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FDA approves Amgen osteoporosis drug


3 Star

FDA approves Amgen osteoporosis drug

Our Review Summary

This story had a number of glaring omissions. Read the full review for details. And, although headlined as a story about osteoporosis, the story veered off to discuss studies evaluating this drug in patients with advanced cancer – again,  with no data to support this tangent. 


Why This Matters

While this story is clearly a business-targeted story, the way we found it online is the way many would find it – and it wasn’t locked away in a special "this is for business interests-only" section. Important information regarding potential harms and degree of efficacy should be included. Furthermore, shareholders deserve the same level of detail that patients need. 


Does the story adequately discuss the costs of the intervention?


According to the story, each injection is estimated to cost $825 and people will require two injections per year. There is no mention of whether insurance companies will cover the cost, particularly since cheaper drugs for osteoporosis are available. 

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

Not Satisfactory
The story did not provide any data from the trial.

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

Not Satisfactory
This story did not discuss adverse effects associated with denosumab. For example, this drug is associated with significantly more cases of infection requiring hospitalization and an increased risk of eczema. Readers should also be aware that long-term effects are unknown. 

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

Not Satisfactory
Despite the headline built around approval of the drug for osteoporosis, there was only a cursory mention of the trial evaluating denosumab for preventing fractures in women with osteoporosis. Oddly, more space was devoted to other studies evaluating this drug in patients with bone metastases.
It would have been helpful to the reader if the story mentioned that the osteoporosis study was a randomized, double-blind, placebo-controlled trial. It also would have been useful to know more about the patients included in the trial (7868 women ages 60-90 years) and how long they took denosumab (36 months).

Does the story commit disease-mongering?

The story did not engage in disease mongering. Statistics from the National Institute of Arthritis and Musculoskeletal and Skin Diseases on osteoporosis-related bone fractures in postmenopausal women were provided.  

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

Not Satisfactory
The quote from the one independent source in the story was lifted directly from a press release and the story also failed to mention that the study was supported by the drug manufacturer, Amgen.

Does the story compare the new approach with existing alternatives?

Not Satisfactory
The story briefly mentioned biphosphonates, suggesting that they are “pretty good” and that a large percentage of women discontinue their use within the first year. We don’t think that’s much of a comparison of the new drug with existing approaches.

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

The story makes it clear that denosumab has only recently been approved by the FDA and will be available in the next two weeks.

Does the story establish the true novelty of the approach?

The story makes it clear that this is a novel drug for osteoporosis.

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

This story does not appear to be based solely on the press release.

Total Score: 5 of 10 Satisfactory


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