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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.
QUESTIONS SUBMITTTED BY SENATOR ARLEN SPECTER
DRUG ABUSE IN PREGNANCY
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
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. The 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
their impact on contraceptive practice and health. The guiding principle that we have followed is that utilization of any method should be voluntary.
CHILD HEALTH RESEARCH CENTERS
Question. Dr. Alexander, for the last two fiscal years, the Subcommittee has encouraged the Institute to establish a Child Health Research Center program and has provided the Institute with funds to accomplish that goal. Would you please update the Subcommittee on the status of the center grant program?
Answer. The Child Health Research Centers Program is intended to increase the ability of pediatric institutions to develop basic science investigative capacities for application to pediatric clinical problems. Seven centers were established in FY 1990.
Question. Do you plan to expand the program in fiscal years 1991 and 1992? If so, how much do you anticipate will be spent in this fiscal year and how much will be necessary to fund the program in fiscal year 1992?
Answer. In FY 1991, the Institute will support four additional centers. A Request for Applications for these additional centers was published on January 25, with a receipt date of April 9, 1991. Initial review of applications is for June 11-13. Grant awards will be made prior to the end of FY 1991. NICHD funding for the 11 centers in FY 1991 is estimated at $3.5 million. The FY 1992 Budget Request provides $3.6 million to continue these 11 centers. No expansion of the program in FY 1992 is included in the request.
QUESTIONS SUBMITTTED BY SENATOR MARK O. HATFIELD
SUDDEN INFANT DEATH SYNDROME (SIDS)
Question. Dr. Alexander, to what extent is Sudden Infant Death Syndrome (SIDS) a factor in our nation's infant mortality problem?
Answer. SIDS is the leading cause of infant mortality between the ages of one month and one year of life. Between 6,000 and 7,000 infants die with this diagnosis each year, with an incidence of one to two deaths per thousand live births.
Question. What is the present status on the implementation of the 5-year Sudden Infant Death Syndrome Research Plan?
Answer. The Institute is currently in the second year of the five-year plan and we are on schedule for our objectives this fiscal year.
The NICHD has issued a request for contract proposals, "Brain and Tissue Bank for Developmental Disorders", to set up a repository to collect, store, and distribute specimens from "unaffected" infants and children, and those with neurodevelopmental disorders. Sudden Infant Death Syndrome is specifically designated as a developmental disorder targeted by this repository. Once established, tissues from the repository will be made available to
qualified investigators to support and facilitate research that will lead to improved understanding of the etiology, pathology, pathogenesis, and clinico-pathological correlations of conditions associated with SIDS, mental retardation, and learning and behavioral deficits. The review process for applications is near completion, and one or two awards will be made in FY 1991.
The criteria for animal models relevant to SIDS, and the research approaches and areas that should be expanded, were explored at the "Animal Models of SIDS Workshop" convened by the NICHD in October, 1990. In addition to providing research recommendations, this workshop served to stimulate new scientists from the areas of neuroscience, thermoregulation, and behavioral biology to consider the scientific problems in SIDS.
The recommendations from this workshop were incorporated into a request for grant applications (RFA), "Animal Models for SIDS," published in February 1991, with a May 1991, receipt date for applications. Up to eight awards are planned for this fiscal year. The objective of the RFA is to stimulate research on animal models that explore some aspect of the SIDS phenotype, to identify and understand possible etiologies and physiologic mechanisms responsible for sudden death in infancy.
A meeting of neonatologists, pulmonary and sleep physiologists, behavioral psychologists, and neurologists was held on January 16, 1990 to provide recommendations for research on cardiorespiratory deficits in future SIDS victims, and the usefulness of apnea monitors. The following priorities were identified: (1) clinical studies of documented monitoring in the home of high-risk infants; (2) prospective clinical studies to identify behavioral, neurologic, and other physiologic risk factors in the first month of life that are predictive of SIDS; (3) development of home monitors for obstructive apnea and oxygen desaturation; and, (4) when the studies outlined above are completed, a randomized trial of appropriate monitors to prevent SIDS deaths would be conducted.
The request for applications for grants to address the first priority, "Event Recordings of High Risk Infants on Apnea Monitors," was issued in March, 1991. Six awards are planned for FY 1991. The purposes of the initiative are to determine whether home apnea monitors employing event recordings of respiratory, cardiac, and oxygenation parameters are effective in identifying clinically relevant episodes, and to determine the conditions that optimize the use of apnea monitors in these infants.
Biomedical research, surveillance, and health service delivery regarding SIDS are under the auspices of several components within the Public Health Service, with related responsibilities in other parts of the Federal Government. The Interagency Panel on SIDS was re-established to exchange information on SIDS activities, enhance productivity through collaboration and coordination, and develop new strategies to understand and combat SIDS. Three meetings of the panel, which included staff from six Public Health Service agencies, were held to share current activities and to discuss difficulties in diagnosing and reporting SIDS.
The five-year research plan called for collaboration between NICHD and other agencies of the Public Health Service to develop and implement epidemiologic studies of SIDS. NICHD is working with CDC and the Indian Health Service to investigate infant deaths among the American Indians of the Aberdeen Reservation. They have an annual SIDS rate three times that of the remaining population in North and South Dakota, making it the highest in the nation. It is important to gain more information on these deaths to (1) determine whether some are not SIDS, and may be preventable through public health efforts, and (2) to learn more about causes of SIDS. The joint project will establish a surveillance network for infant deaths on the Aberdeen reservation, and a pilot protocol to investigate the causes. We plan to fund these efforts through interagency agreements in FY 1991.
NICHD defines research priorities for future years of the fiveyear research plan by convening workshops. On March 25, 1991, NICHD brought together all the researchers that are studying fetal hemoglobin to critically examine the available scientific information, and determine the potential of fetal hemoglobin kinetics to identify infants at risk for SIDS. In the fourth year, we will be conducting a study to evaluate biochemical and metabolic screening technologies for SIDS risk. One of the biochemical markers that may be worth pursuing is fetal hemoglobin. During the first two months of life, infants stop producing the oxygen carrying blood protein they used in utero, called fetal hemoglobin, and produce the adult type of hemoglobin. There is controversy in the scientific literature whether elevated fetal hemoglobin levels in a proportion of SIDS victims discriminate them from other infants. Since there are no defined prognostic tests for SIDS risk at this time, it is important to pursue this biochemical finding for infant screening
Question. How much does the Institute estimate will be spent on SIDS specific research in FY 1991? How much on SIDS related research?
Answer. The NICHD revised estimate for funding SIDS specific research in FY 1991 is $5,500,000; the amount for SIDS related research, $33,000,000.
Question. How much is provided in the President's budget request for SIDS research in fiscal year 1992? Is this sufficient to fully implement the 3rd year of the five-year plan? If not, how much more is necessary to fully implement the 3rd year?
Answer. The FY 1992 President's budget request includes a total of $41,500,000 for SIDS research. Of that amount, $6,100,000 is for activities that relate to the third year of the five-year plan. Full cost for the third year would require an additional $4,400,000 over the budget request, for a total of $10,500,000.
SUBCOMMITTEE RECESS Senator HARKIN. Thank you very much. The subcommittee will stand in recess to reconvene at 1:35 p.m. to hear the rest of the Institutes.
[Whereupon, at 12:34 p.m., Thursday, March 14, the subcommittee was recessed, to reconvene at 1:35 p.m. the same day.)