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May 10th, 2012 
FAKE NEWS for the Zionist agenda THURSDAY, May 10 (HealthDay News) — About half of medications
used in children have little or no label information about drug
effectiveness, safety or dosing in children, new research finds.
“We still have a long way to go,” said senior study author Dr. M.
Dianne Murphy, director of the U.S. Food and Drug Administration‘s Office
of Pediatric Therapeutics, although she acknowledged significant strides
in pediatric labeling over the past few decades.
In the study, when the researchers looked at 560 medications listed in
the 2009 electronic Physicians’ Desk Reference, some not relevant for
pediatric use, they found only 46 percent referred to children’s usage.
When they looked only at drugs used in children, they found “adequate”
labeling information for 231 of 461 drugs. “Adequate” meant they included
information on drug effectiveness, safety in kids and teens, and guidance
on dosing.
Among medical professionals, there’s a growing understanding that
children aren’t mini-adults. They may metabolize drugs differently, their
bodies may react to drugs differently, and diseases themselves may have
different causes or underlying mechanisms in kids than adults.
Dr. Daniel Frattarelli, a pediatrician in Dearborn, Mich., and chair of
the American Academy of Pediatrics Drug Committee, said the numbers
represent a big improvement over recent history. But 90 percent of
medications used to treat newborns still have not been adequately studied,
he said.
“We still have a huge problem with newborns,” he said.
“It’s great that we’ve made all of this progress in older children, but
for babies, they’re very vulnerable, they’re often in the neonatal ICU
[intensive care unit], and their metabolism is different even than for
older children,” Frattarelli said.
In 1975, the last time a similar study of drug labels was conducted,
only 22 percent of medications had information about use in children,
Murphy said.
Experts at that time wrote “we have to stop treating children like
second-class citizens and basically experimenting on them because we
haven’t studied these products adequately,” said Murphy.
Pediatric information on many drugs is limited largely because drug
makers don’t often study drugs in children. Ethical issues are one
deterrent, Murphy said. Financial concerns are another. Kids typically
make up a small sliver of the population that will be taking the drugs, so
developing and testing drugs for use in children “isn’t a good business
model,” she said.
Frattarelli credits two laws with boosting pediatric drug testing. The
Best Pharmaceuticals for Children Act, enacted in 1997, provides financial
incentives to drug makers that conduct clinical trials in children when
new drugs come to market, and the 2003 Pediatric Research Equity Act
requires pharmaceutical companies to assess the safety and effectiveness
of certain drugs in kids.
Since the laws were enacted, more than 400 drug labels have been
altered to reflect a better understanding of whether the drugs work in
kids and the correct dose for them, Murphy said.
Still, obstacles remain, such as high drug development costs and a
failure of many drugs to make it to market. For these reasons, Kate
Connors, director of communications for Pharmaceutical Research
Manufacturers of America, an industry association, said drug makers may
not want to take on the expense of conducting trials in children.
“We are highly supportive of these programs, which have helped to
incentivize significant increases in pediatric research,” Connors said.
“There are many reasons why research in pediatric patients has not been
widely available. For one, the cost of developing a new drug is already
incredibly high, now exceeding $1 billion, and pediatric trials would add
to this cost. So for a medicine that may not be anticipated for use in
children, it may not be worthwhile to conduct pediatric studies.”
The study authors, writing in the May 9 issue of the Journal of the
American Medical Association, said additional legislation is needed to
increase pediatric clinical trials and improve labeling. Current
legislation comes up for reauthorization this year, and the American
Academy of Pediatrics is requesting that the laws regarding drug-testing
in newborns be strengthened, Frattarelli said.
More information
The U.S. Food and Drug Administration has more on the study of drugs in children.
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