Our main constructive criticism is that the story should have emphasized what a Phase 2 study shows and doesn’t show. It says that a Phase 3 study is being planned – but never defines what a Phase 3 study is. These are important concepts for readers to understand but journalists shouldn’t assume that people know what you’re talking about.
Fascinating research, worthy of news coverage.
No discussion of cost. A ballpark could have been given.
Again, the bulleted breakdown of impact on number of angina attacks, exercise tolerance test scores, and nitroglycerin use was appreciated.
We’ll give the story credit for the following – although we think it was incomplete:
“About one in three patients had elevations of a cardiac enzyme that is associated with heart attacks. While the elevations did not appear to be clinically significant, Losordo says the researchers will continue to closely monitor cardiac enzymes in patients who receive the treatment.”
What does that mean? “Associated with heart attacks”? How? Why? How often? In what past research? And what does “did not appear to be clinically significant” mean? Did it cause any problems or didn’t it?
We appreciated the bulleted breakdown of major findings.
But the story never emphasized that this was a Phase 2 study – which is not primarily designed to test efficacy but safety. Yet the subheadline was “Study shows chest pain from heart disease can be treated with stem cell therapy.”
The story finally gets close to where it should be at the very end, quoting Dr. Tomaselli saying “he study shows that the approach is both safe and feasible in patients with significant coronary disease…. The next step is to prove the treatment is clinically useful.”
But it’s better to be overt and clear about what the study didn’t show and to emphasize the uncertainties – perhaps to a greater degree than what may be assumed to be certainties. It wouldn’t require much time or space or effort to define the phases of trials.
No disease mongering here.
The president of the American Heart Association was quoted liberally throughout the story. It could be argued that since the work was published in an AHA journal, he is not the most independent observer, but we’ll give the story the benefit of the doubt on this. Independent researchers working in the field of stem cell experimentation might have been better choices.
The story puts this approach into the context of attempts to help people who have angina despite available treatments.
The story calls the approach “experimental”…says Phase III studies are planned…and ends with “the next step is to prove the treatment is clinicallly useful.”
We are given some sense that this isn’t brand new research:
“The new treatment came from the discovery about a decade ago that CD34 stem cells stimulate the formation of new blood vessels…The approach also showed promise in a 2007 pilot study involving fewer than 30 patients.”
Although a news release from the American Heart Association is cited as one source for the story, we do not see evidence that the story relied solely or largely on that or any news release.