Health News Review

Excellent report that tempered the promising results by projecting potential annual cost estimates of the drug at $10,000, discussing harms, and pointing out the drugmaker’s role in the study.

Our Review Summary

This was an excellent report on two recent randomized trials which found that a new osteoporosis drug, denosumab, reduced the rate of fractures and increased bone density in at-risk men and women.  While the results appear promising, the story tempered excitement by providing potential annual cost estimates of the drug at $10,000 and pointing out that Amgen, the manufacturer of denosumab, funded both of the studies, handled data collection and analysis and took part in writing the journal articles.  Additionally, many of the researchers involved were in receiving fees from Amgen.  The story also discusses the drug’s potential harms and compares it to existing osteoporosis treatments.  Providing outcome data in terms of absolute risk in addition to relative risk would have further strengthened this story.   


Criteria

Satisfactory

Does the story adequately discuss the costs of the intervention?

Satisfactory

Pricing for this drug is not yet available; however, the story suggests that it could be expensive, with similarly engineered drugs costing more than $10,000 a year.  In addition, the costs of currently prescribed osteoporosis medications are provided.     

Not Satisfactory

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

Not Satisfactory

The relative risk reduction for each of the trials is provided, but the story fails to provide the absolute risk reduction (62% of what?).  The writer also mentions that spine bone density loss in the men receiving denosumab was “far smaller” compared to the placebo group; however, the reader is not given any quantitative data to determine the clinical significance of this.

In addition to comparing the absolute risk reduction observed in the denosumab group to the placebo group, it would have been helpful to the reader to know what the risk reduction was for approved and potentially more affordable medications. 

Satisfactory

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

Satisfactory

Citing the FDA’s review of denosumab, as well as the adverse risks reported in the trials, the story mentions that this drug is associated with an increased risk of skin infections and some tumors.  The story also points out that its long-term effects on cancer risk and the immune system are unknown.

Satisfactory

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

Satisfactory

This story adequately describes the methodology of each trial, as well as the patient population.  The story also does a service by alerting the reader that the drug manufacturer, Amgen, funded both of the studies and nearly all of the researchers were receiving fees from said manufacturer. Additionally, it was pointed out that Amgen designed the trials, handled data collection and analysis, and assisted in writing the journal articles.

Satisfactory

Does the story commit disease-mongering?

Satisfactory

This story did not exaggerate the prevalence or seriousness of osteoporosis.  

Satisfactory

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

Satisfactory

Several independent sources were interviewed for this story.  The writer also points out that both trials were paid for by Amgen, the manufacturer of denosumab, and nearly all the researchers were employed by the company or received consulting or advisory fees from them. 

Satisfactory

Does the story compare the new approach with existing alternatives?

Satisfactory

This story discusses several alternative drug options for treating osteoporosis, including vitamins, pills, patches, nasal sprays, and intravenously and subcutaneously injected drugs.  Comparisons in efficacy between denosumab and some of these alternatives are provided.  More information comparing the absolute risk reduction for spine fractures would have been a nice addition, as well.  

Satisfactory

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

Satisfactory

The story makes it clear that the study drug, denosumab, is not yet approved by the FDA, but indicates that it could be available this fall.

Satisfactory

Does the story establish the true novelty of the approach?

Satisfactory

Up front the story states that this is a “first-of-its-kind” drug treatment for osteoporosis.   

Not Applicable

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

Not Applicable

This piece included several independent sources and therefore, does not rely on the news release. 

Total Score: 8 of 9 Satisfactory


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