Every year, Chicago-based cardiologist Ziyad Hijazi accompanies two or three children and their families to his native Jordan for heart operations using medical devices that are not approved in the United States.
In one such case, Hijazi implanted a device to close a hole between the lower chambers of the heart in a child from Massachusetts. The device, called an amplatzer muscular VSD, manufactured by Minneapolis-based AGA Medical, was available for 9 years in Jordan before it was approved in the United States in 2007.
According to Hijazi, who is chief of pediatric cardiology at Rush University Medical Center, and other doctors, children are getting worse treatment in the United States, and have even died, because pediatric medical devices are not approved.
Sherman then uses this mini-narrative as a point of departure to analyze the how-did-we-get-into-this-mess question. Much of that analysis draws upon an interview with Thomas Forbes, director of cardiac catheterization at Children's Hospital of Michigan in Detroit. This is because one of the major areas addressed by the final paragraph of her anecdote concerns the use of stents (small tubes that prop open the walls of blood vessels), which are administered through catheterization. The problem is that both stents and catheters designed for adults can be dangerous when applied to children for the simple reason that they are too large and not flexible enough.
By all rights this should be a golden opportunity for all those innovation evangelists to put aside their usual claptrap and strut their stuff to beneficial effect. Getting beyond the usual problem that too much innovative thinking tends to be in an echo chamber that blocks out any reverberations concerned with consequences, this is an example of a well-defined problem for which a robust solution would greatly benefit the general public. Nevertheless, you are unlikely to find any of those evangelists preaching about this particular problem in dire need of a solution. It does not take long for Sherman to get to the heart of why this is the case:
One factor is that companies that make medical devices focus on adults because the market is bigger. Heart diseases in children, for example, are more likely to be congenital, and rare, while in adults they are more likely to be progressive, and common.
A law signed late last year provides financial incentives to companies for making devices for children, but also requires those companies to track patients at their own expense.
"It's a paperwork nightmare. They have to commit resources and follow these patients forever," Forbes said. "If I'm a J&J stockholder, I'm saying, 'I love kids, I'd love to help them out, but move on.'"
There you have it: When innovation evangelists write their sermons, they are not preaching about solving problems; they are writing about new opportunities for Return on Investment (ROI). Put another way, they are interested in innovations that benefit shareholders; and, in the classic language of The Gilded Age, "the customer be damned." If too many children (or, for that matter, adults) can no longer receive effective health care through improved medical technologies, then the only consequence that seems to matter is that the "surplus population" may be reduced.
There is another lesson from Sherman's anecdote, which is that those who currently can enjoy better health care are those who can afford the expense of having a procedure performed in another country. Thus, the sort of "surplus population" that receives so little thought by our innovation evangelists are, as usual, the poor. The problem is that the poor are not receiving much more attention by the strongest voices of health care reform either, particularly when it comes to a complex socio-technical issue like being able to deploy the best technology to solve the most challenging problems. Thus, like so many other stories about the primacy of the interests of shareholders, this is ultimately another story about the War Against the Poor; and it appears that this particular skirmish is being waged on a battlefield where most of the casualties will be children.