The story does a solid job of explaining that the current research, a Phase I study, can establish only that the procedure is safe, not that it is effective. The reader learns about the differences among the three phases of studies the FDA requires. The reader learns about how stem cells might benefit damaged heart muscle.
Having said that, this story raises an existential question: Should the story have been done?
If the results can prove only safety but not efficacy, why should a reader care? A story that demonstrates safety of a technique of no known benefit would never see mainstream publication.
But the Phase I study results does show some promising benefits, and related research provides reason to believe the technique may indeed be useful. So should CNN report the story because of those apparent benefits, despite their not being established by data?
That’s a lot of worry about one story. CNN decided to run with it. The report adds responsible context. The reader ultimately gets a mostly fair-minded report on promising early research into a new kind of stem cell research for heart disease. No reader would expect that the treatment is available or imminent.
At the end of the day, that’s not a bad outcome.
Despite advances in diagnostics and therapies, heart attack and its consequences represent a significant problem. This report highlights the results of an early phase 1 trial comparing a placebo infusion to an infusion of processed adult stem cells in patients with recent first heart attacks. The approach holds the potential to repair damage caused by a heart attack making subsequent heart failure less likely.
The story reports that harvesting enough stem cells for infusion is difficult and costly, though it fails to cite specific costs.
For research in Phase I, any comment on cost might be purely speculative.
Since the study is designed to prove safety, there are no credible benefits data to report.
The report does allow sources to make general claims of benefit based on that preliminary data, but the reporter shows restraint by not plucking benefits data points from the study.
On a close call, the story earns a satisfactory rating.
While the story briefly mentions the potential for rejection, it fails otherwise to specify the potential side effects of the stem cell harvesting or infusion. This is surprising, given the fact that the Phase I trial is designed to prove safety.
The story makes plain that the evidence from the published study can only prove safety, not efficacy. It does a good job educating readers about the three phases of FDA trials and what each is designed to establish.
The story does nothing to exaggerate the prevalence or severity of the damage to the heart muscle by heart attacks.
The story uses two sources: One stem cell expert who is not involved with the research, and the lead author of the published paper.
While that’s thin sourcing for a story of this length, it’s sufficient to earn a satisfactory rating.
The story compares this process, which involves infusing the patient with a donor’s bone marrow stem cells, with both use of the patient’s own stem cells and with surgical introduction of the cells.
The story does not specify conventional treatments for heart failure, which would have provided useful context. Still, the story earns a satsifactory rating.
Most of the story makes it clear that the technique is in early trials and not in clinical use. Only the opening line is troubling – "If you’ve just had your first heart attack, doctors may one day be able to reverse the damage done with stem cell therapy." Due to clumsy wording, this suggests that if you had your first heart attack in late 2009, doctors may someday be able to reverse today’s damage from it – which is not at all the case.
But this misstep is remedied by a later statement that it would take a best-case scenario to have such an approach approved even in five years.
The story does not make false claims for the procedure’s novelty. See he criterion – "Compare the new approach with existing alternatives" – below.
There’s no evidence that the story relied on 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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