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9 Contraceptive Development: Obstacles and Opportunities THE NEED FOR NEW METHODS Additional contraceptive methods that are safe, effective, and acceptable within the cultural, social, religious, and ethical frameworks of individuals and societies would have a significant positive effect on human well-being. Unlike most other products whose development is regulated by the actions of the marketplace, the development of new contraceptives is influenced by often conflicting and uncoordinated public policies. The impact of these policies, together with other aspects of contraceptive products, such as the complexity of evaluating their risks and benefits and the importance of the social benefits of contraceptive use, has restricted the number of methods currently available and has slowed the development of new methods. Contraceptive decisions, including the decision not to use contraceptives, must be faced by the vast majority of people of reproductive age. Choices are influenced by a variety of factors, including one's cultural background, socioeconomic status, personal aspirations, health status, and intensely felt individual values. The number and characteristics of available contraceptive methods also influence these decisions and the ability of men and women to regulate fertility in a way that is consistent with their values, economic circumstances, and life-styles. The increasing number of younger men and women in the United States who opt for surgical sterilization as a method of family planning, the high prevalence of abortions, and the very high rate of teenage pregnancy all point to the potential advantages that additional contraceptive methods might yield. More difficult to quantify but equally important reasons to develop new methods are the 147

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)48 DEVELOPING NEW CO=~CE~~ES shortcomings of existing products, including method characteristics related to health risks, effectiveness, and convenience as well as to other user preferences. In short, the health, personal, or economic circumstances of many people mean that they are not well served by existing methods. Noteworthy in this regard are teenagers, women over 35 who smoke, breastfeeding women, and women who have contraindications to the use of most available methods. Often these women are at higher risk during pregnancy and therefore in special need of better contraceptive protection. Contraceptive use in other societies is also affected by the situation in the United States. Although the methods that would function best in the different circumstances of each developing country vary widely, a broader spectrum of contraceptive methods would have beneficial effects on the fertility, health, and the well-being of people throughout the developing world. Limited contraceptive options have a greater negative impact in developing countries than in the United States because the health risks of pregnancy and childbirth are higher and the social benefits of contraceptive use can be much greater there than in the United States. The United States has exercised leadership and made significant technological advances in numerous health and development-related areas, but in recent years the field of contraceptive development has not been among them. During the past two decades, scientific and clinical research related to new contraceptive methods has slowed in the United States. Some newer methods or significant improvements in existing methods are now available in Europe, and even in some developing countries, but not in the United States. Although the distribution of methods, education about their use, and the willingness of couples to use them are all important, the committee concludes that there is a significant need for new methods in the United States, particularly given the mounting public concern over the long-term risks associated with oral contraceptives that have received widespread adverse publicity. New contraceptive methods cannot tee developed in a short time. Development is initiated as advances in understanding of basic reproductive biology are transferred to the clinical arena for testing. The process from that point on is long, arduous, and expensive. Since the introduction almost three decades ago of the pill and the IUD, no fundamentally new contraceptive method has been introduced in the United States. Although the pill and the IUD have been modified to increase their safer and effectiveness, they still are not suitable for use by all couples in all circumstances. RESEARCH LEADS New contraceptive methods could become available if greater support for their development existed. Among the promising leads and possibilities are a contraceptive vaccine, long-acting implantable steroids, reversible male and female

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OBSTACi FS AND OPPORTUNITIES 149 sterilization, new spermicidal agents with antiviral properties, a once-a-month pill acting as a menses inducer, new ovulation prediction and self-detection methods, and methods interfering with spermatogenesis in the male. VALUES The contraceptive choices available to American couples are determined not only by the yield of basic research or the profit margins of pharmaceutical companies, but also by the values people hold, which influence the pace of contraceptive development in this country. Although it is difficult to trace and impossible to measure precisely, our heritage has influenced the attitudes of the nation's scientists, executives, politicians, and the public. The net impact of our values has probably been to slow development efforts and reduce the amount of public support for contraceptive research. There is a pervasive sense among women that not enough attention is paid to the desires and needs of current and potential future users. Some minority group members worry about the potential abuses that promoting contraceptive development may encourage. Whatever the reasons, the nation offers far more support for research to alleviate specific illnesses than to prevent the burdens and trauma of unwanted pregnancy and its medical, psychological, and social consequences. Most sexually active people in the United States have some experience with contraceptive use and therefore some interest in methods that are safer, more convenient and, overall, more to their liking. To a large extent the problems and prospects of contraceptive development are increasingly discussed by people with strongly held but often poorly informed points of view. If public discussion could be broadened and if potential users felt that their concerns were being addressed in the development process, it is likely that support for development would increase substantially. ORGANIZATIONS AND RESOURCES Only one large U.S. pharmaceutical company currently maintains a significant contraceptive research program, and only three European firms support such research. As a consequence, the responsibility for contraceptive development has shifted to the government, nonprofit research organizations, and small fines. This change in organizational structure has contributed to the slowing of the development of new contraceptives. As they have become more active in the contraceptive development process, these organizations have encountered a number of problems, including those related to funding constraints, the limitations of technology, and a lack of experienced personnel. Nonprofit organizations have begun to play a much more significant role in all aspects of contraceptive development, but these groups face a variety of obstacles that slow their progress significantly. Increased research costs, greater demand

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150 DEVELOPING NEW CO=RACE~IVES for highly skilled professional staff, and the need for better research facilities require long-term financial commitment of a type that nonprofit organizations cannot easily obtain. It is difficult to plan an effective research program aimed at the development of new contraceptives if support for research cannot be guaranteed for more than two or three years at a time. To the extent consistent with the appropriations process, the federal government, which already provides a majority of the funding for these nonprofit groups, should increase funding and adopt arrangements that provide stability for priority research projects. The committee believes that one of the principal impediments to progress in contraceptive development is the lack of a pool of basic and clinical investigators who are seriously engaged in development efforts. There is a particular need to attract more women and members of minority groups to the field. Federal funds for training have fluctuated dramatically from year to year and have been severely reduced in recent years. This has led to the perception among young scientists that future work in the field is not secure, a perception that lessens the attractiveness of research in this important area. All but a handful of private foundations do not include basic reproductive research and contraceptive development from their programs. Given the value of new methods and the clear opportunities for research, the committee recommends that efforts be made to increase private-sector support for research on reproductive biology and for contraceptive development. The perception of many is that contraceptive failure and unwanted pregnancy are not significant problems in the United States and abroad this view needs to be changed. Contraceptives are among the most widely used drugs and devices in the United States and the contraceptive alternatives available to women and men can be substantially improved and expanded. Since the mid-1970s, federal funding for research in reproductive biology has increased only modestly, and there has been a decrease in the relative funding of applied contraceptive development. Private foundation support for basic research in the reproductive sciences has declined dramatically and steadily since the early 1970s. Most analysts do not give enough attention to the limitations imposed by the existing base of scientific knowledge on technological innovations. When we understand more about the reproductive process, we may find that fundamentally new approaches of fertility control may arise. The length of time required for development, however, will not necessarily be any shorter. Since basic research represents the underpinning of any future development, support for such research must keep pace with the rising cost of research and development in the United States. The product introduction phase of contraceptive development, which in the past has been substantially neglected, also merits greater attention and increased funding. REGULATION The Food and Drug Administration has recently modified He process of approval for contraceptive drugs. FDA regulations for the toxicological and

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OBSTACLES AND OPPORTUNITIES 151 clinical testing of contraceptive steroids have been simplified and the requirements brought into much closer conformity with the guidelines of the World Health Organization and those of other industrialized nations. The establishment of a worldwide consensus on the appropriateness of regulations governing contraceptives might promote further development. Efforts in this direction could be encouraged by an international conference on the regulation of contraceptive development, from which might come a consensus report for consideration by the FDA and the regulatory bodies of other nations. Although local conditions can and should affect regulatory decisions, the basis for such decisions might be clarified and the quality and benefits of these decisions might be improved through more international interaction. Present FDA standards assume that contraceptives are used overwhelmingly by healthy people, for whom their use will not interfere with health. In fact, a large number of would-be users have conditions that make them poor candidates for existing contraceptive methods. The adverse consequences of pill use for women with hypertension are one example; the risks and benefits of oral contraceptives for that group are very different from those for other women. Furthermore, the risks of pregnancy, labor, and delivery vary among individuals and populations and are, in most instances, greater than the risks posed by currently available methods of contraception. In addition, some methods have noncontraceptive health benefits; increased attention should be given to such factors as new contraceptive methods are evaluated. However, some contraceptive- related risks are inevitable or unforeseeable. Therefore, greater postmarketing surveillance and long-term epidemiological studies of contraceptives should be undertaken. The committee supports the rigorous review and approval process provided by the Food and Drug Administration, which adds to the safety of contraceptive practice and public confidence in contraceptive products. The committee believes its recommendations would increase the effective use of contraception in the United States by enabling FDA to approve methods that would allow both users and providers of contraceptives to tailor specific methods more closely to the health conditions and family planning needs of each individual. LIABILITY The most frequently cited barrier to the greater availability and faster development of contraceptives is referred to as the liability crisis. The available evidence suggests, however, that the impact of products liability should be evaluated in conjunction with other factors that influence contraceptive development and use. It is important to keep in mind that companies' decisions about what products to market and what research to support are based on a projection of potential profits. Companies stop or do not begin research and development activities, not because of liability per se, but because the potential risk of liability and the costs of protecting against it are not balanced by a sufficiently greater profit potential.

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152 DEVELOPING NEW CO~RACE"IVES Wornes about liability claims relating to contraceptives appear to be particularly important to the major U.S. pharmaceutical companies, as evidenced by their withdrawal from the market of several FDA-approved IUDs. The expense of litigation must be considered within the framework of the rather modest profit margin generated by a contraceptive method, such as the IUD, that does not require repeat purchases. Within this context, it would seem that the private sector has little incentive to develop a product that by modern contraceptive standards would be considered ideal-one that is relatively inexpensive and used only as needed or over a long period without requiring frequent replacement. The committee concludes that recent products liability litigation and the impact of that litigation on the availability of liability insurance have contributed significantly to a climate of disincentives for the development of new contraceptive products. The committee recommends that certain changes be made in products liability rules to remove some of the negative consequences for contraceptive development without compromising the safety of contraceptive use. Specifically, the committee recommends that Congress enact a products liability statute that establishes uniform standards for products liability lawsuits involving contraceptives and that gives manufacturers of an FDA-reviewed contraceptive product a defense based on FDA's acceptance of that product. The operation of the legal system in the United States makes it very difficult to forecast precisely the extent to which enactment of the proposed statute would change the perception of liability risk. Although the committee believes that the statute is an important first step, we recognize that it will take several years before its impact can be completely evaluated, and that modifications may be needed. A FINAL WORD Our examination of policy issues related to the development of new contraceptives demonstrates that no single factor determines the mix of contraceptive methods available to couples or the speed with which new products are brought to market. While such a conclusion will seem to many readers too obvious to require stating, in our review we found numerous instances of otherwise thoughtful and careful people claiming one or another factor was the sole reason that new contraceptives were not being developed. Since the first major breakthrough in research on the oral contraceptive in the 1950s, the number of people practicing contraception worldwide has more than tripled to about a half billion in 1988. Because of a rapidly increasing population in the reproductive ages and a tremendous growth in contraceptive practice, concern about side effects and the effectiveness of existing methods and a demand for safer, more effective, convenient, and affordable contraceptives has never been greater. The importance of these issues both in He United States and in other countries is likely to increase even more in the decades to come. Although not the focus of this report, attention to the factors that would

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OBSTACLES AND OPPORTUNITIES ~53 promote contraceptive use among individuals not seeking to become pregnant is also important. New birth control methods-even safer and more effective ones-are of little benefit if they are not accessible, if they are not used, or if they are used improperly. Motivation to control fertility and the ability to use various methods effectively come not only from contraceptive research and development but also from better distribution systems, better education, including education about human sexuality and reproduction, and more open communication about sex and birth control. Finally, we have not compared contraceptive development to other worthy causes and therefore do not conclude that having a wider variety of contraceptives outweighs all other social goods. However, the committee believes that developing a wider array of safe and effective contraceptives is highly desirable, valuable, and for the social good. In the committee's judgment, increasing funding and other resources devoted to contraceptive development will have an important positive effect, even though the precise scientific and technological breakthroughs cannot be predicted with certainty. We should move to develop better contraceptives and to work to ensure more appropriate patterns of contraceptive use. New methods can change peoples' motivation to practice contraception. Unless steps are taken now to change public policy related to contraceptive development, contraceptive choice in the next century will not be appreciably different from what it is today. The continuation of contraceptive research and development by U.S. companies and research institutions is important to the health and well-being of people in the United States and around the world. Encouragement and financial support for American research organizations to initiate, resume, or expand their contraceptive development efforts, as well as reevaluation of and changes in the FDA's mechanisms of assessment of the risks and benefits of contraceptives, and changes in products liability rules will speed the development and introduction of safer, more effective, and more acceptable new contraceptives for the twenty-first century.

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