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New Blood Thinner May Lower Chances of Clots in High-Risk Heart Patients: FDA

Rating

2 Star

New Blood Thinner May Lower Chances of Clots in High-Risk Heart Patients: FDA

Our Review Summary

If you’re going to cover this topic at all, couldn’t it at least wait two days until the FDA advisory panel meeting is held?

Couldn’t it include at least one interview with someone knowledgeable on the topic? And how about one independent perspective?

 

Why This Matters

This is an example of why we push for journalists to quantify benefits and harms.  The headline trumpets “may lower chances of clots” but the story never explains by how much.  The story says the drug carries “an increased risk of potentially fatal bleeding” but the story never explains by how much.

We don’t know how news consumers could really make any sense of how big a deal this drug may be…and they’re certainly not given a sense of the big price tag of more than $7 per pill.

Many people with coronary artery disease have to deal with the multitude of issues related to the use of warfarin as their primary blood thinner.  So, a story about an alternative to warfarin is likely to peak the interest of many patients and their family members.  All deserve much more information than this very poor report provides.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

No discussion of costs. Various estimates we found quickly online showed a cost of $7 – 9 per pill – not a trivial issue!

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

Not Satisfactory

Exactly how should one interpret, “…mostly because trial data showed there was a reduction in cardiovascular death, even though there was also an increased risk of potentially fatal bleeding.”  Without any level of quantification, how is this information at all helpful to the reader.  There is a suggestion that the bottom line is fewer deaths but that is merely implied.  How much did it lower cardiovascular events, What were the bleeding events and how did the two balance out?  Isn’t that the real question that needed to be answered?

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

Not Satisfactory

No quantification of harms either – just vague “increased risk of potentially fatal bleeding.”

How big a deal is this drug?  The story never explains with any meaningful detail.

The story cites a talk at a recent conference that followed bleeding in patients in Xarelto or warfarin…but never explained how many had bleeds on which drug – making the citation almost useless.

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

Not Satisfactory

There wasn’t any evaluation of the evidence – just a recitation of FDA briefing documents.

Although the story suggests that Xarelto is superior to warfarin, the FDA briefing document only speaks to the use of Xarelto compared to placebo in addition to aspirin and/or clopidogrel,

“XARELTO® (2.5 mg po BID) has been shown to reduce the rate of a combined endpoint of cardiovascular (CV) death, nonfatal myocardial infarction (MI), or nonfatal stroke, compared to placebo, when administered in addition to standard care consisting of aspirin plus either clopidogrel or ticlopidine. The difference between treatments was driven predominantly by cardiovascular death, with little difference on myocardial infarction and no difference on ischemic stroke.”

The warfarin comparison was not included in the FDA advisory documents and speaks to their use in stroke patients and not patients with acute coronary syndrome.

Does the story commit disease-mongering?

Satisfactory

No disease mongering.

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

Not Satisfactory

No independent source was quoted.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

Warfarin (Coumadin) is mentioned but no meaningful comparison is provided.

As we noted previously, the comments are out of context, not in the advisory document and relate to the use of the drugs in patients with stroke and not acute coronary syndrome.

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

Satisfactory

The story explains that the drug is already used for atrial fibrillation and in people having hip or knee replacement surgery.

And with that general availability comes the ability of people to ask for Xarelto and for their physicians to prescribe it without the benefit of seeing the final recommendation from the scientific advisory board or final FDA approval for this new indication.

Does the story establish the true novelty of the approach?

Satisfactory

The story explains that this is one of a new class of blood thinners “developed to overcome some of the problems that exist with the standard treatment.”

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

Not Satisfactory

The story simply repeated what appeared in FDA briefing documents and in an earlier conference news release.  Apparently no one was interviewed for this story.  That’s not ideal health care journalism.

Total Score: 3 of 10 Satisfactory

Comments (4)

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Irene

May 22, 2012 at 7:26 pm

Just as an aside, journalists cover the FDA briefing documents two days before the panel because it often moves the share price, and is also news in itself — in terms of what FDA reviewers think about an experimental pill. The actual day of the meeting is dominated by what FDA advisers think. Each of those is important, and presents different viewpoints — and both opinions are impossible to cover in depth within the constraints of wire service journalism, for example, unless you’re writing a longer story that doesn’t depend on the day’s events.

Reply

Irene

May 25, 2012 at 10:16 am

Agreed on all counts in terms of why the story falls short. My points is just that I think it’s still worthwhile to do a separate story on the FDA documents before the advisory committee — even if the committee ultimately chooses to go another way.

Reply