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Contraception
Having a Healthy Baby at the Right Time
Contraception has been practiced in some form since ancient times.
The Petri Papyrus of Egypt, which dates to 1850 B.C., carries a prescrip-
tion for a pessary made of sodium carbonate and honey. Another Egyptian
formula of that time was crocodile dung mixed with a pastelike material.
In the mid-1700s, Casanova recommended capping the cervix with half
a lemon, from which the juice had been removed. Condoms date back
to ancient Egypt and China, where men used sheaths made from animal
membranes or oiled silk. The word "condom" was first used in England
and may derive from the name of a Dr. Condom, who supposedly made
a protective sheath for King Charles II to stem his number of illegitimate
children.
In the early 1900s, a movement to make contraceptives and family
planning services available to U.S. women got under way with Margaret
Sanger's first birth control clinics. The synthesis of two orally active
progestogens in 1951, followed by the successful testing of these steroids
as oral contraceptives, began a campaign for widespread access to birth
control in the 1960s described by some observers as a "contraceptive
revolution."
The development of the birth control pill, plus a renewed interest
in the IUD, came at a time when rapid population growth was being
perceived as a threat to the global environment and to the economic and
social health of many countries, particularly those in the Third World.
41
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SCIENCE AND BABIES
~ ' ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ 'A ~ ~ ~ ~ ~ I''' ~ ~~ ': ~ 5~' ~ ~ 5 ~ ~ . at ~
This scrap of papyrus is a prescription written in 1550 BC for a medicated tampon to prevent
conception. Soaked in a mixture of honey and the fermented tips of acacia bush, the tampon was
used as a vaginal suppository. Stewed acacia leaves produce lactic acid, an effective spermicidal
ingredient also used in contraceptive ointments in the 1 940s and 1 950s. The papyrus was
discovered by George Ebers in Luxor in 1873. Credit: National Library of Medicine
In the United States, the increasing number of women entering the work
force created new demand for the control that contraception could give
over one's reproductive life. Stirred by these concerns, governments for
the first time began to fund research on population and contraceptive
development.
The success of the pill encouraged the pharmaceutical industry to
become vigorously involved in developing new contraceptives. By the
mid-1970s, 13 pharmaceutical companies, 9 of them in the United States,
were active in the field, and observers predicted that many new ap-
proaches to contraception would soon be available. Expectations included
a pill for men and a vaccine against pregnancy for women. As recently as
1982 the congressional Office of Technology Assessment estimated that
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CONTRACEPTION
43
by the end of this century more than 20 new or significantly improved
technologies for contraception would be available.
Although these expectations were based on the number of studies
under way, interest and funding soon declined and the predictions have
yet to become realities. In fact, the opposite has occurred. Writing in
Family Planning Perspectives in early 1988, Richard Lincoln and Lisa
Kaeser of the Alan Guttmacher Institute observed:
If in the 1960s we saw the birth of a contraceptive revolution, then in the
1980s we are witnessing the failure of that revolution and the reversal of
many of its hard-won gains. In the United States, where the pill and the
modern IUD were first developed, contraceptive methods are disappearing
faster than new ones can be introduced.
Until very recently IUDs were almost unavailable to women in the
United States; today only two models, the copper-releasing ParaGard and
the progestogen-releasing Progestasert, are marketed. Injectable con-
traceptives, such as Depo-Provera, which are used in practically every
country of the world, are not allowed here. Several new birth control
pills on the market in Europe cannot be prescribed in the United States,
although they are considered safer. The pills contain new progestins that
are thought to cause fewer adverse effects on the cardiovascular system
than the older progestins. RU 486, an abortifacient and menstrual in-
ducer, is being marketed in France and China, but at present there is no
plan to seek the approval of the Food and Drug Administration (FDA) for
use in this country. Lincoln and Kaeser state that clinical research on new
contraceptive methods is practically at a standstill in this country; only
two American pharmaceutical companies, Ortho and Wyeth, are doing
any contraceptive research at all.
In the United States, as in many countries, women begin having
intercourse at a younger age than did women living earlier in this century.
At the same time, many wish to have small families. Observes Dr.
Malcolm Potts, president of Family Health International:
The median age at which U.S. women have their last wanted child is 26.9
years, and 75 percent of all women have all the children they want by age
30. Even a contraceptive method with an annual failure rate of one percent
that is used from age 30 to age 45 will leave one woman in seven with an
unintended pregnancy.
At first it may seem that there are many birth control choices in the
United States, but close examination reveals the opposite. Oral contra-
ceptives are used chiefly by women under age 30 because physicians are
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SCIENCE AND BABIES
anxious about the cardiovascular side effects of the pill among women
over age 35. Furthermore, misinformation about the possible health ef-
fects of the pill discourages many young women and teenagers from
using it. Also because of side effects, IUDs today are being prescribed
only for women in mutually monogamous relationships who have at least
one child. Barrier methods such as the condom and diaphragm are less
effective than the IUD or the pill and are unattractive to many couples.
Because their choices for truly safe and effective contraceptives are
limited, American women often have long intervals during which they
are not protected against the possibility of pregnancy. As a result, over 50
percent of them have unintended pregnancies, and thus the United States
has a higher rate of abortions than most other industrialized countries.
WHY THE DECLINE IN CONTRACEPTIVE DEVELOPMENT?
Many factors played a role in the decline of contraceptive research
and development. Some were economic; others were political and social.
Research on reproduction and contraception is expensive and complex
and takes years. Because reproduction is species specific, much of the
experimental work must be conducted with humans, a pursuit that requires
high-priced and sometimes unavailable liability insurance. In addition,
some side effects, such as the thromboembolic effects of the pill, may
develop only after extensive use and cannot be found beforehand, making
the contraceptive business extremely vulnerable to litigation.
Such risks do not encourage pharmaceutical companies to enter the
field of contraceptive development. In fact, most of the companies that
once were involved in this research have left, and other companies have
reduced their commitment.
Certain developments have accelerated the decline of contraceptive
research, particularly research on entirely new contraceptive methods.
The most harmful developments have been the proliferation of product
liability suits and the sharp rise in liability insurance premiums. Other
negative factors include the lack of both public and private financial
support and a time-consuming FDA approval process.
The Lawsuit Proliferation
In 1982 the National Survey of Family Growth (NSFG) found that
the IUD was the fifth most popular reversible form of contraception in
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CONTRACEPTION
45
the United States, with just over 2 million women using it. A few years
later the three most commonly used IUDs were taken off the market.
The Dalkon Shield, made by A.H. Robins Company, was removed
from the market when a flood of damage suits were filed against it be-
ginning in 1975. The design of the Dalkon Shield, which went on the
market in 1971, before FDA approval of medical devices was required,
was clearly associated with an increased risk of pelvic infection, subse-
quent infertility, and, in some cases, death. The Robins Company knew
of the potential hazards but denied them; other IUDs, which are free of
the Dalkon Shield defects, have been suspect ever since.
Until recently, G.D. Searle and Company made the only copper IUDs
available in the United States. Copper-carrying devices have a lower
pregnancy rate than noncopper ones and their association with pelvic
inflammatory disease has been low. Nevertheless, Searle faces about
350 claims for damages and is appealing a jury verdict that awarded a
plaintiff in Minnesota over $~.1 million. (The jury found Searle negligent
in advertising and labeling its Cu-7 IUD.) Searle's cost of defending four
lawsuits initiated in 1985, which it won, totaled $1.5 million.
By the mid-1980s, both Searle and Ortho Pharmaceutical Corpora-
tion decided to stop selling IUDs. Ortho based its decision on the fact that
its market for the Lippes Loop was being eroded by an overall decline
in IUD sales and by the increasing market share of the copper IUDs. Al-
though its copper IUDs were popular, Searie decided to stop marketing
them in North America. It continues to sell IUDs in 18 other countries,
where it has encountered very few lawsuits. SearIe decided to leave the
U.S. market because of the high cost of defending itself in liability suits
and the difficulty of obtaining liability insurance. Currently, two IUDs
are available in the United States: the Progestasert, made by Alza Cor-
poration, and the copper-wrapped ParaGard, distributed by GynoPharma,
Inc., under license from the Population Council.
Carl Djerassi, a contraceptive expert at Stanford University, de-
scribed other negative effects of liability litigation when he wrote:
In 1980, several pharmaceutical companies claimed to have had more product
liability claims for oral contraceptives than for all other drugs combined,
notwithstanding that probably no group of currently used prescription drugs
has been tested clinically as thoroughly as these steroids. It is not even the
fact that few of these suits are won by the plaintiffs. It is just that the
financial, human, and administrative costs of pursuing them are so high that
few companies wish to expose themselves to such waste.
Djerassi claimed that although most of the active ingredients in the
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SCIENCE AND BABIES
birth control pills being used are off patent, generic equivalents are just
beginning to appear on the market, no new companies are entering the
field, and, in contrast to other drugs no longer under patent, the price of
oral contraceptives is continually increasing.
In 1985 the Upjohn Company announced it was phasing out its
fertility research program. As its reasons the company cited the increase
in adverse litigation, the long approval process, and rising insurance
costs. Some observers suspect that hostility from antiabortion activists
influenced Upjohn as much as anything else. Although Upjohn is no
longer studying prostaglandins for their contraceptive value, the company
continues to investigate the compounds as possible treatments for ulcers
and cardiovascular disease.
The increase in the number of lawsuits was not the only significant
upward trend in the l980s. Jury awards became so large they made
heacllines. Similarly, the cost of defending malpractice and product lia-
bility lawsuits rose. A study by the Institute of Civil Justice at the Rand
Corporation revealed that between 1982 and 1985 there was a 15 percent
annual increase in the cost of defending both malpractice claims and
product liability suits. The cost for defending more routine automobile
claims rose only 6.3 percent annually.
Changes in the Legal Rules
During the past two decades, major modifications were made in the
rules governing liability lawsuits, reports Deborah Hensler of the Institute
of Civil Justice. The locality rule for malpractice suits was overturned, and
new bases for bringing claims, setting damages, and measuring loss were
established. Negligence was no longer necessary as a basis for a product
lawsuit; instead, manufacturers could be held to new and strict concepts
of liability. In many jurisdictions the statute of limitations was relaxed for
injuries that might take more years to develop, and, as with malpractice,
new ways of determining loss were introduced. In describing the result,
Dr. Hensler notes, "There have been numerous small, substantive changes
in the law that most people agree have increased grounds for plaintiffs to
bring claims, increased their chances of being successful, and increased
their chances, if they are successful, of winning large awards."
Also during the past two decades important changes in procedural
rules boosted the number of successful claims and drove up the amount
of jury awards. For example, the rules governing "discovery" permitted
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CONTRACEPTION
47
a greater exchange of the information on which a lawsuit was built,
an important factor in litigation that uses massive amounts of technical
and medical data. Dr. Hensler notes that the proportion of large law
firms has increased and more of them are specializing. In fact, some
law firms concentrate on cases involving only particular products. In
addition, attorneys today use computer technology to build data bases of
the discovery documents developed for particular cases, and these data
bases are being shared among lawyers nationwide.
Two objectives of the tort liability system are to make restitution
to injured people and to deter bad behavior. But studies have found
that people with modest losses are overcompensated for their economic
damages, people with large losses are undercompensated, and those with
very large losses are severely undercompensated. As a method of making
amends, the tort system is costly and not very equitable.
How well does the system deter negligent behavior? Dr. Hensler
believes that more attention is being paid by the medical profession to
quality of care. Manufacturers of products, particularly risky products,
seem to agree that their general level of consciousness about safety is
higher than it was in the past. But the price for such consciousness raising
also appears high and the method is not efficient.
Unfortunately for manufacturers, medical care personnel, and insti-
tutions that might look to litigation outcomes for performance guidelines,
information produced by the legal system is not always clear or consis-
tent. Court decisions vary from state to state and, within states, from
jury to jury. It would be very hard to determine from reading just the
appellate cases what the standard of a particular type of care should be.
And the tort system may be overdeterring, causing beneficial services
and products to be removed from the market. The withdrawal of most
types of IUDs is one example. Dr. Hensler reports that surveys in 1983
and 1987 by the American College of Obstetricians and Gynecologists
showed a sharp increase in the percentage of clinicians who said they
were limiting their practice with regard to high-risk patients. The survey
found that some specialists also no longer provide certain obstetrical
services because of concerns about liability.
The tort liability system and the regulatory system that has been
built in this country do not always coordinate well. Many providers of
medical care and products find themselves caught between the two. For
example, FDA rules can be used as a basis for making judgments in
tort liability suits while in the same lawsuits FDA rules are not allowed
as a defense. There are controversies over these rules, and some efforts
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SCIENCE AND BABIES
toward changing them are being made. Dr. Hensler has noted, however,
that opposition to change is strong, in part because of concern for patient
and consumer safety and in part because of bureaucratic reluctance.
The chilling, unplanned-for effect of court decisions on medical care
and on the availability of safe contraceptives is an indirect cost of these
unsystematic and poorly understood changes in the tort system. Some
observers believe it is time to focus on such consequences of the system
and how they affect all who participate in the health care process.
The Increased Cost of Insurance
Consumers who are injured by a product may expect remuneration
from the manufacturer, either through the courts or directly. Those costs,
which can be extremely high, are covered by professional and product
liability insurance. Conventional liability insurance from commercial in-
surers has become either impossible to obtain or very expensive in recent
years for many products and services, particularly for contraceptives.
Large corporations in the field, such as Ortho, can afford liability insur-
ance or can set aside profits for self-insurance. But although they may
refine current products, they are deterred from developing new contra-
ceptives. Public sector organizations, such as universities and nonprofit
groups like the Population Council, which have been responsible for
much of the contraceptive development and some of the field's more in-
novative research, do not have the funds to pay for commercial insurance
or to insure themselves.
For smaller contraceptive developers, testing on human subjects has
almost stopped because the availability of insurance to cover the testing
is either not dependable from year to year or not available at all. But
the cost and availability of liability insurance may not be related to the
volume of lawsuits or to the cost of defending them. Some observers feel
that the paradox is tied instead to interest rates and profitability: Liability
claims rose at a time when interest rates on invested premiums declined,
reducing the insurer's profit margin. When interest rates were high, critics
say, insurers were interested in writing product liability insurance; when
the rates dropped, insurers compensated by canceling policies held by
contraceptive developers.
Others in the field take a different point of view, saying that liability
insurance for contraceptives is not feasible to underwrite because insur-
ance companies simply cannot assess the liability exposure of a particular
contraceptive product. Contraceptives appear to be an example of a class
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49
of mass-marketed products that have the latent capability of causing dis-
ease and injuries among some users. Such products are viewed as having
a highly uncertain but potentially enormous liability risk. Whatever the
reasons, the high cost of insurance has had a distinct negative effect on
contraceptive research and the development of new methods.
Individual states and the U.S. Congress are considering a range of
bills that would reform both the tort system and liability insurance laws.
Whether these reforms are passed and whether contraceptives will be
covered by such legislation seems unlikely in the near future.
The Funding Gap
Funding for contraceptive development by the pharmaceutical indus-
try and by governments worldwide peaked in 1972 at $74.3 million. It
dropped substantially three years later, and by 1983 spending leveled off
at just under $57 million, spread over 384 research projects involving
70 variations of potential contraceptives. That amounted to just un-
der $150,000 per project. Ortho says that bringing a new contraceptive
method from the laboratory to the market costs the company about $125
million and the process generally takes 10 years, or $1.25 million per year
for one type of contraceptive. Modifications of existing drugs require less
time and money.
The low level of funding has had several results. Most obvious is that
the focus of research has not been on the expensive process of discovering
new methods of contraception that would be either safer or more accept-
able to people for whom present methods are not an option. Instead,
efforts have concentrated on the less expensive process of modifying ex-
isting drugs. Consequently, most of the contraceptives currently available
here and abroad are based on the progestogens synthesized almost 40
years ago, including injectable steroids such as Depo-Provera, steroid-
releasing implantable capsules, and steroid-releasing vaginal rings.
Skimpy funding slows the development of new contraceptives by
limiting the number of drug combinations or formulas that can be explored
at a time. Lincoln and Kaeser state that the new Norplant implantable
capsules could have reached the market many years earlier if more money
had been available during its early years of research. Sixteen years passed
before Norplant was marketed in any country.
In the United States today there is less basic research under way
at universities and other nonprofit institutions than there has been since
the early 1970s. At $9 million for fiscal 1989, federal funding for
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contraceptive research and development is extremely low. Low levels
of private and government support tend to discourage young scientists
from entering the field, inhibiting new discoveries and the use of new
knowledge from other areas for contraceptive development.
FDA Requirements
In 1962, after the thalidomide tragedy, the FDA developed new
procedures to test the safety and efficacy of drugs. Conforming to the
new mandates lengthened the overall time required for drug development.
A later change that had a considerable effect on the development
of contraceptives was a requirement for very stringent toxicology and
carcinogenicity testing in animals for new contraceptives. For other
noncontraceptive drugs, the choice of animals, usually rats and rabbits,
was left to the investigating scientist, and the required lengths of the
repeated-dose toxicity studies used to evaluate the cumulative effects of
drugs were 2 weeks, 4 weeks, and 6 months for Phases I, II, and III,
respectively.
For contraceptive drugs, however, testing requirements were made
stiffer. The FDA insisted that toxicology testing be performed in rats,
dogs, and monkeys and that it extend for 90 days, 1 year, and 2 years for
each of the three phases. While carcinogenicity testing for other drugs
consisted of 2-year rat and 18-month mouse trials, for contraceptives
those tests had to be "lifetimes' trials of 7 years in dogs and 10 years in
monkeys.
Dr. C. Wayne Bardin, vice president of the Population Council,
observes that, "In retrospect, the toxicity testing in animals correctly
predicted that steroidal contraceptives were relatively free of risk com-
pared to other drugs." But such testing, he said, "was not successful
at predicting many of the rare but serious adverse effects of hormonal
contraceptives, such as thromboembolism and hypertension."
Not surprisingly, the very high doses used in the animal studies
produced diseases in dogs that had not been observed in humans. As a
result, many contraceptive drugs were withdrawn from development on
the basis of what in retrospect appears, Dr. Bardin says, to be spurious
observations in animals.
In early 1988 the FDA revised its requirements for testing con-
traceptive steroids to conform more closely to the guidelines espoused
by the World Health Organization (WHO). Today for the first time FDA
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requirements for testing contraceptive drugs are almost identical to the
requirements for other drugs.
In its guidelines the WHO does not recommend beagle and mon-
key studies for contraceptive drugs because available data indicate that
findings of certain cancers in these animals are not accurate predictors of
such cancers in humans.
Still time-consuming and expensive, however, is the amount of doc-
umentation needed to get FDA permission for clinical trials. The annual
reports on such studies must be written in substantially more detail than
in the past. Other countries are also requiring increasingly detailed doc-
umentation. For large companies this means the expense of thousands of
man-hours. For the smaller public sector organizations, the requirements
can be almost impossible to meet; at best, the requirements add years to
the process before a contraceptive can be made available to the public.
Pharmaceutical companies gain financial support for their research
on both successful and unsuccessful contraceptive products from the
sales of those products that do reach the market. Their profits increase
with the length of time they have exclusive rights to the product while
it is under patent. Until such exclusivity was extended somewhat in
1985, patent protection lasted 17 years. Under the original FDA approval
process, contraceptive development in the United States took a long time,
sometimes almost the entire life of the patent. With little opportunity to
recoup their costs, pharmaceutical companies have had little incentive to
develop new contraceptives. In 1988 Dr. Potts noted:
By the time manufacturers bring a new formulation to the marketplace, half
or more of the 17-year patent life may be over, so there is little commercial
incentive for expensive postmarketing surveillance. Either we need to make
premarket testing cheaper and postmarketing surveillance obligatory or we
need to find federal money to support the necessary postmarketing studies.
The clinical trials required by the FDA generally are two years long
and seldom utilize more than 2,500 women. These clinical trials and
the animal tests performed before the drugs are approved for marketing
cannot detect the infrequent but serious side effects that may appear only
after long-term use in a large number of women. The WHO has suggested
that the health of contraceptive steroid users might be better protected
if more emphasis were placed on postmarketing surveillance and less
on animal testing. Organized postmarketing surveillance programs may
prove to be more consistent and accurate in documenting any long-term
adverse effects of contraceptives.
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SCIENCE AND BABIES
sexually active women at risk of unintended pregnancy who do not use
any method of contraception.
As Mahmoud F. Fathalla of the World Health Organization put it,
there will always be a "yes" group of highly motivated people who want
to use contraception and a "no" group of those ideologically opposed
to the concept. But in between there is a large group for whom the
availability of inexpensive and convenient methods could tip the balance
toward their using contraception.
A contraceptive may be highly effective, inexpensive or free of cost,
and readily available and still not be used, because the technology is
unattractive to that particular population. The acceptability of a contra-
ceptive method depends a great deal on how it fits into the perceptions,
culture, or life-style of the prospective user.
Social scientists have observed that modern contraceptives have cer-
tain inherent attributes, such as the sex of the user, the relationship to
coitus, the need to handle the genitalia, or the need for repeated appli-
cations. Susan C.M. Scrimshaw of the University of California at Los
Angeles School of Public Health explains that each of these inherent
attributes elicits different responses in different cultures. For example,
cultures in which women are not allowed to cook for their families during
episodes of vaginal bleeding (as in India) are less accepting of the IUD,
which is associated with increased bleeding. Dr. Scrimshaw found that
women in Spanish Harlem prefer sterilization as a birth control method
because they had to confess that to their priest only once. Some men and
women will not use diaphragms, condoms. or cervical cans because they
dislike handling their genitals.
~-r ~ --A
In addition to the inherent attributes, a set of"perceived" attributes
tend to grow around each contraceptive method. Dr. Scrimshaw says:
While these attributes, such as the notion in Ecuador that the birth control pill
"eats the red blood cells," are not true, they nevertheless affect acceptability.
If people believe them, they are likely to reject the method just as they
would for a culturally or individually undesirable inherent attribute.
It is also possible to have culturally acceptable methods and to
deliver them in such a way that they are used only minimally. Research
has shown that factors such as the type of clinic, its location and hours,
the attitudes or other characteristics of the staff, the tone of staff-to-
patient interaction, and communication with the community all may have
an impact on the acceptability of a program. The cost of a contraceptive
method also is a major factor in its acceptability. Cultural customs also
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can play an important role. Six months after birth control pills were
supplied directly to women in Iran, only 12 precept of the women were
still taking them. When the pills were distributed to the husbands to give
to their wives, 90 percent of the women continued to take them after six
months.
To make contraceptive methods attractive and acceptable to varied
ethnic groups, it is sensible to fit the technology to the people, rather than
the people to the technology. Although additional basic research is needed
to develop more contraceptives, those in existence could be utilized more
fully if they were made acceptable to more populations. Dr. Scrimshaw
believes acceptability can be enhanced by utilizing information from the
behavioral and social sciences:
It is difficult to measure behavior accurately and consistently and even more
difficult to predict it. But when new technologies and programs are launched
without any such measurements, not only can costly errors occur, but it may
be years before it is even clear the programs aren't working.
It is important to note that not all contraceptives are distributed via
clinics. Many are successfully marketed to the general public by being
sold over the counter in pharmacies and other retail outlets, including
the smallest village shops. In some countries oral contraceptives are
vigorously advertised; in many communities they are widely available
without a prescription. In some areas the pill is available from village
women who have been trained to screen prospective users for contraindi-
cations. Subsidizing the price of contraceptives also has made them more
acceptable and cost-effective.
No single method can meet the needs of one woman or one couple,
much less the needs of an entire population, particularly in a heteroge-
neous country such as the United States. For contraceptives to be used
effectively, a "contraceptive supermarket" is necessary, Dr. Djerassi says,
"from which people can pick and choose, because there is no such thing
as an ideal contraceptive" for all populations.
HINDERING CONTRACEPTIVE USE
Why does the United States differ so markedly from other industrial-
ized countries in behaviors associated with reproductive health? Thirteen
percent of sexually active unmarried women of childbearing age in this
country do not practice birth control. Why is this so? In its study of unin-
tended pregnancy, contraceptive practice, and family planning services in
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SCIENCE AND BABIES
20 industrialized nations, researchers from the Alan Guttmacher Institute
noted these contrasts between the United States and similar countries:
· In other countries contraceptive care is integrated into primary
health services and is available at locations that are many, familiar, and
convenient. This is not true in the United States.
· In many countries where the use of effective methods is high
and pregnancy and abortion rates are low, contraceptive care is delivered
chiefly by family physicians rather than by specialists. The family physi-
cians are especially likely to prescribe oral contraceptives. In the United
States obstetricians and gynecologists provide most contraceptive care.
· Family planning clinics in other countries are designed to serve
mostly first-time contraceptive users and other groups who may require
special counseling. They frequently offer evening or weekend hours,
female personnel, and a variety of contraceptive choices. In contrast,
U.S. clinics are meant to provide free or low-cost services to people too
poor to obtain contraceptive care from private physicians. In the United
States the choice of a caregiver is determined by the patient's financial
state; in other countries the determinant is the patient's needs.
· The choice of contraceptives in the United States is narrower
than in other countries. A number of improved or entirely new methods.
including injectable contraceptives and lower-dose formulations of the
pill, are not available.
In most of the countries studied, but not in the United States,
contraceptives are free or inexpensive.
· Information about contraception and sexuality is widely dissem-
inated in some other countries through advertising, publicity, education,
or the distribution of literature from pharmacists. In countries where the
condom is widely advertised, for example, it tends to be more widely
used.
Two other major barriers hinder U.S. women from using contracep-
tives. One is the widespread absence of information, especially among
the young and not well educated, about the dangers of getting preg-
nant and about contraception. The other is the negative attitude held
by a sizable proportion of women toward the most effective contracep-
tive methods. Furthermore, in other nations contraceptive information
and advertising are disseminated through the media, including national
television. Although the conventional thinking in the United States is
that most Americans do not want sex education in the schools and do
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not want to have contraceptives advertised on national television, recent
nationwide opinion polls show the reverse to be true. A 1985 Gallup poll
found that three-fourths of Americans want sex education to be taught
and that they thought it should be done before high school.
A 1987 survey by the Louis Harris organization found that most
Americans have no religious or moral objections to family planning. Six
out of 10 questioned approved of advertising contraceptives on television.
Seventy-two percent, including 73 percent of Catholics and 60 percent of
Evangelicals, said contraceptive advertising would not offend people like
themselves. The Harris poll also reported that 76 percent of Americans
thought "if young people saw that TV stars they admire use birth control,"
they would be more likely to use it themselves. A smaller survey of
800 adults conducted about the same time by NBC and the Wall Street
Journal found that 79 percent of respondents approved of contraceptive
ac vert~s~ng.
Favorable attitudes are a prerequisite for the use of birth control.
Better dissemination of information would help eliminate the barrier
to contraceptive use caused by negative attitudes toward the pill and the
IUD, according to the Gallup poll and a 1987 Guttmacher study of women
at risk for unintended pregnancy. Those surveys found that women avoid
using the pill and IUD, the most effective methods, because they fear
potential health risks. Women also underestimate the efficacy of these
methods.
Their concern is understandable. In recent years there have been
many news articles about the lawsuits over damage caused by the Dalkon
Shield IUD. Most cases of pelvic inflammatory disease (PID) associated
with the IUD are related to exposure to sexually transmitted diseases. In
addition, insertion of an IUD may introduce bacteria into the genital area,
which is why so many of the infections appear early. Because PID can
lead to infertility, IUD use today is limited to women who already have
at least one child and are in a mutually monogamous, stable relationship.
A 35-member American Medical Association Diagnostic and Ther-
apeutic Technology Assessment panel recently pronounced the Proges-
tasert and the ParaGard the two {UDs available in the United States-
safe and effective when users are carefully selected. The opinion of the
panel is important because an IUD fills an important niche in birth con-
trol: It offers effective contraception for the mature woman for whom
oral contraceptives may no longer be ideal.
Studies of oral contraceptive use show that the pill is much safer than
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SCIENCE AND BABIES
U.S. women believe. The mortality risk has dropped with the increased
use of modern-day pills and the discouragement of pill use among women
over age 35 who smoke. As Malcolm Potts says, "If analysis of the health
impact of oral contraceptive use is limited to cardiovascular risks and to
the prevention of ovarian and uterine cancer, the good and bad effects-
virtually cancel each other out."
It is certain that the pill has no important adverse or beneficial effects
on breast cancer. However, more information is needed about the pill's
relationship with that very small but tragic group of women who develop
breast cancer before age 45. Several recent, small epidemiological studies
suggest a link between pill use at an early age (before age 20 or the
first pregnancy) and early breast cancer. Because of inconsistencies
among these studies, the FDA believes the new evidence is not clear cut
enough to warrant changing the prescribing rules for oral contraceptives.
Nevertheless, the possible association between the pill and breast cancer
in young women is an important concern, and a broad investigation is
under way at the Institute of Medicine.
Regular and accurate updates on the safety and efficacy of contracep-
tives are important in keeping women apprised of contraceptive facts. A
flow of accurate information will help women of all ages and educational
backgrounds find a contraceptive that is right for them.
CONCLUSION
Contraceptives are not new, yet their development and use in the
United States are impeded by substantial obstacles. Contraceptive de-
velopment is markedly hindered by a lack of funds, the proliferation of
lawsuits, exorbitant jury awards, and an absence of liability insurance for
contraceptive manufacturers. Many men and women in this country are
badly informed about birth control and about the true effectiveness and
health risks of the methods that are available. Half the pregnancies in
this country are unintended, and the United States has one of the highest
rates of abortion and teenage pregnancy among industrialized countries.
Better contraception is needed in the United States and
throughout the world to broaden the choice of effective approaches
so that men and women of diverse ethnic backgrounds can find con-
traceptives with which they are comfortable. The experience of other
nations suggests that to reduce the number of unintended pregnancies
and abortions in this country, particularly among teenagers, we must
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CONTRACEPTION
63
make contraceptives more easily available and we must be more vigor-
ous in our dissemination of information about birth control and family
planning.
Birth Control Methods Available in the United States
Today and Their Effectiveness
Sterilization for men and women is the leading method of contracep-
tion in the United States; it is safe and 100 percent effective. In general,
it is not reversible, although sophisticated new sterilization methods are
being developed that may make it possible to reverse the procedure in
some cases.
Birth control pills are 95 to 99 percent effective and need less plan-
ning than other substantially effective methods such as the diaphragm
and condom. They do not require any handling of the genitals nor do
they interrupt foreplay. Modern-day pills that combine low doses of es-
trogens and progestogen have fewer adverse effects on the cardiovascular
system than the pills of 30 years ago. A mini-pil1 with no estrogen is
available for women who are breastfeeding or over age 35 and smoke.
The combination pill is not recommended for lactating women. Although
oral contraceptives may have undesirable side effects for some individ-
uals, they protect against cancers of the ovaries and uterus and against
excessive menstrual bleeding.
Intrauterine devices are 98 to 99 percent effective. Of the two types
currently available, the copper-releasing Paragard needs to be changed ev-
ery 4 years, the progestogen-releasing Progestasert once a year. Because
IUDs have been associated with an increased risk of pelvic inflammatory
disease, which can cause infertility, the makers of IUDs recommend that
they be used only by women who have had at least one child and are in
a stable, mutually monogamous relationship. After an IUD is inserted by
a trained health care provider, it requires only an occasional check by the
wearer to ensure that it is still in place.
The condom is growing in popularity because it is readily available
and offers good protection against sexually transmitted diseases, particu-
larly those brands coated with a spermicide. Spermicide creams or foams
can be added to the inside and outside of a condom for extra protection.
The failure rate ranges from 3 to 15 percent, with failure often ascribed
to careless use. Because condoms can leak or break, experts recommend
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SCIENCE AND BABIES
that the female partner use a spermicide foam as extra protection. Con-
doms have no adverse side effects, although the spermicide coating may
cause an allergic reaction in some men and women.
The diaphragm produces few side effects; it can cause urinary tract
infections, and some women may be allergic to the spermicidal cream
or jelly that must be used with it. Its failure rates range from 2 to
20 percent, with most failures arising from improper or inconsistent
use. If used consistently, however, experts believe the diaphragm is
highly effective. In addition, it offers some protection against sexually
transmitted diseases. The diaphragm must be fitted by a health care
provider, and the fit must be checked by a health professional every few
years or after childbearing or a substantial weight chance.
Norplant, a contraceptive implant, steadily diffuses a low dose of
the progestin levonorgestrel directly into the bloodstream. Norplant is
more effective than oral contraceptives and is free of estrogen. It can
cause menstrual irregulatory, but thus far has produced no serious side
effects. Norplant capsules are surgically inserted under the skin of the
arm by a trained health care provider and protect against pregnancy for
5 years. The capsules should be removed at the end of that time because
they become less effective. They can be removed earlier if desired. The
United States will be the thirteenth country to approve Norplant for use;
the method is in clinical trials in some four dozen other countries.
Sponges, foams, creams, jellies, and vaginal suppositories are easier
to obtain because they can be bought in a drugstore and are easy to
use. They do have a failure rate of 3 to 21 percent. Researchers do
not know if this relatively high failure rate is due to inconsistent use or
to inadequacies inherent in the methods. These vaginal methods protect
against pregnancy by inactivating the sperm. To be effective, the sponge
must be kept in place for at least 6 hours after intercourse. To avoid
possible side effects, it should be removed after 24 hours. Because the
_z~_ me, .
same active ingredient, nonoxynol-9, is used in all of these products, if a
woman is allergic to one product, she cannot use any of them.
The cervical cap resembles a small diaphragm. It is filled with a
spermicidal foam or jelly and placed over the cervix. As effective as a
diaphragm, it has an added advantage in that it can be inserted several
days before intercourse and can be left in longer afterward. If left in
place too long, the cervical cap begins to have an odor. Some users report
that the cap, which is smaller than a diaphragm, allows more sexual
pleasure; it also may be a better choice for women with recurring urinary
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CONTRACEPTION
65
tract infections. Accurate placement requires practice. Since receiving
EDA approval in 1988, cervical caps have been manufactured in the
United States; they are available chiefly in large population centers, often
through women's health groups.
Birth Control Methods on the Horizon for the United States
A number of fertility-regulating methods may be available in the
United States in the next 10 to 15 years if sufficient funding is made
available. When funding is in short supply, research efforts must be cut
back. As a result, development can be stretched out over many more
years, delaying the availability of new methods.
Two types of vaginal rings that release steroids into the bloodstream
via the vaginal epithelium are being studied by the Population Council and
the World Health Organization. One releases a combination of estrogen
and progestogen and is worn for 3 weeks; the other, which releases the
progestogen levonorgestrel, is worn continuously for 3 months and is
designed for women who are breastfeeding. The rings are self-inserted.
Although they can cause irregular bleeding, they have fewer side effects
than the pill. Their effectiveness appears to be high, but studies are not
yet complete.
Biodegradable pellets of norethindrone or levonorgestrel, implanted
just under the skin, are effective for 12 to 24 months. They appear to be
highly effective and are now undergoing clinical trials.
A female condom is being developed. Like the male condom, it
would protect against sexually transmitted diseases, would be readily
available, and has no apparent side effects. Used with a lubricant, it is
inserted by the woman.
Transdlermal delivery of hormones is a method that releases con-
traceptive steroids slowly into the circulatory system through the skin
via a patch worn on the body. In the system currently being studied in
the United States, a new skin patch is applied each week for 3 weeks,
followed by a week without a patch to allow menstruation to occur.
Birth Control Methods Not Available in the United States
Injectable contraceptives Depo-Provera and Norigest appear to
be highly effective and are convenient. Currently, both injectables are
available in the United States for menstrual problems and endometriosis
but not for birth control. Depending on the dosage, the slow-release
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SCIENCE AND BABIES
injection into a muscle can be given every 3 or 6 months. The larger,
longer-lasting dose may produce more side effects, such as headaches,
weight gain, depression, and irregular bleeding. Injections of progestogen
alone can cause irregular menstrual bleeding, but another formulation
that adds estrogen appears to produce regular bleeding patterns in most
women. Widely used in many countries, injectables are still being studied
for contraceptive use in the United States.
The CuFix 390 intrauterine device is a string of hanging copper
rings, a design that lessens the chance of pain, bleeding, and expulsion
that is sometimes associated with IUDs. It has perfo~-~ed well in early
trials in other countries, but because of the product liability climate in the
United States, its manufacturers might not seek marketing approval here.
Abortifacients and menstrual inducers fill a major need in current
birth control technology because they can be used a few days or weeks
after unprotected intercourse to induce menstruation. The most studied
is the antiprogestin, mifepr~stone, known as RU 486, which is available
in France and China. A dose of 600 milligrams of mifepr~stone followed
by 1 to 10 milligrams of prostaglandin brings on menstruation in over 95
percent of the women who use it. The use of RU 486 requires medical
supervision. Although any attempt to market this drug in the United
States is expected to lead to protests from antiabortion segments, the
laws of many countries permit "menstrual therapy" even when surgically
induced abortion is not allowed. Although new methods of postcoital
contraception will certainly be opposed by some members of society,
in many parts of the world an inexpensive self-administered menstrual
inducer is expected to receive broad acceptance.
ACKNOWI,EDGMENTS
Chapter 3 was based in part on presentations by Carl Djerassi,
Deborah Hensler, Malcom Potts, and Susan Scrimshaw.
REFERENCES
American College of Obstetricians and Gynecologists. 1985. Gallup poll shows what
public knows and thinks about birth control. Press release, March 6. Washington,
D.C.
Atkinson, L.E., R. Lincoln, and J.D. Forrest. 1985. Worldwide trends in funding for
contraceptive research and evaluation. Family Planning Perspectives. 17~51:196-
207.
OCR for page 67
CONTRACEPTION
67
Atkinson, L.E., R. Lincoln, and J.D. Forrest. 1986. The next contraceptive revolution.
Family Planning Perspectives. 18(1): 19-26.
Bardin, C.W. 1987. Public sector contraceptive development: history, problems, and
prospects for the future. Technology in Society. 9:289-305.
Cushner, I.M. 1986. Reproductive technologies: new choices, new hopes, new
dilemmas. Family Planning Perspectives. 1 8(3 ): 1 29- 1 3 2.
Diagnostic and Therapeutic Technology Assessment panel. 1989. Questions and
answers: intrauterine devices. Journal of the American Medical Association.
261(14):2127-2130.
Djerassi, C. 1987. Contraception in the year 2001. In Contraception in the Year 2001,
edited by P.A. van Keep, K.E. Davis, and D. de Weld. Amsterdam: Elsevier
Science Publishers.
Djerassi, C. 1989. The bitter pill. Science. 245 :356-361.
Ehrlich, P.R. 1968. The Population Bomb. New York: Ballantine Books, Inc.
Family Health International. 1987. Women's perceptions of the safety of the pill: a
survey in eight developing countries. Co-ordinator: Gary S. Grubb. Journal of
Biosocial Sciences. 19:313-321.
Fathalla, M.F. 1988. New contraceptive methods and reproductive health. In Pro-
ceedings of the Conference on Demographic and Programmatic Consequences of
Contraceptive Innovations, edited by S. Segal, A. Tsui, and S. Rogers. New York:
Plenum Press.
Forrest, J.D. 1986. The end of IUD marketing in the United States: what does it mean
for American women? Family Planning Perspectives. 18(2):52-55.
Forrest, J.D. 1987. Unintended pregnancy among American women. Family Planning
Perspectives. 19(2~:76-77.
Forrest, J.D. 1988. U.S. women's contraceptive attitudes and practice: how have they
changed in the 1980s? Family Planning Perspectives. 20~3):112-118.
Forrest, J.D., and S.K. Henshaw. 1988. Effects of new contraceptive methods on abortion
utilization. In Proceedings of the Conference on Demographic and Programmatic
Consequences of Contraceptive Innovations, edited by S. Segal, A. Tsui, and S.
Rogers. New York: Plenum Press.
Grimes, D.A. 1986. Reversible contraception for the 1980s. Journal of the American
Medical Association. 255(19:69-74.
Alan Guttmacher Institute. 1985. Risk of developing primary infertility is at least
twice as high for IUD users as for never-users. Family Planning Perspectives.
17(4):182-183.
Alan Guttmacher Institute. 1987. Poll says most people accept family planning, approve
of condom ads. Family Planning Perspectives. 19(2~:79.
Hatcher, R.A., D. Kowal, F. Guest, et al. 1989. Contraceptive Technology: Interna-
tional Edition. Atlanta: Printed Matter, Inc.
Henshaw, S.K. 1987. Characteristics of U.S. woman having abortions, 1982-1983.
Family Planning Perspectives. 19(1):5-9.
Henshaw, S.K. 1988. The characteristics and prior contraceptive use of U.S. abortion
patients. Family Planning Perspectives. 20(4): 158-168.
Jones, E.F., J.D. Forrest, S.K. Henshaw, J. Silverman, and A. Torres. 1988. Unintended
pregnancy, contraceptive practice and family planning services in developed
countries. Family Planning Perspectives. 20(2):53-67.
OCR for page 68
68
SCIENCE AND BABIES
Kolata, G. 1989. For those concerned with pill risk, a look at the choices. N.Y. Times.
January 12, B-10.
Lincoln, R., and L. Kaeser. 1988. Whatever happened to the contraceptive revolution?
Family Planning Perspectives. 20(1):20-24.
Mosher, W.D., and C.A. Bachrach. 1987. First premarital contraceptive use: United
States, 1960-82. Studies in Family Planning. 18(2):83-95.
PATH and PIACT. 1987. FDA may follow WHO guidelines for contraceptive steroid
testing. Outlook. December, 9-10.
PATH and PIACT. 1988. FDA confirms new requirements for steroid testing. Outlook.
March, 10.
PATH and PIACT. 1988. More contraceptive choices likely by end of century. Outlook.
6(41:2-8.
Population Crisis Committee. 1985. Issues in contraceptive development. Population
No. 15 May. Washington, D.C.
Potts, M. 1988. Birth control methods in the United States. Family Planning Perspec-
tives. 20(6):288-297.
Rosoff, J.I. 1988. Not just teenagers. Family Planning Perspectives. 20(2):52-67.
Silverman, J., A. Torres, and J.D. Forrest. 1987. Barriers to contraceptive services.
Family Planning Perspectives. 19(3):94-102.
Special Programme of Research, Development, and Research Training in Human
Reproduction. 1987. Guidelines for the Toxicological and Clinical Assessment
and Postregistration Surveillance of Steroidal Contraceptive Drugs. Geneva:
World Health Organization.
Skuy, P. 1976. A history of contraception: how far have we really come? Canadian
Pharmaceutical Journal. 109(11):3/335-5/337.
Toufexis, A. 1989. Too many mouths. Time. January 2, 48-50.
Representative terms from entire chapter:
family planning
