DEPARTMENT OF HEALTH AND HUMAN SERVICES
NATIONAL INSTITUTES OF HEALTH
Fiscal Year 2006 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 9, 2005
William Beldon, Deputy Assistant Secretary, Budget
Mr. Chairman and Members of the Committee:
I am pleased to present the fiscal year (FY) 2006 President's budget request for the National Institute of Child Health and Human Development (NICHD). The FY 2006 budget includes $1,277,544,000, an increase of $7,223,000 over the FY 2005 enacted level of $1,270,321, comparable for transfers proposed in the President's request.
With the continued support of this Committee, the National Institutes of Health has the unique ability to invest in complex medical studies that continue for many years. It is particularly satisfying to all of us when an investment in research cures a disease or eradicates a condition. With deep satisfaction, we report a major medical and public health achievement that the New York Times heralded a few weeks ago in a front page headline: U.S. is Close to Eliminating AIDS in Infants.
This progress came in small incremental steps that arose from a large ambitious vision: to eliminate mother-to-child HIV transmission. Just a decade ago, a pregnant woman with HIV who lived in the United States had more than a 25 percent chance of passing the virus on to her child. In the early 1990s, the NICHD and the NIAID formed the Pediatric AIDS Clinical Trials Group to test promising new anti-HIV treatments. One of the first studies showed that the drug AZT administered to the mother and newborn infant at specific times could reduce HIV transmission from 25 percent to 8 percent. Subsequent research tested a drug combination known as highly active anti-retroviral therapy (HAART) and showed that the rate of transmission could be reduced even further. Today, with an expanded array of anti-HIV drug treatments, the chance of a pregnant woman in the United States passing the virus on to her child has plummeted to about 1.2 percent.
COMPOUNDS IN MOTHERS' MILK PROTECT AGAINST DIARRHEA
Human breast milk is known to protect infants from diarrhea, but the responsible components had not been known. Results of a routine investigation to understand the purpose of some complex sugar molecules found in human breast milk may lead to a way to prevent diarrheal diseases from occurring, not just in infants, but in older children and adults as well. The molecules, called oligosaccharides, are abundant in human breast milk. During the last decade, NIH-funded researchers have discovered that oligosaccharides can stop bacteria and viruses from binding to the cells in the intestinal wall, preventing diarrheal diseases from gaining a foothold.
Oligosaccharides have been found to combat E. coli 0157, the deadly bacterium that can infect ground beef and other common foods. They also block the Norwalk virus, which incapacitates thousands of cruise ship voyagers every year, as well as rotavirus, one of the most common causes of diarrheal diseases in children. Oligosaccharides may also provide a means to overcome the problem of bacterial resistance. They function differently than do antibiotics, and bacteria do not appear able to develop resistance to the oligosaccharides.
RESEARCH LEADS TO BETTER HEALTH FOR WOMEN
Fibroids, or leiomyomas, are painful noncancerous growths that develop in the smooth muscle of the uterus. Women with fibroids may have painful menstrual periods, pain during intercourse, infertility, incontinence, and bowel obstruction. Women with fibroids are also more likely to go into labor prematurely and to experience a miscarriage. The exact number of women with fibroids is not known, but between 25 and 40 percent of all U.S. women experience fibroid symptoms. Fibroids disproportionately affect African Americans. One study estimated that 80 percent of African American women have fibroids by age 60. There are few effective ways other than hysterectomy to treat these tumors. Recently, however, NICHD researchers made some basic discoveries about fibroids that may lead to effective non-surgical treatments. In one study, researchers used sophisticated gene analysis technology to learn that fibroids contained abnormally high levels of a protein known as dermatopontin. That study led to another discovery that fibroids are largely made up of abnormal strands of collagen; thus, researchers are now searching for new drug treatments directed toward the abnormal collagen.
Pregnancy and childbirth place women at higher risk for a disorder known as pelvic organ prolapse, which can be painful and disabling, and require surgical treatment. Although surgical procedures may correct the condition, many women may experience urinary incontinence as a result of such treatment, which may require a second surgery to correct. From early results of a clinical trial, NICHD-funded researchers have learned that performing an incontinence surgical procedure during the same operating room session as the prolapse repair markedly decreases the chances for incontinence, without adverse effects. Such findings not only have implications for improving the quality of life for women, but may have implications for helping to reduce the cost of care.
RESEARCH ENHANCES LEARNING
After more than 30 years of careful research—using the same scientific rigor we use to test a new drug or medical procedure—the NICHD has identified the instructional methods that best help children learn to read. A recent brain imaging study has shown that these scientifically proven methods actually change the brain functioning of formerly poor readers so that it resembles the brain functioning of good readers.
Unfortunately, however, many school districts still rely on instructional practices that are not based on scientific research. According to the National Center for Education Statistics, roughly 37 percent of the nation's 4th graders read below grade level. In collaboration with the Department of Education, NICHD staff is working to communicate evidence-based research findings to provide school districts around the country with new approaches to teach reading. To be competitive in the years ahead, U.S. students will also need a thorough grounding in science. A recent study has challenged current thinking on the best way to teach science. The traditional belief was that students would better remember what they learn if they discovered on their own how to conduct an experiment rather than having someone teach it to them. In fact, the researchers found just the opposite: that students learned faster and retained more information if they were given explicit instructions about experimental procedures. The finding provides teachers with important information on how best to convey scientific concepts to their students.
Our basic science laboratories continue to produce discoveries of potential clinical relevance to learning and mental retardation. NICHD scientists discovered that a single protein appears central to the formation of the long-term memories underlying all advanced learning. Two teams of NICHD scientists have discovered how the protein known by the acronym BDNF is produced in the brain and are studying whether defects in the BDNF protein system may lead to disorders of learning and memory. Other scientists have studied an animal model of the defective Rett syndrome gene that causes deterioration of cognitive and motor function in girls to learn how the gene causes anatomic and functional abnormalities. Studies also continue on the genetic and neurobiologic bases of autism.
KIDS MAY SAY OTHERWISE, BUT PARENTS MATTER
Several NICHD studies of child development provide strong evidence that parents can exert a direct and positive influence on the decisions that children and young adults make. For example, researchers had suspected for some time that extensive television viewing at an early age might be associated with decreased attention span in children. However, they had no data from long-term studies to support this observation. So NICHD-funded researchers designed a study to answer an important question: do children who watch increasing amounts of TV at one and three years of age have increase attention problems at age seven? The researchers analyzed data from an ongoing study involving more than 2,600 children and found that the more television very young children watched, the more likely they were at age seven to have attention problems. These findings do not mean that early television viewing is associated with clinically diagnosed attention-deficit/hyperactivity disorder (ADHD). However, the findings support the idea that parents could reduce the risk for attention problems by limiting children's television viewing in their early years.
NICHD scientists have also developed a research-based tool that parents can use to significantly reduce the risks that young, inexperienced drivers face. Insurance companies have known for some time that motor vehicle crash rates are higher for teenagers than for older drivers and are the highest during the first 1,000 miles and the first six months of driving. The researchers developed and tested a program in which the central feature is a contract between the parent and new driver. As part of this contract, the newly licensed driver agrees to limit driving at night, driving with other teens in the car, driving on high-speed roads, and driving in bad weather. NICHD research showed that parents can greatly reduce the risks that new drivers face.
REHABILITATION NETWORKS SEEK TO IMPROVE QUALITY OF LIFE
Serious illness and injury may result in life-long impairment. The Traumatic Brain Injury Clinical Trials Network will evaluate new treatments and rehabilitation techniques for children and adults with brain injury. The Pediatric Critical Care Network will evaluate new treatments for children who have suffered a serious injury or illness. The Network will study the effectiveness of short-term treatment and its relationship to the rehabilitation that patients receive and to the long-term outcomes.
THE BEST PHARMACEUTICALS FOR CHILDREN ACT
The NICHD, as directed by law, in consultation with the FDA and experts in pediatric drug development, has identified and prioritized the most important drugs for further study in children. Currently, children are being recruited to study lorazepam for use as a sedative and anticonvulsant, and nitroprusside for controlling blood pressure of children undergoing surgery. In cooperation with the National Cancer Institute, data pertaining to the drugs vincristine and dactinomycin are being reviewed to provide the first evidence-based look at the efficacy, toxicity, and dosing of these two drugs. The evidence from this review will provide the basis for subsequent studies that will provide specific guidance on the use of these drugs in children. Drugs on the current priority list will form the basis of solicitations in 2006.
THE NATIONAL CHILDREN'S STUDY
NICHD scientists working collaboratively with the NIEHS, the CDC, and the EPA continue to make progress in planning the implementation of the National Children's Study as directed by Congress in the Children's Health Act of 2000. The Study, with 100,000 families, can form the basis of child health guidance, interventions, and policy for generations to come. Funds in the FY 2005 budget are being used to establish four Vanguard Centers that will pilot recruitment strategies and the Study protocol. A data coordinating center will be established to provide the statistical analysis and reporting of the Study results. The protocol for this Study has been drafted and 101 sites across the U.S. have been identified to provide a population-based representative sample. These steps bring us closer to the point at which the full study could be implemented.
The NIH Roadmap initiative is providing an important guide to help the NICHD achieve its research and programmatic goals. The initiative directed to Re-engineering the Clinical Research Enterprise is currently helping to develop future leaders in clinical research. The NICHD is leading several targeted efforts to enhance the training, development, and support of the clinical research teams of the future.
Mr. Chairman and members of this Committee, I would like to thank you for your continued support of our research to improve the health and well being of women, children and families, as well as for your support in the critical task of developing tomorrow's research leaders. I will be pleased to answer any questions.
Duane Frederick Alexander, M.D.
August ll, l940, Baltimore, Maryland
Married Marianne Ellis, Washington D.C., June 23, l963; two children
Pennsylvania State University, University Park, Pennsylvania, B.S. Degree, Pre-Medical, l962
Johns Hopkins University School of Medicine, Baltimore, Maryland, M.D. Degree, l966
Intern and Fellow, Department of Pediatrics, Harriet Lane Service, Johns Hopkins Hospital, l966-l967
Assistant Resident and Fellow, Department of Pediatrics, Harriet Lane Service, Johns Hopkins Hospital, 1967-1968
1968-1970: Surgeon (LCDR), U.S. Public Health Service, and Clinical Associate, Children's Diagnostic and Study Branch, National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Bethesda, Maryland
1971-2000: From Surgeon to Assistant Surgeon General, U.S. Public Health Service
Fellow in Pediatrics (Developmental Disabilities), John F. Kennedy Institute for Habilitation of the Mentally and Physically Handicapped Child, Johns Hopkins Hospital, 1970-71
Maryland Board of Medical Examiners
Diplomate, American Board of Pediatrics, 1973
Assistant to the Scientific Director, NICHD, NIH
Medical Officer (Staff), National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, DHEW
Assistant to the Director, NICHD, NIH
Deputy Director, NICHD, NIH
Director, NICHD, NIH
Department of Health and Human Services, Office of Budget
William R. Beldon
Mr. Beldon is currently serving as Deputy Assistant Secretary, Budget in the Department of Health and Human Services. He has been a Division Director in the Budget Office for sixteen years, most recently as Director of the Division of Discretionary Programs. Mr. Beldon started in federal service as an auditor in the Health, Education and Welfare Financial Management Intern program. Over the course of more than 30 years in the Budget Office, Mr. Beldon has held Program Analyst, Branch Chief and Division Director positions. Mr. Beldon received a Bachelor's Degree in History and Political Science from Marshall University and attended the University of Pittsburgh where he studied Public Administration. He resides in Fort Washington, Maryland.