Our Review Summary
This story reported on two studies published in the same issue of the New England Journal of Medicine. Both studies compared the effects of an anti-clotting medication on a currently available treatment, though the two studies involved different patient populations. The story never made clear whether there was a connection between the two studies reported; as the information provided on the two studies differed, this review focused on the first half of the story about the results of a phase III clinical trial involving the medication ticagrelor.
The reporting on ticagrelor, a medication for use in patients with acute coronary syndrome that may be available in the future. There was discussion of how this drug differs from the currently available therapies and the story discussed, albeit incompletely, some of the reasons this drug may be preferable to those on the market as well as covering some issues that may arise from the use of this drug.
The story would have been improved if it had included results from the other studies that have been conducted which had different results. Providing a more complete picture would better enable readers to understand the value in the new treatment.
Criteria
Satisfactory
As the drug reported on is currently not available a precise cost may not yet be known. However – while not providing a precise cost of this treatment, the story indicated that it is likely to cost more than the currently approved and available clopidogrel especially in 2011 when it will be off patent.
Satisfactory
The story described the benefits of treatment with ticagrelor in terms of the absolute reduction in risk of the composite endpoint of heart attack, stroke, and death from cardiovascular disease as well as the relative risk reduction.
Satisfactory
The story mentioned the disadvantage that this medication required pills to be taken twice a day (as opposed to the once a day dosing with the currently available medications). It also mentioned that this drug had the potential for resulting in shortness of breath and also that the results of the medication wore off faster than the currently available medication. It could have provided readers with some explanation about why this has the potential to be a problem.
Although it included a quote from a doctor indicating that this drug would likely become "the new standard of care," the story did not adequately highlight the new side effects seen with this new treatment to help readers understand that it may not be an appropriate treatment option for all individuals with acute coronary syndrome.
Lastly and perhaps most importantly – the story included the statement "There was no increase in the risk of dangerous bleeding associated with the new drug." This statement is misleading as the study reported on found that outside of bleeding related to coronary-artery bypass grafting, ticagrelor was associated with higher rates of major bleeding (4.5% versus 3.8).
Nonetheless, overall, the story meets the standard for discussing harms.
Satisfactory
The story included sufficient information for readers to appreciate that the study involved a large number of patients and it described the main comparison in absolute terms.
It could have mentioned that this was a phase III clinical trial designed to examine both the drug’s safety and efficacy. It also could have discussed how the result of the current study differs from the previous large, phase III clinical trials that have been conducted.
Satisfactory
While mentioning that acute coronary syndrome results in the hospitalization of more than 1.3 million Americans per year, the story did not engage in overt disease mongering.
Not Satisfactory
There was only one clinician quoted with respect to the utility of the medication ticagrelor. The story should have included other perspectives.
Satisfactory
The story mentioned that there were other medications that prevent platelets from forming clumps, mentioning the two prescription medications, clopdogrel and pasugrel by name.
Satisfactory
The part of the story on the treatment of acute coronary syndrome using the drug ticagrelor ended with a clear sentence indicating that the company is hoping to have FDA approval for this drug by the end of the year and have it commercially available for consumers by early 2010. Placing it here means it could be missed by readers. Further what a company ‘hopes’ may not translate to the drug being available on the timetable outlined. However – a careful read of this story would results in correctly understanding that this drug is currently not FDA approved for sale.
Satisfactory
The story was about a new medication which is not yet available.
Satisfactory
does not appear to rely on a press release
Total Score: 9 of 10 Satisfactory
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