an adequate description of the study it was reporting on.
Although it did include the number of patients given the two drugs, there was an incomplete description of those patients who were studied. The story described them as patients who ‘had stents installed’. There are actually several different conditions for which stents are used. Acute coronary syndrome was mentioned in the story, but are readers expected to know what that is? Finally – some of the patients in the study reported on had coronary bypass surgery and so would not be described as having had a stent installed.
Satisfactory
The story indicated that the drug reported on was needed because ‘blood clots can be a deadly complication of getting a stent’. While this is a true statement, it would be more informative to provide some context about how commonly blood clots occur after a person receives a stent. This information would help readers evaluate the importance of a medicine to prevent this from occurring. Nonetheless, we’ll give the story the benefit of the doubt on this.
Satisfactory
The story quotes one independent source and identifies potential conflicts of interest. It would have been better if the "independent" commenter didn’t have industry ties.
Satisfactory
The story indicated that the drug reported on was more effective than the currently available treatments at reducing death, heart attack, and stent clotting. The story would have been greatly improved had it provided absolute data on the occurrence of these events.
Satisfactory
The story was clear that ticagrelor is not yet have FDA approval.
However, the story stated that ‘approval was likely’ and that the drug will be marketed as Brilinta. Both pieces of information are more akin to marketing than reporting. It would be more accurate to state that the drug is currently under consideration for FDA approval and that the name Brilinta has been proposed.
Satisfactory
The story mentioned in passing that ticagrelor released platelets more readily than the available medications. The story could have included more information about the unique aspects of this drug.
Satisfactory
Does not appear to rely solely on a press release.
Total Score: 8 of 10 Satisfactory
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