While we are happily way beyond the Dickensian era when children were simply thought of, and treated as, "little adults," surprisingly doctors often have little choice but to prescribe medicine for children that have been developed solely for adults. An article by pediatrician Alexander Cvetkovich-Muntañola in the February 2011 Foresight newsletter, an INC Research publication, highlights the problems associated with a "one size fits all" attitude in drug trials.
He writes that 70 percent of the medicines given to children have only been tested in adults. This is despite the fact that kids have smaller airways, less protective muscle around their organs, greater body to surface area to body mass ratio, along with a higher metabolic rate, lower blood pressure, faster heart rate and a less mature immune system.
"Despite these many differences, the majority of drugs are not tested in children, and pediatricians are forced to resort to off-label use and guesstimated dosing," Cvetkovich-Muntañola writes. "Off-label use may result in toxicity from the active ingredients leading to numerous adverse events and mortality and also paradoxal reactions have been reported from additive ingredients. On the other hand, inappropriate dosing might result in ineffectiveness."
Fortunately, he writes, that is changing as new FDA regulatory policies are forcing companies to conduct pediatric studies as an integral part of pharmaceutical development. They're doing that through a reward system that includes six months of marketing exclusivity to sponsors that conduct pediatric clinical trials.
The article also touches on some of the sticky legal issues associated with getting consent to conduct clinical trials on children.
- read the article in Foresight