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Novartis Drug Curbs Repeat Hip Fractures

Rating

4 Star

Novartis Drug Curbs Repeat Hip Fractures

Our Review Summary

This was an interesting story about treatment for an undertreated population of individuals.  It defined the population (mostly women with an average age of 74 who had had a hip fracture – but it could have mentioned that 90% were white) and defined that the endpoint was a reduction in the number who died during the study period and that those in the treated group had a lower risk of dying as well as a smaller overall risk of subsequent bone fracture.

In only 482 words, the story addressed most of our criteria, failing only to discuss costs and to quantify harms.  

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

There was no information about the cost to the consumer for this product. 

The story did, however, provide an estimate about projected annual sales.

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

Satisfactory

The story reported on the composite endpoint of any fracture where those treated were seen to have a statistically significant fewer number that those in the placebo group.  The story did not, however, point out that while the number of hip fractures in the treated group was less than in the placebo group, this difference was not statistically significant.

The story did a good job of providing real numbers for the difference in the number of deaths observed in the two groups. 

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

Not Satisfactory

The story failed to point out that in terms of serious side effects (renal, cardiovascular, or cerebrovascular events), or of people discontinuing treatment because of side effects – there was no difference between those being treated or those who received the placebo.  The story neglected to discuss the side effects commonly seen in the study participants given the treatment; there was a higher incidence of fever and musculoskeletal pain in those infused with the drug. 

 

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

Satisfactory

The evidence provided in the story derives from the research study and accompanying editorial published in the New England Journal of Medicine.  The story provided this reference for readers who might be interested in tracking down more information about the study reported on.

Does the story commit disease-mongering?

Satisfactory

The story provided a clear explanation about the nature of the people in the study it reported on – elderly patients who had already fractured their hip.  Although not including an age range for defining the term ‘elderly’ it did mention the average age of the study participants.

The story did not engage in overt disease mongering.

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

Satisfactory

Although the story contained information and quotes from the editorial accompanying the published research study, it did not appear to tap into the knowledge base of others in the field to assess the importance of the study results.

The story did note that those working on the study had ties to the manufactorer of the drug reported on.

Does the story compare the new approach with existing alternatives?

Satisfactory

The story mentioned that the study demonstrated that there could be benefit from the treatment of elderly hip-fracture patients with this drug or another bisphosphonate.

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

Satisfactory

The story stated that the company that produces the drug is planning on seeking FDA approval for a new indication.  It also reported that the drug is currently available and used for the treatment of Paget’s disease and for treating osteoporosis in wpmen after menopause.

It is noteworthy that this story accurately reported on both of these aspects about availability.

Does the story establish the true novelty of the approach?

Satisfactory

The story was clear that this was a new use (treatment of osteoporosis in elderly individuals who have already sustained a hip fracture) for a treatment that has FDA approval for a slightly different application.

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

Satisfactory

Does not appear to rely on a press release.

Total Score: 8 of 10 Satisfactory

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