This story creates a sense that this experimental approach is about to change the course of heart medicine and that, so far, it has only been made available to a very lucky few. The story notes that a “study researcher … could barely contain his excitement in an interview with WebMD.” It’s the job of journalism to dispassionately evaluate evidence and provide necessary context and caveats. But our reviewers thought too much of the uncontained excitement came through without enough of the C words.
The American Heart Association’s Scientific Sessions is one of the largest medical conferences in the world, generating a lot of overly effusive coverage every year. As difficult as it may be, reporters need to work especially hard during conferences to find independent sources who can provide cautious analysis of a study’s results, especially when a study is this small and has potential pitfalls built into the study’s design.
Although symptomatic treatment of heart failure has improved, the underlying disorder remains a progressive disease with no cure. The use of cardiac stem cells to repair heart muscle damage is a potentially exciting new development. But it is very early in its development.
The story makes no mention of costs. Because this is a phase 1 study, no costs can be determined at this stage. Needless to say, the costs are likely, however, to be significant. There is widespread concern that when stem cell therapies do become available for some conditions that they will be cost prohibitive. The reason so many stem cell studies have enrolled so few patients is, in part, because research costs are so high, and that translates into higher costs for patients down the road.
The story could have benefited from an info-graphic to break down all the numbers of patients used at various times in the story: 20 enrolled, “results are in for only the first 16,” 14 patients analyzed so far, 8 seen for one year. Wouldn’t that have been much more clear than scattering all of these numbers throughout the story? That makes it difficult to understand the scope of the benefits. The story spends a lot of time talking about just one patient and, in an unusual move for a study like this, the story names the patient: Michael Jones.
This anecdote may not reflect the results seen to date in all the subjects treated. Preliminary results can be statistically important but may not be clinically important in the long run. The researchers saw an improvement in the ejection fraction in subjects treated (on average going from 30.3% to 38.5%) It should be noted that to be enrolled, all patients needed to have an ejection fraction of less than 40%. So, in spite of the improvement, the subjects on average still had severe heart failure at the end of this phase of the study.
The story says that there were no side effects from the treatments. We would have liked to have seen more detail on how long the patients were followed (we’re only told that 8 have been followed for one year) and the types of side effects one might expect with this type of therapy. The subjects underwent cardiac surgery during which time cardiac tissue was recovered and the stem cells were injected into the heart via a catheter. Each procedure carries the potential for harm. In reporting on such a small, short-term study, we think the potential for harm is worth at least a line.
The story is reporting on the preliminary results of a phase 1 study in a small number of subjects in an open label trial designed to determine the safety of the approach. All of that is explained at one point or another in the story. But it’s wrapped in language of “major breakthrough…unexpected magnitude…quite encouraging.” While the results to date are encouraging the story provides an overly optimistic view of the study results. Importantly, these are interim results in a handful of the subjects enrolled. Although there are notable attempts to temper the overall enthusiastic view, many readers may walk away with unrealistic expectations. The story makes one nod to problems with the quality of the evidence. It quotes the lead researcher on the study saying, “ Now this is an open-label trial, so patients know they are treated. This means we have to take what they say with a grain of salt.” He then quickly brushes that concern away, though, by saying, “But we see these patients not only are feeling better but doing more.” That’s the overwhelming message from this story, even though the study’s design may have skewed the results.
By the definition of this criterion, the story does not commit disease-mongering about heart failure after heart attack. So we’ll give it a satisfactory score on this criterion.
Many times, though, our reviewers wish to comment on what they consider to be treatment mongering. And that was the case this time as well. The story sets a tone of urgency and awe early in the story that carries through the rest of the story, culminating in the idea that people are somehow missing out on a “breakthrough” – a term used twice in the story. “
The only downside of this early success is that the ongoing study already has enrolled all 20 of the patients who will be treated. The experimental treatment simply will not be available to other patients in the near future.” Readers with heart disease worried that they may have missed their chance to find a cure are told “to maintain close contact with their doctors”. This creates a panic mentality that does not serve patients or stem cell science.
The story presented one independent perspective and a quote from an editorial that accompanied the study.
The experimental approach is not compared to existing alternatives. There is
a passing reference to “lifestyle changes and medical management”. Were all of these patients taking the same medications and following the same diet and exercise routines prior to the study and during the study? What is currently the best course for the types of heart conditions these patients have? These are among the many questions not answered in the story.
The story explains that these findings are from a small study early in the development of a stem cell therapy and that the treatment is not going to be available in the near term. It says that a “larger, phase II study is planned.” More important, it clearly states “the experimental treatment simply will not be available to other patients in the near future.”
The novelty of the treatment is established. The story does note that the technique is new and was developed by one of the researchers.
The story does not rely on a news release.