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.
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.
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.
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.
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.
This story did not exaggerate the prevalence or seriousness of osteoporosis.
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.
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.
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.
Up front the story states that this is a “first-of-its-kind” drug treatment for osteoporosis.
This piece included several independent sources and therefore, does not rely on the news release.
Systematic, Criteria-Driven
The tale of two “negative” studies. Or, how spin is applied to make research findings look more impressive. A must read. https://johnmandrola.substack.com/p/the-tale-of-two-negative-studies
The @nytimes chose to interview one of the editors of the @AnnalsofIM (publisher of this paper) who "gushed with extraordinary glee: It’s huge! There are very few things that reduce your mortality by 30%."
Turns out coffee is not one of those few things despite all that glee. https://twitter.com/garyschwitzer/status/1533202075928215558
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