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Business story on Entresto, newly approved heart failure drug, capably covers most of the health implications


5 Star

F.D.A. Approves Heart Drug Entresto Said to Cut Death Risk by 20%

Our Review Summary

ENT_US_TM_PROM_4CP_FC_POS_BetaThe story focuses on FDA’s approval of a drug called Entresto for use by patients with certain types of heart failure, and discusses the potential profits the drug may accrue for pharmaceutical company Novartis. This story from the business section is as much about the financial implications of the approval as it is about health; the story addresses cost in depth and explores how the drug would fit into a market where competing generic drugs are often less expensive. Overall, there’s plenty of useful information and the story covers quite a bit of ground in not very much space. But a few things could have been done better, particularly a headline and introduction that do not fully explain the extent to which the drug could be of benefit. In addition, the technical language the story uses may make it difficult for many readers to understand which heart patients might benefit from the drug. A comment from an independent expert about the health implications of the drug might have helped with some of these issues. Skeptical voices regarding this new drug combination seem to be few and far between, but this post at the Health Care Renewal blog provides some critical analysis of the study that’s the basis for Entresto’s approval — for those who wish to dive deeper.


Why This Matters

According to the CDC, more than 5 million people in the United States have heart failure, which was responsible for one out of nine deaths in 2009. And a 2013 report from the American Heart Association estimated the economic burden of heart failure to be $31 billion in 2012, with a predicted rise to $70 billion by 2030. Heart failure is clearly a medical condition that affects families and finances nationally. As such, it is certainly worth tracking and reporting on the development of new treatment options and how much they’ll cost. However, it’s also worth making clear to people outside of the medical profession how much help (and hope) a new treatment may provide — and who might benefit from it — in accessible terms.


Does the story adequately discuss the costs of the intervention?


The story does an excellent job here. Not only does it provide the predicted daily and annual cost of the drug ($12.50 and $4,500, respectively), but explains why some health plans may balk at the price (given that competing drugs are significantly less expensive).

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


The story gets a hesitant satisfactory score here. Now, we know that reporters rarely, if ever, write the headlines. But somebody at the Times must take responsibility for the confusion caused by this headline, which states that the drug is “Said to Cut Death Risk by 20%.” This starts the story off on an uncertain note, since it’s not clear who said this or where this information is coming from. In the second paragraph, the story cites results from a clinical trial showing “a 20 percent reduction in the risk of death from cardiovascular causes or hospitalization for worsening heart failure.” So, it seems that the drug is not cutting the risk of death by 20 percent, but the risk of death or hospitalization for worsening heart failure. Then again, if you go to the study itself, you learn that there was indeed a 20% reduction in the outcome of “death from cardiovascular causes,” although this doesn’t seem to be the figure that the headline is referring to, since it’s not mentioned in the text. In terms of overall death from any cause — the outcome that most closely resembles the “death risk” mentioned in the headline — the study shows that there was a 16% reduction.

But that’s not the whole story. Much lower down in the article, we learn that this was actually a relative risk reduction — patients in the clinical trial who took Entresto were 20 percent less likely to die or be hospitalized than patients who took a competing drug called enalapril. This sort of risk reduction is not the same as absolute risk reduction, which provides a more meaningful view of the benefit. The story does get credit for eventually providing the absolute risk of hospitalization/mortality in both groups (21.8 percent of those taking Entresto vs. 26.5 percent for those taking enalapril, or  a 4.7% difference), but putting this information far down in the story, after a confusing headline, is less than ideal.

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


The story addresses both common side effects and severe ones, while also noting which patients may be at increased risk of those side effects. The coverage would have been even stronger with some mention of the rate at which these problems occurred.

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


The story does a nice job of describing the study in concise terms, noting the total number of participants, the study design, the length of the study, and the endpoints that were evaluated.

The discussion is Satisfactory, although we might have wished for a few more details and to have those details included higher up in the story — to complement the reporting on benefits. For example, it’s not until the very end of the story that we learn that drug is a combination pill that in fact includes another angiotensin II receptor blocker that’s already widely available. In addition, many readers will have trouble determining which kinds of heart failure patients may benefit from the drug. The story says Entresto has been approved for patients with “so-called Class II to Class IV chronic heart failure with so-called reduced ejection fraction.” Many readers — including many heart patients and their loved ones — will likely have no idea what this language means. We know this was a business story and that investors and analysts might know these terms. But many online readers will find the story as we found it – in a general search – not by a business-news-only-filtered search.

Does the story commit disease-mongering?


No disease mongering here.

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

Not Satisfactory

Two people are quoted in the story. One is an analyst at an investment firm, with no clear ties to Novartis, who was quoted in regard to the drug’s potential to generate revenue for Novartis. The other is the head of Novartis’s pharmaceutical division. An outside perspective on the potential health impact of the drug would have been very welcome.

Does the story compare the new approach with existing alternatives?


The story does say that Entresto will be competing with generic versions of drugs called “angiotensin-converting enzyme (ACE) inhibitors or somewhat similar angiotensin II receptor blockers.” We’ll award a Satisfactory on that basis. The story could have added value by making it clear that these drugs — or Entresto — would be used as part of a suite of treatments for heart failure. For example, depending on the cause of low, or reduced, heart ejection fraction (meaning your heart is not pumping out blood efficiently), treatment options may include surgically implanting a defibrillator, changes in diet and physical activity, or the prescription of other drugs (including betablockers or inotropes).

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


The story is about the FDA approval of the drug, which suggests that it will shortly be available for purchase. Novartis says as much in its news release which indicates the drug will begin shipping this week. The story doesn’t explicitly address this, but we’ll give the benefit of the doubt. Again, we’d add that half of this drug combination is already widely available.

Does the story establish the true novelty of the approach?


At the very end of the story, it notes that Entresto is made of two drugs — one of which has a novel “mechanism of action” for a heart failure drug. It doesn’t tell us how or why it’s novel, nor does it explain how that mechanism of action works. That would have been worth exploring. That issue aside, the story is also about the FDA approval of the drug, which is clearly a new and noteworthy event.

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


The story incorporates information not included in the news release.

Total Score: 9 of 10 Satisfactory

Comments (1)

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Matthew E

December 4, 2015 at 7:14 pm

I disagree. The story does NOT grasp the quality of the evidence. Lehmans explains how terrible it is here: You say there are few skeptical voices. Several are noted at !