Study deals setback to cholesterol drug
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Rating
Study deals setback to cholesterol drug
Our Review Summary
This is a very clear accounting of the lack of added benefit when a statin medication is coupled with a medication to block absorption of cholesterol from the digestive tract. The story was well balanced including comments from both company officials and independent experts. There is ongoing discussion in the medical literature about whether the benefits from statin medication may go beyond their impact on cholesterol. The results from the ENHANCE trial, the study discussed in this story, likely will be added to this conversation. However – an important shortcoming of this story is that it neglected to mention that the study results it presented have not been published or even presented at a meeting. The story mentions the "long-delayed publication" of results but didn’t make clear that they still haven’t been published. And the story never tells us the source of the information about the unpublished data.
There was also no mention of the harms of treatment other than that the combination medication studied failed to provide greater reduction of cardiovascular risk than from a statin alone. This is another instance in which reporting on unpublished data is troublesome. What harms surfaced in this trial?
Criteria
Satisfactory
The cost of this treatment (two medications in one pill) was provided as well as the costs for other cholesterol lowering medication.
Satisfactory
The story was clear about the benefits of this treatment (i.e. that the outcomes from use of the combination medication were no better than a statin alone).
Not Satisfactory
There was really no mention of the harms of treatment other than that the combination medication studied failed to provide greater reduction of cardiovascular risk than from a statin alone. This is where reporting on unpublished data is troublesome. What harms surfaced in this trial?
Not Satisfactory
The story provided background information about the ENHANCE trial and something about the results. Unfortunately, the ENHANCE study results have not been presented or published. As a result, readers have no ability to validate the story or to obtain additional information. The story should have been more clear about the fact that the data have still not yet been published. They story refers to the "long delayed publication of its results" but it may not be clear to all readers that they’re still not available.
Satisfactory
This story did not engage in overt disease mongering.
Satisfactory
This story included interview quotes from individuals involved in the field of cardiovascular outcomes research, cardiologists, and company spokespeople.
Not Satisfactory
This was story about the failure of one combination therapy to outperform the single, simpler, less expensive therapy. It did not, however, provide information about other means of lowering risks from cardiovascular disease. These should have been mentioned in order to put the results of the ENHANCE study into perspective.
Satisfactory
The drug detailed in the story was described as heavily marketed direct to consumers and several clinicians’ quotes included in the story questioned the wisdom of prescribing this medication.
Satisfactory
The story was clear about the novelty aspect of the product reported on. What is important for consumers is that although the combination may be novel, the treatment of elevated cholesterol and reduction in plaque burden may be accomplished using either one of the test drugs (simvastatin) or one of the other statins.
Not Applicable
We have problems with the fact that we don’t know the source of the story. Was it the "conference hosted by Morgan Stanley earlier this month" that the story mentions? We don’t know. But because the ENHANCE trial data hasn’t been published, we should have been told the source. Nonethless, because we have no direct evidence of any language being lifted directly from a company news release, we give this criterion a shrug-of-the-shoulder and an N/A score.
Total Score: 6 of 9 Satisfactory
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