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Contrary to PR release claim, it’s too early to call asthma pill a “game changer”

Asthma pill could reduce symptoms in severe sufferers

Our Review Summary

This release explains the results of a small clinical trial testing whether the use of a new drug, fevipiprant, would be effective in reducing the serious symptoms of asthma.

It does a good job of reporting data on the primary goal of the research and then slips when suggesting the research had other positive outcomes but fails to provide any data backing that up. The release is further weakened by its inclusion of what is basically a testimonial for the new drug by one of the participants in the study.  And it fails to mention either costs or possible harms from using the drug, and ignores some rather substantial conflicts of interest among the investigators.

 

Why This Matters

The National Heart, Lung and Blood Institute says more than 22 million Americans have asthma, including about 6 million children. There are many more millions with the condition worldwide. A daily pill that might alleviate serious symptoms of the disease, or even prevent asthma attacks, would be a boon to public health, especially considering some of the shortcomings of other current treatments.

New medications to treat the underlying problem, namely airway inflammation, are needed and would translate into improved health for this very common and sometimes serious medical problem.

This release may have helped spawn two news stories that we also reviewed that had glaringly different story framing. One was by Reuters and the other by Medical Daily. The latter of the two didn’t offer “anything beyond what is in the news release,” according to reviewers.

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

The release does not mention the cost of the potential new drug, nor is there any estimate of what the cost might be in comparison to other asthma treatments currently in use including inhalers and corticosteroids. The release would have been more helpful to people with asthma if it had included some cost estimates since new medications tend to be very expensive.

If it’s not too early to promote a treatment to a patient audience, it’s not too early to provide a ballpark cost.

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

Not Satisfactory

If this release would have only discussed the primary outcome goal of the study — “to examine the effects on inflammation in the airway by measuring the sputum eosinophil count” — then we’d probably give it a satisfactory rating on this category since it provided clear numerical data showing a significant reduction in percentages among patients taking the drug versus those on placebo. But the release didn’t stop there. It had the principle investigator add glowingly, “A unique feature of this study was how it included measurements of symptoms, lung function using breathing tests, sampling of the airway wall and CT scans of the chest to give a complete picture of how the new drug works.”

If these additional measurements were so significant in the study, then why was that data excluded from the release?  We need quantification of the actual results of the clinical tests to be able to judge benefits.

Does the news release adequately explain/quantify the harms of the intervention?

Not Satisfactory

It’s particularly important to note side effects associated with new medications but the release makes no mention of any harms arising from the drug’s use in the study. However, the full research paper (which unfortunately is behind a paywall) includes a table of adverse events experienced by both the experimental group and patients receiving a placebo that include problems such as infections, respiratory disorders, gastrointestinal and nervous system disorders. While these may ultimately have been minor problems, they deserve mentioning.

Does the news release seem to grasp the quality of the evidence?

Satisfactory

This release does a good job of explaining the nature of the research and the resulting data (as far as the sputum eosinophil count data goes). As mentioned above, it falls short in providing other indicators which would have strengthened it considerably. But readers are given a clear idea of the degree of improvement the drug provides to patients in terms of the reduction of eosinophil in sputum, compared to those receiving only a placebo.

Does the news release commit disease-mongering?

Satisfactory

The release verges on disease mongering given some of the exuberant language, particularly from the patient testimonial, but it stops short by noting how many asthma suffers there are in the UK. Asthma is a common and often-serious health problem so giving some context was beneficial.

Does the news release identify funding sources & disclose conflicts of interest?

Not Satisfactory

The release gets credit for including the funding sources of the study — Novartis Pharmaceuticals, the National Institute for Health Research in the UK, and the European Union — but it fails to point out any of the linkages among the study’s authors to pharmaceutical firms. According to the published study disclosures, these relationships include speaking fees, consultancies, grants and full-time employment with Novartis and other companies. This transparency is needed for readers to ascertain bias.

Does the news release compare the new approach with existing alternatives?

Not Satisfactory

The release makes no mention of alternative treatments for asthma. There is no comparison with current approaches such as inhalers and corticosteroids or any other approaches regarding this illness.

There are a variety of established treatments that are used according to standard protocols depending on asthma severity.

Does the news release establish the availability of the treatment/test/product/procedure?

Satisfactory

The release is fairly clear in pointing out that this was a clinical trial and that the drug, fevipiprant, isn’t available to the public as of yet.

Does the news release establish the true novelty of the approach?

Not Satisfactory

The release claims novelty with the statement, “The first new asthma pill for nearly 20 years has the power to significantly reduce the severity of the condition.” That’s not correct. In recent years, several new drugs known as leukotriene receptor antagonists have come on the market in the U.S. as tablets.

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Not Satisfactory

The release gets credit for having a conservative headline — “Asthma pill could reduce symptoms in severe sufferers” — but then loses it when it allows the main researcher to proclaim, “This new drug could be a game changer for future treatment of asthma.”  Then it follows that up with what basically is a testimonial from one of the participants in the study who says, “I felt like a completely different person” after taking the drug, adding, “For me, it felt like a complete wonder drug and I can’t wait for it to be available because I really think it could make a huge difference to me.”  She closes by saying that after stopping taking the drug, her health started to “go downhill again very quickly.”  Her comments may be factual and might fit well in marketing advertising but they have no place in a news release explaining new health research.

Interestingly, the University had also issued a second release related to the same research but not linked in the original release, that offered commentary from two unaffiliated experts. One offered that “The data strongly support further studies,” while the other said, “More research is needed and we’re a long way off seeing a pill for asthma being made available over the pharmacy counter.”  Both comments would have improved the value of the initial release, had they been included.

Total Score: 3 of 10 Satisfactory

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