CBS claimed an “exclusive” with this report on the “first person ever to get an infusion of his own heart stem cells” to try to avoid future problems after a heart attack.
OK, they had the exclusive report that the procedure was done.
But they didn’t make clear that:
The segment was clear that this treatment is experimental, but the failure to discuss potential risks, potential harms, costs involved, and current treatment options available to patients were huge omissions.
For anyone who really wants to learn about this area of research, the National Institutes of Health has a website describing the current state of the art. It contains questions we wish the CBS segment had explored, such as (excerpt follows):
"What are the implications for extending the research on differentiated growth of replacement tissues for damaged hearts? There are some practical aspects of producing a sufficient number of cells for clinical application. The repair of one damaged human heart would likely require millions of cells. The unique capacity for embryonic stem cells to replicate in culture may give them an advantage over adult stem cells by providing large numbers of replacement cells in tissue culture for transplantation purposes. Given the current state of the science, it is unclear how adult stem cells could be used to generate sufficient heart muscle outside the body to meet patients’ demand.
Although there is much excitement because researchers now know that adult and embryonic stem cells can repair damaged heart tissue, many questions remain to be answered before clinical applications can be made. For example, how long will the replacement cells continue to function? Do the rodent research models accurately reflect human heart conditions and transplantation responses? Do these new replacement cardiomyocytes derived from stem cells have the electrical-signal-conducting capabilities of native cardiac muscle cells?"
There was no estimate for the costs involved for this approach. While it is in its early stages of investigation, since the story closed with a quote "If this works, it’s going to help so many people.", it is worth some discussion about some of the costs involved.
There is currently nothing known about the benefits of this experimental approach. That simply wasn’t emphasized in the story.
Although the procedure involves two heart catheterization procedures, there was no discussion of possible harms. In addition to the risks associated with the catheterizations, what are the risks of injecting heart stem cells primed to grow? Will they stay put in the heart or is there a chance that they will migrate to other parts of the body, laying down muscle and vasculature where it doesn’t belong? Will the cells in the heart result in structural changes that will increase the risk of other cardiac problems? We don’t know and the report failed to raise this issue of uncertainty.
The current trial, a phase I clinical trial, is designed to determine whether this treatment is safe. That was never mentioned in the segment, which instead focused on the hope of benefit.
There was some discussion that it would be six months before they know if repair to the heart damage due the heart attack had taken place. It would have been helpful to focus the viewer on the fact that although this may appear to be an interesting possibility for treatment – there is currently no evidence that it works. While one can be hopeful that it works out for the featured patient, it is too early to know whether he will gain anything from undergoing the experiment.
The story stated, "Every year, more than a million Americans have a heart attack, and those who survive often live on with scarred or weakened hearts." The implication of that — and of the patient profiled who was "freaked out" – suggests that all should live in fear of this ongoing threat.
Though the segment included a patient and clinician involved in the trial, there were no independent experts to comment on the potential value of the treatment being investigated.
An important omission from this story was information that there are actually treatments currently and widely available that improve the life expectancy and quality of life for individuals who have had a heart attack.
The segment was clear that this is an experimental approach. It included interview material with the first patient. However – the segment failed to inform viewers that this experiment is currently a phase I trial, meaning that it is currently under investigation to evaluate safety. It is important for consumers to understand that not all clinical trials are the same.
Although the segment appeared to be enthusiastic about this procedure, it did not include information about where viewers could go to learn more about the trial or even that the trial is still recruiting participants. If TV is going to cover such early research, at least it could refer people to a website for more information. (For more details: www.clinicaltrials.gov; this is the CADUCEUS trial, which NCT00893360.)
The story was clear that this is a new experimental approach to the treatment of problems resulting from a heart attack.
We can’t be sure of the extent to which the story was influenced by a news release.