Health News Review

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.

Harry Demonaco photo.jpg 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.

Comments

Marshall Scott posted on December 17, 2009 at 11:34 am

As someone who has been involved in hospital ethics for some time, I share the concern about how health stories get reported. This is as true in reports of research – indeed, perhaps more so – than in human interest stories. As a physician himself, one might hope Dr. Gupta would know better; but it’s not something I’ve seen in his reporting.

Bruce posted on December 22, 2009 at 10:09 pm

I guess I am not even sure where to begin. My 3 year old son, Riley, has been kept alive since March 25th of this year with the aid of this device. Riley’s own heart was ravaged by a virus early this year and the left side of his heart was operating at less than 25%. The wonderful staff here at the University of Minnesota has helped us get through this trying time. Without this device Riley could have died from something as simple as a common cold. Riley has florished with the help of the Berlin Heart. Every day people meet us in the hallways of the hospital and they are shocked to learn that Riley was so close to death. Each day he amazes us with his ability to deal with everything that comes his way. He does everything with a smile and that makes everything worthwhile. I don’t know who will read this email but I want to share Riley’s website and let you know that this device has saved his life. His website is http://www.caringbridge.org/visit/rileystearns

Gary Schwitzer posted on December 23, 2009 at 10:47 am

Bruce,
Thanks for your note.
I am sorry to hear of your son’s heart condition but pleased to hear of your satisfaction with his care.
Please understand that the purpose of this website is to review journalism. That is the entire focus of what we posted. In fact, the term “the story” was used 13 times in our blog post. We apply our standards for high quality journalism to the review of health news stories and, in so doing, we stand by our conclusion that: “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.”

James posted on April 15, 2011 at 11:15 am

Four year old Riley Stearns passed away recently, apparently because of a failure of a line to his Berlin heart.