Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter.
Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.
Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.
OCR for page 75
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
OCR for page 76
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.
OCR for page 77
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
OCR for page 78
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
OCR for page 79
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.
OCR for page 80
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
OCR for page 81
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.
OCR for page 82
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
OCR for page 83
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
OCR for page 84
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,
OCR for page 85
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,
OCR for page 86
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.
OCR for page 87
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
OCR for page 88
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.
Representative terms from entire chapter:
reproductive biology