AP and HealthDay told this tale differently, with different context and subplots. Our review of this AP article points out the good stuff and areas for improvement, most importantly the misleading way that benefits are presented.
There’s a need for additional effective, well-tolerated treatment options for uncontrolled asthma, and this study provides early evidence—to be confirmed in future research—of a drug that’s sometimes given to such patients but is not currently approved by the FDA for that use.
The major bone we have to pick with this article is the way it presents benefits data. As the method (and/or source) is not disclosed, we think it’s inappropriate.
But we also note the interesting and important angle AP pursued in detailing the subplot that Glaxo didn’t donate Severent or placebos for use in the study.
Costs of the treatment arms were not discussed.
Our main reason for scoring this criterion as unsatisfactory has to do with the way the data are presented. The study says that people taking Severent gained 51 asthma-free days a year makes it sound like they took the drug for a year in this study. We’re unable to locate data on asthma-free days per year in the publications, and it seems to us that perhaps the writer — or another source — extrapolated the study’s 14-week data out to 1 year. Whatever the source, we feel that the article should’ve been clearer that these were not real days observed in the study; the extrapolation should’ve been disclosed. The results could’ve been very different if the subjects took each drug for 52 weeks instead of 14, and there’s a difference in the quality of evidence from a 14-week treatment period versus year-long treatment. It’s the difference between this trial and a long-term one.
Benefits and harm are related in terms of relief from asthma symptoms, and the article tells us that more study on safety is needed while giving points of view on Spiriva’s safety concerns. But we think safety information from this study, including the rates of serious events, could’ve been mentioned if not quantified.
In addition, the HealthDay article we reviewed pointed out serious safety concerns of Severent.
The 210 subjects, treatment arms, background steroid therapy, and length of therapy are important bits of content. It would’ve been useful to explain that this was high-quality evidence because of its randomized, blinded, placebo-controlled design, and explain why these points matter. Further studies are needed because this study didn’t enroll enough patients nor follow them for a long enough time to answer several important questions about the comparison. In addition, while the article is wholly correct to say that 210 people “took each drug for 14 weeks” with washout periods in between, we’re unsure it’s clear who received what for how long. And how long was the study overall? As a crossover study, these can be challenging points to convey briefly, but we think they’re meaningful. Asking an independent expert or two to evaluate the quality of the evidence would have undoubtedly unearthed these concerns.
We have other concerns about the way the data were presented. See our comments in the "Benefits" criterion below.
It’s up-front and consistent that we’re talking about adults with hard-to-control asthma, a subset of the larger group with asthma described. So no disease-mongering here.
We applaud the writer for citing an Editorial and Commentary from the same issue of the NEJM. It also quotes a Glaxo spokeswoman regarding the donation debate. The perspective on the research from the Commentary was useful. Citing an external independent voice would’ve provided more context on the study as well.
It provides a great deal of detail on the sources of funding and reported conflicts of interest.
The study was designed to compare the new (unapproved) option to two existing treatment options.
It’s clear that both Spiriva and Severent are available, although Spiriva is not indicated for this use. We also appreciate the point, from the NEJM commentary, that some docs already use Spiriva for this purpose.
The article explains that Spiriva is not approved for asthma, although some doctors use it in this population who don’t respond to steroids.
The article could have also explained the similarities and differences between Spiriva and Severent.
We haven’t found evidence that the article relies on a news release.