This story reported the claim of a company called Sequirus that its cell-based flu vaccine, Flucelvax, does a better job of preventing flu than traditional egg-based vaccines. The company called cell-based technologies “a real advance.”
The story provided comparative cost data and established the availability of this product. But it didn’t acknowledge the numerous limitations of reporting on an apparently unpublished and non-peer-reviewed company study that used observational data based on one flu season. Nor did it provide absolute risk reduction data to show the size of the purported benefit.
Further, there were no independent sources who might scrutinize the claim that cell-based shots are a “real advance” that “will help tremendously in the confidence for consumers to go out and get vaccinated.”
It’s the height of flu shot season, and several vaccines are elbowing for market share. We’ve noticed news stories that don’t report absolute risk reduction numbers to explain purported benefits.
For example, The New York Times recently reported that the high-dose Fluzone vaccine was “about 24 percent more effective than standard-dose vaccine in preventing influenza among older recipients.” But it didn’t say what the risk actually was.
In fact a manufacturer’s randomized clinical trial found 1.9% of those who got the high-dose vaccine had laboratory-confirmed flu versus 1.4% who got a standard vaccine. Of course, the actual number of flu cases could be higher, but providing those rates gives consumers a better picture of the actual benefit.
At least the Times reported on a published trial. In this case, readers were fed the results of an unpublished study — which isn’t responsible reporting.
The story did a good job, saying that the “prospect of better protection comes at a higher cost.”
It said “Flucelvax has a list price of $20.47 for a standard 0.5 ml dose — slightly more than egg-based options like Fluzone, Fluarix and FluLaval, whose prices range from $15 to $17, according to Bloomberg data.”
It mentions another egg-free vaccine called Flublok, but doesn’t give its price.
The story said Flucelvax was “36.2 percent more effective in preventing flu-like illness last winter than conventional shots made using chicken eggs.”
But there are no absolute risk reduction numbers provided to tell readers what the risk of developing flu despite being vaccinated was, and how much of a difference a 36% relative risk reduction makes.
The story also didn’t explain how “flu-like illness” was detected and measured.
No harms of flu vaccines were mentioned. While the CDC says they have a good safety record, there are side effects such as soreness, headache, fever, and muscle aches.
Notably lacking was any caution about the iffy nature of this data, which the story said came from a company-sponsored study of medical records from last year’s flu season. We couldn’t find the study online, and it doesn’t appear to have been published in a peer-reviewed journal.
The story was void of basic details, such as which specific flu vaccines were used.
It didn’t explain that observational data can’t prove that one vaccine prevented more flu than another. It’s possible people who got the cell-based vaccine were different from those who received an egg-based vaccine in key ways — such as age, income or occupation — that influenced their likelihood of catching the flu and seeking treatment.
On the plus side, the story said “the shot’s effectiveness varies from year to year, depending on the closeness of the match between that season’s circulating viruses and the vaccine, which is usually reformulated annually.”
It’s worth noting that the CDC has reviewed all these data and expresses no preference for any particular flu vaccine.
No disease-mongering. The story states that vaccination “is recognized as the best way to protect against the respiratory disease, which kills as many as 650,000 people annually.”
It also said that the “2017-2018 Northern American flu season, in which the H3N2 strain dominated, was especially bad, leading to some 900,000 hospitalizations, including 185 pediatric deaths, in the U.S. alone.”
No independent sources were used — a major drawback.
Mentioned were “egg-based options like Fluzone, Fluarix and FluLaval” as well as an “alternative egg-free approach from Paris-based Sanofi, called Flublok.”
The story reported Seqirus made 21 million doses during the 2017-2018 season and has received FDA approvals that will allow it “ramp up supply and respond faster in the event of a flu pandemic or vaccine shortages.”
Remember, though, that true availability actually depends on which flu vaccine products that clinics actually stock.
The story accurately reported that using cell cultures to develop vaccines for flu is a recent alternative to egg-based vaccines. However, there doesn’t appear to be reliable data on whether cell-based vaccines are more effective at preventing disease.
The story didn’t appear to rely on a news release.
Systematic, Criteria-Driven
With the discontinuation of @HealthNewsRevu, there's a genuine concern that well-written and researched "reality checks" in healthcare are not economically interesting. This should be disconcerting to anyone, and yet I'm only seeing more and more piling into "promising findings"
Thanks for ALL you do and have done, Gary. https://t.co/93K4hzQXZj
Thanks for sharing this with all of us today, @garyschwitzer @HealthNewsRevu
A nice gift.
#healthcare #healthcarenews #journalism #reporting #factsmatter #truthmatters https://t.co/hNHdZDl2rc
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