The Center for Disease Control (CDC) provides training to Epidemiologic Intelligence Service (EIS) officers. Some individuals in the program are being trained in an epidemiologic approach to evaluating family planning and population programs. The Family Planning Evaluation Division, CDC, provides assistance to State, local, and international health agencies in the evaluation of family planning programs. EIS officers and Public Health Advisors (PHA) are assigned in Georgia, New York, Tennessee, and California to develop and maintain data processing systems for family planning service statistics, to analyze contraceptive use and effectiveness, and to conduct special studies based on these analyses. In addition to these continuing assignments, short term assistance is given to family planning programs for improving program management, designing service statistics systems, and evaluating family planning program performance. As State abortion laws became less restrictive in 1967, data concerning abortion mortality and the practice of legal abortion became increasingly important. CDC maintains surveillance of abortion practice and abortion deaths through a nationwide reporting system. In 1969 approximately 22,000 legal induced abortions were reported to CDC on a voluntary basis by State and local health departments. The following year more than 180,000 abortions were reported; in 1972 that number increased to 586,760; in 1973 the number increased to 615,831. Since 1972, New York City, Dallas, Philadelphia, Buffalo, Chicago, Portland (Oregon), and the States of New York, Arkansas, and Kansas have been assisted in assessing abortion-related health problems and in determining the measures necessary to prevent them. From the mid-1950's through the mid-1960's, abortion mortality did not decline even though other causes of maternal death decreased substantially. Since then, abortion mortality has continued to decrease. In 1969, 132 abortion-related deaths were reported. In 1970 there were 140 such deaths and, in 1971, 120 occurred. A marked decrease occurred in 1972 when 79 deaths were reported, and data for 1973 indicated a further decline to 47 abortion-related deaths. Data indicate that the risk of mortality increases with the length of gestation. CDC is undertaking a study to determine why women who decide on abortion delay that decision. Federal and State cooperation is necessary if the favorable trend in abortion mortality is to continue. Epidemiologic field investigations of the medical consequences of drugs, devices, and techniques employed in family planning programs are being conducted. Morbidity and mortality associated with the use of the intrauterine device (IUD) was one of the studies conducted. Questionnaires were sent to physicians considered most likely to have inserted IUDs or to have examined women with IUD complications. More than 3,900 hospitalizations and five deaths occurred during the first six months of 1973. DHEW has assigned CDC the task of monitoring Federally-funded sterilizations on minors and those incapable of providing legal consent. Implementation of the Sterilization Surveillance Project is pending finalization of regulations. 31 Alcohol, Drug Abuse, and Mental Health Administration The National Institute of Mental Health (NIMH) is authorized to serve as the principal focus for research and training in the behavioral and basic sciences related to the causes, diagnosis, treatment, and prevention of disorders in the biological and psycho-social factors that determine human behavior and development. Under this broad mandate many activities related to family planning are supported. The National Institute of Mental Health recognizes the special contribution that can be made by mental health personnel in the area of family planning. The Institute is involved in this area of concern through its research, training, and service programs. The Institute views family structure as it relates to the larger social structure and to such social structure variables as occupation, social class, economic status, and life style. Since the Institute recognizes that programs of family planning must be modified to fit the facts of a diverse society, it seeks to determine these facts as they relate to mental health issues. The Institute is interested in the implications of family size for the physical and mental health of family members. It is also interested in child spacing and its effect on family functioning and on the personality development of children. It seeks to determine the strengths and weaknesses of differing family forms and sizes; the effects of abortion and sterilization; the role of adoption; and the implications of working mothers, increased family incomes, and day-care centers on the family planning process. Thus, the Institute seeks to determine the kinds of mental health services needed by families of differing sizes and forms, the adequacy of one-parent homes in providing crisis support to individual members, and the correlations between family size and the emotional characteristics of family members. Biometric data, for example, indicate that the heads of families with one child both parents present have lower admission rates to psychiatric facilities than the heads of those families which contain several children; yet, the children of one-child families both parents present have higher rates of hospitalization than children in families where siblings are present. Data of this nature have important implications for the Institute's contribution to family planning services. The Institute encourages and supports family planning services provided through community mental health facilities. In its training and educational support programs, NIMH stimulates family planning programs in the training of public health nurses, teachers, social workers, and others involved in sex and health education. Through the Center for Studies of Child and Family Mental Health, the Institute encourages research in mental health and the behavioral aspects of family life. Examples of research grant projects which bear indirectly on family planning are communication and decision-making within families; patterns of family life; motivation; sex education; and population characteristics. The Center for Studies of Child and Family Mental Health investigates the structure of the American family; i.e., what factors contribute to breakdown in the family structure in the affluent suburban household; problems of role identification as a father for the third generation AFDC recipients. The NIMH Division of Intramural Research carries out projects on family formation, child spacing, and animal studies of population density. The research programs of the Department in the population sciences are directed by the National Institute of Child Health and Human Development. Section 444 of the Public Health Service Act authorizes the Institute to conduct and support research and training relating to maternal health, child health, and human development, including research and research training in the special health problems and requirements of mothers and children and in the basic sciences relating to the processes of human growth and development, including prenatal development. Section 1004 of Public Law 91-572, "The Family Planning Services and Population Research Act of 1970," authorizes the Secretary of Health, Education, and Welfare to make grants and to enter into contracts "...to promote research in the biomedical, contraceptive development, behavioral, and program implementation fields related to family planning and population..." Expenditures by the Institute in fiscal year 1974 for population research were $51.0 million. They are projected to be $51.0 million for fiscal year 1975. Other components of the National Institutes of Health provided $7.3 The The National Heart and Lung Institute awarded $0.4 million for studies. of the effects of estrogens, progestogens, and steroid contraceptives on blood clotting mechanisms and the physiology of circulation. Several studies in reproductive neuroendocrinology and genetic aspects of reproduction were supported by the National Institute of Neurological Diseases and Stroke and the National Institute of General Medical Sciences, respectively. Support for population research in these two Institutes totalled about $0.2 million in fiscal year 1974. The Division of Research Resources administers approximately $2.3 million in general research support relevant to the population field. 33 The National Institute of Child Health and Human Development (NICHD) and its Center for Population Research (CPR) have primary responsibility for the Federal effort in population research. This report describes research on the development of new means of fertility regulation, the evaluation of contraceptive methods currently in use, and the analysis of social and behavioral determinants and consequences of population size, composition, and distribution. It also discusses the NICHD effort in fundamental research in reproductive biology and the social sciences, upon which advances in contraceptive development and the solution to population problems are dependent. Finally, it describes the Institute's program to support institutions, develop scientific manpower, facilitate the coordination of Federal population research programs, and disseminate population research information. The contraceptive development program involves research aimed at new approaches to fertility regulation. During fiscal year 1974, important developments have taken place in this program. a. Drug Development Drug Synthesis Program. The efforts to produce better chemical contraceptives for both men and women have continued with increasing intensity. The chemical synthesis and the biological evaluation programs have cooperated closely in exploring the contraceptive utility of new chemical entities. Estrogens (female sex hormones) are potent antifertility agents, constituting an essential component of most currently marketed oral contraceptives. However, estrogens are frequently associated with unpleasant side effects, and, in a few women, present real health hazards. One aim of the drug synthesis program is to separate the antifertility activity of estrogens from their unpleasant side effects. In this connection, a class of compounds related to estrogen appears promising. Studies are underway in two species of primates to assess the clinical potential of two of these compounds. Information relating to these studies will be available during fiscal year 1975. If promising results are obtained, preclinical drug safety studies will be initiated which will allow their evaluation in man. Within the same class of compounds, work is in progress to find modifications having even greater separations of antifertility activity from undesirable side effects. 34 Inhibitors of the luteinizing hormone releasing factor (LRF) which are intended to block ovulation have been synthesized and evaluated for biological activity. Even though presently available compounds delay ovulation, their contraceptive utility is limited by their rapid inactivation in the body. Current research involves attempts to develop methods for extending the biological life of these compounds through chemical modifications and through incorporating them into biodegradable drug delivery systems. Biological Drug Testing Facilities Compounds from the drug synthesis program, as well as compounds from other sources, are evaluated for their contraceptive utility at a drug testing facility under contract to the program. The biological testing facility is also utilized to evaluate drug delivery systems. To optimize advanced stages of the drug development program, the CPR has contracted for a new primate (baboon) facility. The present primary aim of this primate facility is to assess the contraceptive efficacy of synthetic estrogens. New Uses of Existing Drugs. Studies on the safety and efficacy of ethynyl estradiol and conjugated natural estrogens for postcoital contraception are being conducted at four U.S. clinics. While no major problems have been encountered, the incidence of nausea and vomiting is high but can be controlled satisfactorily with anti-emetics. Pregnancies occurred in two women who started ethynyl estradiol medication between 48 and 72 hours following unprotected midcycle coitus. This may indicate the necessity for instituting treatment within 48 hours of exposure for maximum contraceptive efficacy. Male Contraception. During fiscal year 1975, the NICHD will conduct additional clinical trials to evaluate the contraceptive efficacy and safety of synthetic male hormones. At the laboratory level, activities in male contraception involve (1) synthesis of new androgens (male sex hormones), (2) synthesis of known androgens and their evaluation as male contraceptives, (3) investigation of new drug delivery systems for the maintenance of steady drug levels in the body, and (4) exploration of potential new target sites for contraceptive interference. The initial clinical trial of chemical contraceptives for men has been completed. This work involved the daily oral administration of a weak synthetic male hormone combined with a once-a-month injection of a potent synthetic male hormone. In most men, sperm numbers decreased significantly after two months of therapy. Such low sperm numbers are considered incompatible with fertility. Sperm numbers returned to normal approximately six weeks after cessation of the therapy. None of the men exhibited undesirable side effects, which lends support to the feasibility of this approach. Future plans call for the expansion of these studies and the search for new chemicals. |