Remarks of Duane Alexander, M.D., Director, National Institute of Child Health and Human Development
September 29, 2005
Good afternoon. Welcome and thank you for coming.
I'd like to thank the United States Surgeon General, Vice Admiral Richard Carmona for being with us today. Thank you also, to the federal study partners who are here:
- Dr. William Farland, Acting Deputy Assistant Administrator for Science, of the Environmental Protection Agency's Environmental Protection Agency's (EPA) Office of Research and Development
- Dr. Dixie Snyder, Chief Science Officer, of the Centers for Disease Control and Prevention
- Dr. Sheila Newton, Director of Science Policy and Planning, National Institute of Environmental Health Sciences
I'm also pleased to welcome several supporters of the National Children's Study:
- Dr. David Schonfeld of the American Academy of Pediatrics
- Dr. Elena Rios of the National Hispanic Medical Association
- Dr. Sandra Gadson of the National Medical Association
- Ms. Nsedu Obot Witherspoon of the Children's Environmental Health Network
- Dr. Nancy Green of the March of Dimes
- Ms. Nancy Sander of the Allergy & Asthma Network Mothers of Asthmatics
- Ms. Juanita Campbell and her son, who will share her hopes about how the National Children's Study may benefit her son, Xavier Campbell, who is also here today, and generations of children.
Today, we will announce the names and locations of the 6 Vanguard Centers that will pilot and complete the first phases of the National Children's Study. They are the first to recruit participants for the planned study, which would eventually take place in 105 representative communities throughout the country. Teams from the Vanguard Centers will collect health information about the participants and the environments in which they live.
Many of you already are familiar with the planned National Children's Study. You've followed the process in which it was designed and the selection of locations where the study would take place.
Others may be less familiar with it. Please allow me to bring you up to date.
As it's envisioned, the National Children's Study would take the most detailed look ever at how the environment influences human health and development. There is strong evidence that early experience-perhaps starting as early as in the womb-shapes adult health and well-being.
Other evidence suggests that environmental influences on the DNA that we inherit from our parents also may affect our health. In fact, parents would be included even before they have children, to see if their health influences their children's health. Similarly, minor variations in our DNA explain why different people respond differently to the same environmental exposure.
The National Children's Study would follow more than 100,000 children, from before birth-and, in some cases, even before pregnancy. It would meticulously measure their environmental exposures while tracking their health and development, from infancy through childhood, until age 21, seeking the root causes of many childhood and adult diseases. In their search for environmental influences on human health, study researchers plan to examine such factors as the food children eat, the air they breathe, their schools and neighborhoods, how often they see a health care provider, and even the composition of the house dust in their homes.
Study researchers plan to enroll more than 100,000 women to ensure that enough children participate. In many cases, the women's partners would also be enrolled in the study. Study scientists plan to include not only pregnant women, but women who are planning to become pregnant. The researchers also intend to include women who have no plans to become pregnant. Many pregnancies are unintended, so including this latter group would allow study scientists to examine factors surrounding planned and unplanned pregnancies for possible effects on health and development.
Study researchers intend to collect biological samples from both parents and children and analyze them for exposure to environmental factors.
Current plans are to include volunteers from roughly 105 locations that are representative of the entire country. A total of about 40 study centers would be selected to conduct the study in these 105 locations. The Vanguard Centers we're announcing today are the first of such study centers.
The goal is for The National Children's Study to be more than just a scientific research study. It is intended as an investment in the future of our children and the future of our nation.
We would expect numerous returns on this investment. Such returns would be received not just during the Study's early years, but throughout its projected 25-year course. Study findings would benefit all Americans by providing researchers, health care providers, and public health officials with the information they need to develop health and safety guidelines, disease prevention strategies, and new treatments.
Depending on funding, the Study's first results-likely on pregnancy and birth-could appear as early as 2010. Periodically, the researchers plan to review the information they've collected. When they uncover important health information, they'll make their findings known to the public.
We expect the Study would uncover information leading to new treatments and perhaps even ways to prevent such conditions as:
- birth defects and other pregnancy-related problems, such as prematurity
- heart disease
- behavioral problems and learning disorders
- mental health disorders
We anticipate that the health information we would gain from the Study would more than compensate for the projected $2.7 billion in funding that it will require over its 25-year span. By comparison, the societal burden of the study's 5 major health outcome theme areas- injury, obesity, diabetes, asthma, and neurobehavioral disorders-totals $758 billion per year.
Today, I am pleased to announce the names and locations of the first Vanguard Centers. These Centers will begin to carry out this research effort in the first six communities to participate in the Study. We are also awarding a contract to one coordinating center. This center will manage information for the Vanguard Centers and support other parts of the Study. It will collect data, compile and analyze statistics, and ensure that the overall Study is proceeding according to plan.
The Coordinating Center is WESTAT in Rockville, Maryland and it will assist the following Vanguard Centers. In the interest of time, I will only mention institutions of the Principal Investigators, recognizing that many have formed larger collaborative networks involving a much longer list of organizations.
- University of California-Irvine for Orange County, California
- University of North Carolina at Chapel Hill, for Duplin County, North Carolina
- Mt. Sinai School of Medicine for Queens County, New York
- Children's Hospital of Philadelphia and Drexel University for Montgomery County, Pennsylvania
- University of Utah for Salt Lake County, Utah; and
- University of Wisconsin - Madison and the Medical College of Wisconsin for Waukesha, Wisconsin.
We are negotiating for two additional Vanguard Centers to serve other areas.
Representatives of the current Vanguard Centers are with us today. Please join me in welcoming:
- Dr. Pathik Wadhwa and Dr. Feizal Waffarn of the University of California-Irvine.
- Dr. Phillip Landrigan of the Mount Sinai School of Medicine.
- Dr. David Savitz of the University of North Carolina at Chapel Hill.
- Dr. Jennifer Culhane of Drexel University.
- Dr. Edward B. Clark of the University of Utah.
- Dr. Maureen Durkin of the University of Wisconsin-Madison and Dr. Chris Cronk of the Medical College of Wisconsin.
The Vanguard Centers were selected from a pool of applicants through a competitive process. They were successful because they have demonstrated the capability to conduct the Study. This capability involves collecting and managing biological and environmental specimens, operating community networks to recruit volunteers, and protecting the privacy of the information they collect.
The Vanguard Centers, which include a variety of universities, hospitals, health departments and other organizations, will work within their communities to begin recruiting participants, collecting and processing data, and piloting new research methods for incorporation into the full Study.
The Study has adequate funding to launch the Vanguard Centers. The federal agencies leading it hope to award additional Study Centers to work in a total of 105 sites, subject to the availability of future funding. Future centers would be selected in a competitive process like the one just completed for the Vanguard Centers. The timing of a new competitive process also depends on future funding.
It's taken five years to plan and develop the National Children's Study. Many of the best and brightest minds in child and environmental health took part in this effort. More than 2,400 researchers from government and the private sector were involved. I am delighted that we have taken this first step to learn how we can improve the health of our nation's children—and all Americans—for generations to come.
It is fitting that these first steps are being taken in 2005. The Surgeon General, Richard Carmona, set the theme for 2005 as "The Year of the Healthy Child." With this theme, Dr. Carmona sought to ensure the health and well being of every child. The National Children's Study would be a giant step toward that objective.
Now, I am pleased to welcome a great advocate for children's health, and for the health of our nation. Please join me in welcoming the 17th Surgeon General of the United States, Vice Admiral Richard H. Carmona.
The NICHD is part of the National Institutes of Health (NIH), the biomedical research arm of the federal government. NIH is an agency of the U.S. Department of Health and Human Services. The NICHD sponsors research on development, before and after birth; maternal, child, and family health; reproductive biology and population issues; and medical rehabilitation.