This investor-minded story looks at a Vericel-funded study on the potential benefits of a new stem cell therapy for advanced heart failure patients. Even though its audience was financial folks, the story included a lot of key details that a general story should have, such as the quantified benefits of both primary (i.e, number of deaths) and secondary endpoints (6-minute distance walk test). The story would have been stronger if it had interviewed an independent source other than a financial analyst who could explain the limitations of this trial.
According to the American Heart Association, of the 5.7 million Americans living with heart failure, 10 percent of them have advanced heart failure. Although the condition can be managed, over time there can be serious consequences. Due to advanced heart failure being a leading cause of hospitalizations, many people within the cardiology community are looking into new therapies that can prevent the need for a transplant or pacemaker.
Stem cell therapy is assumed to be quite expensive, yet there is no mention of potential cost to the patient or health care system. If the new approach is comparable to other approaches then the cost of the alternative methods could be cited. Our rule of thumb: If it’s not too early to talk about how well something might work, then it’’s not too early to start discussing what it may cost.
This article outlined the 37 percent reduction in adverse events due to the stem cell therapy, and explained that the outcome was mainly due to difference in deaths and hospitalizations between the therapy and placebo groups. And, we were very pleased to see the inclusion of absolute numbers related to this–i.e., 7 deaths versus 2 deaths. The story also let us know that the study didn’t show a benefit in secondary endpoints, like heart pumping efficiency and a walk test.
However, we’d have liked to have seen more discussion–ideally from an independent medical experts–on what investors already seem to know, but the reader is left to deduce: Were these results as meaningful as the lead investigator is making them out to be?
Harms were not discussed, although they are important, especially considering the failure of the therapy to improve secondary outcomes.
The story quoted the study’s lead investigator in saying that there is a need to have larger trials for this stem cell therapy to accurately prove its benefits. The story points out that the group consisted of only 109 patients, but there was no mention of how many patients received the stem cell therapy. Sample size can be a limitation of any trial, and there should be a level of caution if the treatment group does not accurately represent a diverse population.
This article accurately expresses the severity of advanced heart failure without making the condition seem hopeless.
The doctor quoted in the story was identified as the lead investigator for the study. However, the story didn’t include his potential conflict of interest–that he received funding from the drug company–which was stated and easy to find in the study. For this reason, we’re rating this Not Satisfactory.
We were please to see the story included an additional outside source, even if it was a financial analyst. A second, independent medical source would have made the story stronger.
The story points out alternatives by stating “despite all available medicinal and interventional therapies, the only options are heart transplant or a pumping assist device.”
The doctor and lead investigator who was interviewed in the story noted the need for larger trials, meaning this therapy is nowhere close to being available to the general public. Although the audience is aware this is early testing, it would have been helpful to know how the study will address the limitations of failing to meet the secondary goals, such as the walk test and heart pumping efficiency.
The story does not attempt to portray this stem cell therapy as a significant scientific breakthrough, but presents the information in a way that allows the audience to believe this may be a viable alternative to existing treatments.
The story contains original commentary, and so it does not appear to rely on a news release.