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Read Original Story

Schering-Plough, Merck cholesterol drug misses goal of reducing heart valve risks in study

Rating

2 Star

Schering-Plough, Merck cholesterol drug misses goal of reducing heart valve risks in study

Our Review Summary

The drug Vytorin is a hot news topic.  It was a big seller until an industry-sponsored study failed to show that it helped slow plaque buildup, and may have made it worse.  This new article describes yet another industry-sponsored study with disappointing results for this drug.  This business-oriented article describes in vague terms the lack of benefit for certain problems and the presence of benefit for others.  The dramatic and incomplete description of increased cancer risk in the treated subjects may overstate the risk, despite later tempering description of further studies.  There is not enough detail about study design for the reader to judge whether the positive effects reported (for non-aortic stenosis related outcomes) are credible.  The inclusion of several experts is good, but their connection to or independence from the study is inadequately described.   Patients, let alone stock-market speculators, would be better served by a more informative analysis.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

Athough the story did mention that one of the components of the study drug Vytorin was available as a cheap generic, it did not contain actual price information for the study drug or the price for the individual components.

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

Although the story mentioned that there was a benefit observed, it did not accurately report what the benefit was, nor did it provide quantitative data indicating the magnitude of the benefit.

Does the story adequately explain/quantify the harms of the intervention?

Not Satisfactory

The story waffled back and forth about the possible effect of the study drug on cancer and cancer death without providing the reader with a clear picture.  The perceived increase in cancer incidence was presented as relative risk rather than absolute risk, which distorts what was actually observed.

In fact, there was about a 9.9% rate of cancers in the Vytorin group and 7% in the control group.  There were 4.1% and 2.5% cancer death rates respectively (borderline significance).  Would these data inform the reader better than the inflammatory news that the researchers were "startled" to see a "50% more" new cancers and cancer deaths among the Vytorin recipients?  It may be the case, after full analysis of other Vytorin studies, that there is no increased cancer risk, and this story makes the point only begrudgingly.

Does the story seem to grasp the quality of the evidence?

Not Satisfactory

The article fails to describe the study in enough detail to understand whether the positive effects of Vytorin that were found are valid.  Journalists need to serve as intelligent filters for their readers to help them understand  that not all studies are equal and that new findings are not the end of the discussion. The story’s description of the side-effects evidence was poor, as already noted.

Does the story commit disease-mongering?

Not Satisfactory

The story did engage in disease mongering in its approach to presenting the information about the effect of Vytorin on cancer incidence.  Rather than provide the absolute increased number of cancer cases and cancer deaths, the story instead chose to report these in relative terms – "50 percent more new cancer cases and cancer deaths in patients who received Vytorin."  Journalists and readers should demand the information – 50% of what? See our primer on this vital statistical detail.

Does the story use independent sources and identify conflicts of interest?

Satisfactory

The story did include several quotes from experts in the field who did not appear to have direct ties to the study reported on, though the story did not actually indicate whether the experts did or did not have ties to the study.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

The story did not provide information about the available treatment options for aortic stenosis.

Does the story establish the availability of the treatment/test/product/procedure?

Not Satisfactory

The story explained that Vytorin, the study drug, was a combination of Zocor and Zetia.  It did not explain whether these are prescription or over-the-counter medications. The story also failed to explain that the drug is not FDA approved for treatment of aortic  valve disease.

Does the story establish the true novelty of the approach?

Satisfactory

The story was clear that the drug being discussed was actually a combination of two previously available medications and that one of the compounds was already available as a generic medication.  However, the story should have been clearer that the use of a cholesterol lowering medication for the purpose of decreasing risk from aortic stenosis is not an accepted practice and so in this sense would be a ‘novel’ indication.

Does the story appear to rely solely or largely on a news release?

Satisfactory

It does not appear that the story relied solely or largely on a news release.

Total Score: 3 of 10 Satisfactory

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