This story is one of two we’re reviewing that describes a clinical trial for fevipiprant, an asthma pill under development by Novartis Pharmaceuticals. The other review covers a story in Reuters.
This story offers readers no information beyond the contents of a news release from the University of Leicester (England), where the trial was performed. It reports a researcher’s sensationalistic claim that the pill may be a “game changer” without comment from an independent source. (We also reviewed the news release.)
While the Reuters story and its headline maintain a measured tone, this headline hyping a “new asthma pill” that makes a “huge difference” may leave the impression that the drug is close to being available when in fact it’s years from potential approval. In sum, asthma sufferers should not plan to chuck out their inhalers any time soon.
The possibility of taking a pill instead of using an inhaler to control symptoms would surely be welcome news to millions of asthma patients. Stories like this will be widely read, which is why it’s so important that journalists go a step beyond the news release to provide important context and information that won’t be found in the publicity efforts. This story didn’t do that.
The story does not address how much fevipiprant might cost or the cost of currently available treatments.
The story explains that the study involved 61 participants, about half of whom were given fevipiprant and half were given a placebo. It accurately reports that over the course of 12 weeks, researchers found that those taking the drug saw a decrease in their level of sputum eosinophil, a marker of white blood cells associated with asthma symptoms, from an average of 5.4 percent to 1.1 percent, which is close to that of a person without symptoms.
However, importantly, the news story stated that the drug “was shown to reduce asthma symptoms as well as inflammation.” But the researchers specifically stated that future studies would have to be done to see if the decline in eosinophil counts resulted in improved symptoms. Right now, no one knows if it will help symptoms. For this reason, we’re rating this Unsatisfactory.
No serious adverse effects were reported in trial participants who took fevipiprant, a fact the story does not mention. The story also should have mentioned mentioned that it remains to be seen whether fevipiprant is safe over decades of continuous use, which is typical for as asthma drug, as well as for patients of various ages and health conditions.
The story does not mention the need for longer-term trials to confirm fevipiprant’s safety and efficacy and to investigate its effect on patients with severe asthma. The story also should have made it clear that the study was looking at changes in lab markers, and not symptoms.
The story does not appear to engage in disease-mongering.
There’s no comment from an independent source, leaving unchallenged a researcher’s assertion that fevipiprant may be a “game changer for the future treatment of asthma.” The story could have let readers know that funding came from Novartis, as well as a European Union grant program, and the Leicester (U.K.) National Institute for Health Research Respiratory Biomedical Research unit. Several researchers involved in the trial reported receiving financial compensation from Novartis and other drug companies.
Current treatment options for asthma aren’t mentioned.
The headline makes it sound as if the pill is readily available, with no mention that further trials and approvals are necessary before the drug could be marketed.
The story says this is the first asthma pill in 20 years–that’s not correct. In recent years, several new drugs known as leukotriene receptor antagonists have come on the market as tablets. (The 20-year statement appears to come from the news release, and a Reuters story had a similar error.)
While the story uses original wording and cites a University of Leicester news release as the source of some of its information, it does not appear that the story offered anything beyond what is in the news release. (We also reviewed the news release.)
Systematic, Criteria-Driven
Monday at #ADA2021, an infectious disease epidemiologist, a journalist, and a researcher shared perspectives on communication of risk in the era of COVID-19: http://ow.ly/ROfR30rMeE7 @AstleyCM @garyschwitzer @berthahidalgo @ADA_DiabetesPro
Shoutouts to @susan_bewley @drkevinknopf @MichaelBaum11 in this call for more than fawning coverage from press releases for these kinds of stories.
Also, linked history inside goes back 5 years just on Grail apparently trying to become Holy Grail. https://twitter.com/garyschwitzer/status/1408849696416841731
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