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New Findings Show Xience Stents Are as Safe and Effective as Others

Rating

1 Star

New Findings Show Xience Stents Are as Safe and Effective as Others

Our Review Summary

This story is an example of what’s often missing in medical research stories in a business section.  The story is about a new cardiovascular stent that may be available if it receives approval from the Food and Drug Administration.  But the story does not provide much insight about the actual utility of implanting stents.  The story quoted an investigator on the project as saying that there was a lower heart-attack rate in those patients receiving this new stent. However – the published study indicated that while there were fewer heart attacks, this difference was not statistically significant. Beyond this, it is a comparison of heart attack rates in individuals who received stents and does include any indication of how this rate compares to that seen in people receiving optimal medical therapy but who don’t get a stent.

The story fails to deliver any independent perspective – only letting us hear from a company spokesman and one study investigator. 

Not everyone who reads medical research stories in a business section is interested primarily as a shareholder.  Some people want more context, more on the quality of the evidence, more on the size of the potential benefits and harms, and more on what this thing is likely to cost them.   This story – which reported more on the competition among or revenues for device manufacturers – didn’t help those readers. And when you think of it, why wouldn’t shareholders want that missing information as well?   

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

The story did not project any cost of this new stent; it did provide estimates for the amount of sales revenue generated by those drug-eluting stents that are currently available to consumers.  (The story also did not provide information about how much these stents cost consumers either.)  There was no discussion of associated costs for the medications that need to accompany the use of these drug eluting stents.

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

Not Satisfactory

The story did not adequately explain the intended appropriate use for this new stent.  The story indicated that the new stent decreased the need for repeat treatment in the target vessel and that the new stent decreased the occurrence rate for heart attacks.  There was no comparison of this stent with no stent at all.  In addition – as the information provided either came from the oral presentation at a conference or from the company news release – and has not been peer reviewed – the story should have been explicit about the source of the limited information it did present.

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

Not Satisfactory

The story provided quantitative data indicating that the rate at which blood clot formation occurred after implanting the new stent was comparable to the rate with one of the currently available drug-eluting stents.  However there was no information about how the harms with this new stent compared with bare metal stents or no stent at all.

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

Not Satisfactory

The story included some quantitative data from the research paper published in April 2008; it mentioned some of the research findings that were presented at a recent meeting.  It did not include the specific data from this meeting which is appropriate given their preliminary nature.  That said, the story is really about claims that this new drug-eluting stent is better than the currently available drug-eluting stents and since the data backing that claim has not yet been reviewed by objective experts in the field, the story should have stated this explicitly.

Does the story commit disease-mongering?

Not Satisfactory

The story engaged in subtle disease mongering because in its discussion of the use for this new product to treat ‘blocked blood vessels’ it failed to acknowlege that in fact, national guidelines don’t recommend the use of stents to treat all blocked coronary arteries, only those through which flow is occluded 70% or more.

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

Not Satisfactory

The story would have benefited greatly by including comment(s) from someone other than a company spokesperson or someone involved in the study. This could have provided readers with some insight about what this new product might add to the field.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

The story did not even provide a clear picture of what would be involved in treatment using the medical device highlighted, let alone outline the other options available for those with cardiovascular disease. 

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

Satisfactory

It’s clear from the story that the stent in question is not yet approved by the FDA.

Does the story establish the true novelty of the approach?

Not Satisfactory

The story was about one more drug-eluting stent that may come on the market but it was unclear about how this stent differs from those currently on the market.

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

Not Applicable

We can’t be sure if the story relied solely or largely on a news release, but the quantitative information about the benefit of this product appears to rely on the company news release. If not, the story should have explained where it came from. We do know the story only included comments from the company and from someone involved in the study – no independent perspectives. 

Total Score: 1 of 9 Satisfactory

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