DEPARTMENT OF HEALTH AND HUMAN SERVICES
NATIONAL INSTITUTES OF HEALTH
Fiscal Year 2010 Budget Request
Witness appearing before the
House Subcommittee on Labor-HHS-Education Appropriations
Duane Alexander, M.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development
May 21, 2009
Mr. Chairman and Members of the Committee:
I am pleased to present the President's budget request for the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The Fiscal Year (FY) 2010 budget requests $1.314 billion and includes an increase of $19 million over the FY 2009 appropriated level of $1.295 billion.
One measure of the strength of a nation is the health and well being of its children and families. Today, I would like to review some of the ways that the research supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development is contributing to healthier children, healthier families and a healthier nation.
Each year, nearly 6 million U.S. women become pregnant. NICHD research has helped women have safer pregnancies and healthier babies. Although we have made great strides, the problem of preterm birth is not only a serious concern, but one that is becoming more common. Preterm birth now occurs in about 12 percent of all pregnancies, 1 out of every 8 births. At birth, infants born preterm are at increased risk for a range of serious health problems, including death in the first year of life, blindness or visual impairment, deafness, and stroke. Our research has also documented that when preterm infants become adults, they are at increased risk for heart disease, diabetes, stroke, and cancer, so prevention of these adult disorders begins with preventing the causes of preterm birth. In one study seeking to prevent preterm birth, NICHD-supported researchers found that giving high-risk women the hormone progesterone during pregnancy reduced the rate of preterm birth in this group by one-third. High risk women in this study were those who had a previous preterm birth. By contrast, another NICHD study demonstrated that this treatment did not reduce the rate of preterm birth in women pregnant with twins or triplets. We are now studying whether progesterone can reduce preterm birth in women at high risk due to a shortened cervix. Cerebral palsy is another common complication of preterm birth. A third of all cases are associated with preterm birth. An NICHD study done jointly with NINDS demonstrated that magnesium sulfate given to the mother during labor significantly reduced the rate of cerebral palsy among their infants. Research can also inform us when to stop a practice that is thought to be beneficial. When preterm birth is threatened, administering one dose of drugs known as corticosteroids will cause babies’ lungs to mature, helping to avoid respiratory illnesses that may lead to severe complications, child or adult chronic lung disease, or even death. Many people believed that repeat doses would give even better results. A large scale NICHD-funded comparative effectiveness study tested this widespread assumption. The study found just the opposite: compared to infants receiving only one treatment, infants who received weekly treatments were slightly smaller at birth, and they also showed no improvement in lung function. Another example shows how important it is to test new ideas early, no matter how promising they may seem at first. A new technology, called fetal pulse oximetry, was developed to monitor the oxygen levels of the unborn infant during labor. The hope was that detecting low oxygen levels would signal a potential problem, and lead attending physicians to take appropriate action to speed delivery. An NICHD funded study found that knowledge of fetal oxygen levels did nothing to change the rate of cesarean section or improve the baby’s outcome, and that an expensive new technology was not worth the cost associated with it.
Testing Medications in Women
Most medications prescribed for pregnant women have never been tested or studied in this population. The NICHD’s Obstetric-Fetal Pharmacology Research Network, established with support from the Office of Research on Women’s Health, seeks to correct this situation. The Network allows researchers to conduct safe, technically sophisticated, and complex studies of drug metabolism, safety, and proper dosage in pregnancy, to help clinicians protect the health of women and the infants they carry, improving birth outcomes and reducing infant death. As a result of our research, we hope the warning label on drugs stating “safety for use in pregnancy has not been established” will become a thing of the past. Another NICHD network, the Contraceptive Clinical Trials Network, is launching a study to assess different marketed oral contraceptive formulations and doses in order to determine which are safest and most effective for women who are obese. Over half the women of childbearing age in the U.S. are overweight or obese and at elevated risk for contraceptive failure or blood clots. Information from this study, made possible by the funds from the American Recovery and Reinvestment Act, will allow physicians to personalize their treatment and prescribe the best regimen for their patients.
Autism spectrum disorders (ASD) encompass a range of conditions that include social interaction problems, poor verbal and nonverbal communication, and repetitive behaviors. These disorders may be mild or severe, and affect about 1 in 150 American children, about three-quarters of whom are boys. The Autism Centers of Excellence program, is cofunded by the NICHD and other NIH institutes. The program supports studies covering a broad range of autism research areas, including early brain development and functioning, social interactions in infants, rare genetic variants and mutations, associations between autism-related genes and physical traits, possible environmental risk factors and biomarkers, and potential new medication treatments. Three recent studies, supported by NICHD and other NIH components, provided a major insight into the genetic underpinnings of this group of disorders. The studies consisted of genome-wide scans of people with and without autism, to identify genetic differences between the two groups. All three studies concluded that the genes involved in autism impair the connections by which brain cells communicate. Another study by NICHD-supported researchers provided preemptive dietary guidance for families of children with autism. The findings showed that children with autism and autism spectrum disorder more often have calcium and vitamin D deficiencies, based on scans showing that the bones of a group of boys with autism were less dense than normal. They cited dairy-free diets—believed by some parents to alleviate the symptoms of autism— or unusual food preferences of many autistic children as a potential reason for these deficiencies.
Traumatic Brain Injury (TBI) has been described as a silent epidemic. Currently, over 3 million people in the U. S. live with the physical, cognitive, psychosocial and economic effects of the injury. Traumatic brain injuries may include contusions, lacerations and hemorrhage. Moreover, TBI often involves secondary effects that may last for days, weeks and even years following the initial insult. To date, no effective drug has been shown to successfully treat TBI despite more than 50 clinical trials. Most of these studies were conducted by individual drug companies testing a single drug. A new paradigm is now emerging as the potential treatment of the future: using a combination of drugs to target the multiple molecular, cellular and biochemical effects of TBI. Currently, the NICHD is supporting research using combination-drug therapy to establish the optimal time of the first dose, the dosage interval, and the duration of treatment. Here, the history of successful treatments using drug combinations for conditions such as cancer and HIV/AIDS serve as a guidepost. The goal of the research we are supporting is to help identify the combinations of drugs that could be used to prevent the long-term effects of TBI.
Investments in research by NICHD often produce long-term future benefits, some of which are finding applications in current policy initiatives. For example, more than 30 years ago, the NICHD provided support to begin and continue the Abecedarian Project, a study to determine the potential benefits of early childhood education among low income children. This landmark study randomly assigned four groups of children born between 1972 and 1977 to an early educational intervention group or to a control group. The intervention group was enrolled in a high quality child care setting, from infancy through age 5. The control group received ordinary care without the early child care services. The educational intervention sought to enhance the children’s social, emotional, and cognitive development, and concentrated on language development. The researchers monitored the children’s progress, checking in with them when they were 12, 15 and 21. Many studies showed that the graduates of the intervention group fared much better than their peers over time. They scored higher academically, often progressing to higher education. They were more likely to postpone parenthood. A recent analysis showed that while the intervention cost twice as much as a typical preschool program, it resulted in an overall return of four dollars for every dollar invested. Children in the intervention group were projected to earn about $143,000 more over their lifetimes than those in the control group. School districts could be expected to save roughly $11,000 per child, because graduates of such programs are less likely to need special educational services. Graduates of the intervention program were also less likely to smoke. The benefits in terms of longer life and reduced health care cost were calculated at $164,000 per person. A similar NICHD-funded program for low income children in the Chicago public school system also found extensive long term benefits for participants. By the time they reached adulthood, graduates of the Child-Parent Centers (CPC) program showed higher educational attainment, lower rates of serious crime and incarceration, and lower rates of depressive symptoms than did non-participants. The CPC program sought to stabilize family life by reaching out to parents, providing parenting classes, high school equivalency classes, career development skills workshops, and other professional training. Graduates of the program were more likely to attend college and to be employed full time. They were also less likely to receive public assistance or to have a disability than those who participated in other programs. These studies, and others that have replicated their findings, are providing the basis for policy and program recommendations today, documenting the long-term benefits of investing in this type of research. Many other examples could be cited that form the basis of the expectation that valuable knowledge will be gained from research such as the National Children’s Study.
In conclusion, Mr. Chairman, I would like to thank you for your long-term support of the work of this Institute, and I look forward to working with you and the subcommittee. I will be happy to provide any additional information.