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 11
The Need for New Contraceptives
Before we discuss how new contraceptives are developed and what opportunities
research offers for safer, more effective, more acceptable, more convenient, and
more easily distributed products, it is important to review how current methods
are used and to understand why problems of availability exist. Moreover, the case
that new contraceptives would be valuable must be established. If there is little or
nothing to be gained from an increase in the number and kinds of contraceptives
available to men and women, there is little or nothing to be gained from further
research. This chapter examines the shortcomings of existing methods, then
considers how new methods might benefit the individuals using them and the
societies in which they live.
An array of contraceptive methods is required to meet the varying needs of
men and women at different stages of their life cycles. One method may be most
appropriate for young people and those having intercourse only occasionally.
Another method may be better suited to young mothers breastfeeding a first child
and eager to space their pregnancies. A third method may be most appropriate for
older couples who want a highly effective long-tenn method, because they do not
want additional children but do not wish to become sterilized. Many people are
not well served by currently available contraceptive methods.
With most products, we expect the normal operations of industry, the
marketplace, and government policy to generate an appropriate range of product
choices and speed of product development. Contraceptives, however, differ from
most products in important ways. Government policies have limited the number
and variety of contraceptive products available to consumers as well as the rate of
11
OCR for page 12
|2 DEVELOPING NEW CO=~CE~~ES
contraceptive development. This situation is the result of the special characteristics
of modern contraceptive methods and our orientation toward them.
Using a contraceptive benefits both the individual using the method and a
variety of groups, from users' immediate families to the communities and countries
in which they live. A woman benefits because contraception may contribute to
her well-being by lowering the likelihood of an unwanted pregnancy and decreasing
the need for abortion. Some contraceptives also help to prevent the transmission
of sexually transmitted diseases. Others reduce the risk of certain cancers.
Avoiding pregnancy reduces the risks of health problems associated with pregnancy
and childbirth. Avoiding pregnancy may also increase a woman's ability to work
outside the home. If she works, her family may benefit from the additional
resources she can provide. Children's health is also improved when their mothers
are able to space their pregnancies. In less developed countries, contraceptive use
may contribute to slower population growth, which in turn may help promote a
country's social and economic development.
The social benefits of contraception argue for public involvement in the
contraceptive development process. The importance of the social dimension of
population is well recognized in other areas. Because of the disparity between
individual actions and state interests with respect to population, most if not all
countries have policies to regulate population growth through immigration. The
vast majority of less developed countries support national family planning programs
to increase contraceptive use in order to reduce population growth or to improve
health by enabling women to avoid high-risk and unwanted pregnancies (Lapham
and Mauldin, 1987~.
The committee believes the lack of an adequate array of contraceptives has
adverse consequences for both individuals and for society as a whole. The
inadequacy of current contraceptive methods contributes to the problems of
unintended pregnancy, unwanted children, and high rates of abortions. The
impact of these problems affects not only the individuals involved, but their
families, friends, and the communities in which they live.
Although reducing unwanted pregnancies and abortions is a potentially important
social benefit of contraception, government policies tend to devalue these and
other benefits of contraceptive use for society. Most U.S. government policies
toward contraception have been directed at ensuring the safe delivery of
contraceptives, not at maximizing the rate of contraceptive development. Policies
designed to regulate contraceptives, for example, may have impeded the rate of
product development. Product reviews by the Food and Drug Administration
~DA), for example, focus on the benefits and risks to individuals and do not
consider adequately the benefits to society if a contraceptive were available and
used by a large number of people.
Contraceptive development has also slowed because of the difficulty of dealing
with the problems posed by new technology, which require careful evaluations of
OCR for page 13
NEED FOR NEW CONTRACEPTIVES 13
complex risks and benefits. Contraceptives need to be used over an individual's
reproductive lifetime: women remain fertile for about 35 years, and men even
longer, and they may want to use contraception for most of that time. It is very
difficult for individual users as well as for scientists and policy makers to evaluate
all the risks and benefits of such long-term use in a reasonable time and at a
reasonable cost. Most individuals lack the information and experience to make
completely informed judgments about contraceptives, particularly regarding
unknown risks and long-term effects. This limitation has been recognized in
extensive government regulation involving the evaluation of product safety in
many areas.
Benefits from therapeutic drugs normally are clear: a person recovers from
disease (with some probability) or has a symptom relieved. The gain from
contraception is no less real, but it requires use of a drug or device for a preventive
purpose, frequently on a long-term basis. In addition to the benefit of reducing
unwanted pregnancies and their consequences, contraceptives also have
noncontraceptive health benefits. But since most people assume that contraceptive
users typically are healthy at the time they contracept, these benefits involving
prevention not only of unwanted pregnancy, but of health risks associated with
pregnancy have not been sufficiently taken into account in the development of
public policy. Contraceptive development has been slowed because the full
individual as well as societal benefits of additional contraceptive products have
not been properly recognized.
Existing public policy affects the availability of contraceptives and the rate at
which new products are developed in many uncoordinated ways. Public funding
supports research; government regulation controls marketing; and liability, rules
affect development. These and other policies help to determine the incentives to
undertake research, development, and marketing of a new product. Policies
affecting contraceptive development originate in different parts of government
and are directed at diverse aims. It is not surprising that the complicated,
uncoordinated, political, legal, and regulatory history of contraception has resulted
in less than optimal progress in the development of new contraceptive methods.
These four factors the social benefits of contraception, the complexity of
contracephve-related risks and benefits, the problems of evaluating the uncertain
impact of long-tenn contraceptive use, and the effects of uncoordinated and
sometimes discrepant public policies interact in complex ways that the committee
believes restrict the availability of contraceptive products. Although contraceptive
use is widespread in the United States, many people lack access to contraceptives
they consider appropriate for their particular circumstances. Every method in use
today has drawbacks, and, collectively, current methods leave major gaps in the
ability of people to control fertility safely, effectively, and in culturally acceptable
ways throughout their reproductive life cycle. New policies could help more
adequately to meet the contraceptive needs of American couples. The needs of
OCR for page 14
14 DEVELOPING NEW CO=RACEPT~ES
people in developing countries for new contraceptives are even greater than those
in the United States. Changes in policies that would increase contraceptive
choices in less developed countries would be particularly welcome.
Although it is necessary to be concerned about the potential for abuse of users
that some methods or delivery strategies present, it is also important to be
concerned about the consequences of a lack of adequate methods. Limited
contraceptive methods force many women and men to make difficult choices to
have an abortion or to be sterilized at a young age-that could be avoided if
additional safe, effective, acceptable, and affordable contraceptives were available.
CURRENT CONTRACEPTIVE USE
Contraceptive Practice
The great social and scientific revolutions of the twentieth century have enhanced
our ability to control childbearing. The vast majority of adults in the United
States and several hundred million people in countries around the world have used
contraceptives. Among the 54 million American women between the ages of 15
and 44 who have had intercourse, 95 percent have used contraception at some
time (Forrest, 1987~. Over 70 percent of all married American women of child-
bearing age or their husbands currently practice contraception. In 1987 the pill
was the single most popular contraceptive method in the United States, followed
by female sterilization, condoms, and vasectomies Forrest and Fordyce, 19889.
Never before in history has a systemic drug such as the oral contraceptive been
used so widely on a continuing basis by predominantly healthy women for a
preventive purpose.
Before describing the potential advantages of new contraceptive methods, it is
useful to review currently available contraceptives. Table 2.1 provides an overview
of contraceptive methods available in the United States; the table includes
information on prevalence of use and failure rates as well as a brief account of the
methods' major advantages and disadvantages. It is important to note that failure
rates, i.e., the rate of accidental pregnancy in the first year of use, include both
user failure-failure to use the method properly as well as lack of consistent
use and method failure.
About a fifth of all women ages 18 to 49 exposed to the risk of unintended
pregnancy have been sterilized. The advantages of sterilization are its high
effectiveness and the fact that a single procedure provides complete protection
with very little health risk. The pe~'nanence of sterilization and the difficulty of
reversing the procedure, however, are disadvantages for some people. Female
sterilization requires a skilled medical practitioner and, although complications
are rare, they are not unheard of.
Vasectomy provides protection for about 15 percent of the partners of the
women exposed to the risk of unintended pregnancy. Like female sterilization,
vasectomy is a permanent method in which a single procedure provides long-term
OCR for page 15
NEED FOR NEW CONTRACEPTIVES 15
protection against pregnancy with an extremely low risk of negative health
effects. Like female sterilization, reversal of vasectomy is possible but successful
only on a limited basis.
Oral contraceptives are used by about one-third of those exposed to the risk of
unintended pregnancy. The pill contains synthetic hormones that stop ovulation
by interfering with cyclical hormonal changes. The pill is easily used. In addition
to being easy to use, the pill causes regular menstrual periods, protects against
ectopic pregnancy, and reduces the risk of certain pelvic infections as well as
ovarian and uterine cancer. The pill's disadvantages include minor side effects
and more serious problems such as a greater risk among oral contraceptive users
of developing blood clots, heart attacks, and strokes. The risk of a heart attack or
stroke is especially high for users over 35 who smoke or who have high blood
pressure. About 3 percent of the women who use the pill will become pregnant
accidentally during the first year of use.
In the United States, the intrauterine device (IUD) is used by 3 percent of
women exposed to the risk of unintended pregnancy. The IUD is a much more
popular method in some other countries. Although the process by which IUDs
prevent pregnancy is still unclear, when placed in the uterus they are believed to
induce an unsuitable environment for both eggs and sperm. The advantages of
IUDs are their long-term protection, their reversibility, and the fact that, once
inserted, they do not require frequent attention. Insertion requires a skilled
medical practitioner, and IUDs may cause increased bleeding or spotting, cramping,
and pain. Perforation of the uterus occurs in about 1 in 2,500 insertions. The most
serious complication associated with [UD use is an increased risk of pelvic
inflammatory disease among women with more than one sexual partner. Accidental
failure rates during the first year of IUD use average 6 percent.
The condom is used by 16 percent of the partners of women, ages 18 to 49,
exposed to the risk of unintended pregnancy. And 12 percent of women whose
partners use condoms will become pregnant accidentally in the first year of use.
The condom is easy to use, inexpensive, and does not require a prescription. Its
greatest advantage may be that it protects against sexually transmitted diseases,
including AIDS. Some people believe the condom and other barrier methods
interfere with sexual relations.
The diaphragm is used by 4~ percent of contraceptors. Two large clinic-
based studies in which women had proper training in diaphragm use had failure
rates of about 2 percent (Vessey et al., 1982; Lane et al., 1976~. Several smaller
clinic-based studies had failure rates of 11 to 13 percent (Malyk and Kompare,
1983; Edelman, 1983~. Population-based studies have had the highest rates up
to 23 percent (Ryder, 1973; Schirm et al., 1982~. The diaphragm offers some
protection against sexually transmitted diseases and pelvic inflammatory disease
and possibly cervical cancer.
The remaining methods the contraceptive sponge, withdrawal, periodic
abstinence, vaginal foams, creams, and jellies have failure rates of between 18
and 21 percent. The advantages of these methods include their availability
OCR for page 16
16
Cq
a,
U)
._
CD
I:
._
CD
D
.a
C`?
o
5::
b
C:
Is
o
Cal
Cq
lo:
C)
:>
·~=
Cal
C)
.=
.=
an
Cal
Cal
To
to
Ed
U)
on
-
Cal
ha:
U)
3
3
o
w
-
"C ~
~ W
~ .S ~
~ ~ o
g a:
ad:
P) _
no - U)
~ ~ _
Al He _
~ o
ou ~
o
o
~ I ] ~ ~ ~ ~ = ~ ~ ~ ~ ~ ~ ~ i ~
o o
.
~ ~ .- ~
3 o ~ -
s U] U.
Cad
O -C o,
~ ~ ~ 8
.s~- &N
E -- E E g c
P.
_-
q) ~
o @ =-o
_ :,
~ ~ C
.s
.S ~ .-
o ~ o
=.
._
. ~
_- ?~
U)
o °
~ 3
.s
V'
8 g ~ @ e
0 ~ ~ 0
U.
~ ~ ~ ~ ~ ~ ~ ~ ' "i ~ 9 ~ ~ S
~o ~C~
_ ~
a E ~5 ~ 8 5 ~
OCR for page 17
17
=, ~ r , . ~ ~ ~ - ~ ~^ c ~ ~
F ~
8 ~ ~ ~ 5 ~ ~ O ~ ~ em _=, a g ~ Y I , 5 E
~s
.g
~ ~ ~ 3
U. ~ ~ ~
~ ~ _ ~ ~
~ ~ BOX o
o ~ ~ o
~ ^_ ~ &] ~ 5 ~ ~ Be, ~ x, - . ' · ~ _
Cal
~ ^
D
C.
~:g
a,
O
1
~ ~ 3 .~
~ Cut ~ ^.5
o
Cal
.O ~
_ ~
:3 ·-
OCR for page 18
18
U7
on
a'
Cot
.~
C}
6
3
_4
3
to
:=
_.
a_
-
"C ~
_ Cat
6 opt
_
. -
~:
o
Em
no O
g6 ~
·_ ~ o
en ~ ~ L- . ._
· ~ ~ 18 · s s ~ I ~i ~ ~ L ~
~3 ~
1 1
a, ~7 ~ _ ~ ~
Y B ~ 5 u < 5 B B e c
.c
cat
c
~ O .
._ =d
~ ~ _
_ C:
I: ~ ~
~ ~ its
Q
~ = ~ ~ ~ ~ 3 3 ~
Cot U) U)
_ ~-_
a
-I ~
O ~
Cot
c
o
OCR for page 19
19
U. ~
=- e ~ 'a
- S ~ , ~Y E C
"c
. - ~
cat
e E e 5 E · E
~Z E ~ ~ C E u
0, ~e Y ' S =` ~ ~ ==,
V) ~t7 ~ '= ~ ~ ~ D cow
qJ Q
lo: ~
5 ~ . i ~ ~ .,, I | ~ ~ ~ ~ -~ ~ ~-!
At: ~
o _
;^ a_
~ ~ o 78 ~3 ~
~ ~ ~.
as as
z ~
g)
Cat
3
:=
.~
C)
C
a_
oo
-
:-
o
ILL
C .
as _-
_ ~
~ X
lo; -
o
_
U)
~ a:
~ _
~ ~3
:3 ~
~ 'Z
i=
~ .
C
_
~ '
~ ;>
TIC ~
Cat
4,
~ ._
._
0
~ C}
·U)
·c
~ X
·;3 -
~ .~
o&<
~ ~ o
oD o ~
43
- ~ o~
·=
.e >.
~ :~ ~
~ o -
~ ~ o
s ~
=- - ~
o ~ ~
~ D
'~
~ ~C
~ ~ '=
~ ~S
OCR for page 20
20 DEYELOPING NEW CO=~CE~WES
without prescription and the lack of serious side effects, independent of those
associated with their relatively high failure rates. These methods are not very
popular in the United States. Withdrawal and periodic abstinence are each used
by about 5 percent of those exposed to the risk of unintended pregnancy; foams,
creams, and jellies and tablets and suppositories by about 1 percent of those
exposed to the risk of pregnancy. In some other countries, methods not approved
for use in the United States are available. These methods are described briefly in
Chapter 3.
The large number of people who practice contraception have different desires,
values, and needs, which can be met best by a variety of contraceptive methods.
Not only do people differ in what they like and dislike, but individuals'
contraceptive needs also change during their reproductive lifetimes. The needs of
adolescents are different from an adult's need for child spacing or for termination
of childbearing. People's health differs, as does their reaction to different
contraceptive products. Because people live under diverse social, economic, and
cultural conditions and are served by a wide variety of health care systems, they
need different methods of contraception. Although a variety of contraceptive
methods exists, the committee believes that substantial gaps remain in the array of
methods available for particular groups.
The importance that couples in the United States give to effective contraception
and the problems they encounter with existing methods are illustrated by the large
proportion of couples who are surgically sterilized. Fifteen or more years after
the* first marriage, 44 percent of all women practicing contraception are sterilized,
and another 24 percent are married to men who are sterilized. These figures
confirm that at some point American women are ready to stop childbearing.
These data also suggest that there are problems with available temporary methods.
Given the absence of acceptable alternative choices and the problems with
existing contraceptive technology, women may seek sterilization earlier than they
might otherwise choose. The side effects of existing methods and concern about
potential problems discourage long-term use of the most modern temporary
methods. Since the likelihood of experiencing a serious adverse side effect with
the pill increases with age, older women are more likely to look for an alternative
method. Indeed, the pill is used by almost half of all contracepting newlyweds,
but its use falls steadily as women's age and duration of marriage increases.
Given the low family size goals characteristic of couples in the United States, they
want a highly effective method. For many of ~em, surgical sterilization is the
chosen alternative. The available data suggest, however, that regret at being
sterilized is not uncommon. One review found between 2 and 13 percent of the
sterilized women suIveyed between 6 months and 6 years following sterilization
expressed regret; between 1 and 3 percent underwent reversal (Lee et al., 1989~.
Requests for surgical repair of sterilization are increasing, particularly among
women sterilized in their twenties or early thirties (Gn~bb et al., 1985~. Estimates
OCR for page 21
NEED FOR NEW CONTRACEPTIVES 21
suggest that as many as 5 to 8 percent of all sterilized women seek surgical repair
(Henry et al., 1980~.
Women in the United States are not alone in their desire for effective
contraception. Worldwide, about a half billion women are currently using some
method of contraception; an estimated three-quarters of these women live in the
less developed world (United Nations, 1987a). Although their choice of methods
may vary from country to county, the vast majority of married women in Westem
industrialized countries practice contraception. In most Western European
countries, for example, between 70 and 85 percent of all women ages 15 to 49 use
contraception United Nations, 1987a). In developing countries, contraceptive
practice ranges from only 1 percent of currently married couples in some African
countries to over 60 percent in such Asian and Latin American countries as
Thailand, South Korea, Panama, and Costa Rica (Mauldin and Segal, 1986~.
In many less developed countries, the proportion of women practicing
contraception is lower than in the industrialized countries, but contraceptives are
employed by a large and typically growing number of women. In the newly
industrialized countries, levels of contraceptive practice are similar to those in the
United States and Western Europe. In Korea, for example, 70 percent of all
married women of reproductive age use contraception. Even in some of the
poorer developing countries, contraceptive use is widespread. Over a third of
married Indian women of reproductive age currently use a contraceptive, as do 30
percent of those in Egypt (United Nations, 1987a). Despite the increase in
contraceptive prevalence in some countries, high failure rates and high
discontinuation resulting from the use of inappropriate methods of contraception
indicate that better delivery systems and more effective, safe, and affordable
contraceptive options are needed.
The safety, effectiveness, and acceptability of contraceptives are particularly
important for the many women who use them, since women bear the greatest
burden of contraceptive side effects. The available contraceptive choices limit the
ability of men, who might otherwise do so, to effectively share responsibility for
contraception with their female partners. The number of American men who use
condoms or who have had vasectomies suggests that many men are willing to
share the responsibility for contraceptive practice, thus reducing periods of exposure
to the risks of contraceptive use for a partner who otherwise would bear the full
responsibility and the full risk.
Several groups of women, particularly older women and those with chronic
diseases, need contraception but are unsuitable or poor candidates for the most
highly effective contraceptives now available. Women with insulin-dependent
diabetes or those with certain types of cardiovascular disease, for example, are not
good candidates for either hormonal or intrauterine contraception. New methods
that do not aggravate systemic diseases and do not increase the risk of infection
would be of great benefit to these women.
OCR for page 22
22 DEVELOPING NEW CO=RACE~~ES
Contraceptive Effectiveness
Although existing contraceptive technology can be highly effective, the situation
is not as bright as most people, including most users, believe. One recent review
of research on contraceptive effectiveness summarized the current situation:
`'Despite the fact that most methods do well if used consistently and correctly,
failure rates in actual use are generally not low. A contraceptive that is inexpensive,
is easy to use, has few side effects, and is highly efficacious is still needed"
(Trussell and Kost, 1987:272~.
The data available on contraceptive effectiveness, shown in Table 2.1, indicate
the range of effectiveness with which contraceptive methods are used. (Failure
rates are expressed in terms of the percentage of women using a method who
become pregnant accidently during the fast year of use.) The studies from which
the data came were conducted mainly in the United States. Evidence from both
developed and less developed countries (Lain", 1978; Thapa et al., 1988) indicates
that the actual effectiveness of temporary methods of contraception varies among
different groups within a country. Effectiveness is higher among better educated
women and among those who want no more children. To the extent that a larger
proportion of the users of a particular method in a developing country are likely to
be less well educated about contraception, the effectiveness of a particular method
will be lower.
The effectiveness of different contraceptive methods varies widely. Fewer
than one half of one percent of the users of sterilization in the United States will
experience an accidental pregnancy in the first year of use. The comparable
figure for oral contraceptives is 3 percent; for the intrauterine device (IUD), 6
percent; for the condom, 12 percent; for the diaphragm, the cervical cap, and
withdrawal, up to 18 percent. Of the women who use spermicides, the contraceptive
sponge, or who practice periodic abstinence as a means of fertility control, 20
percent or more will become pregnant within the first year of use (Trussell and
Kost, 1987~.
The failure rates, which may sound small, can have a substantial impact,
especially, of course, on the women who become pregnant and on their Farmers.
In 1987 an estimated 6.9 million American men used condoms as a method of
contraception. If the average annual accidental pregnancy rate is ~ percent dower
than the 12 percent for the first year because users learn to use their method of
choice more effectively over time, and less effective users tend to stop using the
method), there would be over 500,000 accidental pregnancies in the United States
each year because of the low effectiveness of the condom in actual use. Using
data from the 1987 Ortho survey of married and unmarried women currently
protected by venous contraceptive methods and several estimates of method-
specif~c contraceptive failure, we estimate that between 1.2 and 3.0 million
accidental pregnancies occurred in 1987 as a result of contraceptive failure
(Forrest and Fordyce, 1988~. It is most likely Mat the actual number is between
OCR for page 23
NEED FOR NEW CONTRACEPTIVES 23
1.6 and 2.0 million. Many of these accidental pregnancies result in abortion.
Forrest and Silverman (1988) estimate that about half of the approximately 1.5
million abortions performed in the United States each year are the result of
contraceptive failure.
An important, although not well-studied, determinant of contraceptive
effectiveness is the quality of the system that delivers family planning services
(Bruce, 1987~. People who are well informed about the side effects they will
experience and who understand how to use a method properly practice contraception
more effectively than those who are not properly informed Indeed, the availability
of health personnel, clinics, or pharmacies may determine the effectiveness with
which contraception can be practiced. Even simple matters such as resupply
cannot be taken for granted in the rural areas of many less developed countries.
There are rarely sufficient resources to provide people with the information and
support they need for the most effective use of existing methods. New methods
that are simpler, safer, and more convenient to use could make the task of
providing information, education, and services easier and less of a drain on the
financial and human resources of the service delivery systems of developing
countries.
POTENTIAL EFFECTS OF NEW CONTRACEPTIVES
Reducing Abortions
Low birth rates and a low level of unwanted childbearing can be achieved by
less effective contraceptive methods, if women obtain abortions when contraceptive
failure occurs. The stronger the desire to reduce abortion, the greater should be
the investment to develop new methods of contraception. The effects of new
methods would vary among populations depending on their levels of fertility and
patterns of fertility control. In industrialized nations, in which fertility is already
low, the greatest impact of new methods would probably be to reduce the number
of abortions and to provide couples with a better array of fertility control options.
In developing countries with high birth rates, the greatest impact of new methods
would be to reduce the number of births. However, to the extent that new
contraceptive methods reduced unsafe abortions in developing countries, they
would also help lower maternal mortality. Recent studies have found that between
5 and 30 percent of maternal deaths in developing countries are abortion-related
~ettenmaier et al., 1988~. Increased contraceptive use and more effective
contraceptive practice could help reduce unsafe abortions and the complications
and deaths associated with them (Viel, 1985~.
One recent analysis of the potential impact of improved contraception in six
European countries concluded that a reduction in contraceptive failures would
result in a 5- to 10-percent reduction in pregnancies. However, if the new
OCR for page 24
24 DEVELOPING NEW CO=RACE~IVES
methods increased the overall level of contraceptive use and thus reduced the
occurrence of unwanted pregnancy, a further reduction of one-third to one-half of
all abortions would result (Westoff et al., 1987~.
Contraception and Health
A large volume of evidence from countries at all stages of development and
with a variety of health care systems indicates that using contraception to space
births and to terminate childbearing is safer for women and their children than
unregulated childbearing (Lee et al., 1989~. The contribution new contraceptive
methods may make to improved health for women and their children provides an
important justification for investments in this field.
Even in the United States, for women under the age of 35, not using a
contraceptive is associated with a higher mortality than employing any contraceptive
method, including use of the pill by women who smoke (Ory et al., 1983~.
Contraceptive side effects pose a much more serious risk in poor countries, where
diagnosis and treatment are frequently inadequate and problems resulting from
untreated illness may have far more serious repercussions. New methods that
make possible safer contraceptive practice would provide important health benefits
to men and women around the world.
According to one estimate (World Health Organization, 1986a), the number of
women who die each year from pregnancy-related causes may be as high as
500,000, all but 6,000 or so of them in less developed countries. According to one
recent study, if all unwanted pregnancies were avoided, between 25 and 40
percent of all maternal deaths would also be avoided (Maine and Rosenfield,
1982~. To the extent that new methods would increase contraceptive use and
effectiveness, they could significantly improve women's health.
Children may also benefit when their mothers are able to control their fertility.
Children born at least 2 years apart have lower rates of infant death than those
born closer together. If new methods help to reduce births in high-risk categories
of maternal age or birth order or among women with short birth intervals, then
infant and childhood mortality might decline as the new contraceptives become
more popular (Hobcraft, 1987; Trussell and Pebley, 1984; National Research
Council, 1989~.
Reducing the Problems Associated With Existing Methods
Although the risks of currently approved contraceptive methods are on balance
lower than those of pregnancy, in a small fraction of users the health consequences
of some current contraceptives are serious. There are health complications and
rare deaths associated with existing methods, even though these can be reduced to
a minimum in properly screened women. New contraceptives may have fewer
OCR for page 25
NEED FOR NEW CONTRACEPTIVES 25
side effects and complications than those associated with the existing methods
and thereby add to the attractiveness and safety of contraceptive practice.
The major reason given by American women for not contracepting is fear of
complications (Ory et al., 1983~. Side effects are offered as a major reason for
discontinuing pill use by women in many countries qanowitz et al., 1986; Stephen
and Chamratrithirong, 1988~. Women discontinuing pill use for health reasons
often switch to less effective methods Janowitz et al., 19863.
Nausea, breast enlargement, weight gain, loss of libido, and dizziness are the
most common complaints of oral contraceptive users. But more serious
complications, such as cardiovascular problems that require hospitalization, also
occur among pill users. Although the evidence regarding the link between the pill
and breast cancer is conflicting, the uncertainty of the relationship has caused
concern among many women. The limited popularity of the IUD in the United
States no doubt is due in part to its perceived association with an increased risk of
pelvic inflammatory disease (PID) and infertility. Although rare, perforation of
the uterus is another potentially serious complication of IUD use.
The natural family planning methods have no side effects, but their effectiveness
is low relative to other methods. Periodic abstinence or the daily testing of body
temperature or cervical mucus are viewed by many women as a major
inconvenience. The procedures these methods require reduce the acceptability of
the natural methods for many couples and the effectiveness with which they are
practiced.
Although sterilization is generally a very safe operation in the United States,
major complications of sterilization procedures include unintended major surgery
to control bleeding, rehospitalization because of pelvic infection, vaginal bleeding,
and urinary tract infections. Deaths resulting from sterilization are very rare; the
major cause of death is complications resulting from the use of general anesthesia,
not the sterilization procedure itself. Vasectomy is safer than female sterilization
and has few complications or postoperative hospitalizations associated with it,
even in the developing world.
Barrier methods-condoms, diaphragms, foams, jellies, creams, suppositories,
sponges not have serious side effects. Moreover, barrier methods carry an
important health benefit the prevention of sexually transmitted diseases.
However, failure rates for barrier methods and periodic abstinence are significantly
higher than those for the pill, the IUD, and sterilization. Thus women using these
methods have a greater likelihood of becoming pregnant and thus of being
exposed to the risks associated with childbirth.
The health hazards of existing contraceptive methods are usually due to a
mismatch between the method and the user. Cardiovascular complications of oral
contraceptives, for example, are not a significant risk for young nonsmokers. The
risk of PID is higher among IUD users with several sexual partners. The
availability of a wider range of contraceptive methods would improve the matching
OCR for page 26
26 DEVELOPING NEW CO=RACE~~ES
of methods and users. Fewer people would have to use methods that are not
acceptable or appropriate for their health status or life-style.
Increasing the Coverage and Quality of Contraceptive Services
New contraceptive methods may also help increase the coverage and quality of
contraceptive services, particularly in developing countries. Of the countries that
adopted official policies to provide support for family planning programs, all but
India did so after the pill and {UD became available in the early 1960s (Greep et
al., 1976~. The provision of government support for family planning services was
part of the post-World War II modernization process. As such, it required a new
political and social environment, not simply a new contraceptive technology. But
it is also true that the limitations of then-existing contraceptive methods were so
extensive that many government leaders were discouraged from undertaking
family planning programs. Bernard Berelson noted the importance of the
introduction of the IUD for family planning programs in the 1960s: "By giving
national programs some hope of success . . . [the IUD] stimulated a wholly new
level of effort, improved the morale of family planning workers from the top
down and, most importantly, brought about the development of family planning
organizations in a form and magnitude not previously known" (Berelson, 1969:365~.
The experience of several national family planning programs in developing
countries demonstrates that additional couples begin to practice contraception
each time a new method is introduced Freedman and Berelson, 1976; Fathalla,
1989~. A new method an injectable contraceptive recently had this effect in
Bangladesh (Phillips et al., 1989~. Although some users of new methods are
drawn from the pool of women using existing methods, the available evidence
suggests that new methods attract new users.
There are populations, even in the United States, to whom very few of the
existing available methods are acceptable. Scrimshaw et al. (1987), in a study of
low-income Hispanic women in Los Angeles, found that those who were
breastfeeding and who wished to space their children were without adequate
contraception. They hesitated to take the pill because of its possible impact on
lactation, and they found barrier methods unacceptable to themselves or their
partners. It is possible that the situation among this group is a prologue to what
will happen for increasingly larger gTOUpS of women in the United States as
contraceptive choices become more limited at least in part because of the withdrawal
of contraceptive products from the market by major pharmaceutical firms.
The problems are not only those of the low-income community. U.S. couples
in their twenties and thirties complain about the lack of appropriate methods.
Women in this group who cannot or do not want to use oral contraceptives and are
not ready to be sterilized must rely on less effective barrier methods, periodic
abstinence, withdrawal, or a limited selection of IUDs-providing, of course, that
they are not removed from the market.
OCR for page 27
NEED FOR NEW CONTRACEPTIVES 27
None of the currently available methods is well suited for the immediate
postpartum period. The IUD, which does not interfere with lactation, can be
inserted immediately postpartum or at the time of hospital discharge, but rates of
expulsion, perforation, and unintended pregnancy are higher than when the IUD
is inserted at any other time. Progestin-only oral contraceptives (sometimes
called "minipills") have been recommended for postpartum use, as have subdermal
implants such as NORPLANT~ (see Chapter 3~. However, until more information
on the long-term follow-up is available, the potential risk of synthetic hormone
transfer to the baby is a cause of concern regarding the use of these methods.
THE IMPORTANCE OF CONTRACEPI IVE DELIVERY
Accounts of the large number of people in need of family planning services
warrant the question of whether and to what extent this unmet need could best be
served by better delivery of existing contraceptive methods. Some analysts have
claimed that the problem of contraceptive use is not a so-called hardware problem,
but a software problem (Djerassi, 1981~. From this point of view, the need for
better, more available contraceptives can best be served by improvements in
delivery systems rather than by the development of new products. In many
developing countries, the problems with delivery systems are particularly acute.
Certainly, improved delivery would help and, for the immediate future, it is the
only alternative. But the need to better deliver the contraceptive methods that are
available should not lead one to underestimate the potential impact of new, safer,
and more convenient techniques. The introduction of new methods could stimulate
an expansion in the delivery system in part because, if health and family planning
program managers have something new to sell or offer, they may be encouraged
to expand their outlets.
New methods could influence fertility in several ways by increasing safety
(yielding fewer adverse effects) and effectiveness (yielding fewer pregnancies),
increasing acceptability and use (yielding more users), or increasing continuation
(producing longer durations of use). Because most modern methods of
contraception are relatively effective, the impact of new methods will probably
come from greater acceptance, longer periods of use, or both. If 30 percent of the
population at risk uses a method of contraception (about the current level of
contraceptive practice in Egypt or Bolivia), then a Appoint increase in the
average continuation of use (that is, a 10-percent increase in the number using the
method for a full year) would have the same demographic impact as about a 4.5
percentage point increase in contraceptive prevalence. If continuation rates were
90 percent during the first year of use instead of the 50 to 70 percent for most
temporary methods, it would make a substantial difference (Berelson, 1978~.
It is important, however, not to exaggerate the impact that new technology
would have. A plausible case can be made that improved delivery of existing
OCR for page 28
28 DEVELOPING NEW CO~RACE~IVES
methods could also make a large difference in acceptance rates. The lowest
contraceptive prevalence is typically found in countries with the weakest family
planning programs (Lapham and Mauldin, 1987:671~. Moreover, the experience
of family planning programs in developing countries such as those in Indonesia
and Thailand suggests that large increases in contraceptive use and corresponding
declines in fertility are possible with current methods. Moreover, one possibility
is that in some countries, for example those in sub-Saharan Africa, the demand for
contraception is so low that neither improvements in contraceptive technology
nor better delivery of services would encourage significantly greater use in the
short term.
Nevertheless, the contribution of new contraceptive methods to an improvement
in the coverage and impact of family planning programs is likely to be particularly
important in the less developed world. In a large and growing number of
countries, access to family planning services is considered a basic human right,
similar to good health or literacy. There is little debate about the desirability of
programs to provide couples with access to easy, affordable, and effective means
of family planning.
CONCLUSION
New methods would help couples meet the changing needs for contraception
that they face during different stages of their reproductive lives. An increase in
the total number and type of contraceptive options available would help to ensure
a better, healthier match of methods to users. Furthermore, societal needs change
over time, and new methods could help societies address important social problems.
In recent years in the United States, for example, the pattern of premarital
intercourse has changed, as has exposure to sexually transmitted diseases. To the
extent that such social changes take place, the need for contraceptive methods is
altered. In this respect, then, contraception is not like other aspects of preventive
medicine. One polio vaccine solved the problem of poliomyelitis, but one
contraceptive will never meet all societies' and all individuals' changing needs
for fertility regulation (Potts and Lincoln, 1988~. There are important and obvious
gaps in the range of available methods. These gaps could be filled, in part, by
developing new, safe, effective, and acceptable methods for men, for breastfeeding
women, for teenagers, for older women, and for those with particular health
. .
cone Tons.
There is no simple, straightforward account of the likely impact of new
contraceptive methods on fertility and health. Human reproduction and its control
are elements in a very complex system of multiple interactive variables, which
change over time, vary from place to place, and affect people differently. It is
difficult to measure the importance of a new contraceptive method relative to
improvements in delivery systems, to increased information about existing methods,
to changes in the status of women, or in the motivation to control fertility. New
OCR for page 29
NEED FOR NEW CONTRACEPTIVES 29
methods of contraception are not a panacea for all the problems associated with
unwanted pregnancy and childbirth around the world. Nor should the development
of new methods be viewed as a substitute for improving the delivery of existing
products and increasing education about sexuality, human reproduction, and
family planning. Greater attention must also be given to the factors that promote
contraceptive use among individuals seeking to avoid pregnancy. Better education
about human reproduction, sexuality, and contraception, shared responsibility,
and more open communication between partners about sex, health, and
contraception are likely to increase motivation to use contraception and the ability
of individuals to use methods effectively. Without the proper motivation,
knowledge, and communication among potential users, new and improved
contraceptive methods may gain only limited acceptance or may be used
improperly.
More attention should also be given to developing new contraceptive methods.
We must work to improve the technology used by couples to plan their families.
New methods are needed to help reduce the level of unwanted pregnancy, the use
of abortion, and the health risks of childbearing. The committee believes that the
important societal and individual benefits of safe and effective contraceptive use
argue strongly for a larger number and greater variety of contraceptives.
Representative terms from entire chapter:
family planning
