While attempting to update readers on a new experimental approach for heart disease, this article did not clearly explain that the use of autologous bone marrow stem cells in the treatment of ischemic heart disease was, indeed, an experimental approach currently being evaluated for safety and effectiveness. The results of some recent studies suggest that this approach may hold some promise for some patients. But it should have been emphasized, as in the New England Journal of Medicine editorials, that the effects were clinically marginal, even if statistically significant. It should have been emphasized that the studies were not all positive. The cheaper and well established alternative therapies are relevant but were not discussed in this story. Only about half of patients who have previously had a heart attack are taking the cheap medications we already know could be helping them prolong their lives.
There was no mention of any risks associated with the experimental approach, which is delivered as an intracoronary infusion, nor was there any discussion of short term vs. long term benefit that may be come from this approach. There was also no discussion of what this approach might cost.
There were no estimates for the cost of this experimental approach.
While it was interesting to see the results presented in terms of percent improvement, the article ought to have included some information regarding the statistical and clinical significance of these results. The editorialists in the New England Journal of Medicine emphasize that the findings may be statistically significant but not clinically significant. The author of the news article should be commended for mentioning both absolute benefit (2.9%) as well as relative benefit (7%). But missing the points raised in the editorial is a problem.
There was no mention of any harms associated with the experimental approach. The article mentioned that patients received an infusion of stem cells. It did not mention that the infusion was intracoronary. Readers should be told the details of the process and the potential risks.
The evidence for this article comes from three studies presented in a single recent issue of the New England Journal of Medicine. The author fails to put the most positive study into context with the other two. One of the three studies showed no benefit, and this should be emphasized at the outset. The article was less clear than it ought to be about the nature of the studies.
The article did provide estimates for the number of heart attacks and the number of lethal heart attacks per year. But it failed to indicate what proportion of the group having heart attacks might benefit from the experimental approach described. Are we to believe that this is for all “weakened hearts”? The subheadline reads “Even patients who suffered an episode decades ago can benefit.”
In addition to the information gleaned from the New England Journal of Medicine publications, this article contained additional quotes from clinicians in the field. One of experts quoted in the article is a senior author of one study. An accompanying editorial in the New England Journal of Medicine points out that after the research article was accepted for publication, this researcher formed a commercial venture using this stem-cell technique. The reader should know of the biases of the “experts.”
Midway though the article it mentioned that the patients in the study “were already receiving state-of-the-art drug treatments for their heart disease, including use of beta blockers and cholesterol-lowering statins”. Beyond this statement, there were no other details about treatments for ischemic heart disease.
The article failed to mention that the use of bone marrow stem cells in the treatment of ischemia is an experiment. In fact, it confuses the reader when it says “the researchers are uncertain why the therapy works.” It’s not a therapy yet; it’s an experiment, which the story goes on to admit when it says “stem cells may be gradually moving from the laboratory into viable human therapies.” Furthermore, the editorial in the New England Journal of Medicine accompanying the reports clearly recommends that this approach be limited to controlled experiments with willing subjects. But that editorial isn’t mentioned in the story.
This article reported on recent study results that were published in the New England Journal of Medicine. They represent the latest study results on the use of bone marrow stem cells as an experimental approach for ischemic heart disease. The article does not say what standard treatment is after a heart attack or for chronic congestive heart failure. While indeed stem cell infusion is novel, the reader of the article will not know why.
This article does not appear to rely exclusively on a press release.