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FDA approves AbioCor heart

Rating

3 Star

FDA approves AbioCor heart

Our Review Summary

This is an extremely upbeat article for use of an artificial heart device in the treatment of a very select subset of individuals with end stage heart failure. While mentioning that this device is only for patients with advanced heart failure who have no other options and would otherwise die, the story just three sentences later quotes a surgeon stating that the device’s approval “gives tons of hope to people with end-stage heart failure”. This paints a somewhat unrealistic picture about the limited group of patients for whom the device is an option. In addition to only being intended for those who are not eligible for a heart transplant and who would likely live less than a month without the device, it is only for patients whose chest is large enough to hold the device. Only the results from the longest living recipient of the device were included in the article. For balance, it would have been useful to include the average amount of time that people survived with the device as well as some mention of consequences of the treatment that may affect quality of life.

Further, it is hard to predict who will live “less than a month,” a theme not addressed in the story. It is possible that some recipients may have their life shortened (death in surgery or immediately thereafter).

Costs are not fully explained. A price range of $200,000 to $250,000 for the device was included in the story. However, there was no mention of physician fees or hospital stay costs.

The article contained quotes from physicians directly involved in the clinical trial leading to the humanitarian device exemption, family members of patients who had, on balance, positive experiences with the device and the director of the FDA division responsible for the decision. The article would have been improved had it contained the views of some individuals slightly more removed from the device itself to help provide a framework in which to consider the ramifications of this treatment.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

A price range of $200,000 to $250,000 for the device was included in the story. However, there was no mention of physician fees or hospital stay costs.

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

Not Satisfactory

The longest a patient has lived with device was included in the story, but no range was given for the length of time patients survived with the device for reference. While putting a premium on the “one more Christmas, one more birthday” concept, there was no discussion about the differences in quality of life experienced by the patients receiving the device.

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

Not Satisfactory

Only the results from the longest living recipient of the device were included in the article. For balance, it would have been useful to include the average amount of time that people survived with the device as well as some mention of consequences of the treatment that may affect quality of life.

Further, it is hard to predict who will live “less than a month.” It is possible that some recipients may have their life shortened (death in surgery or immediately thereafter).

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

Satisfactory

The article mentions that the evidence about the device comes from only 14 patients to date who have had it implanted.

Does the story commit disease-mongering?

Satisfactory

No overt disease-mongering, although the story contained no information on the prevelance of heart failure or the percentage of individuals with heart failure for whom this treatment might be considered.

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

Not Satisfactory

The article contained quotes from physicians directly involved in the clinical trial leading to the humanitarian device exemption, family members of patients who had, on balance, positive experiences with the device and the director of the FDA division responsible for the decision. The article would have been improved had it contained the views of some individuals slightly more removed from the device itself to help provide a framework in which to consider the ramifications of this treatment.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

While mentioning that this device is only for patients with advanced heart failure who have no other options and would otherwise die, the story just three sentences later quotes a surgeon stating that the device’s approval “gives tons of hope to people with end-stage heart failure”. This paints a somewhat unrealistic picture about the limited group of patients for whom the device is an option. In addition to only being intended for those who are not eligible for a heart transplant and who would likely live less than a month without the device, it is only for patients whose chest is large enough to hold the device.

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

Satisfactory

Although the story didn’t explain that the device was only approved by the FDA using the “Humanitarian Device Exemption,” it did say that sales of only up to 4,000/yr would be allowed and that it is much more likely that far fewer will be sold. The story also explained that the device will be available at only 5 institutions in the U.S. It is valuable for readers to understand the limited availability of this device for appropriate expectations.

Does the story establish the true novelty of the approach?

Satisfactory

The story was clear that only 14 people have received this medical device.

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

Satisfactory

The article does not appear to rely exclusively on a press release. However, the quotes attributed to Dr. Daniel Schultz, director of the FDA’s Center for Devices and Radiological Health came from the FDA news release on the device, found at http://www.fda.gov/bbs/topics/NEWS/2006/NEW01443.html.

Total Score: 5 of 10 Satisfactory

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