Instead, the headline leaps with optimism about lifting mood quickly. The story quoted no outside sources, gave no cost information, no uncritical evaluation of the evidence, offered limited comparison with alternative therapies, and limited discussion of the potentially harmful effects of putting a sizeable percentage of the population struggling with depression onto a highly addictive narcotic.
On this topic, we need more stories taking a broader view of evaluating current and future treatment options for depression. And doing a better job of evaluating the sometimes limited evidence for new claims.
Three other points of interest:
No mention of costs. Our medical editor on this story advises that ketamine is not particularly expensive. However, it is administered by infusion so there will be costs associated with adminstration.
The story tosses in a few numbers, but it uses them in such a way that they make the benefits seem more impressive than they really are. An honest approach would have been to start with the 18 patients and then give the absolute number of all patients who benefited, did not, or suffered side effects. Instead, the story says, for example, that " Six percent responded to placebo." That’s roughly one person. One person versus the 12 who responded to the drug. Whether this ratio would shrink or expand in a larger, controlled study is never discussed with any other scientists.
The story does not quantify the potential harms. In fact, it minimizes the potential harms by saying there were no "serious adverse events," while listing side effects that included anxiety, feeling woozy or loopy, headache, and dissociative symptoms, meaning a temporary sense of disconnection from reality." People on ketamine may have a different perception of what is serious.
The evidence is not so much evaluated as danced around. The story gets credit for saying in the lead that this is a "small study." But the headline sets the tone of the story: "Ketamine lifts mood quickly in bipolar disorder." This is the same thing that happened, by the way, the last time a ketamine study was published, four years ago to the month. Then, too, 18 people were studied. And, apparently, seven people were studied in the trial before that. Check out this Boston Globe story from 2006, and you’ll feel like you just read the same story, although at least the Globe pulled together some outside sources.
Besides not reminding a general news audience of the limitations of drawing conclusions from a study of 18 people, one of the big limitations not emphasized was the very short followup time of the study.
The press release did more disease mongering than the story. But the story does paint a scary picture, even raising the specter of suicide. "Right now, medications available for treating either major depression or bipolar illness can take weeks, or even months, to work, notes Dr. Carlos A. Zarate Jr. of the National Institutes of Health in Bethesda, Maryland, one of the researchers on the study. And as a person waits for their medications to kick in, he added, they will continue to have difficulty working and coping with social and family life; they may even be having thoughts of suicide." This is a borderline case.
Without additional context or some actual numbers explaining how many people have severe depression that is unresponsive to existing drugs or other therapies, the effect is disease mongering.
This story needed independent voices to comment on the size of the study, the study design, the potential harmful effects, etc.
The story clearly conveys that these patients had tried many treatments. What is unclear is at least 2 things: 1) although these patients had tried many treatments over their lifetime history of bipolar disease, to enter this study they need to fail 1 adequate course of an antidepressant and 1 trial of a mood stabilizer – so while they appear to have recently failed on average 7 drugs, this is not true and the story is misleading in this respect.
Nonetheless because of the mention that was made of alternative approaches, we’ll give the story the benefit of the doubt.
The story makes it clear that ketamine is not currently widely prescribed for depression but that it is available for other purposes, thereby lending itself to off label use.
No inordinate claims of novelty were made. The story mentioned some previous research on the drug. It did not discuss the fact that, if the Boston Globe story mentioned above is to be believed, a total of 43 patients have been studied over 10 years in federally funded ketamine research. Nonetheless, we’ll give the story the benefit of the doubt.
The quotes from Zarate are fresh – clearly not from a news release.
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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