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Executive Summary THE NEED FOR NEW CONTRACEPTIVES Family planning is a socially beneficial activity that affects the well- being of women, men, children, families, and society as a whole. Planned fertility confers the benefits of improved child health and development through the more effective intergenerational transfer of resources and the increased longevity and empowerment of women, with its attendant eco- nomic benefits to the family and the community. It reduces the lifetime risk of chronic illness or death from a pregnancy-related condition. Barrier methods of contraception have the added benefit of lessening the likeli- hood of transmission of sexually transmitted infections (STIs). Conversely, a woman experiencing an unintended pregnancy is at greater risk for depression and physical abuse. She also faces the usual health risks of pregnancy, including maternal death. Closely spaced births carry additional health risks for the mother and child. The child born from an unplanned conception is at greater risk of low birth weight, of dying in its first year of life, of being abused, and of not receiving sufficient resources for healthy development. With an unplanned conception, the mother and father may suffer economic hardship and may fail to achieve their educational and career goals, and their relationship is at greater risk of dissolution. According to a recent analysis by the Global Health Council, the world's 1.3 billion women between the ages of 15 and 45 experienced more than 1.2 billion pregnancies in the 6 years between 1995 and 2000 (Global Health Council, 2002~. Of these, more than 300 million or more than one- 1

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2 NEW FRONTIERS IN CONTRACEPTIVE RESEARCH quarter were unintended, and nearly 700,000 women died as a result of unintended pregnancies. The number of women at risk for unplanned pregnancies will grow as the world's population continues to rise. Over the next decade, 600 million girls are projected to reach adolescence, which will be the largest cohort of young women in human history. Although a number of reversible and nonreversible contraceptive methods are generally effective (barrier methods, hormonal methods, intra- uterine devices, and contraceptive sterilization), no method is 100 percent effective for all users, and some men and women experience undesirable side effects. Studies have shown that more than 120 million women around the world report that they are sexually active, do not want to be- come pregnant, and are not using any form of contraception whether be- cause of cost, governmental policy, lack of access, or other reasons. Most men and women spend the majority of their reproductive years trying to avoid conception, and their contraceptive preferences change during the 30 years that they typically need contraception. Methods are needed for child spacing as well as permanent pregnancy prevention, for young people and those approaching menopause, and for postpartum and breast-feeding women. Methods are also needed for women and men with medical conditions that restrict contraceptive options, for those with few resources, for those with limited access to medical care, and for those whose personal situations make correct and consistent use difficult. The cultural or personal unacceptability of the various methods also points to the need for new options. In addition, the development of new methods that protect against pregnancy as well as against STIs would be enor- mously beneficial, as the HIV/AIDS pandemic threatens world health and continues to devastate sub-Saharan Africa and Asia. Recent scientific and technological advances in genomics, proteomics, new materials, and new drug delivery systems, along with a new under- standing of reproductive biology offer the promise of new, safe, and effec- tive forms of contraception. At the same time, new global consortia work- ing in this area are beginning to provide improved structures to pursue these opportunities collaboratively. The development of novel contracep- tives would help alleviate the growing unmet demand for satisfactory contraception and would improve the lives of families everywhere. Given the unprecedented opportunities for new progress in the field, now is the time to move forward with a bold research agenda. ABOUT THIS REPORT At the request of the Bill and Melinda Gates Foundation, the Institute of Medicine (IOM) established the Committee on New Frontiers in Contra-

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EXECUTIVE SUMMARY 3 ceptive Research to explore scientific opportunities for improving contra- ceptives. The committee was asked to organize an international symposium that brought together individuals with expertise in contraception, basic reproductive biology, new technologies, product development, behavioral science, and international health. The objective was to bring new concepts and analytical frameworks to the discussion of contraceptive research and development. Following the symposium, the committee deliberated on the important issues that were raised at the workshop, in the literature, and from their own experiences. On the basis of those discussions, the committee was charged with producing this report, which identifies priority areas for future research and development in the field of contraception. This report builds on Contraceptive Research and Development: Looking to the Future (Institute of Medicine, 1996), the most recent of several IOM reports about the future of contraceptive research and development. Many of the recommendations put forth in that report are as relevant today as they were in 1996, but the recent unprecedented advances in science and technology warrant a fresh examination of the research goals and agenda in the field of contraception. Although progress has been made since that report was released in 1996, the contraceptive modalities recently devel- oped or introduced are based mainly on preexisting technologies and ap- proaches. The progress in some areas thought to be promising in 1996 has been minimal, and recent discoveries provide new perspectives on previ- ously recommended targets. A major goal of the present committee was to identify ways in which new information and new technologies can be rapidly and efficiently applied to contraceptive target identification, vali- dation, and product development. Moreover, the committee found that there is still a great need to reenergize the field and to translate significant observations from the science of reproductive biology to practical appli- cations in fertility regulation. The committee's recommendations, summarized in the following sec- tions and in Box ES-1, address (1) facilitation of the stages of contraceptive development from target selection to product development and clinical testing and (2) strategies for research success, including participation by developing countries, expansion of public-private partnerships, increased clinical and scientific training and career development in contraception, and strategic management of research efforts. These recommendations cover a diverse range of topics, but all are interconnected and important for improving the range of available contraceptive products, their effica- cies, and their acceptabilities.

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4 NEW FRONTIERS IN CONTRACEPTIVE RESEARCH FROM TARGET SELECTION TO PRODUCT DEVELOPMENT Identify and Validate Novel Contraceptive Targets In the course of genomics research, thousands of genes expressed in the reproductive cells and tissues of model organisms and humans have been identified, and many of these sequences appear to be unique to reproductive tissues and gametes. Remarkably, a recent study found that 4 percent of all genes may be uniquely and exclusively expressed in male

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EXECUTIVE SUMMARY 5 germ cells. More than 200 human genes or related genes in other species have been shown genetically to play roles in reproduction in viva. Re- cent research in proteomics has also led to the discovery of proteins that are unique to reproductive cells and tissues. The identification of genes and proteins that are expressed specifically in the reproductive tract and, more importantly, that function specifically in the reproductive tract could lead to the development of new contraceptives that specifically affect the reproductive tract and thus produce minimal unwanted side effects. More work is needed to define more completely those genes and pro- teins that are unique to reproductive tissues and that are essential for reproductive function. Knowledge about how genes and proteins interact to form regulatory networks will also be important for the identification of key molecular targets for contraceptive development. In addition, more information about the structures and functions of the lipid and carbo- hydrate components of reproductive tissues could lead to the develop- ment of new contraceptive approaches. Recommendation 1: Identify and characterize all genes and proteins uniquely or preferentially expressed in the testis, ovary, and repro- ductive tissues; and define the genetic and protein networks in cells relevant to reproduction, including construction of a protein inter- action map for the sperm and the egg. Develop and apply selective screening methods to identify classes of molecules that have been traditionally targeted by pharmaceuti- cals, including membrane proteins, enzymes, receptors, and ion channels and transporter proteins. Continue the funding of research in progress to define the repro- ductive transcriptome. Convene a broad group of reproductive biologists, bioinformati- cists, biochemists, and physiologists to verify, annotate, and stan- dardize all gene expression data obtained by genomic methods. The information generated should then be stored in readily acces- sible databases based on the World Wide Web. Determine the complete proteomes of the sperm and the egg. Immediately initiate long-term support for efforts to identify and construct regulatory networks in reproductive cells, since genes and proteins do not act autonomously. Recommendation 2: Generate lipidomes and glycomes of the repro- ductive tract tissues and mature gametes. Determine the unique carbohydrate structures on proteins and lipids in reproductive tract cells.

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6 NEW FRONTIERS IN CONTRACEPTIVE RESEARCH Determine the contents and organizations of lipid domains within the membranes of reproductive tract cells. Determine the roles of carbohydrates and lipids in reproductive tract cells to identify targets for small molecules that could act selectively to disrupt membrane structure and function. Recommendation 3: Validate existing and emerging contraceptive targets by using forward and reverse genetic approaches with model organisms. Make use of existing genetic models through more in-depth pheno- typic analysis. This includes characterization by both genomic (e.g., microarray screening) and proteomic (e.g., global changes in protein modification) methods. Fund a small consortium of investigators (public or private) for the sole purpose of completing the genetic validation of all potential targets. Ideally, conditional gene knockout approaches should be used to reduce expression in specific adult tissues in order to repli- cate the use of contraceptives and to avoid artifacts due to develop- mental defects. Newly established genetic models should be rapidly distributed to the community of scientists involved in reproductive biology research for prompt and comprehensive phenotypic analysis. Accelerate the Discovery and Development of Compounds That Modulate Existing and Emerging Targets Several promising new targets for contraceptive development have already been identified, and many more will undoubtedly be discovered through efforts to implement Recommendations 1 to 3. However, vali- dated targets are useful only if compounds can be identified to modulate those targets in humans, and it remains a challenge to select lead mol- ecules for drug development. The most efficient way to initially identify such compounds is by using high-throughput drug discovery approaches. The effort will also require a variety of experimental approaches, from in vitro studies to whole-animal studies, to evaluate lead molecules for the purpose of subsequent clinical development (translational research). Much of the basic research that can lead to the discovery of potential drug targets is undertaken in university laboratories, but university-based researchers have inadequate access to the resources and information needed to develop compounds for the most promising targets that they have identified, and they lack access to the large, diverse libraries of com- pounds for screening as found in the pharmaceutical sector.

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EXECUTIVE SUMMARY Recommendation 4: Implement a mechanism and infrastructure for high-throughput screening facilities and the development of inter- national chemical libraries. Support two to four not-for-profit institutions with data-sharing capacities to develop high-throughput screening facilities for public use. Support and maintain two to four publicly accessible chemical libraries useful for drug development (i.e., via the elimination of potentially toxic molecules, metabolically active molecules, etc.) in not-for-profit organizations. The establishment of a "bioactive small-molecule library," as recently outlined in the National Insti- tutes of Health (NIH) Roadmap,~ could potentially meet this goal, depending on how that program is structured. Seek advice from the legal community regarding intellectual prop- erty ownership as it pertains to such a shared infrastructure for compound screening and chemical library development. Apply high-throughput drug discovery technologies to promising contraceptive target molecules or processes (as they are discovered and for those that have already been identified). Identify specific compounds that could be exploited as new contra- ceptives with noncontraceptive health benefits (e.g., compounds with both contraceptive and antimicrobial properties). Develop information technology that can be used internationally to facilitate sharing of and public access to high-throughput screen- ing and chemical libraries. Recommendation 5: Implement mechanisms to accelerate contra- ceptive product development and clinical testing once a lead molecule or concept prototype has been discovered in an academic laboratory by sharing multidisciplinary national and international resources. Specifically: Create a special projects program in NIH, affiliated with the Contra- ceptive Clinical Trials network, to fund the development of novel contraceptive compounds that offer large potential benefits for the global community. Such a program could perhaps be modeled after the National Cancer Institute's Rapid Access to Intervention Develop- ment program, designed to assist with the clinical translation of new therapeutics that have been discovered in the academic com- munity but for which there is limited interest or capacity for further development in the private sector. iSee www.nihroadmap.nih.gov (accessed October 2003~.

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8 NEW FRONTIERS IN CONTRACEPTIVE RESEARCH Provide incentives to the pharmaceutical and biotechnology indus- tries to expand their contraceptive research and development pro- grams and their collaborative interactions with the public sector to develop contraceptives that meet the needs of populations in both developed and developing countries. Provide adequate funding for contract laboratories to partner with the public sector to make materials, test the compositions of lead molecules, and evaluate the pharmacokinetic and toxicological properties of lead molecules. Support existing not-for-profit infrastructures and promote and fund the development of consortia to perform translational activi- ties for basic researchers. Apply Recent Advances in Drug Delivery Systems Delivery systems for contraceptive agents to date have focused on oral, transdermal, subcutaneous, intrauterine, and vaginal delivery modali- ties of small molecules. With the advent of the genomic and proteomic revolutions, alternative delivery systems will be necessary to accommo- date new generations of contraceptives in a cost-effective manner. The particular delivery mode that is ultimately selected depends on multiple factors, including the physiochemical properties and metabolic stability of the compound, the target, and user acceptability. The science of drug delivery systems is constantly evolving and is technically demanding, highly specialized, and costly. Although most pharmaceutical companies have dedicated groups with expertise in delivery systems, only a few investigators outside of the pharmaceutical industry specialize in this particular applied science. This limits the ability of investigators in not- for-profit organizations to use these technologies in the development of their compounds. Recommendation 6: Develop mechanisms to access, apply, and enhance the technology of drug delivery and formulation science to contraceptive development. Consider and select the best formulation and delivery system for each compound at an early stage of development, with consider- ation given to the physiochemical properties of the compound, the target, and user acceptability. One possible approach is to establish consulting programs in drug formulation and delivery systems available to scientists requiring this expertise. Develop new delivery systems for compounds with unique physio- chemical properties (e.g., peptides) and to enable the specific and

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EXECUTIVE SUMMARY 9 local delivery of existing and new compounds to a target in the reproductive tract. Accelerate and Improve Clinical Testing of New Contraceptive Methods New methods of contraception must offer high levels of effectiveness if they are to be approved by the drug regulatory authorities and if they are to meet user needs. However, measuring effectiveness is not easy. For both ethical and practical reasons, phase I and many phase II clinical trials typically do not use pregnancy as the end point but rather use a surrogate marker of fertility, such as ovulation or sperm count. The assessment of such markers involves the use of expensive tests, which require skilled investigators and which make huge demands on the time and goodwill of the participants. The capacity of each marker to accurately reflect sterility varies, and the contraceptive method dictates which markers can be used. The choice of surrogate markers of sterility may be even more challenging for some of the future potential methods of contraception because they will likely target completely new pathways or steps in reproduction. Researchers can benefit from dialogue with regulatory bodies to address the unique aspects of contraceptive development and to design new approaches to clinical trials. Recommendation 7: Develop new approaches to measure contra- ceptive efficacy that can reduce the time from phase I and II trials to large-scale clinical testing. Develop new surrogate markers to measure sterility, including those relevant for novel contraceptive targets. Develop acceptable new study designs for clinical trials of contra- ceptives. Consider Usability Early in Development To be successful, contraceptive methods must be attractive to poten- tial users and must be feasible for distribution systems to provide. If either of these is likely to be an impediment, it would be best to know that before investing a large effort into product development and clinical trials. There are a number of options for integrating behavioral and operations research into or in parallel with early stage clinical studies so that they will be complementary to the efficient measurement of safety and efficacy.

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0 NEW FRONTIERS IN CONTRACEPTIVE RESEARCH Recommendation 8: Provide incentives and mechanisms for the integration of behavioral and operations research, including the views of providers as well as those of potential users and their part- ners, early in the contraceptive research and development process. Develop tools that can more accurately measure acceptability and potential use, and can more accurately predict the characteristics of contraceptive methods that will be attractive to users in different settings and life stages. Determine which service delivery practices are effective in improv- ing provider and consumer acceptance and use of contraceptive methods. Develop Contraceptive Methods with Other Benefits Most couples need to use contraception for roughly 30 years simply for pregnancy prevention. Health benefits beyond pregnancy prevention offer significant added value to long-term users of a particular contracep- tive method who tolerate the method solely for its contraceptive benefit. Benefits of current methods include alleviation of dysmenorrhea, acne, or premenstrual syndrome; improved endometrial bleeding patterns; or amenorrhea. The protective effect of the combined pill against ovarian and endometrial cancer is perceived as an advantage by providers and enhances continuation rates among well-informed women. Contraceptive methods that reduce the risk of breast cancer and prostate cancer would be enormously attractive to large numbers of women and men, respec- tively. Likewise, a contraceptive method that also confers protection against HIV infection and other STIs is likely to have widespread benefit. The challenge of developing products that have multiple effects (contra- ceptive and noncontraceptive) is substantial, but this goal is worthy of pursuit given the potential value of such an agent. Clinical evaluation and registration of a single product for two indications are more complex and time-consuming, but they have been accomplished for some therapeutic agents. Furthermore, several formulations that exhibit both spermicidal and microbicidal effects are now in clinical trials. Recommendation 9: During the development of drugs and drug delivery systems, efforts should be made to discover, enhance, and promote the noncontraceptive health benefits of existing and new methods of contraception. Intensified efforts to develop contra- ceptive methods that are prophylactic for HIV infection and other STIs are especially needed.

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EXECUTIVE SUMMARY 11 STRATEGIES FOR RESEARCH SUCCESS Expand Public-Private Partnerships Public-private partnerships, such as the International AIDS Vaccine Initiative and the Global Alliance for Tuberculosis Drug Development, have significant track records in attracting and retaining industry interest in a particular scientific area. These partnerships target disease areas that large multinational corporations are reluctant to consider because of unsolved access problems, negative public relations, unresolved intellec- tual property rights issues, and difficult scientific hurdles. This was the rationale for the initiation of several productive partner- ships established since the release of the 1996 IOM report, including the Consortium for Industrial Collaboration in Contraceptive Research (CICCR) and the Global Microbicide Project (GMP). External review committees gave high marks to CICCR and GMP and to their individual program areas for progress toward their stated objectives. Thus, these pro- grams, which were initiated to support innovative high-risk research, to identify novel targets, or to focus new efforts in neglected areas, could serve as models for public-private collaborations in contraceptive development. The committee concludes that the creation of public-private partner- ships is an important mechanism to advance research in reproductive health and contraception. The complementary scientific strengths and focus of the not-for-profit and for-profit sectors are necessary to ensure rapid progress in the translation of lead compounds to products. The sup- port of philanthropic foundations in promoting this concept is commend- able, and further collaboration between public and private organizations active in the field would be worthwhile. Recommendation 10: Expand public-private partnerships that draw on the complementary strengths of the public-sector agencies, indus- try, foundations, consumer groups, and other organizations to expe- dite the translation of lead compounds into contraceptive products. Increase the Participation of Developing Countries Nongovernmental organizations, governmental public health agen- cies, universities, research institutions, medical research councils, and industry in developing countries can make valuable contributions to con- traceptive development in several ways. First, institutions in developing countries can clearly play a role in assessing contraceptive acceptability among users in these countries, for example by determining the preferred

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2 NEW FRONTIERS IN CONTRACEPTIVE RESEARCH routes of administration and delivery vehicles or systems. Second, some developing countries have active research programs that have already made contributions to contraception, including work on injectables in Brazil and male contraceptives in China. Third, a number of developing countries have flourishing pharmaceutical industries, some of which already meet Good Manufacturing Practice standards. Locally produced products may also be more widely accepted in some countries. Fourth, many institutions in developing countries are involved in clinical trials of contraceptives. The cost of clinical trials is generally lower in these coun- tries, and enrollment targets are often achieved faster. This valuable resource could be expanded if funding were available not only for strength- ening capacity but also for ensuring that clinical trial sites meet Good Clinical Practice standards. Establishment of collaborations between developed and developing countries has been supported by the World Health Organization Depart- ment of Reproductive Health and Research and its network of collaborat- ing centers, the Indo-U.S. Joint Working Group on Contraceptives and Reproductive Health Research, the Andrew W. Mellon Foundation's "twinning program" for collaboration between centers of excellence in the United States and developing countries (which will soon cease), and the Fogarty International Center competitive research grants for foreign investigators who are collaborating with a U.S. investigator. The Global Health in Research Initiative provides competitive reentry grants to for- eign scholars who have had postdoctoral training in the United States sponsored by Fogarty International Center training grants. Programs such as CONRAD, the Consortium for Industrial Collaboration in Contracep- tive Research, the GMP, Family Health International, the Program for Ap- propriate Technology in Health, the Population Council, and the World Health Organization also have active collaborations with institutions worldwide, not just for clinical trials but also for preclinical activities and feasibility and proof-of-concept studies. Recommendation 11: Facilitate collaboration between organiza- tions in developed and developing countries in contraceptive de- velopment, clinical testing, and understanding of acceptability of methods. Specifically: Use centers of excellence worldwide, especially in developing countries, to incorporate knowledge of local needs and preferences into research on methods that will be acceptable to different cultures. Collaborate with pharmaceutical companies in developing coun- tries to facilitate the rapid development of new contraceptive agents. Involve sites in developing countries with expertise in conducting basic and clinical research on new contraceptives, and where

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EXECUTIVE SUMMARY 13 necessary, assist these sites in meeting Good Clinical Practice standards. Increase Clinical and Scientific Training and Career Development in Contraception A cadre of scientists and physicians dedicated to contraceptive develop- ment is needed to implement the contraceptive research agenda. Although quantitative data on investigator training or the workforce in the specific field of contraception were not readily available, the committee believes that there is a paucity of such individuals in academe, that the average age of those who are active is rising, and that prospects for new entrants into the field are currently bleak. A major challenge is to identify, attract, train, and support the career development of young investigators in basic, translational, clinical, and social sciences as well as project management who have an interest in and appreciation for the multidisciplinary issues surrounding fertility regulation. More postdoctoral training opportuni- ties are needed, and trainees who complete a rigorous program should be recognized as experts through learned societies or organizations. To en- courage young investigators, there must also be the promise of adequate opportunities to obtain research funding. Given the long period of time required in this field to make substantive contributions that may lead to new products, junior or midlevel faculty need the promise of adequate support. The academic community itself must also appreciate the unique features of contraceptive development research so as not to penalize those who pursue activities that may be viewed as being outside the traditional path (e.g., applied research or team-based research). Recommendation 12: Establish, support, and recognize new pro- grams for training and career advancement in contraceptive research and clinical practice. Establish new basic and clinical fellowship programs for post- doctoral training in contraception. Establish endowed professorships with long-term funding for contraceptive research. Establish Resources and Mechanisms to Strategically Manage and Coordinate Efforts Women and men at different stages of life and from different popula- tions have different notions of the appropriate forms of contraception as well as variable access to health care. The difficulty of identifying promis- ing targets for multiple populations is compounded by the multiplicity of

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4 NEW FRONTIERS IN CONTRACEPTIVE RESEARCH disciplines involved in contraceptive development, the high cost of product development, and the complexity of product introduction and monitor- ing. Decisions about which targets to pursue and which to abandon would be facilitated by access to the combined wisdom of multiple disciplines and parties with diverse interests. At present, there is no central coordi- nating body, information source, or interagency working group on the specific topic of contraception. Collaboration occurs only on an ad hoc basis through the major governmental, nongovernmental, and not-for- profit participants in contraceptive research and development. In contrast, a model exists in the related field of microbicide develop- ment. The Alliance for Microbicide Development acts as a clearinghouse for all new information on microbicides and keeps an up-to-date database showing the progress of all current lead compounds through the research and development pipeline. One level of the database is open to all and contains only information that is in the public domain or that is not pro- prietary. The second level contains proprietary information about the various lead compounds and is open only to developers and their col- laborators and to potential funders. Another strategy for improving communication among the many parties with an interest in this rapidly changing scientific field is a round- table or forum. While an Alliance for Contraceptive Development would collect resource material and disseminate information, a Forum on Contra- ceptive Research would provide a mechanism to facilitate integration of the activities of different stakeholders. This approach has been used suc- cessfully in other areas of biomedical research, such as microbial threats and clinical research. A forum on contraceptive research and development would provide a mechanism by which interested parties from the aca- demic, industrial, consumer, philanthropic, health, and federal research and regulatory perspectives could be convened to discuss sensitive and difficult issues of mutual interest in a neutral setting. The purpose would be to foster dialogue and discussion across sectors and institutions and to illuminate issues but not necessarily resolve them. The forum could also identify and suggest topics for separate, independent study by other groups. Specific agenda topics would be determined by the forum member- ship and would incorporate the interests of all parties and focus on issues of broad concern. Recommendation 13: Create organizations to promote communication among the many parties interested in contraceptive research and to serve as a clearinghouse for information on contraceptive research. Establish an ongoing Forum on Contraceptive Research and Devel- opment at which the different sectors and institutions involved in contraceptive research can discuss topics of common interest.

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EXECUTIVE SUMMARY 15 Create an Alliance for Contraceptive Development, modeled after the Alliance for Microbicide Development, to serve as an information- gathering and information exchange mechanism in the contracep- tive research field. The Alliance should: Create and operate a listserve or other mechanism by which scientists involved in basic research on reproductive biology and contraceptive research and development can communicate (e.g., by providing an opportunity to pose questions or problems re- quiring generation of laboratory data on compounds, which other listserv members might answer). Use the power of the Internet to provide resource information to scientists regarding drug delivery efforts in other research ar- eas, analysis of current delivery systems in the contraceptive field, and contact information for contract laboratories. Stimulate and maintain public awareness and support for con- traceptive research and development by providing ongoing in- formation through an Internet site reporting the progress of re- search activities. CONCLUSION The development of new contraceptives benefits men, women, and families worldwide, because contraception is one of the most effective means of improving reproductive health and quality of life. Governments and institutions worldwide can and do make valuable contributions to efforts aimed at developing and disseminating contraceptive technologies, but support from the United States, the largest single fonder of biomedical research, is important for meaningful progress in the field. Responding to both national and international unmet needs with respect to contracep- tion is a matter of self-interest for the United States, and deploying the nation's intellectual and technical resources to address the problem of fertility control and family planning worldwide helps fulfill the humani- tarian responsibility of the United States. Success in this area can provide indirect benefits to all countries of the world, including the United States, through improvements in political and economic order and through better stewardship of the environment, leading to improved quality of life globally. The extraordinary recent advances in science and technology provide unprecedented opportunities to develop completely new approaches to contraception. Progress in the field will depend on adequate and sustained funding, as well as a new influx of broadly trained scientists and clini- cians focused on contraceptive research; failure to immediately capitalize on these opportunities through new research initiatives would be tragic

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16 NEW FRONTIERS IN CONTRACEPTIVE RESEARCH for the future generations of the world. Now is the time to address the critical needs and issues identified in this report and to ensure that future investments in contraceptive research, discovery, and development are brought to fruition to improve the lives and health of people worldwide. REFERENCES Global Health Council. 2002. Promises to Keep: The Toll of Unintended Pregnancies on Women's Lives in the Developing World. Washington, DC: Global Health Council. Institute of Medicine. 1996. Contraceptive Research and Development: Looking to the Future. Harrison PF, Rosenfield A, eds. Washington, DC: National Academy Press.