Contraceptive Research and Development Looking to the Future (1996) / Chapter Skim
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1 Introduction
1 Introduction
Pages 1-28
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While the existing array of contraceptive options represents a major contribution of science and industry to human well-being, it fails to meet needs in significant 1
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Slightly restated, these are contraceptives that are also protective against sexually transmitted diseases (STDs) , including human immunodeficiency virus (HIV)
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Thus, greater knowledge about reproductive health and, in that context, contraception, is essential for providers, consumers, and the public at large, if fully informed, free, and appropriate choices are to be made about fertility regulation and sexuality. In turn, the proper use of contraceptive technologies for fertility regulation is linked both to the availability of quality contraceptive services providing a full range of safe, approved methods of contraception and an earnest and continuing search for more and better methods for more people.
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The committee agrees that the large numbers of unplanned and unwanted pregnancies in the world are not due solely to inadequate contraceptive methods. It is surely true that substandard health services; lack of public education; inadequate provider training; misunderstandings about risks and poor understanding of how people calculate risk; and social, cultural, and religious influences on family planning behavior, all can play a role in whether contraception is used and whether it is used appropriately and properly.
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Abortion Approximately one-third of the 190 million pregnancies in the world in 1995 ended in abortion; that same proportion applies in the United States. Clearly, those millions of women who choose to terminate a pregnancy, many submitting to unsafe and illegal procedures that can be life-threatening, attest to the need for improved access to and utilization of existing contraceptive methods and the need for new and improved contraceptive options.
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Indicators of Market Demand Contraceptive Side Effects, Failure, and Discontinuation Like any medical intervention, all contraceptive methods have side effects, some of which are burdensome, some unacceptable. The most popular forms of reversible contraception are hormonally based, namely, oral, injectable, and implant contraceptives.
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While sterilization can stand as an indicator of willingness to spend a considerable sum to terminate childbearing, that reading is somewhat compromised by the fact that, in many cases and particularly in the United States, some third-party payer is willing to assume the costs for the intervention, yet not willing to assume the costs for provision of reversible contraceptives. Sexually Transmitted Disease, Including Human Immunodeficiency Virus (HIV)
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The short- and long-term costs of unintended pregnancy and sexually transmitted disease are high; the cost-effectiveness of all contraceptive methods is excellent. Furthermore, availability of a good method mix has an independently positive effect: The addition of even a single major method to a family planning program can account for significant increase in contraceptive use-prevalence and reduction in crude birth rates.
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THE PROSPECTS OF THE SCIENCE The next question was whether there are possibilities that have been generated through the insights and mechanisms unfolding in contemporary science that would offer fresh, exciting, and plausible leads for a whole new generation of contraceptives. The committee dedicated vigorous effort to this question, reviewing a large body of evidence and expert testimony about possible leads to new contraceptive technologies, with special emphasis on those that respond to priority needs and might also evoke market demand.
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From page 10... ...
Such an approach highlights the need for improvements and new advances in contraceptives for women, and in areas where there are few or inad equate 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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Absent such investment, it is hard to see where innovative new approaches to contraception will come from. The science is also potentially responsive not only to the requirements of contraception but to the additional imperative of addressing the mounting burden of the sexually transmitted diseases, including HIV.
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Approaches to New Contraceptive Methods for Females and for Males Recommendation 3. Toward development of new contraceptive meth ods 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 S-1 and S-2.
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SUMMARY 13 Box S-1 Approaches to New Contraceptive Methods for Females Vaginal Methods (Barriers) Short-to-medium term: • identifying agents that are spermiostatic rather than spermicidal • developing antifertility agents that inhibit virus and/or other pathogenic or ganisms in the vagina • modifying mucous secretions from cervical epithelial cells to prevent sperm passage Monthly Methods and Menses-inducers Short term: • evaluating combinations of antiprogestins, antiestrogens, and inhibitors of enzymes involved in steroid synthesis to induce menses Long term: • understanding factors involved in blastocyst implantation • developing specific luteolytic agents Inhibition of Ovulation Long term: • inhibiting ovulation using nonpeptide GnRH antagonist/hormone combina tions • understanding the mechanism controlling follicular rupture as a way to pre vent ovulation while permitting development of the corpus luteum Inhibition of Fertilization • inhibiting sperm-egg fusion, acrosome reaction induction, and sperm trans port • understanding the molecular basis of follicular atresia and luteinization, to provide leads for specific induction of atresia in the dominant follicle Recommendation 4.
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, and HPV (human papilloma virus) Monthly Methods and Menses-inducers The area of menses-inducers or, more generally, postimplantation technologies, is one of the most complex of those discussed in this report.
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Because of persistent controversy, the development of postimplantation technologies is unlikely to attract the capital and research efforts of most large pharmaceutical firms, either in the United States or in Europe, nor is it likely that U.S. public sector entities can play a significant role in developing these methods independently.
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Even though the committee believes that there is considerable unmet need for new contraceptive technologies in the industrial and developing economies of the world; even though a compelling public health case can be made for the development of a broader portfolio of contraceptive options for women and men; even though contraceptives are highly cost-effective; and even though there are likely to be large savings to be realized from the prevention of sexually transmitted diseases; that may not be enough. The response of industry is conditioned by how all this can be translated into a strong, profitable, politically safe, and reasonably predictable market for prospective products.
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In the committee's judgment, the development of new contraceptive technologies will depend, among other things, on assurance of a substantial market for both existing and new technologies. Thus, broader provision of third-party coverage for contraceptive services could be important to the maintenance of a strong market demand.
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The characteristic solution has been that international bilateral and multilateral external assistance programs procure large quantities of contraceptive commodities from developers or manufacturers at a public sector contract price sufficient (given large volumes and low distribution and marketing costs) to cover developers' costs, with a modest profit.
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The committee strongly endorses continued public sector support of, first, basic research in innovative areas of reproduc tive 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 committee believes that the great est value added will accrue to strategies focused on attracting invest ment in those smaller domestic and foreign firms able and willing to do early-stage research in contraceptives or in a fundamental reproductive mechanism of particular promise.
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The FDA has been working on the problems of delays in its approval processes and a number of internal reforms and procedural modifications have been implemented. In its contacts with industry, the committee encountered no generalized sentiment for diluting the rigor of FDA approval processes; in fact, any possibility that pending tort reform legislation might include a federal product liability statute giving contraceptive manufacturers credit for FDA approval of contraceptive drugs and devices argued against such dilution.
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This could affect the new two-rod Norplant II implant system, new female barrier methods now in clinical trials, hormone-releasing IUDs made with silicone, new male and female barrier methods made with silicone and analogous polymers, and tubal ligation clips, not to mention the loss of options in connection with other conditions such as cardiovascular disease. The committee encountered mixed views on the relative impact of liability on pharmaceutical innovation, in general, and contraceptive research and development, in particular.
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In its 1990 report, the National Research Council and Institute of Medicine Committee on Contraceptive Development recommended that the U.S. Congress enact a federal product liability statute that would give contraceptive manufacturers credit for approval of contraceptive drugs and devices (and their labeling)
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Congress enact a federal product liability statute that gives contraceptive manufacturers credit for FDA approval of contraceptive drugs and devices. When the FDA has con sidered 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.
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The point is often made that at least some of the failure rates associated with contraceptive methods (e.g., barrier methods) are a function of inadequate information and support or, as in the case of emergency contraception, an almost total lack of communication from provider to client.
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From page 25... ...
Labeling can be dismissed as a small matter, or at least smaller than other forces that impinge on the availability and use of contraceptives, such as the media, advocacy groups, and the ideas, information and, sometimes, misinformation that flow through them. Still, a single categorical location where intelligible, accurate information about the technical aspects of individual contraceptive technologies -- their risks, side effects, contraindications, benefits, and proper use -- is consistently available, could anchor the information base.
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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.
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From page 27... ...
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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