It’s understandable that the researchers who appear to have found a way to reverse scarring in heart tissue would be excited about their own work, especially given that the lead researcher stands to profit from future treatments based on the research. It’s less understandable for a news story to get caught up in the same excitement. The second sentence sets the overly effusive tone: “The finding, just in time for Valentine’s Day, is the clearest evidence yet that literally broken hearts can heal.” There is no skepticism, no hint at what a treatment like this might cost, and no independent analysis to help readers understand whether phrases such as “this could change the nature of medicine” are warranted.
Most important, the story ignores the fact that the stem cell treatment failed to improve the overall functioning of the heart of the treated patients.
Stem cell medicine and genetic medicine are regularly championed in the press as panaceas that are going to alter the course of human health. So far, they have had a very limited impact, and stories should always bring in multiple independent experts to place a study like this in context. Heart disease is one of the leading killers of men and women in the United States, and there are studies published every week that explore new approaches to the problem. Just because one study included stem cells does not make it more important or more viable.
The use of autologous stem cells to repair damaged heart muscle has been studied previously with mixed results. This phase 1 study (designed to determine the safety of the stem cell infusions) was conducted in a small group of patients who had previously suffered a heart attack and now had evidence of heart failure. Although the survival of heart attack has improved, the residual effects (heart failure) remains an elusive target. This study demonstrated small but important changes in the area of the heart attack in the treated patients. Somewhat puzzling however was the lack of improvement in the degree of heart failure in the treated patients as compared to controls. This important fact seems to have been missed in the story. Additional studies are necessary to see if in fact this approach actually improves heart function.
The treatment is too experimental, and there are no comparable treatments to allow for a meaningful discussion of costs.
The story explains benefits in this way: “A year later, the mass of scar tissue in the treated patients’ hearts got 42% smaller. And healthy heart muscle increased by 60%. No such regeneration was seen in the patients who got standard care.” We thought the story should have spent more time, though, explaining the next sentence: “Because all of the patients were doing relatively well, there was no dramatic difference in clinical outcome.” If there was no dramatic difference in clinical outcome, then what exactly is the basis for all of the optimism in this story? Yes, there was more muscle regenerated but no it did not make any difference in the overall performance. So, more muscle did not equate to better function
There is no mention of harms in the story. Bloomberg BusinessWeek reported on the same study and said, “A year after the procedure, six patients in the stem cell group had serious side effects, including a heart attack, chest pain, a coronary bypass, implantation of a defibrillator, and two other events unrelated to the heart.”
The basic outlines of the study are described, but there is no mention of the study’s limitations or hurdles that lie ahead for this to be translated into a clinical treatment. As a result, it leaves the reader with the impression that the results are far more important than they really may be. There are numerous hurdles between a successful phase 1 study and commercialization. This fact is not made clear in the the story
Some of the language in the story skirts close to disease mongering. It presents heart scarring as if it is the same as heart failure, using terms such as “resurrects” and “broken hearts.” The word “cure” creeps in and is not qualified. The stem cells “seem to be doing something much more amazing,” the story says. As noted above, the study and this story say that there were no differences in the clinical outcomes of patients who received stem cells versus those who did not.
Nonetheless, we can’t ding it for disease-mongering by the definition of that criterion.
No interviews with independent sources are in evidence in the story. There is one quote from an accompanying editorial. The bulk of the story is given over to effusive quotes from the lead researcher, Eduardo Marban. We appreciate that the story made note of the fact that “He invented the “cardiosphere” culture technique used to create the stem cells and founded the company developing the treatment.” We think, though, that his conflict of interest should have prompted a few calls to independent sources.
There is no comparison to alternative treatments. What do patients typically do after suffering a heart attack? Given what modern medicine has achieved so far with heart care, how long can someone expect to live after having a heart attack? Are there surgical options, pharmaceutical treatments or lifestyle changes that could make a difference? Even in a short, 511-word story, some of the space devoted to the lead researcher’s quotes could have been given to even one sentence about alternatives.
The story makes it clear that the treatment is still in the experimental stage.
The story hints at novelty but leaves readers confused. It says that this “is the first completed, controlled clinical trial showing that scarred heart tissue can be repaired. Earlier work in patients with heart failure, using different stem cells or bone-marrow stem cells, also showed that the heart can regenerate itself.” The press release for the study also makes a claim of novelty, saying that “this has never been accomplished before, despite a decade of cell therapy trials for patients with heart attacks.” We wish the story had more clearly explained how this study was a significant improvement on earlier studies.
The story did not rely on this press release from Cedars-Sinai Medical Center.
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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