The story reports on research published in the Journal of the American Medical Association studying an experimental drug known as abaloparatide and its ability to prevent a new vertebral fracture in postmenopausal women with osteoporosis.
A standout positive for this story is its choice to report the absolute risk, rather than relative risk, of fracture due to low bone density (see Disease Mongering criterion below). Read more on why this matters.
But, there are a few problems concerning the subtleties of the study design. Specifically, the research study was not powered to detect significant differences between abaloparatide and its currently-available competitor, Forteo (teriparatide). Thus, any juxtaposition of quantitative figures comparing the efficacy of the two drugs must be presented with important caveats, which we didn’t see emphasized enough in the news story.
Instead, the story leads with a claim that abaloparatide reduces fracture risk “better” than the competing drug–something the study wasn’t designed to address and which is misleading.
We’d note that a JAMA news release about the study, which we also reviewed, largely sidesteps this issue by avoiding any statements that directly compare the two drugs. But could the release have helped reporters out here by making a clear, unambiguous statement regarding the purpose of the study and its limitations? The researchers include such a statement in the text of the research article itself (see below under the “Evidence” criterion), and in hindsight it seems that the news release would have done well to emphasize this key nuance.
Another way journalists can avoid this problem? Emphasize the findings related to the study’s primary endpoints, and always read the study’s discussion and limitations sections to find important caveats. Accompanying editorials also often have illuminating points to make, too.
Given the prevalence of osteoporosis, paired with the few treatment options, a new safe, effective medication would be welcomed. Accurate distillation of the research is essential in news coverage.
Although it is not known how much abaloparatide will cost at this stage, the article does discuss the cost of its would-be competitor, Forteo, which costs about $2,500 a month for those without insurance.
The story does a good job discussing the quantitative evidence from the study. (The few missteps, which are actually quite critical in their nature, were related to a not-entirely-adequate grasp of the study design. This we discuss in detail in a separate criterion, Quality of Evidence, below.)
The story discusses several measures by which the effectiveness of abaloparatide was compared to the placebo (and Forteo), including the number of spine fractures, the number of other types of fractures, and the number of cases of hypercalcemia. And it does so using actual numbers. For example:
“Fewer women on the injectable drug abaloparatide had spine fractures (0.58 percent) than women receiving a placebo (4.22 percent)…”
The story lists nausea and heart palpitations among the serious side effects of both abaloparatide and Forteo.
The story contains a subtle misunderstanding of the study design that leads it to misinterpret the quantitative evidence for abaloparatide and Forteo. The study’s presentation of the quantitative results suggest that the figures can be directly juxtaposed for the two drugs, when this is not actually the case. Toward the end of the research article on which the story is based, we have the following statement:
“Comparison of abaloparatide vs teriparatide [Forteo] for the primary efficacy end point [cases of spine fractures] was not part of the study objectives because the study would have required a sample size of approximately 22,000 per treatment group to provide 90% power to detect the treatment difference between abaloparatide (observed rate, 0.58%) and teriparatide (observed rate, 0.84%) based on our study results.”
This effectively means that comparing the 0.58% observed rate of spine fractures under abaloparatide and the 0.84% rate under Forteo, is, quite simply put, rather meaningless. The clinical trial study was never powered to discover a significant difference between the two, i.e. the study was not designed to be able to detect any meaningful difference. Indeed, the statements by Dr. Caroline Messer, interviewed in the story, and the research article’s accompanying editorial, partly reprinted at the end of the story, both emphasize that this research study does not in fact compare abaloparatide directly to Forteo.
Another minor point is that Forteo had to be injected via its trademarked injection pen in the study, rather than subcutaneously as was done with abaloparatide and the placebo. This obviously has implications for the blinded nature of the study. While an ideal clinical trial is double-blinded, in this case both patients and doctors knew when Forteo was being administered.
The story shares the fact that
“A study based on 2010 U.S. Census data estimated that more than 3 million women between the ages of 50 and 69 have osteoporosis. A 60-year-old woman has a 44 percent lifetime risk of fracture due to low bone density.”
An explanation of the term “lifetime risk” would be helpful to the reader. (In this setting, it means the probability of experiencing a fracture during the remaining years of life. In fact, the figure reported is really a “residual lifetime risk.”)
Now for a slight tangent: It is great that the story chose to report an absolute risk here rather than a relative risk. This is a point we at HealthNewsReview.org try to hammer home. In a 2007 article in the Journal of Bone and Mineral Research, Nguyen et. al. in their article titled “Residual lifetime risk of fractures in women and men” had the following comment on relative versus absolute risk:
Communication of risk in the osteoporosis field has traditionally relied on the concept of relative risk. However, relative risk can be misleading to patients and clinicians,(42) because the interpretation of a relative risk or its change is highly dependent on the baseline risk. For instance, doubling a minor risk is still minor, but doubling a common risk is alarming. It is therefore desirable that individuals who have BMD measurements be informed about their fracture probability risk category instead of their relative scores.(4) The lifetime risk estimates from this study provide such a means for communication of risk to an individual patient.
Dr. Caroline Messer of the Center for Pituitary and Neuroendocrine Disorders at Lenox Hill Hospital was interviewed as an independent source. She correctly pointed out that a head-to-head trial directly comparing Forteo and abaloparatide is needed in the next step of research.
The story also discloses that the research study was funded by the maker of abaloparatide, Radius Health.
However, the story doesn’t point out that the study author (whom they quote extensively) also serves on a Radius Health Advisory Board.
The story describes Forteo, the current dominant drug on the market for treating low bone mineral density. But see Quality of Evidence section above for how this could have been done better.
The story states that abaloparatide is currently in a Phase 3 trial stage.
The story does not make clear the novelty of abaloparatide, and seems to focus rather on the similarities between it and Forteo.
The story does not appear to rely on a news release.
Systematic, Criteria-Driven
With the discontinuation of @HealthNewsRevu, there's a genuine concern that well-written and researched "reality checks" in healthcare are not economically interesting. This should be disconcerting to anyone, and yet I'm only seeing more and more piling into "promising findings"
Thanks for ALL you do and have done, Gary. https://t.co/93K4hzQXZj
Thanks for sharing this with all of us today, @garyschwitzer @HealthNewsRevu
A nice gift.
#healthcare #healthcarenews #journalism #reporting #factsmatter #truthmatters https://t.co/hNHdZDl2rc
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