Director's Opening Statement on the FY 2007 President's Budget Request for the Senate Subcommittee on Labor-HHS-Education Appropriations

National Institutes of Health

Fiscal Year 2007 Budget Request

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

March 29, 2006

Mr. Chairman and Members of the Committee:

I am pleased to present the fiscal year (FY) 2007 President's budget request for the National Institute of Child Health and Human Development (NICHD). The FY 2007 budget includes $1,257,418,000, a decrease of $7,351,000 over the FY 2006 enacted level of $1,264,769,000 comparable for transfers proposed in the President's request.

The mission of the NICHD is vital to the NIH goal of ensuring the overall health and well-being of the American people. Our research focuses on both child health and human development. Increasingly, researchers are confirming that lifelong health and well-being are strongly influenced by events occurring early in life.

Understanding human development evolves from understanding normal growth and change processes before birth through adulthood. It begins at the most basic molecular and cellular levels and encompasses cognitive, behavioral, physical and social development. By understanding what goes “right,” NICHD research provides clues as to what may go “wrong,” laying the critical scientific foundation not only for understanding many disease processes, but also for preventing them altogether.

Fetal Development: Jump Start On Life

We now know that mothers who have undernourishment and obesity have children with increased risk of chronic disease later in life. This is a problem world wide and it is an increasing problem in the United States.

To understand and reverse the epidemic of type 2 diabetes among young people, we need to look beyond their diet. The health and nutrition of the mother during fetal development influences not only how children function but also the later development of diabetes, high blood pressure, heart disease and other conditions. To better understand fetal origins of adult disease, researchers recently discovered links between birth weight and stress hormone (cortisol) levels in boys and girls who were small at birth, but healthy term babies. Cortisol helps to regulate blood pressure, energy production, and response to stress. The researchers found that the lower birth weight boys had higher levels of cortisol under stressful conditions compared to the higher birth weight boys. They found that the lower birth weight girls had higher cortisol levels at the beginning of the day. This discovery demonstrates how low birth weight can have lasting, yet different, effects on stress hormone levels in girls and boys. These alterations in cortisol may predispose children to obesity, hypertension, and glucose intolerance later in life.

Predicting Preeclampsia

Preeclampsia is a sudden, dangerously high increase in high blood pressure that threatens the health of a pregnant woman and her fetus. Preeclampsia strikes without warning and can result in maternal seizures and even death. The researchers studying this condition found that women who, in mid-pregnancy, have a lower level of a substance known as placental growth factor were more likely to develop preeclampsia. This advance may lead to a screening test for preeclampsia and a treatment to help women avoid the condition.

Obstetric Pharmacology - Treatment For Pregnant Women

Most drugs used to treat pregnant women are prescribed without full knowledge about safety and efficacy. In many cases, no data exists to predict how the drug’s dynamics may interfere with a woman’s pregnancy. To fill this knowledge gap, the NICHD has established the Obstetric-Fetal Pharmacology Research Units (OFPRU) Network to develop improved safety and efficacy drug information for pregnant women. One drug currently being studied is used to control gestational diabetes. Gestational diabetes affects up to 15 percent of all pregnancies according to the March of Dimes. The condition results from a sudden inability of the body to remove sugar from the blood. Untreated, gestational diabetes results in large, stocky babies who may cease breathing unexpectedly, have difficulty feeding, and must eat frequently to avoid seizures. Children of mothers with gestational diabetes are also likely to have obesity during childhood and adulthood.

For many years, physicians treated gestational diabetes with injections of insulin. Recently, however, physicians began treating pregnant women with glyburide, which stimulates the pancreas to gradually release small quantities of insulin. Many patients preferred the convenience of taking a pill to giving themselves an injection. Although many pregnant women have taken glyburide, no studies have ever tested the drug’s effectiveness in treating gestational diabetes. A new study is examining the use of glyburide in pregnancy, to determine if the current dosing schedule is the most effective means to treat the disorder.

Premature Birth Research

Reducing preterm birth (PTB) is a major public health priority and a major research priority for this Institute. One out of eight infants in the U.S. is born preterm. This amounts to about 476,000 infants a year. The March of Dimes estimates that babies born too soon or too small cost the U.S. health system $18.1 billion a year. Preterm infants face a number of serious health problems and life-threatening conditions. PTB accounts for nearly half of the neurological problems among newborns who are at risk of having learning disabilities and mental retardation. When preterm infants reach adulthood, they also face much higher risks of cardiovascular disease and diabetes.

The NIH investment in preterm birth research is paying dividends. For the first time, we now have a method to reduce the risk of PTB for some women. One of our studies found that weekly injections of a synthetic form of progesterone reduces the chances of preterm delivery in women who had already given birth prematurely. For the first time, this research gives doctors an intervention that has been shown to be both safe and effective in reducing the risks of preterm birth. This discovery also illustrates how quickly research can be turned into practice. Shortly after this research was published, The American College of Obstetricians and Gynecologists recommended that all of their members use progesterone to prevent PTB for women with previous PTB. Another study found that pregnant women who have a condition known as bacterial vaginosis have a greater likelihood of delivering prematurely. For many years, these women have been treated with antibiotics. Contrary to existing clinical thinking, treating the infection with an antibiotic during pregnancy did not reduce the incidence of preterm birth. Still another NICHD study found that women with a condition known as trichomoniasis are also at increased risk for preterm delivery. The study found that giving antibiotics does not reduce the risk of preterm birth associated with infection; moreover, this treatment actually increased the preterm birth rate.

The new knowledge gained from each of these three studies was created by one of the multidisciplinary clinical research networks supported by the NICHD. With these networks in place, NICHD scientists working with researchers around the country can answer important scientific questions quickly, and work through professional organizations to help clinicians translate the new knowledge into practice.

The NICHD recently established the Genomics and Proteomics Network for Premature Birth Research. This new network will focus on the hereditary information in DNA and the structure and function of proteins to understand the underlying processes that lead to preterm birth.

Genes May Hold The Key To Treating Uterine Fibroids

Each year, more than 200,000 women in the United States undergo a hysterectomy to treat the chronic pain and abnormal bleeding caused by fibroids. Scientists are exploring alternative ways to treat fibroids without surgery. Previously, these researchers identified a molecule called transforming growth factor beta (TGF-b) that helps to regulate several processes including the growth of uterine fibroids. Using a powerful new technology, the researchers identified the different genes influenced by the growth factor in both normal and fibroid cells. The researchers then tested a gene therapy that appeared to block production and action of TGF-b. This insight may lead to novel, non-surgical therapeutic approaches, not only to prevent uterine fibroid growth, but also to treat other reproductive conditions.

BufferGel Shown To Be Safe Contraceptive

Researchers have made a major step forward in developing contraceptives that protect women against HIV. One product, BufferGel, can be used with a diaphragm, much like a conventional spermicide. The results of a recent study demonstrate that BufferGel is as effective at preventing pregnancy as is currently available spermicides. A study is now in progress to determine if BufferGel can reduce transmission of the AIDS virus.

Gene Programs Early Development and Neural Migration

NICHD researchers made a significant advance in understanding dyslexia. In an article that Science Magazine called one of the 10 major breakthroughs in 2005, the researchers linked the developmental gene DCDC2 to dyslexia. This gene functions to control nerve cell migration in early brain development. This work suggests that genetic miscues alter brain biology in the womb in a way that predisposes people to problems later in life.

Future Research: Newborn Screening

The NICHD Newborn Screening Initiative is moving forward in its effort to develop and employ the latest technology for improving the availability, accessibility, and quality of genetic and other diagnostic laboratory testing for rare diseases and conditions affecting newborns. Ultimately, this research could help identify at-risk infants as early as possible and provide the data needed to develop therapies for many of these conditions. As a cornerstone activity, the NICHD funded a major grant for developing and refining a newborn screening test for spinal muscular atrophy (SMA), a common fatal neuromuscular disease in children. The NICHD will soon be funding additional grants to increase understanding of conditions such as SMA or other genetic conditions.

Mathematics and Science Cognition and Learning

The NICHD is enhancing its program to better understand the underlying developmental processes that allow children to learn math and science. One goal is to help researchers understand the developmental and cognitive processes needed to help children transition successfully from arithmetic to algebraic reasoning, a fundamental skill needed to allow children to advance their understanding of mathematical concepts. In turn, mastering math-related concepts such as recognizing patterns, representing relationships, and making generalizations is key to learning and understanding science. These critical program activities fill a major research need to clarify the cognitive factors needed for scientific thinking and learning.

Community-Based Rehabilitation Intervention

The aging of the baby-boom generation and expected pressures on the U.S. health care system make research into effective therapies in community settings a high priority. Clinical trials of rehabilitation therapies have demonstrated the efficacy of novel interventions in preventing or significantly lessening disabling conditions associated with stroke, traumatic brain injury, and other disorders and conditions. Little is known, however, about whether and how well such therapies will work in less-controlled community practice settings. Scientists do not know whether—or how—efficacious rehabilitative therapies and even clinical trial design may need to be modified for community settings. To address these critical questions, the NICHD will solicit applications for clinical trials by scientists partnering with persons with disabilities, practitioners, and others in the community.

Mr. Chairman and members of the Committee, the support you have shown for medical research has allowed scientists in research centers around the country to make discoveries that advance the health of women, children and families. I will be pleased to answer any questions.

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