Both stories had overall strengths, but both missed the cost question and could have done more to explain both harms and benefits. In all, though, they took a dispassionate look at studies that easily could have been hyped.
Whenever you have a drugmaker moving into the naming phase on a product line, you know the marketing machine is getting revved up. That’s what is happening with Esmya. This story attempts to explain both the science behind the drug and the marketing push. With a little harder look at the science and a little better explanation of the studies’ ties to the drugmakers, the story could have been stronger.
No mention of costs. If the drug is awaiting marketing approval in Europe, some estimate could have been obtained. And, since the drug has the active chemical of the Ella contraceptive drug – only in smaller doses – at least the cost of Ella could have been cited.
Adequate discussion of benefits as seen in the two published studies.
This story at least mentioned potential harms and that “it remains to be seen if the drug is safe for long-term, intermittent use.”
But we think it is inadequate to simply state that those on the drug had “significantly fewer side effects.” What does “significantly fewer” mean? And what were they?
Both stories we reviewed could have talked a bit more about the experimental nature of this drug and the problems seen in the past with hormone-regulating drugs.
The competing Associated Press story did a better job explaining the specifics behind the study and actually providing the number of patients studied. This story did a decent job, though, summarizing the evidence and bringing in the researcher who wrote an accompanying editorial to say that “it remains to be seen if the drug is safe for long-term, intermittent use.”
No disease mongering. This story provided a few more facts than the AP story and made it clear why these findings may be hugely important for women with fibroids. It said, “Uterine fibroids are the most common indication for the close to 600,000 hysterectomies performed each year in the U.S. About 1 in 4 women in their childbearing years have symptoms related to fibroids, such as heavy periods and related iron deficiency, abdominal pain, and fertility problems, according to figures from the National Institutes of Health.”
We were happy to see this story explain which drugmakers were interested in Esmya as a product line, but the story failed to make the same connection made in the AP story. The AP pointed out that the study was funded by these drug companies and that the researchers had worked as advisers for the companies. This is a big omission. The independent commentary from the researcher who wrote the accompanying editorial was welcome.
The story ended with an important message about patient decision-making and with an expert quote that there are good alternatives to hysterectomy but many patients never hear about them. But then the story missed the golden opportunity of outlining what those alternatives are.
The story makes it clear that the drug is a variation of a drug already on the market but that it is not yet approved for use.
Neither story was very clear on this point, but the WebMD story did not make a claim of novelty the way the AP story did. Contrast the two leads:
WebMD: “A new drug appears to be effective for shrinking uterine fibroids and controlling the heavy menstrual bleeding they often cause, according to new research from Europe.”
AP: “New research offers hope for the first pill to treat a common problem in young women: fibroids in the uterus. The growths can cause pain, heavy bleeding and fertility problems, and they are the leading cause of hysterectomies.”
We’ll give a lukewarm “satisfactory” grade.
Neither story relied on a press release.
Systematic, Criteria-Driven
The tale of two “negative” studies. Or, how spin is applied to make research findings look more impressive. A must read. https://johnmandrola.substack.com/p/the-tale-of-two-negative-studies
The @nytimes chose to interview one of the editors of the @AnnalsofIM (publisher of this paper) who "gushed with extraordinary glee: It’s huge! There are very few things that reduce your mortality by 30%."
Turns out coffee is not one of those few things despite all that glee. https://twitter.com/garyschwitzer/status/1533202075928215558
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