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Harry Shirkey, a medical practitioner, coined the term “therapeutic orphans” more than 40 years ago to describe how children are overlooked in medical research; his observations remain true today. Despite the best efforts of the American Academy of Pediatrics (AAP) and the Federal Drug Administration (FDA), nothing has really changed.
The fact is that the majority of drugs given to children have never been tested specifically for them. Physicians are prescribing drugs based on a “best guess” as to the dosage, efficacy, and even safety.
It’s becoming clearer to federal regulators and physicians alike that children are not just “small adults.” With their bodies in different stages of development, they process medication differently: sometimes faster, sometimes slower, and sometimes turning it into poison. Their body chemistry has not fully matured and yet adult drugs are being prescribed to children on a regular basis despite these facts. Dr. Joseph M. Wiley, Chief of Pediatrics at Sinai Hospital in Baltimore says, “If you extrapolate from an adult dose to a pediatric dose, you may be right…you may be wrong.”
The Path to Pediatric Testing
The road to pediatric drug testing has been a rocky one. Nobody wants to use children as guinea pigs, but the problem remains that drugs are being given to children in potentially unsafe doses.
The FDA understands that giving medications to children for which there is only adult data available could harm children, considering the fact that they have dosing concerns and sideeffect risks that differ from adults. The latest legislation has made some headway in the battle against the lack of proper labeling; yet it still fails to completely overcome the absence of research, particularly in the older medications.
This year, the Government Accountability Office said that only one-third of the drugs prescribed for children have been studied and labeled for pediatric use. The pediatric research that has been done includes some frightening results: of the older drugs just recently studied in children, 87% were being improperly prescribed. Children were getting medicine that didn’t work at all, were being underdosed, were being overdosed, or were being exposed to some possibly deadly side effects.
Dr. Dianne Murphy of the FDA’s Office of Pediatric Therapeutics had this to say, “We found out that you can’t predict how kids are going to handle things.” The problem is that once a medication has been approved for use in adults, it can legally be prescribed to anyone for any reason; despite the lack of pediatric testing or proper labeling.