- The Washington Times - Wednesday, September 13, 2006


Finding out how prescription drugs affect children isn’t easy, even for pediatricians, a study says. That’s because very little research on children and drugs is published in medical journals that can help guide doctors on treatment.

The result is that some prescribe the wrong dose or use drugs that could be harmful to children.

“Ironically, some of the times when drugs do work [in children], they’re still not getting published,” said Dr. Danny Benjamin, an associate professor at Duke University who led the study and works for the U.S. Food and Drug Administration.

He said an FDA program meant to encourage pharmaceutical companies to test how drugs affect children has led to hundreds of studies. But about half the time, the results don’t get published in peer-reviewed medical journals, mainly because researchers and sponsors don’t submit them for publication, Dr. Benjamin said.

Drug companies that conduct or sponsor pediatric research are motivated mostly to get their products on the market, “not to tend to the public health concerns,” Dr. Benjamin said.

Also, parents often are reluctant to let their children participate in studies. So the research often involves many institutions with a few children at each location, which complicates compiling data and submitting them for publication, he said.

Examples the authors cited include unpublished data suggesting that an anesthesia drug might increase children’s risk of death when used for sedation. Also, unpublished data has suggested that some steroid creams used for skin rashes in adults could cause a hormone imbalance in children.

“People slather this on children, particularly babies,” said study co-author Dr. Dianne Murphy, director of the FDA’s Office of Pediatric Therapeutics.

In both cases, precautions are listed on the drug label but not in much detail. They also appear on the FDA’s Web site, but that’s not where doctors usually look for such information, the researchers said.

“We’ve just got to get the data out to people who are caring for children,” said Dr. Benjamin, whose study appeared in yesterday’s Journal of the American Medical Association.



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