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FDA as Sacred Institution

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pump [2]My last two posts have questioned the costs of having the Food and Drug Administration oversee the safety of our medical devices and drugs.  Here’s another inspiring and depressing story.  From the Stanford University press release [3]:

Five-month-old Miles Coulson, blue-eyed and chubby-cheeked, sits in his bouncy seat in the cardiovascular intensive care unit at Lucile Packard Children’s Hospital, eagerly tracking the plastic fish swimming on a play toy before his eyes. His father, Adrian Coulson, is attentive to the baby’s every movement and expression, for the slightest change could signify some complicating factor. The father periodically suctions fluid from the baby’s mouth, the remains of Miles’ tube-fed lunch.

Miles is a bit of a technological wonder, for he would not be alive today without the benefit of a German heart pump that’s been used only three times before in this country. The pump, a fist-sized piece of polyurethane shaped like a diaphragm, thumps quietly at the baby’s side, collecting the blood from the left side of Miles’ failing heart and directing it back to the body via the aorta.

Alas, that German heart pump is illegal because it has not received FDA approval.  Lucky for Miles, the Stanford doctors were very enterprising:

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.

Look at the key sentence 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.

Special dispensation.  The FDA smiled beneficently on the Stanford doctors and allowed them to save the life of a child.  How many others have not been so lucky, either because the doctors didn’t make the effort or because the FDA said no?

The picture at the top of the post is Miles playing with his dad.  May he live long and well.

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