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--> 8 Recommendations This study began with three questions. The first was: Is there really a need for new contraceptives and, if so, why? The second was: If, as has been said, the field of contraceptive research and development has somehow lost the energy that characterized it at the time of what is called the "first contraceptive revolution," are there new prospects in the science that could reenergize it? The third was: Given such prospects, would they be sufficient to accomplish that revitalization; if not, why not; and what sort of climate and resources would be required for that to happen? Thus, the Institute of Medicine and this study committee were challenged not only with investigating what the new science had to offer, but with examining the climate for collaboration between the public and private sectors in translating those offerings so as to meet the need and demand for new contraceptive options. Throughout its work, the committee sought to frame its exploration and possible response to these issues around contraceptive research and development in a way that might offer a fresh outlook on the subject. Four concepts seemed to merit integration into such a framework: the idea of a "woman-centered agenda," the challenge of unintended pregnancy, consideration of contraceptives from both the perspective of need and market demand, and new possibilities for collaboration between the sectors. The committee concluded that there is indeed a need for new contraceptives, as well as evidence of a real market for them. While the existing array of contraceptive options represents a major contribution of science and industry to human well-being, nonetheless it fails to meet needs in significant populations;
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--> furthermore, the costs of that failure are high, for societies, for families, and for individuals. The committee also found that an agenda for contraceptive research and development that is "woman-centered" to be reasonable, just, and also market-worthy. The challenge is to find creative ways to elicit the best response from the scientific and industrial communities in a conducive climate that protects the integrity of inquiry and the safety of consumers. The issue of climate is central. The aspects of context that press on every effort to provide safe and effective contraceptive technologies are complex and reflective of deeply rooted differences and deeply held beliefs. In addition, there is the current atmosphere of fiscal austerity in so much of the world, an atmosphere that cannot be ignored. At the same time, what is to be done about real, urgent, and unmet needs that affect public health and well-being everywhere? The committee opted for a set of recommendations that are neither glamorous nor sweeping. They are, instead, unified by their practicality, located in the middle ground of policy, and intended to respond to what seem to be the needs of a significant majority. Finally, the committee chose to use this closing chapter to simply list its recommendations, without elaboration and divided into two main sections: first, the criteria for and the prospects of the science and, second, the elements of context that will need to be affected if the science is to advance significantly and the needs and demands of individuals and families are to be met. The reader is referred to the summary at the very outset of this report which frames each recommendation in the larger setting to which it corresponds. Each presentation serves a slightly different policy objective for different audiences, while the report as a whole is meant as a review of the various key dimensions of this very complicated but very essential topic. The Prospects of the Science Recommendation 1. The committee recommends that priorities for new research be assessed against the preference criteria presented in a new "womancentered agenda" and that existing public sector contraceptive research and development portfolios be reassessed similarly. Such an approach highlights the need for improvements and new advances in contraceptives for women, and in areas where there are few or inadequate options, namely: Methods that act as chemical or physical barriers to conception and to transmission of sexually transmitted diseases, including the human immunodeficiency virus (HIV); Menses-inducers and once-a-month methods targeted at different points in the menstrual cycle; Methods for males that would expand their contraceptive choices and responsibility.
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--> Recommendation 2. Modern scientific methods now exist that can identify genes whose products are involved solely in reproduction and are therefore prime targets for inhibition of conception. Fundamental research on the cells, tissues, and organs that contribute to conception can now be carried out with a new and incisive precision using tools of modern biology. The committee recommends, therefore, that priority be accorded to work with genes whose products are truly specific and urges attention to the fact that investment in basic research in contraception will be essential if work with these elements is to proceed with reasonable dispatch. Absent such investment, it is hard to see where innovative new approaches to contraception will come from. Recommendation 3. Toward development of new contraceptive methods for females and for males, the areas of specific research that have come to light during this study and that this committee believes deserve the greatest attention in the shorter and longer terms are presented in Boxes 8-1 and 8-2. Recommendation 4. The committee believes that the field of immunocontraception holds promise: for contraception, for innovative approaches to barriers to infection, and for areas of science with broader applications. The committee recommends the emphases presented in Box 8-3. Recommendation 5. The committee urges that the research and development of anti-implantation and postimplantation methods be pursued as a response to a major public health need and to evidence of demand. Nonetheless, because the area of postimplantation is so controversial and thus unlikely to attract investment by large pharmaceutical companies, partnerships between smaller firms and nonprofit organizations may represent the most appropriate avenues for research, in the United States and elsewhere. The committee recommends this area of research and development as a priority for funders for whom this controversy is not constraining. Research on monthly methods up to and including implantation should also have high priority. Advancing the Science and Translating Unmet Need into Market Demand Recommendation 6. The committee recommends that, to make a full range of contraceptive products accessible to consumers and to increase demand for contraceptive products to something closer to the level of unmet need, there should be continued and sufficient government support of contraceptive services—for males as well as females—particularly for low-income individuals and particularly in developing countries. The committee also recommends that third-party payers, who bear the costs and may reap the benefits of the health status of their covered populations, include contraception as a covered service. Ideally, family
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--> planning services and the management of sexual health would be integrated as components of comprehensive reproductive health services. Recommendation 7. The committee recommends that consideration be given to a multilateral approach that would enlist the participation of public agencies and private philanthropic organizations toward support for an extension of the Global
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--> Contraceptive Commodity Programme that would create incentives for the development of new contraceptives. Since contraceptive procurement is already tiered and since both purchasers and vendors appear to accept that as a fact of life, an additional tier might be constructed for volume commitments for procurement of new contraceptives at prices that would constitute an incremental attraction to industry and still be feasible for countries able and willing to expand the range of contraceptives available to their populations. Recommendation 8. The committee strongly endorses continued public sector support of, first, basic research in innovative areas of reproductive biology as a source of new leads for contraceptive research and development and, second, in the applied research that will bring the most promising leads to fruition. The
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--> committee believes that the greatest value added will accrue to strategies focused on attracting investment in those smaller domestic and foreign firms able and willing to do upstream research in contraceptives or in a fundamental reproductive mechanism of particular promise. In this connection, the committee calls attention to the new Consortium for Industrial Collaboration in Contraceptive Research, whose purpose is to catalyze funding for feasibility studies and matching industry investment in early-stage contraceptive research and development in priority areas of the woman-centered agenda. The committee believes this initiative to be a creative and potentially high-payoff mechanism for sponsor investment. Recommendation 9. The committee recommends that approval guidelines be developed as quickly as possible for the high-priority area of vaginal microbicides and spermicides, as a first step toward clarifying requirements for clinical trials and monitoring of novel contraceptives in general. A consensus conference on this topic is recommended, perhaps convened by the World Health Organization. Of special concern in this specific context are guidelines for what would constitute clinically significant levels of anti-infective efficacy, as well as risk of possible fetal exposure. Recommendation 10. The committee reiterates the 1990 NRC/IOM committee recommendation that the U.S. Congress enact a federal product liability statute that gives contraceptive manufacturers credit for FDA approval of contraceptive drugs and devices. When the FDA has considered the relevant health and safety data on a contraceptive product, has approved the product, and has required warning and instructions to accompany it, it is sound national policy to make this approval available to manufacturers as a limited defense and not to penalize them for something they could not have known at an earlier point. Because the statute would interact with postmarketing surveillance efforts, this recommendation would be more compelling were formal postmarketing surveillance studies to be generally required. This said, the committee adds emphatically that it endorses a government standards defense only in the context of existing levels of rigor and scrutiny in approval processes and presentation of all relevant data by manufacturers. Recommendation 11. The committee believes that users of contraceptives have a right to information about them that is balanced, accurate, and intelligible. Significant sources of such information are the labels and inserts that are integral to pharmaceutical packaging. The legal, regulatory, educational, sociocultural, scientific, and even artistic aspects of these packaging elements are large and complex, so that modifying them significantly will require cross-disciplinary and cross-sectoral effort. The committee urges that this topic be addressed soon, for
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--> two reasons. First, balanced, accurate, and intelligible contraceptive packaging is of potential benefit to contraceptive users, health providers, manufacturers, and entities concerned with public health and welfare, since it could contribute to the more appropriate and wiser use of contraceptive technologies. Second, the activity in itself offers the opportunity for much-needed dialogue within and across sectors, genders, classes, and systems of belief. Closing Comment Despite the undeniable richness of the science that could be marshaled to give the women and men of the world a broader, safer, more effective array of options for implementing decisions about contraception, childbearing, and prevention of sexually transmitted disease, dilemmas remain. These dilemmas have to do with laws and regulations, politics and ideology, economics and individual behavior, all interacting in a very complex synergy that could lead to the conclusion that nothing can be done to resolve the dilemmas because everything needs to be done. This committee examined the development of vaccines for the world's children as an experience with many analogies to contraceptive research and development. That experience informs us that the dilemmas around controversial medical products, whatever the sources of controversy, tend to be incremental and systemic in their resolution. Modification of the terrain for vaccine research and development took time—two decades of working groups charged with solving "the vaccine problem," a decade of legislative attempts to construct a passable bill, and close to a decade for industry to perceive that the legislative remedy was effective. Change came from several sources—from a surge of discovery in the science, from legislative action that modified public policy, from leadership at national and international policy levels, and from the decision of a major international donor to seek outside guidance in assessing its processes and their impact. This does not mean that the same amount of time will be needed for improvement in the contraceptive landscape, nor will the solutions be the same. The central implication is that there is not likely to be a "silver bullet" solution to the dilemmas faced by the field of contraceptive research and development. Each piece of the dilemma will have to be tackled in cumulative fashion as part of a coherent strategy, each resolution improving matters somewhat and eventually amassing enough weight to tip the balance in a more positive direction. What this study committee has tried to do is identify a relatively small set of emphases and changes that, altogether, could turn the field around, but that, even partially implemented, could open up the field to freer, more equitable access to those who require its fruits.
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