The story did a better job than a competing WebMD story in covering most of the necessary ground to give readers a realistic assessment of this stem cell study. It described the actual study with an appropriate level of detail. However, it missed two important points that were noted in the WebMD piece: the lead researcher’s conflict of interest and the fact that there was no significant difference in clinical outcomes between the two groups.
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. One of the best aspects of this story is how it repeatedly shows what the researchers still don’t know. Instead of presenting this as a breakthrough with a clear path to clinical application, the story uses phrases such as, “why this is happening is still unclear.” 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 improve heart function.
It’s too early to have a meaningful discussion of costs.
The story does not provide a lot of hard data on benefits, and we would have liked to have seen more. For example, it says that “about half of their scar tissue dissolved and the reduction in scar size appears to get bigger after the first six months.” But we appreciated some of the specific details it does provide, including: “Marbán says the amount of new heart tissue that grew was not subtle. [On average] “22 grams (about .78 ounces) of new heart tissue grew,” which he says is quite remarkable considering this had never been done before and the average weight of the part of the heart that is responsible for pumping the blood through the body is about 150 grams (about 5.3 ounces).”
Having said that however, the story misses an important point. The patients treated with the stem cells did not have an improvement in their overall heart function. So while there appeared to be a considerable amount of regenerated heart muscle, it did not make any difference in the performance of the heart so that patients did not likely see any benefit to the procedure.
The story at least mentioned harms. Another story on the study, by WebMD, did not. This one says, “After 12 months, researchers report only one patient appeared to have a serious side effect that may have been connected to the experimental cells.” Competing coverage discussed a broader group of patients who had bad outcomes, although it is not clear that all of those outcomes were a result of the treatment. Pinpointing the cause of a side effect can be tricky, and given the lead researcher’s financial interest in this stem cell therapy, we think stories should err on the side of providing more information about potential harms.
The story did a better job than some of the other coverage of the study in explaining exactly what this study entailed and the study’s limitations. The story says, for example, “She cautions that this procedure has to be tested on many more patients and they have to be observed for longer periods than in the current study, but she says these results are all very positive.”
The story does not engage in disease mongering. It makes it clear that this was a study in a particular group of patients, not just any patient with heart disease. “To qualify for this clinical trial, patients had to have suffered a recent heart attack and “had to have a significant amount of damage to begin with and weren’t squeezing [blood into the body] as well as they should have, says Dr. Peter Johnston, one of the study authors who injected the new heart cells into patients treated at Johns Hopkins Hospital.”
The story could have sought a little wider circle of independent experts. But we thought the reporter elicited good comments from Sonia Skarlatos, Ph.D and deputy director of the Division of Cardiovascular Sciences at the NIH’s National Heart, Lung, and Blood Institute, which funded the study. We have to give an “unsatisfactory” here, though, because the story failed to mention the financial interest that the lead researcher has in the stem cell therapy. The press release for the study mentions this, as does a competing WebMD story.
There is no discussion of alternatives in this story. One might think that the only option for heart attack patients is to wait around until stem cell treatments become available. Even an additional line about alternatives would have been appreciated.
The story makes it clear not only that the treatment is experimental but that it has to clear many more hurdles before becoming a clinical option.
The story improves on a competing WebMD story by explaining the novelty of this study. “This is the first instance of therapeutic regeneration,” says Dr. Eduardo Marbán, director of the Cedars-Sinai Heart Institute. He says while nature abounds with examples of spontaneous regeneration of limbs or tissues – like a salamander’s new tail or a human liver regrowing to full size if partially damaged – doctors have not been able to help patients regrow heart tissue. This could change in the future if larger clinical trials and longer patient outcomes confirm the results of this early research published Monday in the journal The Lancet. Marbán and his colleagues first presented this research at an American Heart Association conference in November.
The story goes beyond the Cedars-Sinai press release.