CBS News ran a segment last night on a little girl who apparently benefited from the use of a left ventricular assist device called “The Berlin Heart” – a device that supported her heart for a few days while she waited for a heart transplant. The girl was the daughter of Chicago Bears football player Charles Tillman.
Sanjay Gupta – on loan to CBS for this story from CNN – said the technology “saved her life.” But no one can say that with any certainty. She was on the pump for a few days. No one can say if she would have survived those few days without the use of the device.
There was no mention of how much the device and its implantation cost. The cost of the device alone is $115,500, not counting the costs of hospitalization, surgery, etc. (Publisher’s update of 12/16/09: This cost figure came from a document that was publicly available to anyone on the Berlin Heart corporate website on the day we posted this. The document has now apparently been removed from the Berlin Heart website, so we have removed the link that was once part of this story.) Pro football players are paid very well. How would others in the audience pay for the device or have access to it? These were questions the story didn’t address.
Once the little girl went on the pump, did that automatically move her up higher on the transplant waiting list? If so, is that appropriate? And if so, how did the parents of other children on the waiting list feel about that? There was no discussion of the issue of how some people move up on transplant waiting lists, either.
The story did mention that the device is not approved by the FDA. Why not? The story didn’t explain. It didn’t explain whether the company had applied for approval and was rejected, whether it had applied but the FDA hadn’t decided yet, or whether it simply hadn’t applied yet. Regardless, there was no discussion of the evidence behind the device – and evidence is what matters.
Harold DeMonaco tracks innovation in medicine in his job as Director of the Innovation Support Center at the Massachusetts General Hospital. He’s also one of our medical editors. He wrote to me:
“Unfortunately, in my view, the story strays from a purely human interest story to one that could be taken as a swipe at the FDA. I am particularly troubled by the statement, “Each time, doctors have to get permission from the FDA, and have it flown in from Germany.” The obvious implication is that once again government is needlessly impeding delivery of vital care. But the story neglects to point out costs, that the Berlin Heart is not without problems, and that there is an alternative option (extracorporeal membrane oxygenation or ECMO) that has been used successfully for years and is a common approach in most academic medical centers.”
So while this was a warm and touching human interest story, it did not educate viewers very well about the technology that the story claimed saved the girl’s life, when, indeed, we don’t know that. Stories about new medical technologies – even those with such an emotional personal anecdote – should deal with evidence, not hyperbole about one anecdote.
Indeed, another anecdote reported to the FDA tells quite a different story about the Berlin Heart. It describes another child who had the device implanted. Repeated problems with clots forming on the pump’s outflow valve led to one, then two pump replacements. A crack developed in the device. The child had to have emergency resuscitation. Another crack developed, which led to bleeding and probable brain damage. The report concludes: “After a long discussion with the family, their wish was to withdraw further support, and to make the child’s organs available for donation.”
That’s quite a different story than the one CBS chose to tell last night. The failure to scrutinize evidence – on harms as well as benefits – and to discuss costs and other options rendered the CBS piece incomplete and imbalanced.