STIFLING BUREAUCRACY IN AMERICA TOO


The bureaucratic FDA as a huge obstacle to medical care. The battle to save a sick baby:


"It became clear that his heart wouldn't hold up over time and that he would need a transplant, Rosenthal said.

But infant heart transplants are hard to come by and the wait can be a long one. Of the three babies who've received transplants at Packard, the wait has ranged from 10 to 200 days, Rosenthal said. So he and his colleagues began looking at options to keep Miles alive until a heart small enough for the 15-pound infant might come through.

None of the heart pumps available in this country is small enough to serve an infant population. So Miles' doctors looked to a device known as the Berlin Heart, named for its city of origin, which has been used in 50 to 100 children worldwide. Getting it here -- and in short order -- was something else again.

It required a special evening meeting of the Institutional Review Board, which oversees research involving human subjects at Stanford, and special dispensation from the U.S. Food and Drug Administration to bring it into the country. And it took a massive organizational effort at Packard to ensure everything was in place -- from skilled nursing care to customs release forms to the proper electrical adaptors for the device, Rosenthal said".