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Heartless Regulation May End Up Killing Kids

Posted: 07/06/07 12:26 PM ET

In recent years, the Food and Drug Administration has more often than not been damned for regulating too little rather than too much; but in a horrible twist, reported by Thomas M. Burton and Shelly Banjo in Thursday's Wall Street Journal, the very scientific principles which stand between the public and quackery will, if legally enforced, guarantee worse treatment and possibly death for deeply ill children.

The story is about a man who ought to be celebrated for his ingenuity if not his acumen: Allen Tower is the world's top manufacturer of customized stents for infants and children with congenital heart defects -- a position he achieved by being able to engineer devices to a doctor's particular requirements at incredible speed and then ship them around the world. "You tell him what you need, and in 24 hours he gives you a prototype," William E. Hellenbrand, chief of pediatric cardiology at New York Presbyterian/Columbia, tells the Journal.

But it is precisely those qualities that save infant lives -- device customization and swift delivery -- that have brought Allen into conflict with federal regulation. The problem is that by virtue of scale, development, and variation, heart defects in infants preclude the use of off-the-shelf devices, while adult stents and balloons have the brute, destructive potential of a Gulliver trampling through Lilliput. But customization means that Allen's devices are not approved for sale in the U.S.; however, doctors have been able to get them through a "custom device exemption" in the law.

This wouldn't have been a problem if Allen's devices had not become so popular, or if he and his company, had exercised greater diligence in navigating federal marketing regulations. As a consequence of three families filing suit in Wilmington, DE over the injuries to their children they say were caused by the use of "unapproved" medical devices, the FDA "appears to have concluded that doctors at the hospital were using [Allen's] devices too often and so actual marketing was involved instead of exceptions for emergencies." (One wonders whether the families would also have sued if the doctors had merely provided "approved" care and the children suffered similar or worse injuries or died).

Still, there is an intractable problem at the heart of this story (no pun intended): How do you regulate customized medical devices, when, by definition, there is no real uniformity in treatment? You can't conduct a randomized control trial, where some infants get one device and others get a different device or nothing at all -- and it's not merely because of the small numbers of pediatric heart cases hampering the creation of such a trial; it's hard to see how it would be ethical to provide infants with standard care when, for obvious reasons of dimension, the devices customized for infants are by definition superior to the adult devices. In effect, you would be condemning some children to death.

And that's what the FDA may end up doing, albeit unintentionally, as it cracks down on the devices and Allen's company, NuMED. As the Journal reported, FDA scrutiny has increased the delivery time for stents, leading one doctor to claim that a child died of a ruptured aorta because of the inability to get a particular device. In a bizarre twist, the FDA would probably not be involved in this issue at all if each doctor built his own stent rather than simply stipulated its specifications for someone else to build; that would most likely fall under the practice of medicine. Nor can the FDA stop wealthy families taking their children to Europe to get Allen's devices, where they are approved for use in pediatric cardiology.

Given the speed with which Rep. Henry Waxman moved the House Committee on Oversight and Government Reform to investigate how the FDA handled the risks of the diabetes drug Avandia -- all on the basis of a weak statistical study -- surely Congress can muster an equal sense of urgency to solve a problem that puts infants and children with fatal conditions at such obvious risk?