Paediatrics

Children Treated Abroad as US Doctors Push for Devices

More than 90 percent of the medical devices he uses on children are 'off-label'

Every year, Chicago-based cardiologist Dr 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 nine years in Jordan before it was approved in the United States in 2007.

According to Dr Hijazi, who is Chief of Paediatric Cardiology at Rush University Medical Center, children are getting worse treatment in the United States, and have even died, because pediatric medical devices are not approved. Hijazi said that more than 90 per cent of the medical devices he uses on children are 'off-label,' meaning that they are approved by the US Food and Drug Administration (FDA) for other uses, for example for use in adults. "We take responsibility as physicians, for using unapproved devices on kids," Dr Hijazi said. From 1989 to 2000, only one stent- was appropriate to use in children according to Dr Thomas Forbes, Director of Cardiac Catheterisation at Children's Hospital of Michigan. "In the 90s, we lost lives in the cath lab. Patients have died on the table because we were using stents that were made for adults and were not flexible enough," Forbes said. There are currently three stents that can be modified for paediatric use, but none of them is approved for use in children in the United States. While much of the focus is on cardiology, pediatric doctors from other specialties, like orthopedics, echo these concerns, saying they either use devices approved for adults or hand-make their own devices. 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. Dr Richard Ringel, a paediatric cardiologist at Johns Hopkins Hospital, said he is awaiting the next innovation in cardiovascular medicine— stents that dissolve inside the body. "We're all anxious for the dissolvable stent. But do you think Johnson & Johnson is going to be interested in doing this for babies? No, they want to do it for (adult) coronary patients because the numbers are so much larger," Dr Ringel said. Edwards Lifesciences, the world's biggest maker of heart valves, is one example of a public company that has developed a product for children - a blood-oxygen monitor, but the company acknowledges the limitations.

Sales of Edwards' first paediatric device generated sales of just a couple million since its launch last year. The company said the potential of the market is $30 million to $35 million, a fifth to a quarter of the adult market. Moreover, ethical issues associated with conducting clinical trials on children and legal liability, are two other big obstacles.

Reuters