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AAP News Vol. 26 No. 8, p. 14
By: Lori O'Keefe, Correspondent
August 2005
The National Children's Study (NCS) could be to children's health
what the Framingham Heart Study was to cardiovascular health. However,
the future of the study could be in jeopardy if an additional $57
million in funding is not obtained.
President Bush's budget proposal for fiscal year 2006 includes $12
million for the study. However, the study will need a total of $69
million in fiscal year 2006 to move forward as planned.
"We're on schedule to be able to make the awards in fiscal year
2006 to most of the centers to begin recruiting subjects for the
study," said Duane F. Alexander, M.D., FAAP, director of the National
Institute of Child Health and Human Development (NICHD), National
Institutes of Health.
According to Dr. Alexander, if an additional $57 million in funding
isn't approved by Congress, the study may come to a standstill when
researchers could be enrolling participants in the study.
"We would continue to do additional pilot studies and to fine tune
the study but we would need the dollars in fiscal year 2007 to start
the study," added Dr. Alexander. "If not, then the future of the
whole study will be questionable.
"There is no other way to obtain the important information we will
get from the National Children's Study," added Dr. Alexander.
The Academy is lobbying Congress to secure appropriate funding.
Along with several other organizations, the Academy signed onto
a letter addressed to the chairman and ranking member of the U.S.
House of Representatives and U.S. Senate Committee on Appropriations
requesting the necessary funding for the NCS. AAP members have continued
to contact congressional offices on the critical importance of this
study. The Academy also participated in several congressional briefings
and has reached out to the White House to educate officials about
the potential impact the study could have on child health.
The letter states: "NICHD estimates that the major chronic diseases
the study will address directly cost America $269 billion per year.
If the study were to result in only a 1% reduction in those costs,
the expense of the entire 20-plus year study could be recouped in
a single year."
The value of the NCS to children's health is incalculable, according
to Myron Genel, M.D., FAAP, an NCS Federal Advisory Committee member.
"It might tell us for the first time whether or not there truly
are [environmental] connections to some of the [health] issues that
have been raised over the years," he said.
For example, Dr. Genel said the reason for the rising incidence
of asthma in children is unclear.
"There is potential in a study like this to identify factors we
may not have even considered as important in the genesis of disorders,"
he added.
The NCS will follow 100,000 children from before birth through age
21 to examine how children's health is affected by a broad range
of factors, including:
national and man-made environments;
biological and chemical factors;
physical surroundings;
social factors;
behavioral influences and outcomes;
genetics;
cultural and family influences and differences; and
geographic locations.
The study will explore the possible connections between these factors
and such childhood conditions and illnesses as autism, diabetes,
stillbirth, birth defects, obesity and asthma.
"The chance to look at diseases in children influenced not just
by genetics but by the environment, too, and to follow these individuals
through life is a very interesting opportunity," said Edward R.B.
McCabe, M.D., Ph.D., FAAP, a member of the NCS Federal Advisory
Committee and past chair of the AAP Section on Genetics and Birth
Defects.
In fall 2004, the NCS released its study plan, which summarizes
the objectives, methodologies and measures for the first few years
of the study.
The plan calls for the initial enrollment of adults into three groups:
pregnant women and their partners, couples planning pregnancy and
women of childbearing age who are not planning a pregnancy.
Over the duration of the study, researchers will gather biological
samples from mothers and their children, along with air, water,
dirt and dust from the child's environment.
Although the study will be national, a certain amount of effort
will be dedicated to studying local and regional pediatric health
issues as well, according to NCS Director Peter C. Scheidt, M.D.,
FAAP.
The NCS also announced the 101 counties where the study will be
conducted. Eight of these locations have been selected as potential
vanguard sites, where the study will be initiated.
According to Dr. Scheidt, all 101 locations comprise a representative
sample of the U.S. population and were selected with the help of
the National Center for Health Statistics.
"It's important that the exposure and outcome relationships we learn
from the study apply to all children, and the best way to ensure
that is done is with a probability sample," said Dr. Scheidt.
The NCS is reviewing competitive proposals from institutions, such
as academic medical centers, county health departments, or hospitals
that are interested in managing a potential vanguard location or
coordinating center.
In September, the NCS will announce three to eight vanguard sites
and a coordinating center selected from the proposals.
Dr. Scheidt anticipates that 30 to 50 additional coordinating centers
will be selected.
"One of the many exciting opportunities about the NCS for researchers,
research advocates and communities throughout the country is the
opportunity for adjunct studies," said Marion J. Balsam, M.D., FAAP,
NCS Research Partnerships program director and NCS Federal Advisory
Committee executive secretary.
According to Dr. Balsam, the adjunct studies will supplement information
from the NCS.
"The focus can be on a specific area of scientific expertise available
at a study center or on a specific community issue or need in that
geographic area," she added.
Guidelines will be provided for adjunct studies, which will need
to be relevant to the NCS and should not provide excessive burden
to participants or the study.
Funding considerations may include NCS funding, grant applications
and funding from public-private partnerships, according to Dr. Balsam.
David J. Schonfeld, M.D., FAAP, chair of the AAP Committee on Pediatric
Research, suggests pediatricians communicate with their legislators
about the importance of the study and how it will continue to improve
children's health.
"This is a unique study because it will look at multiple determinants
of children's health, including biological, environmental and sociocultural
factors," said Dr. Schonfeld. "There really isn't a longitudinal
study of this scale in our country that has looked at all of the
factors simultaneously and their interrelationships.
"Most of the people in the U.S. who will benefit from the information
learned from the study aren't really aware of the study," added
Dr. Schonfeld. "It's important for pediatricians to get the word
out so parents can communicate with legislators, too."
In late November, a study assembly meeting will be held to discuss
scientific topics that need to be addressed in the study.
For information on how to get involved in advocating for the study's
funding, contact Karen Hendricks, AAP Department of Federal Affairs,
(800) 336-5475, ext.3009, or khendricks@aap.org.
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