Finding out how prescription drugs affect children isn't easy, even for pediatricians, a new study says.
That's because very little research on children and drugs is
published in medical journals that help guide doctors on treatment. The
result is that some prescribe the wrong dose or use drugs that could be
harmful to kids.
"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 also works
for the U.S.
Food and Drug Administration.
He said an FDA program meant to encourage drug companies to test how
drugs affect children has led to hundreds of studies. The problem is
that 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, 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," 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, Benjamin 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Examples the authors cited include unpublished data suggesting that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 Also, unpublished data has suggested that some steroid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," Benjamin said.
His study appears in Wednesday's
Journal of the American Medical Association.
JAMA is among the top peer-reviewed journals but editor-in-chief Dr.
Catherine DeAngelis said few studies submitted to JAMA involve the
effects of medication on children.
The researchers studied the impact of 1997 legislation authorizing a
measure that grants drug companies longer patent protection when they
agree to study a medication's effects in children.
Between 1998 and 2004, 253 pediatric studies were submitted to the
FDA under this program but only 45 percent were published in
peer-reviewed journals, the researchers found.
Dr. Peter Lurie of the watchdog organization Public Citizen's Health
Research Group said drug companies and academics need to push harder to
publish.
"It really is like the tree falling in the woods. The study is of no
use whatsoever if it never reaches the practicing physician," Lurie
said.
Scott Lassman of Pharmaceutical Research and Manufacturers of
America, an industry trade group, said drug companies shouldn't be
faulted.
While he agreed publication in a peer-reviewed journal is "the gold
standard for getting information out," Lassman said companies often
present data at medical conferences and or post them in an online
industry database, http://www.clinicalstudyresults.org.
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