Jew World Order

WEDNESDAY, July 25 (HealthDay News) — A new review finds that
while children account for almost 60 percent of those with five common
medical conditions, only 12 percent of clinical trials of drugs for those
conditions examined their effects on pediatric patients.

Yet, the review authors noted, previous research has shown that
off-label drugs, where the medicine has only been approved for adult use
by the U.S. Food and Drug Administration, make up as much as 79 percent of
the medications given to children in hospitals and up to 56 percent of
drugs prescribed for kids in doctors’ offices.

“We think this contrast is striking, and speaks to the
under-representation of research on kids,” said review author Dr. Florence
Bourgeois, an assistant professor of pediatrics at Boston Children’s
Hospital and Harvard Medical School in Boston. “Understandably, whenever
we see an adverse event the concern is, ‘Could these drugs really be
dangerous?’ and we are left wondering.”

The results were released online July 23 in advance of publication in
the August print issue of the journal Pediatrics.

The FDA requires that clinical trials demonstrate a drug’s safety and
effectiveness for a condition before it approves the drug to treat that
condition, but many drugs are only tested in adults. As a result,
physicians are often left to rely on trial-and-error to decide how to use
drugs off-label in children, the review noted.

Bourgeois and her team found that, while just over 21 percent of people
in high-income countries who are afflicted by conditions such as
depression, asthma, migraines, schizophrenia and bipolar disorder are
children and adolescents, less than 10 percent of clinical trials studying
these conditions included patients under the age of 18.

The gap was even wider for developing countries, where children and
adolescents bear nearly 62 percent of the disease burden for conditions
such as malaria, diarrhea, HIV and depression, but only about 12 percent
of clinical trials of treatments for these diseases include pediatric
patients.

A number of professional organizations, including the Institute of
Medicine, the American Academy of Pediatrics and the Royal College of
Paediatrics and Child Health in England, have all published statements on
the importance of evaluating medical treatments for children using
randomized, controlled trials. A randomized, controlled trial, in which
study participants are randomly chosen to either receive a treatment or
not, is the gold standard for medical research.

“In some instances, it may be fine to extrapolate adult [dosing]
information and scale down, but the way drugs are metabolized and excreted
from the body is different in children,” Bourgeois said. “Children might
metabolize faster and need a greater dose than one might think just in
terms of scaling down.”

Children are also a special patient group because their bodies are
still developing, and leaving them out of clinical trials means the
possible effects of drugs on their growth go unaddressed, said review
co-author Dr. Kenneth Mandl, an associate professor of pediatrics at
Boston Children’s Hospital.

In addition, some drugs taken by adults work the opposite way in kids,
explained Albert Wertheimer, a professor of pharmacoeconomics at Temple
University in Philadelphia.

“Drugs for [attention-deficit disorder] are stimulants that people take
to stay up for a test, but when used in kids, they settle them down,”
Wertheimer noted.

For the review, Bourgeois and her colleagues reviewed all the clinical
trials that were registered at ClinicalTrials.gov, the largest repository
of clinical trials conducted around the world, between 2006 and 2011 for
major pediatric conditions.

One reason for the lack of pediatric clinical trials could be who pays
for them: The current study found that, while half of funding for trials
on adults came from industry sources such as drug makers, the major source
of funding for trials on kids was nonprofit groups.

Although the lack of industry funding of children’s drug trials could
be viewed as a good thing because industry backing has been shown to
introduce biases, “it’s tricky because there are limited resources when it
comes to nonprofits, so it would limit the amount you can do,” Bourgeois
explained.

Pharmaceutical companies make a “conscious decision” to exclude
children from trials of their drugs because it is more difficult and
expensive to recruit children and get parental consent, and they have a
higher rate of dropping out of trials, Wertheimer said.

On top of that, the payoff is higher for adults, Mandl said. “There are
even larger markets of adult chronic conditions that are in the sweet spot
for profitability of blockbuster drugs.”

In an effort to spur drug research in kids, the U.S. government has
been offering financial incentives to drug companies that carry out
pediatric studies for more than a decade.

But, Bourgeois thinks that more is needed. “It should be a combination
of financial incentives and some requirements around what drugs need to be
tested in children,” she explained.

And, in high-income countries, the drugs to treat mental illness should
require the most research. “It’s really neuropsychiatric conditions that
have overtaken physical impairments,” Bourgeois explained. “Children might
be deprived of effective treatments if clinicians are not willing to use
drugs off-label in them.”

Wertheimer agreed that greater requirements for pediatric clinical
trials might be in order.

“For any drug that has a high probability of being used in children, it
wouldn’t be a bad idea to mandate that the drug be tested in some
population of children,” said Wertheimer, who added that drugs such as
antibiotics would likely have a large market in children.

In the meantime, the pace of research in children is at least picking
up, even if the rate has not been increasing as much as it has for adults,
Bourgeois noted.

More information

You can learn more about pediatric studies in children by visiting the
Institute of Medicine.