I’ve always said that the The Wall Street Journal does a great job covering children’s health issues. Thomas Burton and Shelly Banjo ran a nice piece this week on Allen Tower, founder of a little company by the name of NuMED. If you have a child with serious congenital heart disease a NuMED product may very well have touched your child. They produce some of the catheter devices that are used to treat complicated heart disease in children. Catheters, among other things, are used to stretch small vessels or insert stents to make congenitally small areas of vessels bigger. These devices are also used to block aberrant arteries and veins that are creating problems. In many cases these appliances are made to order by courageous interventional pediatric cardiologists because heart disease in babies often requires tailor-made creativity.
It seems this is the problem.
In many cases such unique appliances are so custom and so unique that achieving FDA approval is impossible. With so few children with a given problem it’s impossible to create studies with the numbers necessary to prove to The Feds that they’re safe and effective. In these cases we’ve always depended on the judgment of pediatric cardiologists to decide what’s in the best interest of a critically ill baby. And Mr. Tower and NuMED have been there to provide the tools for what needs to be done. He’s unfortunately the subject of a criminal investigation currently being conducted by the FDA. It seems they have concerns about his custom development of heart appliances in kids. If the government successful, the criminalization of NuMED could eliminate a resource that our country’s best pediatric cardiologists are dependent upon.
The testimony of interventional pediatric cardiology luminaries such as Dr. Chuck Mullins of Texas Children’s Hospital in Houston and Dr. James Lock of Boston Children’s Hospital should serve as evidence enough that NuMEDs unique services should be allowed to flourish. This is one more case where the government just doesn’t know more than the doctors caring for the kids.
Shown is the Mullins Ultra high pressure dilatation catheter developed by NuMED.