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Introduction
Family planning is a socially beneficial activity that affects the well-
being of women, men, children, families, and society as a whole. The ben-
efits of planned fertility include the more effective intergenerational trans-
fer of resources, resulting in improved child health and development (Lee,
2003~; increased longevity and empowerment of women, with the atten-
dant economic benefits to the family and the community; and a reduced
lifetime risk of chronic illness or death from a pregnancy-related condi-
tion. Contraception, when practiced with barrier methods, also lessens
the likelihood of sexually transmitted diseases. By consciously practicing
family planning, couples can choose to contribute to the overall health,
stability, and economy of their families and their communities.
Conversely, the consequences of unintended pregnancy are quite
serious, imposing significant burdens on children, women, men, and
families (reviewed by the Institute of Medicine, 1995~. The child born from
an unplanned conception is at greater risk of low birth weight, dying in
its first year of life, being abused, and not receiving sufficient resources
for healthy development. An unplanned conception also exposes women
to the usual health risks of pregnancy, which can include maternal death.
Closely spaced births pose additional risks for the mother and child. In a
study that controlled for socioeconomic and demographic differences, it
was found that women who spaced childbearing at 27- to 32-month inter-
vals were 2.5 times more likely to survive childbirth than women who
gave birth at 9- to 14-month intervals. Children born 3 to 4 years after a
previous birth were found to be 2.3 times more likely to survive the first
year of life than children born less than 2 years after a previous birth
17
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8
NEW FRONTIERS IN CONTRACEPTIVE RESEARCH
(Rinehart et al., 2002~. When a pregnancy is unplanned, the mother also
has a greater risk of depression and of being physically abused, and her
relationship with her partner is at greater risk of dissolution. Both the
mother and the father of the child may suffer economic hardship and may
fail to achieve their educational and career goals. Given these issues, a
woman experiencing an unintended pregnancy may also face the deci-
sion to have an abortion.
Unintended pregnancy is frequent and widespread in the United
States (Institute of Medicine, 1995) and the world (Global Health Council,
2002~. In the United States, about half of all pregnancies are unintended at
the time of conception (Henshaw, 1998; Institute of Medicine, 1995~.
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.~ Of these,
more than 300 million or more than one-quarter were unintended.
Unintended pregnancy affects all segments of society it is not just a prob-
lem of teenagers or unmarried women, poor women or minorities, or
women living in the developing world. For example, a survey of more
than 14,000 French households revealed that 33 percent of pregnancies
occurring over a 5-year period were unplanned, half of which were
terminated by abortion. Sixty-five percent of the unplanned pregnancies
occurred among women using contraception (Bajos et al., 2003~. A survey
in the United States found that 50 percent of unintended pregnancies
occurred among couples using some form of contraception (Henshaw,
1998~.
Poor women in developing countries bear the greatest burden with
regard to maternal mortality and morbidity due to unplanned preg-
nancies. The lifetime risk of dying during pregnancy and childbirth in
these countries is several hundred times higher than that in wealthier
nations (1 in 4,000 in North America and Europe versus 1 in 15 in Africa).
Maternal mortality is highest in countries where women are least likely to
have access to modern contraceptive services (Global Health Council,
2002~. In Burkina Faso, where only 4 percent of women use family plan-
ning methods, 1 in 14 will die of maternal causes over the course of her
iThe Global Health Council compiled a country-by-country profile of all 227 countries in
the world, based on the best available statistics from the U.S. Census Bureau, United Nations
agencies, country reports, and specialized surveys carried out by a variety of respected
research organizations. For each country and each year, data were generated on the number
of pregnancies that occurred, the number that ended in miscarriages and abortions, and the
number carried to term. For each of these, the data sources were used to assess the number
that resulted from unintended pregnancies and the number of unintended pregnancies that
resulted in the death of the mother.
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INTRODUCTION
19
lifetime. In Brazil, the opposite is true; nearly three-quarters of the female
population regularly use family planning services, and their lifetime risk
of maternal mortality is considerably lower: 1 in 130 (Global Health
Council, 2002~. In Russia, abortion has long been the traditional method
of family planning (Gadasina, 1997), and Russia has the highest abortion
rate in the world.2 Although pregnancy terminations are freely available,
contraception is not. Nonetheless, even with the easy availability of abor-
tion services, an estimated 15 percent of procedures are performed in
illegal private facilities. The lack of contraceptive choices has resulted in
excess maternal mortality nearly one-third of maternal deaths in Russia
are estimated to be due to abortion procedures and an explosion in
sexually transmitted infections (Karelova, 1999; Parfitt, 2003~.
Although the number of live births has stabilized at about 131 million
per year worldwide, the number of women dying each year as a result of
unintended pregnancy has increased since 1995. Over the 6 years exam-
ined, nearly 700,000 women died as a result of unintended pregnancies.
Although more than one-third died from problems associated with preg-
nancy, labor, and delivery, the majority more than 400,000 died as a
result of complications resulting from abortions carried out under unsafe
and often illegal conditions. An unintended pregnancy often leads to the
decision to have an abortion. Furthermore, for every maternal death, an
estimated 30 additional women suffer pregnancy-related health problems
that are frequently permanently debilitating (Global Health Council,
2002~.
The death of a mother is emotionally, socially, and economically
destructive to families and communities (Global Health Council, 2002~. In
developing nations, where an estimated 98 percent of pregnancy-related
deaths take place, the loss of a mother translates into the increased likeli-
hood that surviving family members will not be able to properly care for
existing children, and such children have a much greater risk of dying
themselves (Steiner et al., 2000~. Moreover, because these women typi-
cally die between the ages of 15 and 45, elevated rates of maternal mortal-
ity represent a significant threat to the broader socioeconomic systems
(reviewed by the Global Health Council, 2002~.
CONTRACEPTIVE USE
Contraceptive use in developing countries has increased greatly since
the 1960s and in many cases is now approaching the levels observed in
2See The Library of Congress Country Studies, 1996, available online at http://www.
lupinfo.com/country-guide-study/russia/russia65.html (accessed October 2003~.
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20
NEW FRONTIERS IN CONTRACEPTIVE RESEARCH
developed countries (overall rates of use, 60 and 70 percent of couples,
respectively). Worldwide, more than 580 million women use modern
methods of contraception (Figure 1.1), contributing to a large drop in the
total fertility rate in developing countries (United Nations Development
Programme, 2003; United Nations Population Fund, 2001; World Bank,
2003; World Health Organization, 2003~. The trend is notable not only for
its demographic impact but also for its ability to free women to pursue a
productive life in addition to a reproductive life. However, studies show
that more than 120 million people around the world do not use any form
of contraception, even though they report that they are sexually active
and do not wish to become pregnant (Figure 1.1~.
Although a number of effective reversible and nonreversible contra-
ceptive methods exist (barrier methods, hormonal methods, intrauterine
devices, and contraceptive sterilization), all have shortcomings in the form
of failure rates and undesirable side effects that lead to the discontinua-
tion of reversible methods. WHO's recent warnings against the use of
spermicides by women at high risk of HIV infection may lead to further
reduction in the use of barrier methods. The effectiveness of many contra-
ceptives depends on correct and consistent use, which can be difficult for
people to achieve (Trussell and Stewart, 1998~. Indeed, U.S. women and
their partners relying on reversible means of contraception and those using
no contraception contribute roughly equally to the pool of unintended
pregnancies. In the United States, the 7 percent of women who are at risk
for unintended pregnancy and who use no method of contraception
account for about half of all unintended pregnancies that occur each year
(Henshaw,1998~. The remaining 50 percent of all unintended pregnancies
occurred among 93 percent of at-risk U.S. couples practicing some form of
contraception, partly reflecting the inconsistent use of effective methods.
The same pattern is true in other developed countries (Bajos et al., 2003;
Darroch et al., 2001~.
In addition, most currently available methods have discontinuation
rates approaching 50 percent after 1 year of use, usually because of side
effects (Rosenberg et al., 1995; Trussell and Vaughan, l999~. When women
discontinue highly effective methods, they usually choose a less effective
method. For example, one study showed that 70 percent of women who
discontinue oral contraceptives begin using a less effective method, and
20 percent use no contraceptive method at all (Rosenberg et al., 1995~.
Moreover, women who continue using a method often do so despite the
3See http: / /www.who.int/reproductive-health/family_planning/updates.html (accessed
November 2003~.
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INTRODUCTION
1,800 -
1,500 -
1,200-
600
O-
21
Contraceptive use and need
(Year 2000)
Total
1,047
~ Marital status1
...................... MARRIED .................
using
contraception
-648 million
582
Women of Married women Unmarried Users of
reproductive of reproductive women of modern
age age reproductive methods
age
. ,,, ~ ,.................................
PiPi
-
| UNKNOWN |
.... 1 ..... 1 | need I
UNMET
l need .
l
. ~
1 7632
i
! ~
. t::::::::::::::::::::::::. :::::
23
i
Usersof Non-users, No information
traditional sexually active
methods
FIGURE 1.1 Contraceptive use and need worldwide. Traditional methods include
withdrawal, periodic abstinence, and other non-supply-related methods. Modern
methods include hormonal contraceptives and barrier methods such as dia-
phragms, condoms, and intrauterine devices.
Column 1: Total number of women of reproductive age (15-49) is 1.553 billion
in the year 2000 (Population Division of the Department of Economic and Social
Affairs of the United Nations Secretariat, 2003~.
Column 2: Total number of women of reproductive age (15-49) married or in
union is 1.047 billion (Population Division of the Department of Economic and
Social Affairs of the United Nations Secretariat, 2002~.
Column 3: Unmarried women of reproductive age number 506 million (sub-
tracting Column 2 from Column 1~. This figure is included because we know very
little about the needs of these women and if or how they are being met. Some of
them are sexually active and using contraceptive methods, some are sexually
active and are not using any method of family planning, some may wish to con-
ceive, and some are not sexually active.
Columns 4 and 5: Married women using contraceptive methods, separated ac-
cording to "modern" and "traditional" (Population Division of the Department of
Economic and Social Affairs of the United Nations Secretariat, 2002~.
Column 6: 123 million: Unmet need as defined by the number of women wish-
ing to space or limit births but not currently using a method of contraception. This
number includes married and unmarried women in developing countries (exclud-
ing China) and the former Soviet Union, but not the West and so is probably an
underestimation. Numbers in other columns are world-wide (Ross and Winfrey
International Family Planning perspectives, 2002~.
Column 7: Use and needs for 782 million women are unaccounted for in the
graph (subtract Columns 4, 5, and 6 from Column 1~. Their needs may be met,
unmet, or unknown, depending on their sexual activity and desire for pregnancy.
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22
NEW FRONTIERS IN CONTRACEPTIVE RESEARCH
presence of unwanted side effects, which they tolerate in return for preg-
nancy prevention. Thus, continuation rates are not a surrogate for accept-
ability (Severy, 1999; Severy and Thapa, 1994~. The cultural, personal, or
political unacceptability of the various methods also can contribute to a
lack of contraceptive use.
Access to effective methods may also be quite limited for many seg-
ments of society, especially those in developing countries with inadequate
resources for health care. Beginning in 1998, 20 U.S. states have required
that health insurers cover all contraceptives approved by the FDA (Alan
Guttmacher Institute, 2003~. However, at the federal level, legislation in-
troduced in 1997, 1999, and 2001 to mandate such coverage was never
brought to a vote. Further, an estimated 43.6 million people lacked health
insurance for all of 2002 (U.S. Department of Commerce, 2003) and none
of these people would have benefited from a mandated coverage of con-
traception by health insurers.
Even if total contraceptive prevalence were to remain the same, the
need for access to effective contraceptive methods will continue to rise as
increasing numbers of people worldwide attain reproductive age. World-
wide, about 60 percent of couples at risk for pregnancy use contracep-
tives, but in some developing countries, the rates of contraceptive use are
much lower. Countries in sub-Saharan Africa, for example, have contra-
ceptive use rates of only about 20 percent.4 Although the population
growth rate is slowing and in fact has become negative in a number of
Western countries, the population of the world as a whole continues to
rise, particularly in developing countries. As a result, during the next
decade, 600 million girls will become adolescents, which will be the largest
cohort of young women in human history (Global Health Council, 2002~.
Because these young women will be from diverse backgrounds, there will
be an urgent need for a larger variety of contraceptive methods. More-
over, it is now well appreciated that there is no "perfect" contraceptive
because the contraception needs of women and men change over the
reproductive and family life cycles. Methods are needed for child spacing
as well as permanent pregnancy prevention, for adolescents as well as
those approaching menopause, for postpartum and breast-feeding
women, for women and men with medical conditions that restrict the con-
traceptive that they can use, for men and women with few resources, and
for men and women whose personal situations make correct and consis-
tent use difficult. In addition, the development of new dual protection
methods those that protect against pregnancy as well as against HIV/
AIDS and other sexually transmitted infections would be highly benefi-
4According to 2002 data of the United Nations Population Division.
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INTRODUCTION
23
cial, since the HIV/AIDS pandemic threatens world health and continues
to devastate sub-Saharan Africa and Asia. Clearly, there is an enormous
unmet need for effective and acceptable family planning worldwide. For
many men, women, children, families, and communities, the negative con-
sequences of not meeting family planning needs are high.
Cost, accessibility, and consistent and correct use of existing methods
still present enormous challenges to international family planning efforts
in particular. Although there is value in improving the characteristics and
means of delivery of current methods, there is also urgency in proceeding
with new research on and the development of new methods to meet the
range of contraceptive needs throughout the world and across the human
life span. The usual time line from basic research through target identifi-
cation and then to product introduction of 10 to 14 years means that an
effort initiated today would barely be on track to meet the aforementioned
contraception needs of the coming decade. The development of new
contraceptives that increase the range of options available to women and
men worldwide would improve the lives of families everywhere.
In 1996, the Institute of Medicine (1996) issued its most recent of
several reports assessing the state of contraceptive research and develop-
ment. That report exposed and analyzed the reasons for the apparent lack
of activity and progress in the field since the first "contraceptive revolu-
tion," which began in the 1950s and 1960s, when most of the current
contraceptive methods were initially developed (Institute of Medicine,
1996~. Many of the recommendations put forth in that report are as rel-
evant 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 field of contraception. Although progress has been made in
the intervening years, contraceptive modalities recently developed or in-
troduced are mainly variations on preexisting approaches. Furthermore,
progress in some areas thought to be promising in 1996 (e.g., immuno-
contraception) has been minimal, whereas new discoveries point to prom-
ising new opportunities. Moreover, there is still a great need to reenergize
the field and to translate significant observations from the science of re-
productive biology to practical application in fertility regulation. Many
barriers remain, but the progress that has been made is evidence that they
can be surmounted with committed resources and hard work.
COMMITTEE CHARGE
The current IOM committee was charged with recommending priority
areas for future research and development in the field of contraception.
To accomplish that goal, the committee assumed three main tasks in this
study:
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24
NEW FRONTIERS IN CONTRACEPTIVE RESEARCH
· In basic science, to identify opportunities derived from recent
advances in biomedical research.
· In the product development process, to propose new strategies and
frameworks for contraceptive development.
· In implementation, to describe the resources, infrastructure, and
coordination needed to achieve success.
With respect to science, revolutionary changes have occurred in basic
biomedical research, materials sciences, and drug delivery since publica-
tion of the 1996 IOM report. The advances in biomedical research have
provided exciting new opportunities for studying the basic biology of
reproduction, which could in turn lead to the discovery of new targets for
contraception. In particular, the tools and technologies of genomics,
proteomics, lipidomics, and glycomics have great potential for identify-
ing targets that could facilitate the development of radically new ap-
proaches to contraception. Novel approaches for the development and
delivery of drugs and other products could also provide new insights into
ways to create innovative contraceptives once potential targets have been
identified. Despite these advances, however, there has been flagging
interest in contraceptive development not only in the pharmaceutical
industry but also in the broader scientific community that must be
revived if these innovations are to generate products that satisfy the
demand for safe, effective, and convenient contraceptives.
Regarding the product development process, many obstacles to con-
traceptive development were identified in past IOM reports, particularly
the 1996 report, and many continue to plague the field. However, new
paradigms for science, including large-scale science, have emerged in the
past few years, along with new models for public-private collaboration.
In terms of implementation, new parties are interested in the process
of contraceptive development and dissemination, and new global con-
sortia are also dealing with reproductive health. These new participants
offer unique opportunities to move contraceptive development forward if
there is an expansion of the number and the breadth of expertise of scien-
tists and clinicians dedicated to contraceptive research and development.
Those who are active in the field are nearing retirement, with prospects
for new blood seemingly bleak without a widespread commitment to and
enthusiasm about contraceptive research and development. A major chal-
lenge is to identify, attract, train, and support the career development of
individuals who have an appreciation for the multidisciplinary issues sur-
rounding fertility regulation. This will require a significant departure from
the current ways in which investigators are trained as well as a special-
ized environment for carrying out research in this area. These topics will
be addressed in greater detail in the remaining chapters of this report.
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INTRODUCTION
25
FRAMEWORK OF THE REPORT
Chapter 2 provides an overview of technological advances that have
revolutionized the fields of biomedical research, drug discovery, and drug
development and that could thus have a tremendous impact on contra-
ceptive research and development. The committee examines ways in
which the new methods can be used to identify and validate targets before
drug development.
Chapter 3 describes the challenges associated with product identi-
fication and development, once potential new targets for contraceptive
development have been identified, and suggests a variety of approaches
to stimulate and speed progress in translational research and drug
development.
Chapter 4 examines the role of the social and behavioral sciences in
shaping the pursuit of leads that are likely to find a receptive set of users
and that are appropriate to particular populations or circumstances. This
chapter also examines ways to improve the use and acceptability of cur-
rent and new contraceptives, such as enhancing and promoting other
health benefits beyond pregnancy prevention.
Chapter 5 delineates a variety of strategies that can be used to capital-
ize on advances in science and technology and to overcome remaining
obstacles to progress in contraceptive research and development.
Because of the important role of the 1996 IOM report Contraceptive
Research and Development: Looking to the Future as a foundation for the
committee's work, an update on developments that have occurred since
that report was published is included in Appendix A. The agenda for and
participants in the committee's workshop are provided in Appendix B.
and a short biography of each member of the committee is presented in
Appendix C.
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1 ~
Representative terms from entire chapter:
health council
