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Director's Opening Statement on the FY 2003 President's Budget Request for the House Subcommittee on Labor-HHS-Education Appropriations

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

NATIONAL INSTITUTES OF HEALTH

Fiscal Year 2003 Budget Request

Witness appearing before the
House Subcommittee on Labor-HHS-Education Appropriations

Duane Alexander, M.D., Director
National Institute of Child Health and Human Development

March 13, 2002

Kerry Weems, Acting Deputy Assistant Secretary, Budget

Mr. Chairman and Members of the Committee:

I am pleased to present the FY 2003 President's budget request for the National Institute of Child Health and Human Development (NICHD) of $1,218,112,000 which reflects an increase of $100,870,000 over the comparable FY 2002 appropriation.

The NIH budget request includes the performance information required by the Government Performance and Results Act (GPRA) of 1993. Prominent in the performance data is NIH's second annual performance report which compares our FY 2001 results to the goals in our FY 2001 performance plan.

For almost 40 years the NICHD has conducted research that touches Americans throughout their lives. We seek to ensure that people are able to have the children they want at the time they want them; that women experience pregnancy without complications and suffer no adverse consequences from the reproductive process; that every child is born healthy and wanted; that all children experience healthy physical, cognitive, behavioral, and social development and reach adulthood free of disease and disability and able to fulfill their potential for a productive life; and that people of all ages who experience disability as a consequence of congenital defects, injury, or disease achieve maximum function through the best rehabilitation we can provide. We have a broad mission, and we have a dynamic program of research in all of these areas.

EARLY CHILDHOOD EDUCATION AND SCHOOL READINESS

Reading skills are essential to function in our society. Yet many children, particularly children born in poverty, never learn to read. This inability to read has profound and long term implications for the children in terms of their health, their participation in civic life, and their ability to function in an increasingly complex world. Our research has demonstrated that getting children ready to read before kindergarten is a critical step in actually learning to read. Children need to have a basic understanding that there is a connection between sounds, letters, words and print before and during kindergarten to learn to read by the first grade. Our research has also revealed that the vast majority of students who are poor readers in the first grade remain poor readers in the fourth grade and that almost all children who are good readers in the first grade remain good readers in the later grades. Early intervention is critical to developing good reading skills and the interventions should start before kindergarten. The NICHD, in cooperation with the NIMH and the Department of Education, is launching a new program to identify the most effective ways to help children develop their learning abilities. The program has a comprehensive focus that includes promoting cognitive, language and early reading and math abilities as well as self regulation skills, social competency, and emotional health. We strongly believe that every healthy child can and must learn to read.

ADVANCES IN MENTAL RETARDATION

Since the NICHD was established, we have made remarkable progress in identifying, treating, and preventing many of the causes of mental retardation. Today, parents do not have to fear phenylketonuria (PKU), congenital hypothyroidism, or Hemophilus influenzae type b meningitis because these major causes of mental retardation have been virtually eliminated. Moreover, other causes of mental retardation such as measles encephalitis, congenital rubella syndrome, and bilirubin encephalopathy have nearly disappeared. And we are making progress in learning more about the most common inherited cause of mental retardation – Fragile X syndrome.

NICHD has a long history of supporting research on Fragile X syndrome. In the early 1990s, our research led to the identification of the gene affected in Fragile X, FMR1. Last year, in a unique collaboration between the NICHD, the NIMH and the FRAXA Research Foundation, we funded researchers exploring the neurobiology and genetics of Fragile X syndrome. This year, we will establish three new Fragile X Research Centers to conduct research directly related to the causes, treatment and prevention of Fragile X syndrome.

We are also increasing our research in autism. Within the NIH, five Institutes are members of the NIH Autism Coordinating Committee (NICHD, NIMH, NINDS, NIDCD, and NIEHS). Since this Committee was established a few years ago, the NIH has substantially increased its support of autism research from $22 million in 1997 to more than $55 million in 2001. The Collaborative Programs of Excellence in Autism (CPEAs) are a major focus of our research in autism. The CPEAs, which we fund along with the NIDCD, link more than 2,500 families of people with autism to more than 75 researchers in 26 universities around the country. The CPEA Network in turn is linked to a six-nation European autism consortium. The Network serves as a resource for individuals with autism and their families. The CPEA Network is now studying the world's largest group of well-diagnosed people with autism whose genotype and phenotype are available. NICHD will also join other NIH Institutes in funding at least five new comprehensive Centers of Excellence in Autism Research as required by the Children's Health Act of 2000.

Our Institute is committed to understanding and eliminating the causes of mental retardation. We are equally committed to applying the results of our research to the elimination of the barriers that people with mental retardation experience. The President's New Freedom Initiative calls for all Americans to be able to realize the dream of equal access to full participation in American society. For people with mental retardation, we came closer to realizing that dream in our collaboration with the Surgeon General on the Conference on Health Disparities and Mental Retardation. This unique conference was planned and carried out with the full participation of people with mental retardation. It resulted in a blueprint that we all can use to reduce these disparities.

MOBILITY FOR ALL

Traumatic injury is the leading cause of death for children and adolescents in the United States. Major advances in medicine and emergency room services have helped children survive their injuries, but many survive with disabilities and long term effects on their quality of life. Their conditions are managed through a variety of rehabilitation interventions such as medications, physical therapy, and adaptive equipment or prostheses. However, we have little information on the effectiveness of many interventions for children. A wide range of developmental events distinguishes the rehabilitation of infants, children, and adolescents from that of adults. Therefore we are establishing a series of clinical trial planning grants in pediatric rehabilitation. Our goal is to assure that infants and children who experience traumatic injury are restored to their maximum function through the best rehabilitation we can provide.

Traumatic brain injury (TBI) is a leading cause of disability among adults. During the last two decades, our understanding of traumatic brain injury has increased dramatically. For instance, we now know that not all neurologic damage occurs at the moment of injury, but evolves over the ensuing minutes, hours and days. We are therefore establishing a multi-center network of clinical sites to evaluate the relationship between acute care practice and rehabilitation strategies and the long term well-being of TBI patients. Our goal is to identify which of the interventions are most likely to result in long term improvements.

PREMATURE BIRTHS

Infants born prematurely have much greater risk of dying in infancy than do other infants. Premature birth puts infants at greater risk for life-threatening infections, for a serious lung condition known as respiratory distress syndrome, and for serious damage to the intestines. The earlier infants are born, the more problems they are likely to face. Some may develop lifelong disabilities, such as blindness, mental retardation, and cerebral palsy. The causes of premature birth remain a puzzle. Physicians have been largely powerless to prevent this serious, and often deadly, complication of pregnancy. Now, however, two groups of NICHD scientists have put many of the puzzle pieces in place and a clearer picture is taking shape.

Recently, NICHD scientists and their colleagues discovered that a surge in a stress hormone may signal the beginning of premature labor. They found that women who gave birth prematurely had higher levels of the stress hormone than did women who gave birth at full term. They also found that women who had a low level of education, received public assistance, or worked at jobs requiring them to stand or walk for more than six hours a day, also were more likely both to have high levels of the stress hormone and to give birth prematurely. These researchers are now looking for ways to reduce the levels of stress hormone during pregnancy to help prevent premature birth.

Our research is also changing the way we think about prematurity. Traditionally, researchers have believed that premature labor is an accident in which the uterus begins to contract before the unborn infant has reached full term. NICHD scientists have now uncovered evidence that in many cases, the fetus becomes seriously ill and chemically signals the beginning of labor in order to escape a hostile uterine environment. Instead of being an accident, the initiation of early labor may be a means that nature developed to spare mothers and babies from infection. We are now trying to find ways to identify women who have these infections and who may be at risk for premature labor and find successful ways to treat them. We are also exploring why African American women are more likely to give birth prematurely than are women in other ethnic groups. For example, we have discovered that some African American families are more likely to possess variations in the genes that signal rupture of the membranes, the prelude to labor. These variations may make it more likely that labor will begin prematurely.

DECLINE IN SIDS RATES

Since we began a public health campaign eight years ago urging parents and caretakers to place infants on their backs to sleep, we have witnessed a continuous and steady decline in the number of infants dying from Sudden Infant Death Syndrome or SIDS. Provisional data from the CDC show that the SIDS rate has declined by more than 50 percent since the campaign began. This remarkable achievement is a result of the thousands of individuals and the many organizations who have taken part in this national public health education effort.

Although the number of infants who die of SIDS has declined in all ethnic groups, African American infants are twice as likely to die from SIDS as white infants. To address and help eliminate this disparity, we are working with several national African American organizations including Alpha Kappa Alpha, 100 Black Women, and the Women of the NAACP who are meeting with parents and caretakers in schools, in churches, and in a variety of community settings on the ways to reduce the risks of SIDS. In the last 12 months more than 50 individual workshops have been conducted, and many more workshops are planned in the coming months in our effort to eliminate the disparity in the rate of SIDS.

DRUGS TO IMPROVE THE HEALTH OF CHILDREN AND PREGNANT WOMEN

Until fairly recently, over the counter and prescription drugs that were safe for adults were considered safe for children. However, in addition to being a smaller size, children's brains, bones, and metabolism are different from those of adults. Many of the drugs that have been shown to be safe and effective for adults have never been tested with children and in fact may behave very differently in children. In 1994 the NICHD established the Pediatric Pharmacology Research Unit (PPRU) network as a resource for testing the safety and effectiveness of drugs for infants, children and adolescents, and immediately began conducting research on drugs that have been inadequately studied. The network consists of a partnership among the NIH, the pharmaceutical industry, and university-based researchers. The PPRU network has grown considerably since the 1997 passage of the Food and Drug Administration Modernization Act. Thus far, the PPRU network has conducted more than 100 studies of drugs in children, including a new anti-diabetic drug. The working group is also developing new and advanced techniques to monitor a child's blood sugar. The PPRU network demonstrates that studies of drugs can be ethically and efficiently conducted in children.

The study of drugs used during pregnancy is another area of significant concern. Surveys reveal that nearly two- thirds of all pregnant women take at least four or five drugs during their pregnancy. Most of these drugs have never received FDA approval for obstetric use. Funds in the FY 2003 request will enable the NICHD to establish a network of Obstetric Pharmacology Research Units (OPRUs) to conduct studies of drugs during pregnancy to assess dose and safety issues in a way that will provide the necessary information for labeling for use in pregnancy.

WOMEN'S HEALTH RESEARCH

In another area of women's health, NICHD has established a Clinical Trials Network in Female Pelvic Floor Disorders and has funded eight sites in this network this year. Each site in the network supports a multidisciplinary team with the expertise, resources, and infrastructure needed to conduct the clinical studies in pelvic floor dysfunction, such as pelvic organ prolapse and incontinence. We are also collaborating with the NIDDK in funding a Urinary Incontinence Treatment Network. Through this array of support of basic and clinical research we hope to discover better ways to prevent and treat pelvic floor disorders.

ANTHRAX VACCINE

Scientists in NICHD's intramural laboratories, using funds provided in the DHHS Bioterrorism Initiative in the last three years, have developed a new approach to a vaccine against anthrax that they believe will require fewer injections, have fewer side effects, and induce better immunity. Funds in the FY 2003 budget request will support clinical trials of this new vaccine.

Mr. Chairman, I will be happy to provide answers to any questions you have.

Last Updated Date: 11/30/2012
Last Reviewed Date: 11/30/2012
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