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The Need for New Contraceptives Before we discuss how new contraceptives are developed and what opportunities research offers for safer, more effective, more acceptable, more convenient, and more easily distributed products, it is important to review how current methods are used and to understand why problems of availability exist. Moreover, the case that new contraceptives would be valuable must be established. If there is little or nothing to be gained from an increase in the number and kinds of contraceptives available to men and women, there is little or nothing to be gained from further research. This chapter examines the shortcomings of existing methods, then considers how new methods might benefit the individuals using them and the societies in which they live. An array of contraceptive methods is required to meet the varying needs of men and women at different stages of their life cycles. One method may be most appropriate for young people and those having intercourse only occasionally. Another method may be better suited to young mothers breastfeeding a first child and eager to space their pregnancies. A third method may be most appropriate for older couples who want a highly effective long-tenn method, because they do not want additional children but do not wish to become sterilized. Many people are not well served by currently available contraceptive methods. With most products, we expect the normal operations of industry, the marketplace, and government policy to generate an appropriate range of product choices and speed of product development. Contraceptives, however, differ from most products in important ways. Government policies have limited the number and variety of contraceptive products available to consumers as well as the rate of 11

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|2 DEVELOPING NEW CO=~CE~~ES contraceptive development. This situation is the result of the special characteristics of modern contraceptive methods and our orientation toward them. Using a contraceptive benefits both the individual using the method and a variety of groups, from users' immediate families to the communities and countries in which they live. A woman benefits because contraception may contribute to her well-being by lowering the likelihood of an unwanted pregnancy and decreasing the need for abortion. Some contraceptives also help to prevent the transmission of sexually transmitted diseases. Others reduce the risk of certain cancers. Avoiding pregnancy reduces the risks of health problems associated with pregnancy and childbirth. Avoiding pregnancy may also increase a woman's ability to work outside the home. If she works, her family may benefit from the additional resources she can provide. Children's health is also improved when their mothers are able to space their pregnancies. In less developed countries, contraceptive use may contribute to slower population growth, which in turn may help promote a country's social and economic development. The social benefits of contraception argue for public involvement in the contraceptive development process. The importance of the social dimension of population is well recognized in other areas. Because of the disparity between individual actions and state interests with respect to population, most if not all countries have policies to regulate population growth through immigration. The vast majority of less developed countries support national family planning programs to increase contraceptive use in order to reduce population growth or to improve health by enabling women to avoid high-risk and unwanted pregnancies (Lapham and Mauldin, 1987~. The committee believes the lack of an adequate array of contraceptives has adverse consequences for both individuals and for society as a whole. The inadequacy of current contraceptive methods contributes to the problems of unintended pregnancy, unwanted children, and high rates of abortions. The impact of these problems affects not only the individuals involved, but their families, friends, and the communities in which they live. Although reducing unwanted pregnancies and abortions is a potentially important social benefit of contraception, government policies tend to devalue these and other benefits of contraceptive use for society. Most U.S. government policies toward contraception have been directed at ensuring the safe delivery of contraceptives, not at maximizing the rate of contraceptive development. Policies designed to regulate contraceptives, for example, may have impeded the rate of product development. Product reviews by the Food and Drug Administration ~DA), for example, focus on the benefits and risks to individuals and do not consider adequately the benefits to society if a contraceptive were available and used by a large number of people. Contraceptive development has also slowed because of the difficulty of dealing with the problems posed by new technology, which require careful evaluations of

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NEED FOR NEW CONTRACEPTIVES 13 complex risks and benefits. Contraceptives need to be used over an individual's reproductive lifetime: women remain fertile for about 35 years, and men even longer, and they may want to use contraception for most of that time. It is very difficult for individual users as well as for scientists and policy makers to evaluate all the risks and benefits of such long-term use in a reasonable time and at a reasonable cost. Most individuals lack the information and experience to make completely informed judgments about contraceptives, particularly regarding unknown risks and long-term effects. This limitation has been recognized in extensive government regulation involving the evaluation of product safety in many areas. Benefits from therapeutic drugs normally are clear: a person recovers from disease (with some probability) or has a symptom relieved. The gain from contraception is no less real, but it requires use of a drug or device for a preventive purpose, frequently on a long-term basis. In addition to the benefit of reducing unwanted pregnancies and their consequences, contraceptives also have noncontraceptive health benefits. But since most people assume that contraceptive users typically are healthy at the time they contracept, these benefits involving prevention not only of unwanted pregnancy, but of health risks associated with pregnancy have not been sufficiently taken into account in the development of public policy. Contraceptive development has been slowed because the full individual as well as societal benefits of additional contraceptive products have not been properly recognized. Existing public policy affects the availability of contraceptives and the rate at which new products are developed in many uncoordinated ways. Public funding supports research; government regulation controls marketing; and liability, rules affect development. These and other policies help to determine the incentives to undertake research, development, and marketing of a new product. Policies affecting contraceptive development originate in different parts of government and are directed at diverse aims. It is not surprising that the complicated, uncoordinated, political, legal, and regulatory history of contraception has resulted in less than optimal progress in the development of new contraceptive methods. These four factors the social benefits of contraception, the complexity of contracephve-related risks and benefits, the problems of evaluating the uncertain impact of long-tenn contraceptive use, and the effects of uncoordinated and sometimes discrepant public policies interact in complex ways that the committee believes restrict the availability of contraceptive products. Although contraceptive use is widespread in the United States, many people lack access to contraceptives they consider appropriate for their particular circumstances. Every method in use today has drawbacks, and, collectively, current methods leave major gaps in the ability of people to control fertility safely, effectively, and in culturally acceptable ways throughout their reproductive life cycle. New policies could help more adequately to meet the contraceptive needs of American couples. The needs of

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14 DEVELOPING NEW CO=RACEPT~ES people in developing countries for new contraceptives are even greater than those in the United States. Changes in policies that would increase contraceptive choices in less developed countries would be particularly welcome. Although it is necessary to be concerned about the potential for abuse of users that some methods or delivery strategies present, it is also important to be concerned about the consequences of a lack of adequate methods. Limited contraceptive methods force many women and men to make difficult choices to have an abortion or to be sterilized at a young age-that could be avoided if additional safe, effective, acceptable, and affordable contraceptives were available. CURRENT CONTRACEPTIVE USE Contraceptive Practice The great social and scientific revolutions of the twentieth century have enhanced our ability to control childbearing. The vast majority of adults in the United States and several hundred million people in countries around the world have used contraceptives. Among the 54 million American women between the ages of 15 and 44 who have had intercourse, 95 percent have used contraception at some time (Forrest, 1987~. Over 70 percent of all married American women of child- bearing age or their husbands currently practice contraception. In 1987 the pill was the single most popular contraceptive method in the United States, followed by female sterilization, condoms, and vasectomies Forrest and Fordyce, 19889. Never before in history has a systemic drug such as the oral contraceptive been used so widely on a continuing basis by predominantly healthy women for a preventive purpose. Before describing the potential advantages of new contraceptive methods, it is useful to review currently available contraceptives. Table 2.1 provides an overview of contraceptive methods available in the United States; the table includes information on prevalence of use and failure rates as well as a brief account of the methods' major advantages and disadvantages. It is important to note that failure rates, i.e., the rate of accidental pregnancy in the first year of use, include both user failure-failure to use the method properly as well as lack of consistent use and method failure. About a fifth of all women ages 18 to 49 exposed to the risk of unintended pregnancy have been sterilized. The advantages of sterilization are its high effectiveness and the fact that a single procedure provides complete protection with very little health risk. The pe~'nanence of sterilization and the difficulty of reversing the procedure, however, are disadvantages for some people. Female sterilization requires a skilled medical practitioner and, although complications are rare, they are not unheard of. Vasectomy provides protection for about 15 percent of the partners of the women exposed to the risk of unintended pregnancy. Like female sterilization, vasectomy is a permanent method in which a single procedure provides long-term

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NEED FOR NEW CONTRACEPTIVES 15 protection against pregnancy with an extremely low risk of negative health effects. Like female sterilization, reversal of vasectomy is possible but successful only on a limited basis. Oral contraceptives are used by about one-third of those exposed to the risk of unintended pregnancy. The pill contains synthetic hormones that stop ovulation by interfering with cyclical hormonal changes. The pill is easily used. In addition to being easy to use, the pill causes regular menstrual periods, protects against ectopic pregnancy, and reduces the risk of certain pelvic infections as well as ovarian and uterine cancer. The pill's disadvantages include minor side effects and more serious problems such as a greater risk among oral contraceptive users of developing blood clots, heart attacks, and strokes. The risk of a heart attack or stroke is especially high for users over 35 who smoke or who have high blood pressure. About 3 percent of the women who use the pill will become pregnant accidentally during the first year of use. In the United States, the intrauterine device (IUD) is used by 3 percent of women exposed to the risk of unintended pregnancy. The IUD is a much more popular method in some other countries. Although the process by which IUDs prevent pregnancy is still unclear, when placed in the uterus they are believed to induce an unsuitable environment for both eggs and sperm. The advantages of IUDs are their long-term protection, their reversibility, and the fact that, once inserted, they do not require frequent attention. Insertion requires a skilled medical practitioner, and IUDs may cause increased bleeding or spotting, cramping, and pain. Perforation of the uterus occurs in about 1 in 2,500 insertions. The most serious complication associated with [UD use is an increased risk of pelvic inflammatory disease among women with more than one sexual partner. Accidental failure rates during the first year of IUD use average 6 percent. The condom is used by 16 percent of the partners of women, ages 18 to 49, exposed to the risk of unintended pregnancy. And 12 percent of women whose partners use condoms will become pregnant accidentally in the first year of use. The condom is easy to use, inexpensive, and does not require a prescription. Its greatest advantage may be that it protects against sexually transmitted diseases, including AIDS. Some people believe the condom and other barrier methods interfere with sexual relations. The diaphragm is used by 4~ percent of contraceptors. Two large clinic- based studies in which women had proper training in diaphragm use had failure rates of about 2 percent (Vessey et al., 1982; Lane et al., 1976~. Several smaller clinic-based studies had failure rates of 11 to 13 percent (Malyk and Kompare, 1983; Edelman, 1983~. Population-based studies have had the highest rates up to 23 percent (Ryder, 1973; Schirm et al., 1982~. The diaphragm offers some protection against sexually transmitted diseases and pelvic inflammatory disease and possibly cervical cancer. The remaining methods the contraceptive sponge, withdrawal, periodic abstinence, vaginal foams, creams, and jellies have failure rates of between 18 and 21 percent. The advantages of these methods include their availability

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20 DEYELOPING NEW CO=~CE~WES without prescription and the lack of serious side effects, independent of those associated with their relatively high failure rates. These methods are not very popular in the United States. Withdrawal and periodic abstinence are each used by about 5 percent of those exposed to the risk of unintended pregnancy; foams, creams, and jellies and tablets and suppositories by about 1 percent of those exposed to the risk of pregnancy. In some other countries, methods not approved for use in the United States are available. These methods are described briefly in Chapter 3. The large number of people who practice contraception have different desires, values, and needs, which can be met best by a variety of contraceptive methods. Not only do people differ in what they like and dislike, but individuals' contraceptive needs also change during their reproductive lifetimes. The needs of adolescents are different from an adult's need for child spacing or for termination of childbearing. People's health differs, as does their reaction to different contraceptive products. Because people live under diverse social, economic, and cultural conditions and are served by a wide variety of health care systems, they need different methods of contraception. Although a variety of contraceptive methods exists, the committee believes that substantial gaps remain in the array of methods available for particular groups. The importance that couples in the United States give to effective contraception and the problems they encounter with existing methods are illustrated by the large proportion of couples who are surgically sterilized. Fifteen or more years after the* first marriage, 44 percent of all women practicing contraception are sterilized, and another 24 percent are married to men who are sterilized. These figures confirm that at some point American women are ready to stop childbearing. These data also suggest that there are problems with available temporary methods. Given the absence of acceptable alternative choices and the problems with existing contraceptive technology, women may seek sterilization earlier than they might otherwise choose. The side effects of existing methods and concern about potential problems discourage long-term use of the most modern temporary methods. Since the likelihood of experiencing a serious adverse side effect with the pill increases with age, older women are more likely to look for an alternative method. Indeed, the pill is used by almost half of all contracepting newlyweds, but its use falls steadily as women's age and duration of marriage increases. Given the low family size goals characteristic of couples in the United States, they want a highly effective method. For many of ~em, surgical sterilization is the chosen alternative. The available data suggest, however, that regret at being sterilized is not uncommon. One review found between 2 and 13 percent of the sterilized women suIveyed between 6 months and 6 years following sterilization expressed regret; between 1 and 3 percent underwent reversal (Lee et al., 1989~. Requests for surgical repair of sterilization are increasing, particularly among women sterilized in their twenties or early thirties (Gn~bb et al., 1985~. Estimates

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NEED FOR NEW CONTRACEPTIVES 21 suggest that as many as 5 to 8 percent of all sterilized women seek surgical repair (Henry et al., 1980~. Women in the United States are not alone in their desire for effective contraception. Worldwide, about a half billion women are currently using some method of contraception; an estimated three-quarters of these women live in the less developed world (United Nations, 1987a). Although their choice of methods may vary from country to county, the vast majority of married women in Westem industrialized countries practice contraception. In most Western European countries, for example, between 70 and 85 percent of all women ages 15 to 49 use contraception United Nations, 1987a). In developing countries, contraceptive practice ranges from only 1 percent of currently married couples in some African countries to over 60 percent in such Asian and Latin American countries as Thailand, South Korea, Panama, and Costa Rica (Mauldin and Segal, 1986~. In many less developed countries, the proportion of women practicing contraception is lower than in the industrialized countries, but contraceptives are employed by a large and typically growing number of women. In the newly industrialized countries, levels of contraceptive practice are similar to those in the United States and Western Europe. In Korea, for example, 70 percent of all married women of reproductive age use contraception. Even in some of the poorer developing countries, contraceptive use is widespread. Over a third of married Indian women of reproductive age currently use a contraceptive, as do 30 percent of those in Egypt (United Nations, 1987a). Despite the increase in contraceptive prevalence in some countries, high failure rates and high discontinuation resulting from the use of inappropriate methods of contraception indicate that better delivery systems and more effective, safe, and affordable contraceptive options are needed. The safety, effectiveness, and acceptability of contraceptives are particularly important for the many women who use them, since women bear the greatest burden of contraceptive side effects. The available contraceptive choices limit the ability of men, who might otherwise do so, to effectively share responsibility for contraception with their female partners. The number of American men who use condoms or who have had vasectomies suggests that many men are willing to share the responsibility for contraceptive practice, thus reducing periods of exposure to the risks of contraceptive use for a partner who otherwise would bear the full responsibility and the full risk. Several groups of women, particularly older women and those with chronic diseases, need contraception but are unsuitable or poor candidates for the most highly effective contraceptives now available. Women with insulin-dependent diabetes or those with certain types of cardiovascular disease, for example, are not good candidates for either hormonal or intrauterine contraception. New methods that do not aggravate systemic diseases and do not increase the risk of infection would be of great benefit to these women.

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22 DEVELOPING NEW CO=RACE~~ES Contraceptive Effectiveness Although existing contraceptive technology can be highly effective, the situation is not as bright as most people, including most users, believe. One recent review of research on contraceptive effectiveness summarized the current situation: `'Despite the fact that most methods do well if used consistently and correctly, failure rates in actual use are generally not low. A contraceptive that is inexpensive, is easy to use, has few side effects, and is highly efficacious is still needed" (Trussell and Kost, 1987:272~. The data available on contraceptive effectiveness, shown in Table 2.1, indicate the range of effectiveness with which contraceptive methods are used. (Failure rates are expressed in terms of the percentage of women using a method who become pregnant accidently during the fast year of use.) The studies from which the data came were conducted mainly in the United States. Evidence from both developed and less developed countries (Lain", 1978; Thapa et al., 1988) indicates that the actual effectiveness of temporary methods of contraception varies among different groups within a country. Effectiveness is higher among better educated women and among those who want no more children. To the extent that a larger proportion of the users of a particular method in a developing country are likely to be less well educated about contraception, the effectiveness of a particular method will be lower. The effectiveness of different contraceptive methods varies widely. Fewer than one half of one percent of the users of sterilization in the United States will experience an accidental pregnancy in the first year of use. The comparable figure for oral contraceptives is 3 percent; for the intrauterine device (IUD), 6 percent; for the condom, 12 percent; for the diaphragm, the cervical cap, and withdrawal, up to 18 percent. Of the women who use spermicides, the contraceptive sponge, or who practice periodic abstinence as a means of fertility control, 20 percent or more will become pregnant within the first year of use (Trussell and Kost, 1987~. The failure rates, which may sound small, can have a substantial impact, especially, of course, on the women who become pregnant and on their Farmers. In 1987 an estimated 6.9 million American men used condoms as a method of contraception. If the average annual accidental pregnancy rate is ~ percent dower than the 12 percent for the first year because users learn to use their method of choice more effectively over time, and less effective users tend to stop using the method), there would be over 500,000 accidental pregnancies in the United States each year because of the low effectiveness of the condom in actual use. Using data from the 1987 Ortho survey of married and unmarried women currently protected by venous contraceptive methods and several estimates of method- specif~c contraceptive failure, we estimate that between 1.2 and 3.0 million accidental pregnancies occurred in 1987 as a result of contraceptive failure (Forrest and Fordyce, 1988~. It is most likely Mat the actual number is between

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NEED FOR NEW CONTRACEPTIVES 23 1.6 and 2.0 million. Many of these accidental pregnancies result in abortion. Forrest and Silverman (1988) estimate that about half of the approximately 1.5 million abortions performed in the United States each year are the result of contraceptive failure. An important, although not well-studied, determinant of contraceptive effectiveness is the quality of the system that delivers family planning services (Bruce, 1987~. People who are well informed about the side effects they will experience and who understand how to use a method properly practice contraception more effectively than those who are not properly informed Indeed, the availability of health personnel, clinics, or pharmacies may determine the effectiveness with which contraception can be practiced. Even simple matters such as resupply cannot be taken for granted in the rural areas of many less developed countries. There are rarely sufficient resources to provide people with the information and support they need for the most effective use of existing methods. New methods that are simpler, safer, and more convenient to use could make the task of providing information, education, and services easier and less of a drain on the financial and human resources of the service delivery systems of developing countries. POTENTIAL EFFECTS OF NEW CONTRACEPTIVES Reducing Abortions Low birth rates and a low level of unwanted childbearing can be achieved by less effective contraceptive methods, if women obtain abortions when contraceptive failure occurs. The stronger the desire to reduce abortion, the greater should be the investment to develop new methods of contraception. The effects of new methods would vary among populations depending on their levels of fertility and patterns of fertility control. In industrialized nations, in which fertility is already low, the greatest impact of new methods would probably be to reduce the number of abortions and to provide couples with a better array of fertility control options. In developing countries with high birth rates, the greatest impact of new methods would be to reduce the number of births. However, to the extent that new contraceptive methods reduced unsafe abortions in developing countries, they would also help lower maternal mortality. Recent studies have found that between 5 and 30 percent of maternal deaths in developing countries are abortion-related ~ettenmaier et al., 1988~. Increased contraceptive use and more effective contraceptive practice could help reduce unsafe abortions and the complications and deaths associated with them (Viel, 1985~. One recent analysis of the potential impact of improved contraception in six European countries concluded that a reduction in contraceptive failures would result in a 5- to 10-percent reduction in pregnancies. However, if the new

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24 DEVELOPING NEW CO=RACE~IVES methods increased the overall level of contraceptive use and thus reduced the occurrence of unwanted pregnancy, a further reduction of one-third to one-half of all abortions would result (Westoff et al., 1987~. Contraception and Health A large volume of evidence from countries at all stages of development and with a variety of health care systems indicates that using contraception to space births and to terminate childbearing is safer for women and their children than unregulated childbearing (Lee et al., 1989~. The contribution new contraceptive methods may make to improved health for women and their children provides an important justification for investments in this field. Even in the United States, for women under the age of 35, not using a contraceptive is associated with a higher mortality than employing any contraceptive method, including use of the pill by women who smoke (Ory et al., 1983~. Contraceptive side effects pose a much more serious risk in poor countries, where diagnosis and treatment are frequently inadequate and problems resulting from untreated illness may have far more serious repercussions. New methods that make possible safer contraceptive practice would provide important health benefits to men and women around the world. According to one estimate (World Health Organization, 1986a), the number of women who die each year from pregnancy-related causes may be as high as 500,000, all but 6,000 or so of them in less developed countries. According to one recent study, if all unwanted pregnancies were avoided, between 25 and 40 percent of all maternal deaths would also be avoided (Maine and Rosenfield, 1982~. To the extent that new methods would increase contraceptive use and effectiveness, they could significantly improve women's health. Children may also benefit when their mothers are able to control their fertility. Children born at least 2 years apart have lower rates of infant death than those born closer together. If new methods help to reduce births in high-risk categories of maternal age or birth order or among women with short birth intervals, then infant and childhood mortality might decline as the new contraceptives become more popular (Hobcraft, 1987; Trussell and Pebley, 1984; National Research Council, 1989~. Reducing the Problems Associated With Existing Methods Although the risks of currently approved contraceptive methods are on balance lower than those of pregnancy, in a small fraction of users the health consequences of some current contraceptives are serious. There are health complications and rare deaths associated with existing methods, even though these can be reduced to a minimum in properly screened women. New contraceptives may have fewer

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NEED FOR NEW CONTRACEPTIVES 25 side effects and complications than those associated with the existing methods and thereby add to the attractiveness and safety of contraceptive practice. The major reason given by American women for not contracepting is fear of complications (Ory et al., 1983~. Side effects are offered as a major reason for discontinuing pill use by women in many countries qanowitz et al., 1986; Stephen and Chamratrithirong, 1988~. Women discontinuing pill use for health reasons often switch to less effective methods Janowitz et al., 19863. Nausea, breast enlargement, weight gain, loss of libido, and dizziness are the most common complaints of oral contraceptive users. But more serious complications, such as cardiovascular problems that require hospitalization, also occur among pill users. Although the evidence regarding the link between the pill and breast cancer is conflicting, the uncertainty of the relationship has caused concern among many women. The limited popularity of the IUD in the United States no doubt is due in part to its perceived association with an increased risk of pelvic inflammatory disease (PID) and infertility. Although rare, perforation of the uterus is another potentially serious complication of IUD use. The natural family planning methods have no side effects, but their effectiveness is low relative to other methods. Periodic abstinence or the daily testing of body temperature or cervical mucus are viewed by many women as a major inconvenience. The procedures these methods require reduce the acceptability of the natural methods for many couples and the effectiveness with which they are practiced. Although sterilization is generally a very safe operation in the United States, major complications of sterilization procedures include unintended major surgery to control bleeding, rehospitalization because of pelvic infection, vaginal bleeding, and urinary tract infections. Deaths resulting from sterilization are very rare; the major cause of death is complications resulting from the use of general anesthesia, not the sterilization procedure itself. Vasectomy is safer than female sterilization and has few complications or postoperative hospitalizations associated with it, even in the developing world. Barrier methods-condoms, diaphragms, foams, jellies, creams, suppositories, sponges not have serious side effects. Moreover, barrier methods carry an important health benefit the prevention of sexually transmitted diseases. However, failure rates for barrier methods and periodic abstinence are significantly higher than those for the pill, the IUD, and sterilization. Thus women using these methods have a greater likelihood of becoming pregnant and thus of being exposed to the risks associated with childbirth. The health hazards of existing contraceptive methods are usually due to a mismatch between the method and the user. Cardiovascular complications of oral contraceptives, for example, are not a significant risk for young nonsmokers. The risk of PID is higher among IUD users with several sexual partners. The availability of a wider range of contraceptive methods would improve the matching

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26 DEVELOPING NEW CO=RACE~~ES of methods and users. Fewer people would have to use methods that are not acceptable or appropriate for their health status or life-style. Increasing the Coverage and Quality of Contraceptive Services New contraceptive methods may also help increase the coverage and quality of contraceptive services, particularly in developing countries. Of the countries that adopted official policies to provide support for family planning programs, all but India did so after the pill and {UD became available in the early 1960s (Greep et al., 1976~. The provision of government support for family planning services was part of the post-World War II modernization process. As such, it required a new political and social environment, not simply a new contraceptive technology. But it is also true that the limitations of then-existing contraceptive methods were so extensive that many government leaders were discouraged from undertaking family planning programs. Bernard Berelson noted the importance of the introduction of the IUD for family planning programs in the 1960s: "By giving national programs some hope of success . . . [the IUD] stimulated a wholly new level of effort, improved the morale of family planning workers from the top down and, most importantly, brought about the development of family planning organizations in a form and magnitude not previously known" (Berelson, 1969:365~. The experience of several national family planning programs in developing countries demonstrates that additional couples begin to practice contraception each time a new method is introduced Freedman and Berelson, 1976; Fathalla, 1989~. A new method an injectable contraceptive recently had this effect in Bangladesh (Phillips et al., 1989~. Although some users of new methods are drawn from the pool of women using existing methods, the available evidence suggests that new methods attract new users. There are populations, even in the United States, to whom very few of the existing available methods are acceptable. Scrimshaw et al. (1987), in a study of low-income Hispanic women in Los Angeles, found that those who were breastfeeding and who wished to space their children were without adequate contraception. They hesitated to take the pill because of its possible impact on lactation, and they found barrier methods unacceptable to themselves or their partners. It is possible that the situation among this group is a prologue to what will happen for increasingly larger gTOUpS of women in the United States as contraceptive choices become more limited at least in part because of the withdrawal of contraceptive products from the market by major pharmaceutical firms. The problems are not only those of the low-income community. U.S. couples in their twenties and thirties complain about the lack of appropriate methods. Women in this group who cannot or do not want to use oral contraceptives and are not ready to be sterilized must rely on less effective barrier methods, periodic abstinence, withdrawal, or a limited selection of IUDs-providing, of course, that they are not removed from the market.

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NEED FOR NEW CONTRACEPTIVES 27 None of the currently available methods is well suited for the immediate postpartum period. The IUD, which does not interfere with lactation, can be inserted immediately postpartum or at the time of hospital discharge, but rates of expulsion, perforation, and unintended pregnancy are higher than when the IUD is inserted at any other time. Progestin-only oral contraceptives (sometimes called "minipills") have been recommended for postpartum use, as have subdermal implants such as NORPLANT~ (see Chapter 3~. However, until more information on the long-term follow-up is available, the potential risk of synthetic hormone transfer to the baby is a cause of concern regarding the use of these methods. THE IMPORTANCE OF CONTRACEPI IVE DELIVERY Accounts of the large number of people in need of family planning services warrant the question of whether and to what extent this unmet need could best be served by better delivery of existing contraceptive methods. Some analysts have claimed that the problem of contraceptive use is not a so-called hardware problem, but a software problem (Djerassi, 1981~. From this point of view, the need for better, more available contraceptives can best be served by improvements in delivery systems rather than by the development of new products. In many developing countries, the problems with delivery systems are particularly acute. Certainly, improved delivery would help and, for the immediate future, it is the only alternative. But the need to better deliver the contraceptive methods that are available should not lead one to underestimate the potential impact of new, safer, and more convenient techniques. The introduction of new methods could stimulate an expansion in the delivery system in part because, if health and family planning program managers have something new to sell or offer, they may be encouraged to expand their outlets. New methods could influence fertility in several ways by increasing safety (yielding fewer adverse effects) and effectiveness (yielding fewer pregnancies), increasing acceptability and use (yielding more users), or increasing continuation (producing longer durations of use). Because most modern methods of contraception are relatively effective, the impact of new methods will probably come from greater acceptance, longer periods of use, or both. If 30 percent of the population at risk uses a method of contraception (about the current level of contraceptive practice in Egypt or Bolivia), then a Appoint increase in the average continuation of use (that is, a 10-percent increase in the number using the method for a full year) would have the same demographic impact as about a 4.5 percentage point increase in contraceptive prevalence. If continuation rates were 90 percent during the first year of use instead of the 50 to 70 percent for most temporary methods, it would make a substantial difference (Berelson, 1978~. It is important, however, not to exaggerate the impact that new technology would have. A plausible case can be made that improved delivery of existing

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28 DEVELOPING NEW CO~RACE~IVES methods could also make a large difference in acceptance rates. The lowest contraceptive prevalence is typically found in countries with the weakest family planning programs (Lapham and Mauldin, 1987:671~. Moreover, the experience of family planning programs in developing countries such as those in Indonesia and Thailand suggests that large increases in contraceptive use and corresponding declines in fertility are possible with current methods. Moreover, one possibility is that in some countries, for example those in sub-Saharan Africa, the demand for contraception is so low that neither improvements in contraceptive technology nor better delivery of services would encourage significantly greater use in the short term. Nevertheless, the contribution of new contraceptive methods to an improvement in the coverage and impact of family planning programs is likely to be particularly important in the less developed world. In a large and growing number of countries, access to family planning services is considered a basic human right, similar to good health or literacy. There is little debate about the desirability of programs to provide couples with access to easy, affordable, and effective means of family planning. CONCLUSION New methods would help couples meet the changing needs for contraception that they face during different stages of their reproductive lives. An increase in the total number and type of contraceptive options available would help to ensure a better, healthier match of methods to users. Furthermore, societal needs change over time, and new methods could help societies address important social problems. In recent years in the United States, for example, the pattern of premarital intercourse has changed, as has exposure to sexually transmitted diseases. To the extent that such social changes take place, the need for contraceptive methods is altered. In this respect, then, contraception is not like other aspects of preventive medicine. One polio vaccine solved the problem of poliomyelitis, but one contraceptive will never meet all societies' and all individuals' changing needs for fertility regulation (Potts and Lincoln, 1988~. There are important and obvious gaps in the range of available methods. These gaps could be filled, in part, by developing new, safe, effective, and acceptable methods for men, for breastfeeding women, for teenagers, for older women, and for those with particular health . . cone Tons. There is no simple, straightforward account of the likely impact of new contraceptive methods on fertility and health. Human reproduction and its control are elements in a very complex system of multiple interactive variables, which change over time, vary from place to place, and affect people differently. It is difficult to measure the importance of a new contraceptive method relative to improvements in delivery systems, to increased information about existing methods, to changes in the status of women, or in the motivation to control fertility. New

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NEED FOR NEW CONTRACEPTIVES 29 methods of contraception are not a panacea for all the problems associated with unwanted pregnancy and childbirth around the world. Nor should the development of new methods be viewed as a substitute for improving the delivery of existing products and increasing education about sexuality, human reproduction, and family planning. Greater attention must also be given to the factors that promote contraceptive use among individuals seeking to avoid pregnancy. Better education about human reproduction, sexuality, and contraception, shared responsibility, and more open communication between partners about sex, health, and contraception are likely to increase motivation to use contraception and the ability of individuals to use methods effectively. Without the proper motivation, knowledge, and communication among potential users, new and improved contraceptive methods may gain only limited acceptance or may be used improperly. More attention should also be given to developing new contraceptive methods. We must work to improve the technology used by couples to plan their families. New methods are needed to help reduce the level of unwanted pregnancy, the use of abortion, and the health risks of childbearing. The committee believes that the important societal and individual benefits of safe and effective contraceptive use argue strongly for a larger number and greater variety of contraceptives.