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1 Reproductive Health Issues Reproductive health, ideally, means that every baby is wanted and planned for and that every pregnant woman has access to the resources she needs for her own and her baby's robustness. It means putting more effort into improving the survival, health, and development of infants. It also means helping to solve problems of infertility for men and women who want to have a baby and cannot. It means finding more acceptable, safer contraceptive methods and making existing methods more available, with vigorous dissemination of information about contraception and other health matters that affect reproduction. It means increasing support to eliminate or alleviate genetic diseases. Most important, it means devel- oping the view that healthy reproduction is intrinsic to the vitality of the nation and, with it, the commitment to use all possible means, including education, research, ethical inquiry, and political action, to achieve that goal. Since 1980 the reproductive health status of Americans has deteri- orated. The rates for unintended pregnancy and abortion in the United States are among the highest in the Western world, and our rates for adolescent pregnancy, abortion, and childbearing are the highest. In in- fant mortality, a key indicator of national health, the United States ranks twentieth among industrialized nations, behind Hong Kong and Singa- pore. Despite our considerable research resources, American women have fewer contraceptive choices than their European counterparts. More

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2 SCIENCE AND BABIES than half the 6 million pregnancies that occur annually in this coun- try are unintended, and half those unintended pregnancies about 1.6 million end In abortion. Meanwhile, concern about infertility appears to be increasing among many women and men. The United States has long been a leader in clinical obstetrics and pediatrics. ~J.S. professionals launched the "contraceptive revolution" in the 1960s with the development of the pill and the modern IUD. Yet reproductive health in this country has deteriorated in recent years as changes In society and biology have collided. Today, most young women and men are not prepared to take on adult responsibilities until they are in their 20s, but their bodies often are sexually mature by age 12. Sexual development brings the risk of pregnancy and sexually transmitted diseases. The arrival of puberty before social maturity causes problems for which few answers exist. Fearful of arousing protests from religious groups and antiabortionists, government does little to support contraceptive development and sex education. There is great reluctance to advertise contraceptives, although the alternative has been a very high abortion rate and increased welfare costs for the care of children born to parents unable to provide for them. In the heterogeneous society of the United States, reaching a national consensus about issues tied closely to sexual and religious mores is a major task. In recent years it has been made more difficult by a lack of political leadership and the lack of an official national framework in which to discuss and resolve the many ethical and emotional issues that surround human reproduction. Every American pays the price for the absence of a national commit- ment to good reproductive health. Many of the unwanted births in this country have long-term deleterious effects on the lives of the women and girls who experience them as well as on their families and communities. The majority of unintended pregnancies occur in teenagers and young women who often have few financial resources and are uninsured for childbirth. They are less likely to receive adequate prenatal care and are at greater risk of giving birth prematurely. As a result, it is not unusual for their babies to need more intensive care. Hospitals annually incur $7 billion in debt for unreimbursed maternity care, and that debt is passed along to the public. Furthermore, studies have demonstrated that the unplanned-for child continues to need more support from public assistance programs, sometimes for many years. There exists a dichotomy in reproductive health today. On one

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REPRODUCTIVE HEALTH ISSUES A drop of blood is taken from a newborn Abyss heel to test for certain inherited metabolic diseases. Early treatment for some disorders results in a healthy child. Credit: National Institute of Child Health and Human Development hand are the many pregnancies that are unplanned and economically and emotionally stressful; on the other is the substantial problem of infertility and the willingness of many infertile couples to pay thousands of dollars for help getting pregnant. Before the first test tube baby was born in 1978, the only available techniques to overcome infertility were artificial insemination, drugs to induce ovulation, and surgery to repair the reproductive tract in men and women. Since then, an entire "baby- making'' industry that uses the latest in reproductive technologies has sprung into existence. It is an area in which costs are high and success rates are low, but because the industry is privately funded, it operates largely without public scrutiny. Although concern about infertility is on the rise, the inability to settle the ethical and emotional issues related to human reproduction has severely slowed breakthroughs regarding the fertilization process and the early development of the human embryo. Generally, major research in the United States is funded by the federal govemment. But because research on fertility and the early stages of life might mean using excess embryos from in vitro fertilization programs, right-to-life groups protested against

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4 SCIENCE AND BABIES government support of such studies when they were originally proposed in the mid-1970s. In 1978 some attempt was made to resolve the conflict by establishing an Ethical Advisory Board (which subsequently became known as the Ethics Advisory Board or EAB), but the EAB accomplished little before its funding and charter ended in 1980. Without a mechanism for resolving the ethical issues associated with reproductive research, federal funding became unavailable. The few studies that have been conducted have been funded by private organizations. The result has been an unofficial but effective moratorium on the development of new knowledge and no public oversight of private efforts, which include a variety of infertility interventions and the manipulation of eggs and embryos. The United States is not alone in facing these new ethical and so- cial concerns. Although most other developed countries have surpassed the United States in providing adequate family planning, improved con- traception, and good prenatal care, our ethical questions and concerns arising from new reproductive technologies are the same. They include: When does human life begin? allowed? Up to what stage of embryo development should research be Who owns the cryopreserved embryos when the parents have divorced or died? Is research on early-stage embryos ethically acceptable? . Is it permissible to create embryos or to use excess embryos specifically for research purposes? Committees and commissions in every involved country have wres- tled with these questions and at least 85 statements on the new reproduc- tive technologies have been issued, but in this country many questions remain unresolved. Some concerns will fade with experience and the passage of time, but others will need thoughtful analysis and new public , . . policies. INFERTILITY For every 12 married couples in this country who achieve a preg- nancy when they choose to, there is a couple who cannot have a baby because of some childbearing impairment. According to the National Center for Health Statistics, in 1988 at least 2.3 million couples ex- perienced infertility. Although the center's National Survey of Family

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REPRODUCTIVE HEALTH ISSUES 5 Growth revealed that infertility overall had declined somewhat since 1965, it also found that the problem had increased from 4 to 7 percent in young women in their early 20s, a rise attributed largely to the spread of sexually transmitted diseases in this highly sexually active age group. Conception cannot occur if one of the essential reproductive com- ponents is lacking: ovulation; enough competent sperm at the site of fertilization; and at least one functioning fallopian tube, where the egg can be fertilized and then, as it develops, be transported to the hormone- primed uterus. Physiological causes of infertility include the absence of ovulation; sperm that may be deficient in number or in ability to reach the egg; and damage to the fallopian tubes, uterus, or cervix. In women the inflammatory infections of sexually transmitted diseases (STDs) leave scar tissue that can affect the functioning of the fallopian tubes and uterus. In men such infections may impair sperm production and quality. Less common is infertility caused by an abnormal interaction between the sperm and the woman's cervical mucus. In 90 percent of infertility cases the reason can be found through a series of tests, and approximately half the couples treated for infertility will become pregnant at least once, and most of them will successfully birth a child. Some causes, however, are more difficult to pinpoint. Sperm quality, for example, is hard to measure, and even when it appears to be the source of the infertility, too few treatments exist for overcoming sperm deficiencies. Similarly, not enough is known about the process of sperm movement through the female reproductive system or how sperm recognize, penetrate, and bond with the egg. Efforts to circumvent unknown or intractable obstacles to repro- duction have led to the development of new reproductive technologies: artificial insemination, treatments for stimulating ovulation, fallopian tube reconstruction, in vitro fertilization (IVF), and gamete intrafallopian transfer (GIFT). In IVF a number of eggs are fertilized by sperm outside the body and several of the healthy embryos that may result are returned to the uterus to continue their growth. In GIFT, sperm and two or three healthy eggs are injected together near the end of the fallopian tube, where fertilization would normally occur. The success rates for GIFT are somewhat higher than for IVF. Clinics to treat infertility have existed for decades and have had considerable success treating ovulation disorders. With the advent of IVF in 1978 and the more recent development of GIFT in the mid-l9SOs,

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6 SCIENCE AND BABIES the desire of infertile couples to have children has led to the burgeoning of centers specializing in these two techniques. According to a recent survey by the Subcommittee on Regulation, Business Opportunities, and Energy of the U.S. House of Representatives' Committee ore Small Business, by late 1988 there were 190 such centers in the United States. Forty opened in 1987 alone. Each attempt at IVF or GIFT can cost $4,000 or more, with some women undergoing four to six attempts. Success rates are low. On average the 1987 and 1988 success rate for IVE birds per stimulated cycle was 9 percent. For GlE-l the success rate per stimulated cycle was 11 percent in 1987 md 16 percent in 1988. Some of the clinics so far have produced no births. Ike Office of Technology Assessment reports that only one in ten couples who undergo IVF or GRIT procedures takes home a baby. IVF and GIFT have become far more popular than even their advo- cates expected. Women disrupt their lives for months' making trip after trip to the fertility center for hormone treatment, egg harvesting, and then implantation of developing embryos for a chance at having a biologic child. Despite their efforts' a large proportion of them never take home a baby. The increased number of fertility clinics offering IVF and GIFT may make these techniques somewhat more accessible, but their proliferation and the advent of commercial pressures have brought new concerns. Questions have been raised regarding the truthfulness of clinics' adver- tised success rates, the high costs' whether they we continue to limit the technique to those who can afford it, and what tests are in place to make certain that donated sperm is free from serious infections. As new technologies become available that make it possible to choose an embryo's gender or to alter its genetic makeup' new ethical concerns are bound to arise. At He root of these issues is the fact that there are no controls regarding quality and safety because the technology has been developed with private funds. In the absence of a federal role ~n the development of reproductive technologies' the only controls are those of supply and demand. CONTRACEPTION In contrast to couples who carmot have the baby they want are the many more women who each month fear that they are pregnant. For the

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REPRODUCTIVE HEALTH ISSUES 7 main part these women and girls are not using contraceptives because of their side effects or because they have not found a method that is reliable or easy enough to use. Despite current assumptions that anxiety about acquired immune deficiency syndrome (AIDS) has encouraged a decrease in intercourse among young unmarried Americans, a 1987 survey by Ortho Pharmaceutical Corporation uncovered little indication that levels of sexual activity have decreased since 1982. The survey also found that more than 3 million fertile, sexually active women in the United States do not use contraception at all. And of those who do, a considerable percentage use less effective nonmedical methods such as rhythm, withdrawal, or douching. The proportion of women of childbearing age in the United States who use no contraception is much higher than it is in other developed countries. Rates of childbearing and abortion also are greater in the United States. A recent study by the Alan Guttmacher Institute examined the relationships between contraceptive use and public family planning policies and programs in the United States and in 19 other countries with similar economic, social, and demographic backgrounds. The study found that the United States leads the industrialized world in the number of abortions and unplanned births per capita. According to the Guttmacher study, differences in contraceptive apse among the 20 countries reflect differences in how contraceptive care is offered. Outside the United States contraceptive care generally is inte- grated into primary health services, making it less expensive and readily available at convenient and familiar locations. Family planning clinics offer counseling, extended hours, and a broad range of contraceptive methods to the general population. In the United States such clinics are set up chiefly to serve the poor and often are perceived as offering a lower standard of care. In addition, other nations offer reliable contraceptive methods that are not available in the United States because of liability considerations and the abortion controversy. Contraceptives often are inexpensive or free in other countries. There is also substantially greater dissemination of information about contraception and sexuality through advertising, publicity, and education. Birth control is treated in a nonemotional way as a routine health matter. Instead of the decrease in contraceptive costs and the increase in variety that observers had expected to see in the United States by 1990, prices are rising and access to some methods, such as lUDs, has sharply

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8 SCIENCE AND BABIES declined. In the early 1970s, 13 pharmaceutical firms were active world- wide in contraceptive research and development; by 1987 that number had dropped to four, with only two located in the United States. U.S. interest in developing contraceptive methods has been flagging for some years. Insufficient funding, a fading concern about population growth, the regulatory hurdles of the Food and Drug Administration (FDA), less scientific interest, and the abortion controversy have all had a negative impact. Moreover, the prevalence of product litigation has dealt a severe blow to the pharmaceutical industry, which was already unenthusiastic about its contraceptive business. But modest efforts to change the situation are under way. The Nor- plant implantable contraceptive is expected to be available by early 1991 in the United States, and FDA requirements for testing contraceptive steroids recently were made almost identical to the testing requirements for other drugs. Increased federal funding also has been proposed. A study published in February 1990 showed that taxpayers save $4.40 for every public dollar spent to provide birth control services to women who otherwise might not have access to them. Although professionals are concerned, the decline in contraceptive availability has received little notice either from the U.S. public or from policymakers. The misconception that many methods are readily avail- able appears to still exist, but the increased number of abortions is a noteworthy signal of poor contraceptive accessibility. TEENAGE PARENTHOOD More than 1 million adolescent girls in the United States become pregnant each year. For a pregnant teenager the considerable gap between her ability to reproduce and her ability to be self-sufficient causes a range of problems that will affect her life, her infant, and her community for years. More than 400,000 of these pregnant teenagers obtain abortions and approximately 470,000 of them give birth. Their rate of miscarriage is high. Most of the births are to unmarried teenagers, and nearly half of those new mothers are not yet 18. Despite an overall decline in the U.S. birth rate and despite the fact that teenage sexual activity in this country is similar to that of other westernized countries, the rate of adolescent pregnancy, childbearing, and abortion is still substantially higher in the United States. In this country girls under age 15 are at least five times more likely to have a baby than girls their age in other countries.

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REPRODUCTIVE HEALTH ISSUES 9 A l9X7 study by the National Research Council Panel on Adolescent Pregnancy and Childbearing reported: "For teenage parents and their children, prospects for a healthy and independent life are significantly reduced. Young mothers, in the absence of adequate nutrition and appro- priate prenatal care, are at a heightened risk of pregnancy complications and poor birth outcomes.... The infants of teenage mothers also face greater health and developmental risks." The study also noted that adolescent parents are more likely to experience chronic unemployment and inadequate income and that they and their children are "highly likely to become dependent on public assistance and to remain dependent longer...." It concluded that "in both human and monetary terms, it is less costly to prevent a pregnancy than to cope with its consequences." Consider this finding by the Alan Guttmacher Institute: In 1985 families started by a teenage birth absorbed approximately 53 percent of the total expenditures of the three major public programs for families Aid to Families with Dependent Children (AFDC), food stamps, and Medicaid. Aside from the personal and public costs of the epidemic of children having children, the unflagging rate of adolescent pregnancy in the United States is a case study for the argument for better contraception and better dissemination of information about sexual matters and contraception. It also illustrates what can happen when a nation does not deal directly with these issues. The social factors that contribute to an unintended early pregnancy have been identified, and a variety of policies, programs, and studies to alter some of these factors are under way. Until such interventions prove successful, however, the most reliable strategy for reducing the number of unintended pregnancies among sexually active teenagers is to encourage the use of contraception. Not enough is known about how to make adolescents more precisely aware of the social and physical consequences of intercourse, including the dangers of sexually transmitted diseases. Sex education at home and at school appears to be easily overridden by the powerful sex-promotion messages of television and advertising. At least one survey indicates that Americans approve of condom advertising, but a national consensus about advertising to promote responsible attitudes toward sex has not been sought, largely out of fear of opposition from some religious groups. PRENATAL CARE Whether her pregnancy was planned or not, a woman or adoles- cent has a much better chance of having a healthy baby if she receives

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10 SCIENCE AND BABIES even a minimum of prenatal care. Such care appears to be especially important to both mother and child when the mother is at increased risk of medical or social problems. Prenatal care is also cost-effective because it significantly reduces the danger of having a low birthweight infant with its concomitant need for expensive medical treatment. Prenatal care also increases the baby's chance of surviving. In the poorest neighborhoods of New York City, for example, where many mothers receive little or no prenatal care, the mortality rate for newborns is more than twice that of the rest of the city. Although the importance of prenatal care has been well established, during the 1980s its use in the United States declined. In 1985, 33 percent of all U.S. babies were born to mothers who did not obtain the recommended minimum amount of prenatal care, 25 percent were born to mothers who started care only after their third month of pregnancy, and 5 percent were born to women who began prenatal care in their last trimester or received no care at all. And 1985 was the sixth consecutive year in which no progress was made in reducing the number of women in the final group. Among blacks, those receiving little or no care increased from 8.8 percent in 1980 to 10.3 percent in l9X5. Despite the fact that the United States spends more per person for prenatal care than any other ~ndustnalized nation, barriers to such care obviously still exist, and the system is not working well. There is controversy about the content, costs, and effectiveness of the various public prenatal care programs. What constitutes good care has not been clearly defined, and the lack of a universal definition contributes to the dispute. Other questions have yet to be answered: Should care be measured by the number of visits or by what tales place during those visits? Should care entail only scheduled medical appointments, or should it include a range of educational and nutritional services in a setting that is flexible and appropriate to the cultural background of the community? Are the components of the care useful to the women being served? What are the best ways to draw women into care? What prevents women from seeking prenatal care? ETHICAL ISSUES Research on the earliest stages of life in animals and in humans has made it possible to fertilize human eggs in the laboratory and to store frozen embryos indefinitely. Recombinant DNA technology is providing

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REPRODUCTIVE HEALTH ISSUES 11 tools for identifying genetic diseases in the embryo and for pinpointing the gene that determines the gender of a child. Studies of animal and human cells are allowing researchers to evaluate the chromosomal health of eggs and embryos in the hope of increasing the success of new reproductive techniques by choosing embryos that are normal. Much of what we know about the reproductive process has been learned from research on animals, particularly farm animals Technolo- gies such as artificial insemination and the transfer, freezing, and division of embryos were originally developed for agricultural purposes. Newer technologies, such as determining the gender of embryos, growing em- bryos in the laboratory' and transferring genes, are being attempted with both animal and human cells. Two laboratories have altered the genetic composition of animal embryo cells so that the cells won't recognize such pathogens as the herpes virus. Although many animal technologies have been adapted successfully to human use, important questions about human reproduction remain that cannot be answered by animal research. The future of IVF is tied to embryo research. The success of IVF and embryo transfer? in fact' could be improved if it were possible to determine whether the embryo was normal. The manipulation of embryos and studies of embryonic cells have led this and other countries into an area of ethics that is only sketchily charted. Some theologians, right-to- life groups, and others argue that life begins at the moment an egg is fertilized and that an embryo should have all the rights and protections accorded any other human being. Some say that an embryo has no human rights whatever. Others believe that research on embryos not used for implantation may be morally problematic but not without solution, much like using experimental treatments on terminally iI1 patients. When federal regulations on fetal research were issued in 1975, their intent was to treat all fetuses equally after implantation, regardless of gestational age or whether abortion was intended. The commission that helped develop the regulations realized, however, that conflicts would inevitably develop between the obligation to treat all fetuses equally and the obligation to benefit individuals and society through fetal research. So the Ethics Advisory Board (EAB) was established within the U.S. Department of Health, Education, and Welfare to advise the department about the ethical acceptability of research proposals involving human subjects. The issue of embryo research was assigned to the EAB in 1978. A report favoring federal funding of research on the safety and efficacy of IVF as an infertility treatment was issued by the EAB in 1979.

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12 SCIENCE AND BABIES Because medical researchers rely heavily on federal funding, the demise of the EAB in 1980 because its funding was not renewed and its charter was allowed to lapse was viewed by most U.S. scientists as a de facto ban on fetal research. As a result, very few new studies have since been proposed for federal funding. Some research is supported by private institutions, but the absence of the EAB has severely limited research on reproduction. It also has meant that ethically sensitive research is being performed without federal oversight and public input. Without an EAB the federal government has had no way to evaluate the current ethical standards associated with reproductive technologies. Such an evaluation could examine the ethical implications of present and future public policies regarding artificial insemination, GIFT and IVF, egg donation, studies on embryo health, cryopreservation of both eggs and embryos, and other treatments for infertility or genetic diseases. It could then establish guides to research and clinical care in these areas. To encourage more responsible conception, research and develop- ment on better contraceptives will have to be encouraged by policies that somehow protect both the consumer and the developer. In addition, long-term programs are needed to make the use of contraceptives less expensive and more of a social norm. As Kenneth Ryan emphasized at the 1988 Institute of Medicine's annual meeting, these problems regarding reproductive health raise not only major scientific and clinical care issues but also vital public concerns that can best be addressed and resolved by the development of government policy. REFERENCES Fletcher, J.C., and K.J. Ryan. 1988. Federal regulations for fetal research: a case for reform. Law, Medicine & Health Care. 15:3. Forrest, J.D., and R.R. Fordyce. 1988. U.S. women's contraceptive attitudes and practice: how have they changed in the 1980s? Family Planning Perspectives. 20(3)1 12-1 18. Forrest, J.D., and S. Singh. 1990. Public-sector savings resulting from expenditures for contraceptive services. Family Planning Perspectives. 22~1~:6-15. Harkness, C. 1987. The Infertility Book. San Francisco: Volcano Press. Institute of Medicine. 1988. Prenatal Care: Reaching Mothers, Reaching Infants. Sarah S. Brown, ea., Washington, D.C.: National Academy Press. Jones, E.F., J.D. Forrest, S.K. Henshaw, et al. 1988. Unintended pregnancy, contracep- tive practice and family planning services in developed countries. Family Planning Perspectives. 20(2~:53-67.

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REPRODUCTIVE HEALTH ISSUES 13 Lincoln, R., and L. Kaeser. 1988. Whatever happened to the contraceptive revolution? Family Planning Perspectives. 20(1):20-24. McShane, P.M. 1987. In vitro fertilization, GIFT and related technologies hope in a test tube. In Women & Health. 13:31-46. Binghamton, N.Y.: The Haworth Press. National Institutes of Health. 1989. Sex can cause more than AIDS. Healthline. August:3-4. National Research Council. 1987. Risking the Future: Adolescent Sexuality, Pregnancy, and Childbearing. Washington, D.C.: National Academy Press. Powledge, T.M. 1987. Reproductive technologies and the bottom line. In Women & Health. 13:203-209. Binghamton, N.Y.: The Haworth Press. Raymond, C.A. 1988. In vitro fertilization enters stormy adolescence as experts debate the odds. Journal of the American Medical Association. 259(4):464. Silverman, J., A. Torres, and J.D. Forrest. 1987. Barriers to contraceptive services. Family Planning Perspectives. 19(3):94-102. Singh, S. 1986. Adolescent pregnancy in the United States: an interstate analysis. Family Planning Perspectives. 18(5):210-226. United States Department of Health, Education, and Welfare, Ethics Advisory Board. 1979. HEW Support of Research Involving Human In Vitro Fertilization and Embryo Transfer. May 4. Walters, L. 1987. Ethics and new reproductive technologies: an international review of committee statements. Hastings Center Report, Special Supplement. June. Wallach, E.E. 1988. Testimony at the Hearing on Consumer Protection Issues Involving In Vitro Fertilization Clinics, before the House Subcommittee on Regulation and Business Opportunities. Washington, D.C. June 1. Wyden, R. 1989. Opening remarks and testimony at the Hearing on Consumer Protection Issues Involving In Vitro Fertilization Clinics, before the House Subcommittee on Regulation, Business Opportunities, and Energy, Washington, D.C. March 9.