This story’s headline makes a bold statement: “A flu drug—shown to reduce duration of symptoms—could upend treatment in U.S.” The next two paragraphs ramp up the excitement regarding the FDA’s announcement that it has granted priority review to a new single-dose flu drug that is “unlike anything else on the market.”
The remainder of the article breaks down the details in a 5w’s of journalism—who, what, where, when, why—fashion. In doing so, readers learn the basics about what Genentech has revealed about the drug, baloxavir marboxil, and how it works. We were especially pleased to see a discussion about how much it might cost, if approved.
We would have liked to have seen—and think readers would have benefitted from—a more critical review that explained that the study Genentech presented to the FDA for review has not been peer reviewed or published, which means no one other than the drug’s manufacturer has seen the actual data analysis.
We also do not think readers benefit from an article that doesn’t question who benefits from potential approval of a new flu drug that “could upend treatment” before the next flu season. Why? Because we’ve seen this excitement before. There was a lot of enthusiasm about Tamiflu when it was first introduced. But in all the hoopla about Tamiflu being able to reduce the duration of flu symptoms–by a day!–an important point was lost. Yes, the flu makes you miserable. But the real concern about the flu is that in some populations–in particular children, the elderly, and those with impaired immune systems or other health conditions– the flu can be deadly. Yet there is limited evidence that Tamiflu will prevent flu-related complications, hospitalization, or death.
Lastly, and importantly, the story left out any discussion of side effects. For an in-depth look at why this matters, see Drug kills flu in a day, news headlines claim. Here’s why that’s bad for public health.
As Genentech noted in its news release about the FDA granting priority review for its new drug, the flu is responsible for up to 650,000 deaths worldwide each year. It would be great if there was a drug that reduced deaths from the flu. Genentech has provided no evidence that baloxavir marboxil is this drug.
There is a lot of money to be made off a drug that can treat the flu effectively. The new drug, baloxavir marboxil, was not better than Tamiflu at reducing flu symptoms, according to data Genentech included in its news release about the FDA’s decision to grant priority review. And like Tamiflu, it has to be taken within 48 hours of flu symptoms developing. The difference is that baloxavir marboxil is a single dose, one-time treatment, whereas Tamiflu must be taken twice a day, for five days. The release also hints at the idea that the drug made people less infectious, but there is no evidence that those who took baloxavir marboxil infected fewer people than those who were on the placebo or on Tamiflu.
Moreover, all this ignores the bigger question: When it comes to the flu, what does “effective” mean? Getting you back to work a day sooner? Or keeping you from dying?
The story makes clear the “big unknown” remains the price and “how much people are willing to spend to cut a day or so off of a bout of flu.” The story reports that Genentech, the drug’s manufacturer, said it’s too early to comment on the drug’s U.S. price. The story also notes that in Japan, where the drug was invented, it “sells for the equivalent of about $43.50.”
The story uses terms like “a little more than a day” and “nearly a day” and “substantially” to describe the drug’s reduction in flu symptoms, fever, and coughing and sneezing, respectively.
It does not explain, as the news release does, that:
“Similar efficacy results were seen between baloxavir marboxil and [Tamiflu] in relation to duration of symptoms and fever reduction.” In other words, on the symptom front, both drugs were the same.
According to the news release, a difference was seen in the length of time the virus was shed from the body (presumably through coughing and sneezing): 24 hours for baloxavir marboxil verses 72 hours for Tamiflu. The news release also states that there was also a difference seen in the level of virus in the nose and throat, but it provides no precise numbers.
It is not known whether this benefit translates into less infection transmission, and the story should have made that clear.
The news release issued by Genentech about the FDA’s decision to grant priority review describes baloxavir marboxil’s most common side effects: diarrhea, bronchitis, nausea and sinusitis. The news release also states that overall incidence of adverse events seen in patients taking baloxavir marboxil were lower than those seen in both the placebo group and the group taking Tamiflu.
The STAT News story does not mention any potential harms.
This evidence comes from the randomized phase III Capstone-1 study the FDA will review, which included 1,436 people in the US and Japan. It excluded people older than 64. The news story does not note this exclusion, nor does it state a key problem with this study: It has never been published in a peer-reviewed journal (instead, a study abstract was released as part of ID Week 2017). This means the full data analysis has never been seen by anyone other than the researchers. We explained why this is important in February 2018, when we discussed news coverage of the drug’s approval in Japan.
The 2017-2018 flu season was the worst the US had experienced in nearly a decade. The flu impacted the entire country, and was responsible for 172 pediatric deaths. The news article did not use these or any other flu-related statistics to increase fear about the flu and, in turn, the need for this medication.
The article includes two sources: Mark Eisner, Genentech’s VP of product development for immunology, infectious diseases and ophthalmology and Richard Webby, head of the World Health Organization’s influenza collaborating center at St. Jude Children’s Research Hospital in Memphis.
Eisner’s affiliation with Genentech, the drug’s manufacturer, is clearly noted. Webby does not appear to have any conflicts of interest. The article would have been stronger if it had included a third source who commented on what–if anything–is known about whether reducing the duration of symptoms leads to reduced levels of transmission that result in fewer people contracting the flu and fewer deaths.
The story explains that the only other drug approved to treat the flu is Tamiflu, which is not widely used. The writer explains that both drugs need to be taken within 48 hours of symptom onset and that baloxavir marboxil is a single one-time dose, while Tamiflu must be taken twice daily for five days.
It is clear from the story that the FDA is expected to decide by the end of the year whether to approve this new flu medication.
The story explains that it’s been more than 20 years since a new class of flu drug has been developed and marketed. (It is available in Japan.)
The catalyst for the story was a news release issued by Genentech about the FDA granting priority review of baloxavir marboxil, but the story does not use direct quotes from the news release.