Few Drugs or Devices to Treat Cardiovascular Disease Are Designed With Children in Mind.
Matthew Emmerline was born with a heart defect, with a critically narrowed aortic valve that prevented his heart from getting an adequate supply of blood to the rest of his body. Doctor's had the know how to inflate the heart but not the devise they needed.
They were able to improvise but Matthew’s situation highlights an enduring reality for children born with life-threatening heart defects: Hardly any of the myriad drugs and devices developed for the multibillion-dollar market for cardiovascular disease are designed with kids in mind. Children with heart disease represent too small a segment of that market to justify companies’ investing the time and resources needed to develop specialized products. Litigation worries over products intended for children—and the challenge of conducting clinical trials for treatments often administered to newborns—are other impediments.
It all adds up to what Jim Lock, chief of cardiology at Children’s Hospital Boston, calls a “profitability gap” between the market for children and the much-larger business of treating adults with heart disease.
Drugs also pose a dilemma. Children younger than 7 or 8 typically need medication in liquid, not pill, form. But many common heart drugs, such as beta blockers and ACE-inhibitors, aren’t readily available as liquids and have to be specially prepared.
Devising medication regimens for children also can be difficult. Doses are often based on a child’s weight and are typically calculated from standard doses given to adults, a strategy whose safety and efficacy don’t have substantial backing in scientific studies. Pediatric cardiologists have to deal with patients ranging from “a 400-gram infant born prematurely all the way to a 400[-pound] extremely obese adolescent,” says Marlene Miller, a doctor at Johns Hopkins Children’s Center in Baltimore, who led a recently published study of heart-drug medical errors in children. “That’s enormous variation. Adults don’t vary that much in size.”
For the rest of Matthew's story and to read the complete article go to: http://online.wsj.com/article/SB10001424052970203674704574336671475911680.html
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