This is story about a small, early test of a new type of drug to treat postpartum depression.
The story is careful to note the preliminary nature of the findings and that the only source is company statements, since the study report has not been submitted for peer-review.
However, it is hard to see the health news in a tiny phase 2 study, especially when no independent sources are included in the story to help provide balance to the claims. As readers, we’re also left wondering about potential harms specific to pregnant and new mothers, such as the drug’s ability to affect a baby in utero or pass through breastmilk.
(Editor’s note: STAT has updated the story since this review was posted, and the “Read Original Story” link above will take you to the updated version, not the original version that we saw. Some of these changes address several of the Not Satisfactory ratings below. However, our ratings still stand: While updates are great, they aren’t likely to be seen by people who read the original story.)
This story reports some positive early hints about an experimental drug tested in a few women with the symptoms of major depression. But with phrases like “paradigm shift,” readers could easily get the impression that the results are far more reliable, and relevant to many more women, than is justified based on the company announcement.
And STAT was far from the only news outlet writing about the study in such a way. It got a lot of play in the financial press and in investor circles, helping boost the company’s stock price, with the price closing up 37%. But whether the source is STAT or a more financial-minded publication, all stories posted online have the potential to reach and influence readers who are searching for health news. That’s why all such stories with health claims should scrutinize medical evidence.
The drug is still in early experiments, but it would have been nice to give readers some indication of how the eventual price of this drug might compare to available antidepressants.
We will give the story a satisfactory rating because it specifies that 7 of 10 patients given SAGE-547 reported significant improvement in their depression within 60 hours, which persisted for up to 30 days.
However, the story did not tell readers that the depression questionnaire used in this study, Hamilton Depression Rating Scale (HAM-D), has been criticized as placing greater emphasis on sleep than on suicidal thoughts, so that the scores of some patients may improve even if their thoughts of suicide increase.
Readers should have been told that the form of the drug used in this trial is given as an IV solution and that it will not be known if a pill can produce similar results until separate trials are completed.
Although the story does report that the company said the only problems reported by patients were dizziness or a sedative effect (in both the treatment and placebo groups), it should have specifically cautioned readers that there could be other potential harms that cannot be identified by a one-month test in which only 10 patients received the active drug–notably, if this drug can pass into breastmilk or affect babies in utero. Also, as noted above, the story fails to tell readers that the form of the drug used in this trial is given as an inpatient IV treatment, which carries risks.
The story tells readers the study is small, has not been peer reviewed, and that the results were reported in a press release.
However, it should have specifically noted that this sort of small, phase 2 trial is not designed to prove whether or not an experimental drug really is effective.
The story did not disease monger. However, because milder symptoms of the “baby blues” are common in pregnant women and new mothers, the story should have been clearer about distinguishing the features of a “Major Depressive Episode” like those experienced by the women in this trial from the more common blues that readers are likely to be familiar with.
Although the story notes that the results were released in a news release and a company conference call, and were not peer reviewed (thus making it clear that the source is only the company and that the results have not been independently reviewed), the story should have included comments from independent experts.
This is a barely passing satisfactory as the story does briefly acknowledge alternatives. The only reference to conventional antidepressant treatment is that it doesn’t work as quickly as this experimental drug appears to. Talk therapy is mentioned, but there is no mention of its effectiveness. While it is true that antidepressants can take weeks, they and mood stabilizing drugs for women with bipolar disorder do treat postpartum depression. In women with a history of this highly recurrent condition, antidepressant treatment may be started or maintained during pregnancy.
The story makes clear that this drug is still being tested and that the company has not applied for FDA approval.
The story does not mention other GABA-receptor drugs in development. Indeed, it includes a quote from the company CEO calling the study data a “paradigm shift in how the disease is thought about,” thus giving the incorrect impression that this drug is the only one like it being studied.
The story clearly states that the study results were put out in a company news release. The story includes a quote from a company conference call, in addition to the numbers from the news release. However, the reliance on company sources undermines the value of the story.
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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