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language skills; social and emotional development of infants and toddlers; the effects of child care arrangements in the first year of life on the developmental progress of children two and three years old; and child care conditions that lead to favorable developmental outcomes as well as those conditions that lead to poor outcomes at 15, 24, and 36 months of age. Such information will be useful to parents when they consider child care arrangements and could also lead policy makers to require that providers of care for infants meet standards shown by this study to be important.

Question. Will following these children to age 3 be long


Answer. Following the children through the age of three will provide useful and scientifically important information. Since developmental milestones and goals change with the child's age, additional knowledge could be gained by following the development of these children beyond age 3. For example, it would be interesting to find out to what extent their early experiences hinder or enhance their ability to master age appropriate developmental challenges such as the ability to make friends and to maintain friendships, the ability to reach goals through harmonious interactions with others, and the ability to acquire reading and math skills. At this time, however, no decision has been made to follow the children for a longer time period. NICHD would like to progress further along into the current study before making any further plans.


Question. Dr. Alexander, the budget for the new National Center on Medical Rehabilitation Research for persons with physical disabilities has $3.8 million for grants and I understand another $1.2 million for intramural activity and staffing. Since the Center is now established and can be in full gear in 1992, is that enough money given the immense needs for improved medical rehabilitation and technology for persons with disabilities? What is your professional judgment about a budget level to meet the needs in this field?

Answer. The FY 1992 budget request for the National Center on Medical Rehabilitation Research (NCMRR) will establish a broad-based research program that will include research project grants, research career awards, research training and R&D contracts. Subsequent to the passage of legislation in November, 1990, establishing the NCMRR, a budget request for FY 1992 was presented by NICHD to NIH in the amount of $14 million, which included extramural and intramural research on medical rehabilitation, as well as administrative costs.


Question. Dr. Alexander, last year the Senate Appropriations Committee provided $1.5 million for the limitation of negotiated reductions at 14 Mental Retardation Research Centers supported by NICHD. Please describe how you complied with that congressional directive.

Answer. Although the Senate Committee provided funds for additional Mental Retardation Research Centers and relief of inflationary pressures in FY 1991, the appropriation included an

increase of funds only for additional centers. Thus, the NICHD will award grants for two additional centers for a total of 14 in

FY 1991, and continuation awards for existing centers will be at approximately the same level as in FY 1990.


Question. How is the Institute addressing the fetal alcohol syndrome (FAS) problem?

Answer. Research on alcohol and pregnancy, including Fetal Alcohol Syndrome (FAS), is part of the mission of the National Institute on Alcohol Abuse and Alcoholism (NIAAA). Research supported by NIAAA first led to the identification and description of FAS in the 1970s, and found that heavy maternal drinking was a clear health risk to the infant.

Question. Is money being allotted for research in this area for FY 1992?

Answer. NIAAA support for alcohol and pregnancy research in FY 1992 is estimated at $11,500,000. The NICHD does not conduct research on Fetal Alcohol Syndrome.

Question. Does your Institute coordinate or plan to coordinate FAS research with the Indian Health Service?

Answer. As the focal point for FAS research in the Public Health Service, the NIAAA actively coordinates its FAS research with the Indian Health Service, and with the Centers for Disease Control and the Office of Substance Abuse Prevention.


Question. Is your Institute currently funding projects using the drug RU-486? If so please explain the objectives of these studies.

Answer. At the present time the NICHD is supporting one extramural grant and conducting one intramural study using the drug RU-486. The extramural grant is seeking to increase our understanding of the cellular mechanisms underlying preterm labor, which is a major cause of infant mortality and morbidity in the United States. Data obtained from this research grant should help provide a fundamental basis for the development of new preventive therapies and risk assessments for preterm labor. The intramural study currently being conducted by the NICHD is designed to evaluate the effects of a small daily dose of RU-486 on the endometrium, the lining of the uterus. Utilizing its ability to block the action of progesterone, this low dosage of the drug may prevent the normal development of the secretory endometrium and thereby prevent pregnancy. Further research, based on the findings of the current study, holds the potential of the development of RU-486 as a new, safe and effective means of preventing pregnancy.



Question. The President's budget quotes the publication "Costs of Injury Prevention: a Report to Congress," noting that the potential savings from reducing injuries is in the billions of dollars. What types of injuries do we know the least about preventing, and do you have plans to expand the program of injury prevention research at NICHD in FY 92?

Answer. Of the major types of injuries, we know the least about preventing injuries to pedestrians, suicide, homicide, drowning in minorities, and all injuries to adolescents. The NICHD plans to expand its support of studies on these subjects, as part of a five year initiative in childhood injury prevention research. Specific plans include solicitation of research proposals on alternative methods to study life threatening injuries; interventions based on new understanding of the mechanisms of injuries; and injury prevention in adolescents.


Question. I've heard a lot recently about the need for more research on the adolescent population, since it's considered an under-studied population. Does NICHD plan to expand its portfolio on adolescent studies?

Answer. Yes, the NICHD does plan a significant expansion in this area. We have long considered adolescence a critical period of development, and there has been longstanding support for research on the entry of adolescents into sexual activity and then subsequent fertility-related behavior. We plan to support a major, integrative study of adolescent behavior that examines peer and family influences on adolescent behavior. Additionally, this study would investigate how adolescent development may be affected by different contexts--social, economic and school. Researchers have long considered how these aspects of adolescents' lives fit together, and this will be a major new study to address them in a coherent manner. We view this as the beginning of a new generation of research on adolescent behavior. Another feature of this initiative is the concern about understanding the diversity of the teen population. Given the different rates at which white and black teens experience early childbearing or poor educational outcomes, it is important that studies be designed so that we can separate the effects of race and ethnicity from those of economic conditions. This project could provide information that is critical to our understanding of how adolescents traverse these difficult years successfully and our ability to intervene when the process is not going well.

Research on adolescent sexual behavior and fertility will be expanded to encompass the risk of AIDS for the adolescent population, as part of our broader effort to understand the role of risk-taking in a more general sense. While much of the concern about adolescents revolves around social and behavioral issues, there are many questions about the processes of puberty and control of growth that are also high on our agenda of ongoing and expanded research efforts.


Question. Last year NICHD began work on a multi-site project to assess the similarities and differences in children in various child care arrangements. How is this project funded under the Administration's budget proposal, and is it funded adequately, in your professional judgment?

Answer. Support for the NICHD Child Day Care Network in FY 1992 is estimated at $4,100,000. This amount is adequate to provide for implementation of research protocols at all ten sites that have been established. The FY 1992 funding level is the same as FY 1991, and will allow us to continue the project. Were additional available, they would be used to support additional protocols.



Question. Dr. Alexander, a recent article which appeared in the New York Times indicated that the first wave of children prenatally exposed to crack has entered the nation's schools and that teachers are being caught unprepared to deal with the children's problems. Last year, this Committee included $2,000,000 for the Institute to initiate a long-term study to answer questions regarding the consequences of maternal drug use so that we have a better understanding of how to address the problems of these children. Would you please tell the Committee the status of this important project?

Answer. The Institute has undertaken a comprehensive analysis of the literature and relevant data on the issue of substance abuse in pregnancy and its consequences in infants and children. This analysis is well under way. It is being conducted under the leadership of Dr. James Mills of the NICHD Prevention Research Program, a pediatric epidemiologist. He is being assisted by other NICHD staff members with a variety of expertise. In addition, Dr. Lee Robins of Washington University in St. Louis, an outside expert on the subject of substance abuse, is working full-time on the project. The report of this analysis should be available in September, 1991. It will contain a research agenda that will address the new knowledge needed to answer the questions about longrange effects on infants and children and how this agenda should be accomplished. One of the problems confronting researchers will be the difficulty of differentiating the effects of drug abuse during pregnancy from environmental effects occurring during infancy and childhood.


Question. Dr. Alexander, AIDS is an increasing problem among infants, children and women. I am advised that soon it will be the fifth leading cause of death for children and youth under 24 years of age. What action has the Institute taken in FY 1991 to expand its pediatric AIDS clinical trials program?

Answer. The NICHD has joined its pediatric and maternal AIDS clinical trials network consisting of 21 centers to that of the NIAID, to facilitate access to state-of-the art care and therapeutic research to a large portion of the HIV infected children and pregnant women in the United States. This change has resulted in a unified Federal effort to develop new therapeutic strategies to treat HIV infection in children and to interrupt the transmission of the human immunodeficiency virus from infected pregnant women to offspring. This effort is a cost-effective approach to the development of new ways of treating and preventing infection. NICHD approach is also time and cost-effective for the investigators involved, as new centers can be added readily to this clinical trials network through a mechanism that also allows for optimal consistency in research protocols.


Question. Are funds included in the FY 1992 budget to expand this important program?

Answer. Funds to expand this network are not included in the FY 1992 budget.

Question. In your professional judgment, do the scientific opportunities merit expanding this network of clinical trials units?

Answer. Yes, scientific opportunities do merit the expansion of this network. There is only one drug, AZT, currently approved for use in the treatment of HIV infection in children. Also, there are no drugs which eliminate the transmission of HIV from pregnant women to offspring, and there has been almost no research on improved treatment of opportunistic infections, which are one of the major killers of children with HIV infection. In addition, there has been little research done to determine how the impaired immune systems of infected children can be restored or to assess what surrogate markers may be used appropriately to determine drug efficacy in infants and children. We are only at the very beginning of the work to be done in this arena.


Question. Dr. Alexander, approval of the long lasting contraceptive Norplant has sparked a debate over the ethical and public policy implications of government either imposing directly by order, or indirectly through coercion, contraception upon women. What has the Institute's role been in the development of Norplant?

Answer. The Institute has not played a direct role in the development of Norplant. We did provide to the Population Council, the developer of Norplant, the toxicology reports on an implant that we are developing and which uses levonorgestrel as the contraceptive drug. This is the same drug as is used in Norplant. The toxicology study indicated that the drug was safe for long term implant use.

Question. Have you supported research into the ethical implications of new contraceptive technologies, such as Norplant?

Answer. We have not supported any research dealing with ethical implications of new contraceptive technologies, such as Norplant. We have, however, participated in many discussions concerning development of a variety of contraceptive methods and

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