Testimony

Statement by
Peter C. Van Dyck, M.D., M.P.H.
Associate Administrator for Child and Maternal Health
Health Resources and Services Administration
Dept. of Health and Human Services
on
NIH Ethics Concerns: Consulting Arrangements and Outside Awards
before the
The Subcommittee on Children and Families
Committee on Health Eduction, Labor and Pensions U.S. Senate

May 12, 2004

Good morning, Mr. Chairman and members of the Committee.

I am Dr. Peter van Dyck, the Health Resources and Services Administration's Associate Administrator for the Maternal and Child Health Bureau in the Department of Health and Human Services. Thank you for the opportunity to testify today about prematurity and the related HRSA programs and activities.

The Health Resources and Services Administration (HRSA) - often referred to as the "access" agency - provides health care and social services to millions of low-income Americans, many of whom lack health insurance and live in remote rural communities and inner-city areas where health care services are scarce. We work in partnership with States and local communities. The Bureau I direct, the Maternal and Child Health Bureau, has a long history of working towards reducing prematurity and low birth weight as we strive to improve the health of our Nation's mothers and infants.

We recognize that low birth weight and preterm birth constitute a significant and costly health problem for this nation. Our efforts in this area include various programs and initiatives.

1. One program that has a significant impact on prematurity is the Maternal and Child Health Block Grant authorized by Title V of the Social Security Act. All Title V Block Grants, funded by Title V and issued through HRSA's Maternal and Child Health Bureau address aspects of prematurity and stipulate that grantees are required to submit annual performance measures. For the block grant, national core performance measures are collected. Pertaining to prematurity, these include:

Percent of very low birth weight infants among all live births
Percent of very low birth weight infants delivered at facilities for high-risk deliveries and neonates.

Approaches to reducing prematurity vary throughout the states from direct care to enabling services to infrastructure building. Each State tracks annually performance goals that include preterm infants as well as related performance measures such as increasing early access to prenatal care and decreasing the disparate ratio of black-white infant mortality rates. Based upon the specific needs of their State, these programs also develop and report on individual state performance measures targeting low birth weight, preterm birth, and infant mortality. Some examples of specific state performance measures include: Michigan which measures the percent of preterm births; Delaware which measures the percent of low birth weight black infants among all live births to black women; and New Jersey which reports the percentage of black non-Hispanic preterm infants.

2. Another HRSA program that deals with prematurity is "The Healthy Start" program. Healthy Start supports 114 projects located in 96 communities across the nation which have excessive rates of prematurity, low birth weight and infant mortality. Healthy Start strives to institute the best community-oriented methods to assure that at-risk pregnant women and their infants gain early access to necessary services during pregnancy and are followed through a continuum of care until two years post-delivery. This program emphasizes outreach, case management, screening and referral for perinatal depression and health education interventions to reduce risk factors such as smoking, alcohol and substance abuse. Selected projects are also examining interventions to address interconceptional care for women and infants identified as high-risk following delivery, to prevent future occurrences of these adverse pregnancy outcomes and optimize the development of the low birth weight/preterm infant over the next two years.

3. HRSA supports the African American-Focused Risk Reduction component of the Department's Closing the Health Gap Initiative on Infant Mortality. This is supported with funding from the Healthy Start program in conjunction with funds from the Department's Office of Minority Health. The goal is to reduce African American infant mortality due to low birth weight/preterm birth and Sudden Infant Death Syndrome (SIDS), the primary areas of infant mortality disparities for the African American population. HRSA will pilot projects in four States selected on the basis of having significant African American births and high infant mortality rates due to low birth weight/preterm births and SIDS. South Carolina, Michigan, Mississippi and Illinois will implement pilot projects in one to two communities within each State that: 1) build on existing activities that contribute to infant mortality reduction; and 2) employ evidence-based interventions that could contribute to reductions in low birth weight/preterm births. Awards are expected to be made this summer.

4. HRSA also supports a number of research projects that address factors associated with preterm birth or relevant clinical practices:

Multiple projects are using a new type of analysis to gain a better understanding of how multiple levels of influence � community or neighborhood factors as well as individual factors � are associated with adverse outcomes in pregnancy. For instance:

Several investigators are using Multi-Level Hierarchical Modeling to Examine Community-Level Factors Associated with Preterm Birth, particularly the racial/ethnic disparities in rates of preterm delivery.
Another study is investigating Modifiable Neighborhood-Level Factors and Low Birth Weight: This research project seeks to identify modifiable neighborhood level factors that are associated with intrauterine growth retardation and preterm birth in Louisiana during 1997-2000. The study will use several data sets, including the Louisiana birth certificate database and the Pregnancy Risk Assessment Monitoring System (PRAMS) survey for individual-level variables, and the U.S. census and various state health department databases for neighborhood level variables. The analysis will assess the relationships between neighborhood factors and pregnancy outcomes, and measure the extent to which the effects of the neighborhood factors are mediated by individual level biologic and behavioral factors.

Assessing the Stress and Preterm Birth/Low Birth Weight Relationship: Strenuous working conditions and occupational fatigue in pregnancy have been associated with preterm delivery and low birth weight among working women. This study will test the extent to which occupational stressors vary by race/ethnicity and how stressors (including racial discrimination) impact the risk for preterm birth and/or low birth weight. By investigating the relationships between stress during pregnancy, placental corticotrophin releasing hormone (CRH) and antenatal leave, this study will help identify the risks and protective factors that contribute to pregnancy outcomes among working women.
Collaborative Ambulatory Research Network: Using a network of practicing obstetrician-gynecologists, this project assesses current practice patterns, the relevant knowledge base and opinions around various issues related to maternal and fetal health. The findings will have implications for changes in provider education and practice.

In addition, HRSA is involved in translating Research into Policy and Programs. Initial work will focus on Women's Periodontal Health and Pregnancy Outcomes. A forum, planned for Fall 2004, will summarize the evidence around periodontal disease and preterm birth and identify relevant provider, system, and community actions for policy and program development.

5. HRSA supports and manages the Departmental Advisory Committee on Infant Mortality (ACIM). This is the national advisory committee established to advise the Secretary of HHS concerning the issue of infant mortality, including such causes as low birth weight/preterm birth, and the most appropriate steps that might be taken to address this problem. It also provides expert advice on how best to coordinate the variety of Federal, state, local and private programs and efforts underway that are designed to deal with health and social problems impacting on infant mortality.

6. We are proud of the fact that HRSA's health centers have fewer low birth weight babies than the national average. We can improve on that at the primary, community health level. As part of the HRSA strategy to close the gap in health disparities, HRSA-supported health centers will develop a cutting edge process to improve and change their systems of perinatal care. This initiative will be a part of the Perinatal/Patient Safety Pilot Collaborative. The aims of the Pilot Collaborative are to develop comprehensive perinatal system change interventions based upon the Care Model (which emphasizes evidence based, planned, integrated collaborative care) that will:

Generate major improvements in process and outcome measures for perinatal care, for example, decreased infant mortality disparity for African Americans and decreased rates of maternal and infant HIV transmission, low birth weight/preterm infants and sudden infant death syndrome; and
Establish and document the safety of the perinatal system for both infants and mothers. HRSA's Bureau of Primary Health Care also has a "best practices" project specifically addressed to low birth weight. It's a study to identify programs, policies and procedures of selected health centers that resulted in lowering the rates of low birth weight among racial/ethnic minority infants. A secondary aim of the project was to distinguish practices that could be replicated in other supported health centers with the hope of reducing low birth weights in communities of color. In the next six to nine months, the results of this study will be disseminated via presentations at professional meetings and through publications in peer-reviewed journals.

The Committee asked us specifically to address the Health and Human Services (HHS) Interagency Coordinating Council on Low Birth Weight and Preterm Birth. HRSA co-chairs and staffs this coordinating council. In response to recommendations of the Advisory Committee on Infant Mortality (ACIM), Secretary Thompson asked HRSA and the National Institutes of Health (NIH) to organize this HHS Interagency Coordinating Council. I'm proud to serve as co-chair along with Dr. Duane Alexander, Director of NIH's National Institute of Child Health and Human Development. The group includes representatives from 12 agencies and/or offices in the Department and 2 liaison members from the ACIM. The staff work for the Coordinating Council is being supported by HRSA.

The purpose of the Coordinating Council is to galvanize multidisciplinary research, scientific exchange, policy initiatives, and collaboration among the Department's agencies and to assist in targeting efforts to achieve the greatest advances toward the national goal of reducing infant mortality. In particular, Secretary Thompson requested the development of a department-wide research agenda on low birth weight and preterm birth, major contributors to infant mortality. Subsequently, Deputy Secretary Allen expanded the charge by requesting the Coordinating Council to include in its focus attention to racial/ethnic disparities and to Sudden Infant Death Syndrome (SIDS) as contributors to infant mortality.

The Coordinating Council is working in conjunction with the Advisory Committee on Infant Mortality to further efforts to formulate recommendations for a coordinated research agenda for the Secretary. Challenges for the Coordinating Council include efforts to assure adequacy of data on low birth weight and preterm births, uncovering new knowledge and developing a coordinated research agenda on preterm birth/low birth weight, and delivering and financing relevant health care. Currently, the Coordinating Council is compiling an "Inventory of Research and Databases Pertaining to Low Birth Weight and Preterm Birth and Sudden Infant Death Syndrome." This is a compilation of current and planned activities within the Department that address preterm birth and low birth weight. The Coordinating Council will use this information to examine gaps and identify priorities for future research addressing these issues.

The Coordinating Council is also contributing to the research coordination component of the HHS initiative mentioned earlier, Closing the Health Gap Initiative on Infant Mortality", in two ways:

The group has broadened its task to identify HHS research and programmatic activities pertaining to low birth weight/preterm birth prevention in African Americans and Sudden Infant Death Syndrome (SIDS) Prevention in African Americans and American Indian/Alaska Natives.
The group was asked to identify evidence-based interventions that can contribute to reductions in SIDS, reductions in low birth weight/preterm births, and infant mortality associated with low birth weight/preterm births. In its deliberations, the group discussed interventions that have been shown to be effective through a systematic search and review of the best available scientific evidence. Overall, the scientific literature reveals few successful interventions to prevent low birth weight/preterm births, although there are confirmed interventions that improve the survival of these infants. The interventions that the Coordinating Council identified will be utilized in the implementation of future health disparities initiatives.

Many of our programs at HRSA, especially those that provide direct and enabling services to women, provide a variety of education and training opportunities for providers concerning preterm labor, high-risk pregnancy, and risk factors. We have taken a proactive approach to reducing the risk of preterm labor and other adverse perinatal outcomes, including depression and tobacco use during pregnancy. Through a cooperative agreement with the American College of Obstetricians and Gynecologists, we have worked to educate obstetric and women's health providers to be able to recognize and address the critical public health issues associated with these events.

By partnering with federal, state and local governments, as well as the public and private sectors and professional and faith-based organizations, the Health Resources and Services Administration provides leadership in improving access to and improving the quality of health care and services for millions of Americans. We are hard at work identifying and translating into everyday practice across the nation the very best evidence-based interventions to overcome barriers to the nation's health care.

Thank you for the opportunity to appear before this Committee and summarize HRSA's activities that address prematurity. I would be happy to answer your questions.

Last Revised: May 17, 2004

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