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6 Funding for Contraceptive Development Fostering creativity and stimulating innovation in the field of contraceptive development depends on the training and employment of creative people; on steady financial support and, therefore a stable working environment; on the timely funding of promising new ideas; on support for cross-disciplinary and international collaboration; and on the ability to provide scientists with personal recognition and rewards (Westwood and Sekine, 1988~. This chapter examines the resources that are currently available to make these things happen. We present data on Mends in the funding of contraceptive development and of basic research in reproductive biology and review the support provided by the National Institutes of Health (NIH), the Agency for International Development (AID), private foundations, as well as pharmaceutical companies and venture capitalists. Unfortunately, data are not available to measure the impact that federal and private funding of contraceptive development has had on the frequency of innovation or to determine the exact level of funding necessary to bring a promising new contraceptive to the market. The first organized support of reproductive research in the United States was provided by the Rockefeller family in 1921, through the Committee on Research in Problems of Sex, which was organized by the National Academy of Sciences (Greep et al., 1976~. The committee operated until 1963, when the National Institute of Child Health and Human Development (NICHD) was established and began funding research on human reproduction and contraceptive methods. Wig the creation of the Center for Population Research (CPR) at NICHD in 1968, and concomitant increased commitment to contraceptive research by the Office of Population at the Agency for International Development, federal support for 75

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76 DEVELOPING NEW CO~CE~~ES reproductive biology and contraceptive development increased substantially. Private foundations provided additional support for contraceptive development during the 1960s and 1970s. The drug industry also supported contraceptive R&D, which had been initiated in the 1950s with research on contraceptive steroids. Around 1970, at least a half dozen large U.S. drug companies were each spending several million dollars annually on contraceptive research and development. Since that time, these companies have continued to market oral contraceptives and to study alternative formulations for them. But only Ortho Pharmaceutical Corp. has continued a significant research program aimed at developing new contraceptives for the American market. Federal funding, which had increased significantly from the mid-1960s to the mid-1970s, did not continue to grow as fast as it had. The Ford Foundation, once a major supporter of research on reproductive biology and contraceptive development, withdrew from the field. While some new funds came from small firms or venture capitalists and from increases in AID's expenditure for contraceptive development, the trend was no longer steadily upward. Today the funding of contraceptive development is a dynamic process in which funds flow in multiple directions, both to and from organizations involved in different phases of the contraceptive development process. The development of a new contraceptive is rarely funded by a single source. The federal government and private foundations fund basic research at universities. Results of this work may then be used by pharmaceutical firms, which conduct applied contraceptive R&D in their laboratories, by scientists working at nonprofit research organizations supported by AID, or by clinical investigators collaborating with the World Health Organization. FUNDING FOR CONTRACEPI IVE DEVELOPMENT Figure 6.1 provides a schematic representation of the flow of funds for contraceptive development. Funds generally move from government funding agencies and private foundations to university research centers, nonprofit research organizations, and small research firms. Some of the funds received by nonprofit organizations, such as Family Health International? the Population Council, and universities (as in the CONRAD program), are provided to researchers around the world and small R&D firms for work on the development of new contraceptives. Nonprofit organizations occasionally receive funds from other sources: for example, FHI receives funds from its for-profit subsidiary, Clinical Research International (CRI), and the Population Council uses funds from its endowment to support some contraceptive research. Although the magnitude is not known, some R&D funds also flow from large drug companies to small R&D firms, universities, and nonprofit research organizations involved in various stages of contraceptive development.

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FUNDING FOR CO=RACEPTIVE DEVELOPMEV 77 U.S. Federal Government Lit _ l U.S. Private Foundations 1 1 International Funding Agencies l _ 1 r ' I Nonprofit Large , Drug _ _ Companies - - Steady Flow of Funds Irregular Funding of Projects FIGURE 6.1 Flow of funds for oontracep~ve development. . _ _ - _ Universities Be_ _ _ ~ ~1 1 Small For-profit Companies ~ Venture | r capitalists| Many of the resources provided by American organizations are used outside the United States. The Rockefeller Foundation supports contraceptive development overseas, and PHI and the Population Council fund networks of clinical investigators and research centers around the world. U.S. contributions to the World Bank, the United Nations, and other organizations indirectly contribute to contraceptive development efforts in less developed countries. NIH's funding of contraceptive development, however, is confined largely to U.S. institutions. Pharmaceutical Industry Funding Our analysis of the funding of contraceptive research and development is incomplete because we have only a very limited picture of the pharmaceutical industry's contributions. Given the resources available and the proprietary nature of the information, the committee found it impossible to obtain reliable estimates of the amount of money being spent on research on reproductive biology or contraceptive development by American pharmaceutical firms. Data from the Pharmaceutical Manufacturers Association show that the U.S. drug industry's total R&D expenditures for all types of drugs combined not simply those related to contraception have increased steadily between 1970 and 1986, in both absolute dollars and as a percentage of total sales. This does not imply, however, that research expenditures for contraceptive R&D have increased. The largest American pharmaceutical firm carrying out research on new contraceptives is Ortho Pharmaceutical Corporation, whose annual R&D budget was approximately $160 million in 1986. It is not known, however, how much of

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78 DEVELOPING NEW CO=RACE~IVES this went to contraceptive R&D. Ortho Pharmaceutical Corporation and a few European drug companies are currently supporting contraceptive research and development being conducted by smaller research firms, such as Stolle Research and Development Corporation, Endocon CoIporation, and Cygnus Inc. ALZA Corporation is funding the development of new drug delivery systems (e.g., transdermal patches and oral osmotic pills), which may have applications in the field of hormonal contraception, but the amount of funds it allocates to these activities is not known. The extent to which other large drug companies fund research by small firms or at universities is also not known. Based on informal reports from scientists in the field and pharmaceutical industry executives, our judgment is that there has been a substantial decline in the amount of funding provided for contraceptive R&D on the part of the drug industry since the mid- 1970s. Quite often the small private firms involved in contraceptive development activities rely on initial funding from venture capital groups or individual private investors. However, in most cases, the details of these arrangements are not publicly known. Development of the Today contraceptive sponge, for example, was supported by venture capital. Contracap and Gynex, two companies presently developing contraceptive products, were initially funded by the same private investor before going public in 1983 and 1986, respectively. Given the lack of data available on private organizations, this chapter concentrates on the public sector and foundation funding of contraceptive development. It should be clear, however, that large pharmaceutical firms are an important potential source of support for research and development related to new contraceptives. Federal Funding To analyze trends in government and foundation funding of contraceptive development and of basic research in reproductive biology in the United States, the committee relied primarily on the data collected and published annually by the National Institute of Child Health and Human Development through the Interagency Council on Population Research (ICPR). In 1985 the Alan Guttmacher Institute (AGI) published a study examining the worldwide funding of contraceptive research and development between 1980 and 1983 (Atkinson et al., 1985~. The AGI survey produced estimates of U.S. government funding that were lower than the figures provided by NIH for the same years. AGI estimates of government funding of basic research in reproductive biology are about half of those reported in NICHD and about 5 percent less than NIH estimates of government funding of contraceptive development. AGI estimates of foundation funding of basic research in reproductive biology and of contraceptive development are one-third less than the estimates reported by NICHD. The main source of the differences between the NICHD and the AGI estimates

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FUNDING FOR CO=RACEPTIVE DEVELOPME ~79 are differences in the classification of projects as basic reproductive research or applied contraceptive development. For this report' we accept the broader definition of basic research in reproductive biology used by NICHD. NICHD divides basic research in reproductive biology into the following areas: development and function of the reproductive system; female fertility; male and female fertility; fertilization, including immediate prefertilization processes; preimplantation development; implantation; and reproductive endocrinology. As defined by NICHD, contraceptive development includes research on drug syntheses and testing, drug delivery systems and oral formulations testing, vaginal and uterine contraceptive devices and drugs, and sterilization. Contraceptive development also includes studies of ". . . natural or synthetic agents other than presently used contraceptives, new contraceptive devices and reversible sterilization techniques" (National Institute of Child Health and Human Oevelopment,1987:7~. There is no inherent bias in the sources of data NICHD used, and its methodology and criteria for classifying and categorizing projects appear to be sound. Furthermore, NICHD has collected data annually for nearly 20 years, making it possible to estimate long-term trends in funding. Researchers from AGI categorized projects on the basis of their titles, a procedure that is not a clear improvement. The NICHD may overestimate the amount of contraceptive-related research under way, especially since much of the reported basic biological research is not conducted with a contraceptive application in view (although such applications may result). Table 6.1 presents data on the trend in the funding of research on reproductive biology and contraceptive development in constant 1973 dollars by the federal government and private foundations. Support for both basic research on reproductive biology and contraceptive development increased between 1973 and 1987. In current dollars, spending for reproductive biology research more than quadrupled, from $30 million in 1973 to $135 million in 1987; spending for contraceptive development grew from $7 million in 1973 to $36 million in 1987. In constant dollars, funding for reproductive biology research increased by 64 percent, from $30.2 million in 1973 to 49.5 million in 1987; funding for contraceptive development increased by 78 percent, from $7.4 million to $13.2 million. Although the increases in funding have been substantial, the pattern of support concerns some of those in the contraceptive development field. An important source of the difference between the AGI and NICHD estimates of funding is based on the conclusion of the AGI researchers that "most fundamental nondirected research . . . does not contribute directly to the development of new methods" and so including funding for it"has tended to misleadingly suggest that the funds available for contraceptive development were larger than they actually were" (Atkinson et al., 1985:1981. Atkinson and her colleagues note that there may be differences of opinion as to which category a particular research project should be assigned.

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80 DEVELOPING NEW CO~RACE~IVES TABLE 6.1 Federal and Foundation Funding for Basic Research in Reproductive Biology and Contraceptive Development (fiscal years 1973-1987, in constant 1973 dollars-millions) Reproductive Biology Contraceptive Development Year Totala HHS AID Foundaiionsb Total AID HHS Foundaiionsb 1973 30.2 22.8 6.7 7.4 2.9 3.2 1.3 1974 33.7 27.6 5.6 9.6 2.1 3.9 3.6 1975 29.7 24.5 4.7 10.3 2.8 5.1 2.3 1976 32.6 27.9 3.4 10.9 3.6 5.3 2.1 1977 29.9 25.6 3.3 14.1 5.3 5.4 3.3 1978 35.6 30.4 3.6 1 1.8 4.5 4.9 2.4 1979 38.5 33.1 3.6 1 1.2 4.8 4.5 1.8 1980 39.4 35.4 1.9 10.8 4.3 4.9 1.5 1981 43.1 39.0 2.0 10.6 3.5 4.8 2.3 1982 42.6 38.0 1.9 9.8 3.6 4.4 1.7 1983 44.5 40.8 1.3 9.5 3.4 4.4 1.7 1984 43.0 40.2 .8 9.0 4.5 3.1 1.4 1985 43.4 39.4 1.1 1 1.6 6.8 3.8 1.0 1986 43.6 38.4 1.5 12.3 7.3 3.6 1.4 1987 49.5 44.4 1.7 13.2 8.1 3.8 1.3 aTotal includes other federal sources not shown separately in table. bPopulaiion Council plus Ford, Rockefeller, and Mellon foundations. Source: Unpublished data from the National ~siitute of Child Health and Human Development (NICHD), National Institutes of Health, Bethesda, Maryland. The committee did not have the resources to conduct an independent review of the allocation of projects and so is not in a position to endorse either AGI's or the NICHD's Interagency Council on Population Research's allocation. That said, however, it is worth noting that many active in the contraceptive development field believe that the substantial increases shown in Table 6.1 are not an accurate reflection of the trend in funding for activities directly related to contraceptive development. Another factor in the funding trend for basic research in reproductive biology is the decline in foundation support for such work. The increase in support from NICHD and the decline in foundation support means that foundation funding now plays a very small role in supporting basic research in reproductive biology. In 1973, foundations accounted for about a fifth of all funding for basic research in reproductive biology; by 1987, foundations contributed less than 2 percent of all funds spent on basic biological research. Funding for contraceptive development has also increased between 1973 and

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FUNDING FOR CO=RACEPT~E DEVE~PME ~ 1 1986, but it was always considerably less than the amount devoted to basic research. In most years for which data are available, the total spent on contraceptive development was between 25 and 30 percent of the total spent on basic research. Annual foundation funding for contraceptive development has been relatively stable throughout the 1980s, but at a lower level than in the 1970s. Funding from NICHD was relatively stable after declining from the highest years of 1975, 1976, and 1977. However, there was a sharp decline in NICHD funding of contraceptive development in 1984. Some of that loss has been made up in more recent years, but NICHD now provides more than $1.5 million less (in constant dollars) than it did in the mid-1970s. The contributions of the Agency for International Development to the funding of contraceptive development have followed the pattern of NICHD; increases in funding occurred in the mid-1970s and declines took place in the early 1980s. Between 1983 and 1987, however, AID funding of contraceptive development increased by 138 percent (in constant dollars). It seems unlikely that such increases will continue, but the recent growth in federal funding for contraceptive development has given greater visibility to AID-funded organizations, such as Family Health International. Basic research on reproductive biology has enjoyed the largest proportion of federal funding in the population sciences, and its share has been increasing. Since 1981 over 50 percent of all federal funding for population research has been channeled to basic research in reproductive biology. From 1974 to 1987 the proportion of federal dollars spent on basic research in reproductive biology has increased from 50 to 71 percent. Studies of reproductive endocrinology have dominated this research area and have consistently received 36 percent to 45 percent of all research funds allocated to reproductive biology. Between 1973 and 1987 the National Institutes of Health provided over 90 percent of the money for research in reproductive biology. Funding of reproductive research by other federal agencies has not increased significantly in constant 1973 dollars over the past 14 years. The Environmental Protection Agency, which provided funding for research on reproductive biology from 1980 to 1985, discontinued funding in 1986. The Veterans Administration began funding research in reproductive biology in 1975 but discontinued reporting funding activity in 1981, although it still funds a small number of projects. The Department of Agriculture began funding population research in 1986; the major portion of its funds go to research in reproductive biology. The Department of Energy first funded research in reproductive biology in 1979, and the National Science Foundation has concentrated its population research funding in this area since 1981. Only AID and NICHD support contraceptive development. The largest concentration of funds in contraceptive development has been for "general or multiple studies of contraceptives," because AID funds for clinical trials are included in this category. However, the largest number of projects has consistently been in the drug synthesis and testing category.

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82 DEVELOPING NEW CO=^CE~~ES Foundation Funding Since 1973 the Ford and Rockefeller foundations have provided information on their grants for research related to population and contraceptive development to the Interagency Committee on Population Research at NICHI). The Andrew W. Mellon Foundation began reporting in 1979. The Ford Foundation began funding reproductive research and contraceptive development in the l950s. The Rockefeller Foundation declared population to be one of its main areas of interest in 1963. The Mellon Foundation began funding population research in 1979, although it had previously supported the Population Council and the Planned Parenthood Federation. In 1980 the Ford, Rockefeller, and Mellon foundations established a collaborative contraceptive development research program in an effort to accelerate the development of new and improved contraceptives. In 1985, however, the Ford Foundation discontinued its program of support for contraceptive development. Some of the Ford and Rockefeller funding is also reported to the ICPR by the Population Council. This happens because the Population Council is supported by grants from foundations (including Ford, Rockefeller, and Mellon), international organizations, and federal agencies (including AID and NICHD), which it then uses to support contraceptive development, most of which falls under the auspices of its International Committee for Contraception Research (ICCR). For this analysis, funds reported by the Population Council for contraceptive development and reproductive processes that come from other sources are attributed to the original donor, whether it was a private foundation or a federal agency. PHI, the CONRAD program, and other organizations that receive their funds from private foundations or federal agencies are treated in the same way as the Population Council. Beginning in 1988, the John D. and Catherine T. MacArthur Foundation, the William and Flora Hewlett Foundation, and the Berlex Foundation were included in Interagency Committee on Population Research's annual survey. In 1987 the Berlex Foundation began providing fellowships for innovative research in reproductive medicine, including contraceptive and fertility-related research. Although the MacArthur, Hewlett, and David and Lucite Packard foundations support family planning programs, they have not supported contraceptive development. In the early 1970s, private foundation funding provided for population research was concentrated on support to studies of reproductive biology; only 10 percent went to support contraceptive development activities. Dunng the 1980s, foundation funding for reproductive biology has decreased and now represents about 10 percent of all the foundation funding for population. The proportion allocated to contraceptive development tnpled, going from 10 percent in 1973 to 29 percent in 1977; however, it has since declined and in 1985, the last year for which data are available, was at approximately the level it had been in the early 1970s. At the same time these changes were taking place, the proportion of foundation support

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FUNDING FOR CO~RACEPT~E DEVELOPMENT 83 allocated to research in the social and behavioral sciences related to population more than doubled, from 25 percent in 1973 to 60 percent in 1985. Funding Worldwide The annual inventories of funding for population-related research published by the Interagency Council on Population Research provide data only on funding provided by U.S. government agencies and private foundations. It has been estimated that the United States is the source of approximately 75 percent of the worldwide funding for reproductive research and contraceptive development (Atkinson et al., 1985~. To provide an indication of the trends in funding outside the United States, we have relied on studies by Greep (1979), Greep et al. (1976), and Atkinson et al. (1980, 1985), which provide the most complete account of the levels and sources of worldwide funding for contraceptive development. Unfortunately, the most recent of these studies reports on trends only to 1983. Moreover, as noted above, the data provided by Atkinson et al. are a lower estimate of the financial support provided by the U.S. government than are the data presented earlier in this report. After reaching a peak in 1972, annual worldwide funding for contraceptive development dropped sharply in 1975 (Lincoln and Kaeser,1987~. Between 1977 and 1983, funding remained at a relatively constant level. Moreover, support for contraceptive development from developed countries other than the United States has been declining in both current and constant dollars since the late 1970s (Atkinson et al., 1985~. During 1980-1983, the average annual worldwide expenditure on basic reproductive research and contraceptive development was approximately $154 million, of which an estimated $63 million was spent for contraceptive development. This figure includes funding for the evaluation of long-term safety of existing methods (Atkinson et al., 1985~. Less developed countries contributed only about 1 percent of these funds. A few developing countries, such as China, India, Chile, Mexico, and Brazil (Atkinson, 1985), have made significant contributions, but most other developing countries have not. Atkinson et al. estimate that private industry spent an estimated $22 million or about 35 percent of the total provided for contraceptive development, and seven specialized contraceptive development organizations spent an estimated $26 million or 41 percent of worldwide expenditures for contraceptive development. The remaining 24 percent of expenditures was provided mainly by national governments that funded mission-onented research projects. World Health Organization Between 1970 and 1980, support for the World Health Organization's Special Programme on Human Reproduction increased steadily from about $1 million to almost $20 million. From 1980 to 1984, funds dropped to $13 million. Since

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84 DEVELOPING NEW CO=RACE~IVES then, funding has increased to more than $20 million in 1987, of which about $9 million was allocated for the development of new contraceptives (WHO, 1987~. In 1987 the World Bank began to provide direct financial support to HRP, with an initial contribution of $2 million. The United Nations Development Programme, the World Bank, and the United Nations Fund for Population Activities joined WHO in sponsoring HRP in 1987. Of the more than $182 million provided between 1970 and 1986 to the Human Reproduction Programme (WHO, 1987) by national governments and other donors, the United States contributed only $3.2 million in two installments, the first in 198~1981 for $3 million, and the second in 1986 for $165,000. The level of American support for HRP reflects a statutory prohibition against donations to HRP passed by Congress in 1982 and justified on the grounds that it was necessary to shift funding from contraceptive development toward service delivery. In 1986 the prohibition was repealed and $165,000 was given to HRP. Since then, no additional funds have been provided by the United States. However, some of the support HRP receives from WHO, the United Nations Development Programme, and the World Bank takes advantage of the U.S. contributions to these organizations. Sweden (which gave $73 million), Norway (which gave $26 million), United Kingdom ($24 million), the United Nations Fund for Population Activities ($17 million), Denmark ($13 million), and Canada ($8 million) were the largest contributors to HRP during the 197~1986 period. TRAINING The training of scientists in reproductive biology and fields related to contraceptive development is considered by many experts to be of prime importance for continued advances in the field. It usually takes three to six years to complete the training necessary for a career in basic reproductive research or applied contraceptive development. Declining or sporadic funding from foundations and government agencies contributes to a reduction of the number of scientists who are being trained in the field of reproductive biology and contraceptive development. The lessened interest of most pharmaceutical companies also contributes to a lack of opportunities in the field. The decision to go into a particular field depends on expected career opportunities after training, and the costs of going through training. While the costs of training have risen in recent years, the expected benefits and career opportunities have fallen. The Ford and Rockefeller foundations supported training programs in the l950s and 1960s. Although the Rockefeller Foundation continues to support some Paining, in recent years the National Institutes of Health and the Andrew W. Mellon Foundation have been the major source of funds for training in reproductive biology and contraceptive development in the United States. However, NIH funding for training in the reproductive sciences has fluctuated. Between 1970 and 1987, predoctoral NIH fellowship grants ranged from 48 to 100 per year,

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FUNDING FOR CO=RACEPT~E DEVE=PME ~85 while postdoctoral NIH fellowships in the reproductive sciences ranged from 37 to 68 per year. Between 1970 and 1987, NIH faculty fellow awards in reproductive sciences ranged from a low of 8 awards in 1973 to a high of 61 awards in 1979, to 37 awards in 1987. Between 1975 and 1985, 208 people were trained in the reproductive sciences with support from Mellon's fellowship program. There was an increase in the number of Mellon fellowships awarded, from 2 in 1975 to a peak number of 101 in 1982. However, the number of fellowships declined to 86 in 1985. Most of the Mellon fellowships have been to postdoctoral researchers (71 percent) and faculty fellows (28 percent). Although the reduced pool of scientific personnel in this area and the decline of fellowship awards may be the result of a decrease in demand, the converse may also be true: a reduction in available personnel may be contributing to the decline in contraceptive research and development. Expanding the research output of any science requires an adequate number of trained people working in the field. Training programs are essential to ensure long-term increases in scientific output; it is therefore important to support training for the nation's scientists. Reproductive biology and contraceptive development must compete with other research areas for funds for training. Allocation of additional funds for training in these areas would demonstrate greater national commitment to this field. The training of scientists in human reproduction and contraceptive development and the supply of scientists who continue to work in this field is also influenced by the availability of good jobs and the prospects of support for research in contraceptive research. The sensitive and sometimes publicly controversial nature of contraceptive research has probably made the field less attractive. The recent focus of public attention and scientific research interest on AIDS, on new biotechnology, and on genetic engineering, as well as the increased funding and research opportunities in these areas, together with the pharmaceutical industry's interest in programs to develop new drugs for degenerative diseases may also be diverting some scientists from the field of contraceptive development. The decline in the number of training grants in the reproductive sciences during the 1980s, combined with the other factors that have reduced the number of people entering the field, has led to a concern about the aging of scientists active in contraceptive development. One important consequence of the limited number of researchers involved in contraceptive development is an undesirable thinness in this field, resulting in a sparse literature on each new contraceptive method (Segal, 1989~. Replications of clinical studies are needed but often not done because of the limited financial and human resources available. The limits of the field's resources and the steadily increasing cost of scientific equipment have created another problem that is often overlooked in discussions of the prospects for new methods. New areas of contraceptive research will require even more sophisticated equipment and research laboratories than ever before. As contraceptive development moves in the direction of new biotechnology,

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86 DEVELOPING NEW CO~RACE~IVES genetic engineering, and molecular biology, more complex equipment will be required. The need for state-of-the-art technology in university laboratories and in the contraceptive development field will cause R&D costs to grow, as research organizations attempt to keep up with higher and higher scientific standards. In 1976, Greep and his collaborators estimated that between 2,500 and 3,000 scientists were actively involved in research on reproduction and contraceptive development in 419 institutions worldwide (Greep, 1979~. The vast majority of the institutions where research and training were taking place were in developed countries. In the early 1960s the Ford Foundation, in an effort to expand the scientific infrastructure devoted to contraceptive development in developing countries, began supporting training in the field of reproductive and contraceptive research outside the United States. In more recent years, the World Health Organization's Human Reproduction Programme, recognizing the need to build training and institutional research capabilities in developing countries, has taken a leading role in these areas. Medical research councils and foundations in some European countries and some developing countries also provide funds for training in basic reproductive research and contraceptive development. Unfortunately, we were unable to establish the amount spent on such activities. In the 1985 Alan Guttmacher Institute survey (Atkinson et al., 1985), for example, it is not possible to separate funding for training from support for basic research provided by developed countries other than the United States or by developing countries. But total expenditures for both training and research on reproductive biology outside the United States amounted to only 6 percent of the worldwide total expended in 1983 thus the contribution of these other countries is not large (Atkinson et al., 1985). Although not a focus of this report, it is worth noting that the training needs of scientists in less developed countries appear particularly urgent. Declines in funding and dramatic increases in tuition in developed countries, where most such training is available, have not been compensated for by the increased availability of training opportunities in developing countries themselves. The net result of these changes appears to be a decrease in the number of scientists from less developed countries going abroad for Ph.D. training in research related to reproductive biology or contraceptive development (Kessler, 1983:185~. RECOMMENDATIONS We believe that research in reproductive biology and contraceptive development is underfunded. Development of new contraceptive methods is expensive, and additional resources could accelerate the process of innovation. Federal funding in these areas should keep pace with the rising costs of research and development. With the decline in industry's support, NIH should consider increasing its funding of contraceptive development to help bridge the gap between basic research and the marketing of new contraceptives.

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FUND]NC FOR CO=RACEPT]VE DEVELOPMENT 87 Although the contributions of the Rockefeller and Mellon foundations to contraceptive development in recent years have been significant, the committee encourages these and other private foundations to initiate, resume, or expand their support of applied contraceptive research and development. Nonprofit organizations involved in the costly process of bringing new contraceptive products through clinical testing, gaining regulatory approval, and helping introduce them to the market are in particular need of increased support. Long-term funding is particularly important for those involved in contraceptive development; to the extent possible, federal agencies and private foundations should provide long- term funding commitments. If the nation wishes to increase the priority of research on reproductive biology and contraceptive development, it is important to increase the pool of young scientists entering the field. Several researchers told the committee that bright young scientists are attracted to other fields of research, in which more funding is available for fellowships and research. A special grants program for young scientists might attract new talent and encourage more innovative research in the fields of reproductive biology and contraceptive development. The committee recommends that NIH expand its training program in the reproductive sciences and contraceptive development, preferably at a high and predictable level. The Mellon Foundation training program has been successful and the committee recommends that other private foundations consider support for training. As pm of an expanded effort to attract qualified people to this area of research, as well as to be more responsive to the contraceptive needs and concerns of women and minority groups, more women and more members of minority groups should be encouraged to enter the field of contraceptive development. Continued support for contraceptive development and research training in other countries, particularly in the developing world, should be encouraged as part of a worldwide effort to help meet county-specific contraceptive needs. The United States should provide direct financial support to the WHO's Human Reproduction Programme to help achieve this goal. CONCLUSION In a recent review of funding for contraceptive development, Harkavy (1987) noted that levels of funding for contraceptive development have remained remarkably modest and uncertain and that "public sector R&D organizations have difficulty in obtaining substantial support from governmental and private donors because of impatience for short-term results, concern that small-scale operations are not effective, tensions between U.S. and European donors, and even ambivalence on the usefulness of new technology" (p. 307~. Federal funds for contraceptive development have remained virtually unchanged (in constant dollars) over the last decade, while pharmaceutical industry and private foundation support for contraceptive development has diminished. Although federal funds for research on reproductive processes has increased in

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88 DEVELOPING NEW CO~RACE~IVES constant dollars since the mid-1970s, private foundation support has declined substantially, and the loss of the industry's resources has been critical. Because of the decline in industry's support of contraceptive R&D and the limited amount and unpredictable character of foundation support, the federal government, through NIH and AID, has assumed an increasingly important funding role. The committee believes that federal funding should keep pace with the rising costs of research and development. We believe that current funding arrangements in the contraceptive development field need to be reevaluated by those directly involved to determine whether they are the most useful, productive, and cost- effective allocation of funds and are most likely to lead to the development of new contraceptive methods. We have not attempted to determine what allocation of funds would maximize productivity in the field of contraceptive development. Atkinson et al. (1985) estimated that a 75-percent increase in the annual total expenditures in contraceptive development from the 1985 level of $30 million by eight major contraceptive R&D organizations could significantly accelerate progress on new methods now under development. These estimates were based on the amounts said to be needed by executives for these groups in 198~1988 to accelerate progress or to follow up new contraceptive leads (Atkinson et al., 1986~. Although our judgment is that this estimate is low, we have not conducted a detailed assessment of the funds needed to develop and market the potential new methods discussed in Chapter 3. Training grants in the reproductive sciences fluctuate widely from year to year, and there is a concern that the number of scientists actively involved in contraceptive development is very small and that the scientific literature on various new methods makes confirmation of the effectiveness and the risks and benefits of new methods difficult.