Eighteen new grants worth $8.5 million represent part of an ongoing effort by the NIH to re-think old attitudes toward drug testing in kids.
The grants, awarded this week to researchers around the country, including Stanford's Gregory Hammer, MD, will fund studies of medications and devices used in pediatric cardiology, neonatology and pediatric neurology. Hammer's team at Lucile Packard Children's Hospital will compare two morphine-like painkillers used after cardiac surgery in newborns, infants and young children. The Stanford/Packard team hypothesizes that methadone may provide better pain relief with fewer side effects than commonly-used opioid painkillers, but no one has done a direct comparison to find out what works best for babies and children. The researchers will also study the blood levels of the study drugs and their metabolites, about which very little information currently exists.
Hammer's study provides a good example of the knowledge gap the NIH is trying to fill. In the past, scientists have hesitated to test drugs in children, partly because of ethical concerns that kids couldn't consent to participate in medical experiments. But that created a different ethical problem. Doctors were left guessing: After this infant's lifesaving surgery, which painkiller should I give? How much? How often? Because drug metabolism changes during development, they couldn't rely on results from studies in adults for answers.
So, the NIH is encouraging some drug testing in children, as well as studies that will give scientists the right equipment to monitor children's health during future drug trials. The press release announcing the new awards says:
The Best Pharmaceuticals for Children Act of 2002 established a process to study on-patent and off-patent drugs for children and to improve pediatric therapeutics through collaboration on scientific investigation, clinical study design, weight of evidence, and ethical and labeling issues.
"People of different ages require research outcome measures that are tailored to their size and condition," said Steven Hirschfeld, M.D., Ph.D., NICHD associate director for clinical research.
Read the complete press release here. More details about Hammer's newly funded trial and the other studies that received funding are available here.