This story is one of two we are reviewing that focuses on FDA’s approval of a drug designed to speed patient recovery from flu symptoms (the second story is from The New York Times). The drug is baloxavir marboxil, marketed under the trade name Xofluza.
This ABC News story didn’t adequately address cost, potential harms, or the fact that Xofluza worked no better than oseltamivir (sold as Tamiflu) at reducing flu symptoms in a clinical trial. It also told readers that researchers think the drug “will reduce spread of the flu,” but didn’t point out that there is no evidence to show that as a possible benefit.
Influenza is fairly common, as recent findings from the CDC make clear. That means that many people will likely have to make decisions about how to deal with the flu and flu symptoms in the coming year. Making an informed decision requires patients to have good information on costs and potential health risks associated with their treatment options — and that’s particularly true when new treatment options come onto the market. This story doesn’t adequately address those key issues.
Costs are not addressed. As the New York Times reported in its second paragraph:
The pill will cost $150, according to a spokeswoman for Genentech, which will sell Xofluza in this country. Genentech will offer coupons that lower the price to $30 for patients with health insurance and to about $90 for the uninsured.
The story explains that Xofluza is designed to reduce the duration of flu symptoms by more than one day, which is more than the New York Times did — but it’s still not a quantified benefit. What’s more, while the NYT story made clear that clinical trial results showed the benefits to be comparable between Xofluza and Tamiflu, this story doesn’t mention the finding.
Also, neither ABC News nor NYT reported that there was not a statistically significant difference for the Xofluza group when it came to study participants reporting they were feeling back to their usual state of health.
Lastly, ABC News stated that “researchers believe the medication will prevent patients from spreading the flu”–but the story didn’t explain that there is no evidence to show this benefit exists.
The story states that Xofluza is associated with “less side effects” than Tamiflu, but it doesn’t mention any potential harms. The company that markets Xofluza notes that its most common side effects include diarrhea, bronchitis, headache, nausea and common cold symptoms. Those potential side effects are worth mentioning. In addition, neither this story nor the NYT story noted that the drug should not be used by nursing mothers or women who are pregnant, given the lack of information about whether Xofluza can get into breastmilk or how it may affect prenatal health.
The study mentions only that Xofluza was compared to a placebo in clinical trials. That’s not enough to give readers a sense of the quality of the evidence.
No disease mongering here. And the story does provide some useful context about flu prevalence in the 2017-18 flu season.
The story makes it clear when citing sources associated with the drug’s parent company. It also included one physician not connected to the drug. However, it didn’t disclose that this physician, Todd Ellerin, has significant relevant financial relationships with antiviral drug manufacturers.
The story doesn’t mention that clinical trial results showed the benefits to be comparable between Xofluza and Tamiflu. That’s a fundamental oversight. Why does it matter? Well, for one thing, the cost of generic Tamiflu will be much lower than the cost of Xofluza (since there will be no generic on the market).
The story tackles this head on: “The pill will be available across the U.S. in the coming weeks, according to the FDA.”
The story addresses novelty directly, noting: “The medication is the first in a new class of antiviral medications that blocks an enzyme within the flu virus, which stops viral replication early in the influenza cycle, the FDA announced.”
This is a close one. For the most part, the story seems to draw heavily from two news releases — the one issued by the FDA, and the one issued by Genentech (which markets Xofluza). However, the story does incorporate input from an independent source. That’s enough to put it over the top here.
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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