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9
Contraceptive Development:
Obstacles and Opportunities
THE NEED FOR NEW METHODS
Additional contraceptive methods that are safe, effective, and acceptable within
the cultural, social, religious, and ethical frameworks of individuals and societies
would have a significant positive effect on human well-being. Unlike most other
products whose development is regulated by the actions of the marketplace, the
development of new contraceptives is influenced by often conflicting and
uncoordinated public policies. The impact of these policies, together with other
aspects of contraceptive products, such as the complexity of evaluating their risks
and benefits and the importance of the social benefits of contraceptive use, has
restricted the number of methods currently available and has slowed the
development of new methods.
Contraceptive decisions, including the decision not to use contraceptives, must
be faced by the vast majority of people of reproductive age. Choices are influenced
by a variety of factors, including one's cultural background, socioeconomic
status, personal aspirations, health status, and intensely felt individual values.
The number and characteristics of available contraceptive methods also influence
these decisions and the ability of men and women to regulate fertility in a way that
is consistent with their values, economic circumstances, and life-styles. The
increasing number of younger men and women in the United States who opt for
surgical sterilization as a method of family planning, the high prevalence of
abortions, and the very high rate of teenage pregnancy all point to the potential
advantages that additional contraceptive methods might yield. More difficult to
quantify but equally important reasons to develop new methods are the
147
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)48 DEVELOPING NEW CO=~CE~~ES
shortcomings of existing products, including method characteristics related to
health risks, effectiveness, and convenience as well as to other user preferences.
In short, the health, personal, or economic circumstances of many people mean
that they are not well served by existing methods. Noteworthy in this regard are
teenagers, women over 35 who smoke, breastfeeding women, and women who
have contraindications to the use of most available methods. Often these women
are at higher risk during pregnancy and therefore in special need of better
contraceptive protection.
Contraceptive use in other societies is also affected by the situation in the
United States. Although the methods that would function best in the different
circumstances of each developing country vary widely, a broader spectrum of
contraceptive methods would have beneficial effects on the fertility, health, and
the well-being of people throughout the developing world. Limited contraceptive
options have a greater negative impact in developing countries than in the United
States because the health risks of pregnancy and childbirth are higher and the
social benefits of contraceptive use can be much greater there than in the United
States.
The United States has exercised leadership and made significant technological
advances in numerous health and development-related areas, but in recent years
the field of contraceptive development has not been among them. During the past
two decades, scientific and clinical research related to new contraceptive methods
has slowed in the United States. Some newer methods or significant improvements
in existing methods are now available in Europe, and even in some developing
countries, but not in the United States.
Although the distribution of methods, education about their use, and the
willingness of couples to use them are all important, the committee concludes that
there is a significant need for new methods in the United States, particularly given
the mounting public concern over the long-term risks associated with oral
contraceptives that have received widespread adverse publicity.
New contraceptive methods cannot tee developed in a short time. Development
is initiated as advances in understanding of basic reproductive biology are
transferred to the clinical arena for testing. The process from that point on is long,
arduous, and expensive. Since the introduction almost three decades ago of the
pill and the IUD, no fundamentally new contraceptive method has been introduced
in the United States. Although the pill and the IUD have been modified to
increase their safer and effectiveness, they still are not suitable for use by all
couples in all circumstances.
RESEARCH LEADS
New contraceptive methods could become available if greater support for their
development existed. Among the promising leads and possibilities are a
contraceptive vaccine, long-acting implantable steroids, reversible male and female
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OBSTACi FS AND OPPORTUNITIES 149
sterilization, new spermicidal agents with antiviral properties, a once-a-month pill
acting as a menses inducer, new ovulation prediction and self-detection methods,
and methods interfering with spermatogenesis in the male.
VALUES
The contraceptive choices available to American couples are determined not
only by the yield of basic research or the profit margins of pharmaceutical
companies, but also by the values people hold, which influence the pace of
contraceptive development in this country. Although it is difficult to trace and
impossible to measure precisely, our heritage has influenced the attitudes of the
nation's scientists, executives, politicians, and the public. The net impact of our
values has probably been to slow development efforts and reduce the amount of
public support for contraceptive research. There is a pervasive sense among
women that not enough attention is paid to the desires and needs of current and
potential future users. Some minority group members worry about the potential
abuses that promoting contraceptive development may encourage. Whatever the
reasons, the nation offers far more support for research to alleviate specific
illnesses than to prevent the burdens and trauma of unwanted pregnancy and its
medical, psychological, and social consequences.
Most sexually active people in the United States have some experience with
contraceptive use and therefore some interest in methods that are safer, more
convenient and, overall, more to their liking. To a large extent the problems and
prospects of contraceptive development are increasingly discussed by people with
strongly held but often poorly informed points of view. If public discussion could
be broadened and if potential users felt that their concerns were being addressed
in the development process, it is likely that support for development would
increase substantially.
ORGANIZATIONS AND RESOURCES
Only one large U.S. pharmaceutical company currently maintains a significant
contraceptive research program, and only three European firms support such
research. As a consequence, the responsibility for contraceptive development has
shifted to the government, nonprofit research organizations, and small fines. This
change in organizational structure has contributed to the slowing of the development
of new contraceptives. As they have become more active in the contraceptive
development process, these organizations have encountered a number of problems,
including those related to funding constraints, the limitations of technology, and a
lack of experienced personnel.
Nonprofit organizations have begun to play a much more significant role in all
aspects of contraceptive development, but these groups face a variety of obstacles
that slow their progress significantly. Increased research costs, greater demand
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150 DEVELOPING NEW CO=RACE~IVES
for highly skilled professional staff, and the need for better research facilities
require long-term financial commitment of a type that nonprofit organizations
cannot easily obtain. It is difficult to plan an effective research program aimed at
the development of new contraceptives if support for research cannot be guaranteed
for more than two or three years at a time. To the extent consistent with the
appropriations process, the federal government, which already provides a majority
of the funding for these nonprofit groups, should increase funding and adopt
arrangements that provide stability for priority research projects.
The committee believes that one of the principal impediments to progress in
contraceptive development is the lack of a pool of basic and clinical investigators
who are seriously engaged in development efforts. There is a particular need to
attract more women and members of minority groups to the field.
Federal funds for training have fluctuated dramatically from year to year and
have been severely reduced in recent years. This has led to the perception among
young scientists that future work in the field is not secure, a perception that
lessens the attractiveness of research in this important area. All but a handful of
private foundations do not include basic reproductive research and contraceptive
development from their programs. Given the value of new methods and the clear
opportunities for research, the committee recommends that efforts be made to
increase private-sector support for research on reproductive biology and for
contraceptive development. The perception of many is that contraceptive failure
and unwanted pregnancy are not significant problems in the United States and
abroad this view needs to be changed. Contraceptives are among the most
widely used drugs and devices in the United States and the contraceptive alternatives
available to women and men can be substantially improved and expanded.
Since the mid-1970s, federal funding for research in reproductive biology has
increased only modestly, and there has been a decrease in the relative funding of
applied contraceptive development. Private foundation support for basic research
in the reproductive sciences has declined dramatically and steadily since the early
1970s.
Most analysts do not give enough attention to the limitations imposed by the
existing base of scientific knowledge on technological innovations. When we
understand more about the reproductive process, we may find that fundamentally
new approaches of fertility control may arise. The length of time required for
development, however, will not necessarily be any shorter. Since basic research
represents the underpinning of any future development, support for such research
must keep pace with the rising cost of research and development in the United
States. The product introduction phase of contraceptive development, which in
the past has been substantially neglected, also merits greater attention and increased
funding.
REGULATION
The Food and Drug Administration has recently modified He process of
approval for contraceptive drugs. FDA regulations for the toxicological and
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OBSTACLES AND OPPORTUNITIES 151
clinical testing of contraceptive steroids have been simplified and the requirements
brought into much closer conformity with the guidelines of the World Health
Organization and those of other industrialized nations.
The establishment of a worldwide consensus on the appropriateness of
regulations governing contraceptives might promote further development. Efforts
in this direction could be encouraged by an international conference on the
regulation of contraceptive development, from which might come a consensus
report for consideration by the FDA and the regulatory bodies of other nations.
Although local conditions can and should affect regulatory decisions, the basis for
such decisions might be clarified and the quality and benefits of these decisions
might be improved through more international interaction.
Present FDA standards assume that contraceptives are used overwhelmingly
by healthy people, for whom their use will not interfere with health. In fact, a
large number of would-be users have conditions that make them poor candidates
for existing contraceptive methods. The adverse consequences of pill use for
women with hypertension are one example; the risks and benefits of oral
contraceptives for that group are very different from those for other women.
Furthermore, the risks of pregnancy, labor, and delivery vary among individuals
and populations and are, in most instances, greater than the risks posed by
currently available methods of contraception. In addition, some methods have
noncontraceptive health benefits; increased attention should be given to such
factors as new contraceptive methods are evaluated. However, some contraceptive-
related risks are inevitable or unforeseeable. Therefore, greater postmarketing
surveillance and long-term epidemiological studies of contraceptives should be
undertaken.
The committee supports the rigorous review and approval process provided by
the Food and Drug Administration, which adds to the safety of contraceptive
practice and public confidence in contraceptive products. The committee believes
its recommendations would increase the effective use of contraception in the
United States by enabling FDA to approve methods that would allow both users
and providers of contraceptives to tailor specific methods more closely to the
health conditions and family planning needs of each individual.
LIABILITY
The most frequently cited barrier to the greater availability and faster
development of contraceptives is referred to as the liability crisis. The available
evidence suggests, however, that the impact of products liability should be evaluated
in conjunction with other factors that influence contraceptive development and
use. It is important to keep in mind that companies' decisions about what
products to market and what research to support are based on a projection of
potential profits. Companies stop or do not begin research and development
activities, not because of liability per se, but because the potential risk of liability
and the costs of protecting against it are not balanced by a sufficiently greater
profit potential.
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152 DEVELOPING NEW CO~RACE"IVES
Wornes about liability claims relating to contraceptives appear to be particularly
important to the major U.S. pharmaceutical companies, as evidenced by their
withdrawal from the market of several FDA-approved IUDs. The expense of
litigation must be considered within the framework of the rather modest profit
margin generated by a contraceptive method, such as the IUD, that does not
require repeat purchases. Within this context, it would seem that the private
sector has little incentive to develop a product that by modern contraceptive
standards would be considered ideal-one that is relatively inexpensive and used
only as needed or over a long period without requiring frequent replacement.
The committee concludes that recent products liability litigation and the impact
of that litigation on the availability of liability insurance have contributed
significantly to a climate of disincentives for the development of new contraceptive
products. The committee recommends that certain changes be made in products
liability rules to remove some of the negative consequences for contraceptive
development without compromising the safety of contraceptive use. Specifically,
the committee recommends that Congress enact a products liability statute that
establishes uniform standards for products liability lawsuits involving
contraceptives and that gives manufacturers of an FDA-reviewed contraceptive
product a defense based on FDA's acceptance of that product.
The operation of the legal system in the United States makes it very difficult to
forecast precisely the extent to which enactment of the proposed statute would
change the perception of liability risk. Although the committee believes that the
statute is an important first step, we recognize that it will take several years before
its impact can be completely evaluated, and that modifications may be needed.
A FINAL WORD
Our examination of policy issues related to the development of new
contraceptives demonstrates that no single factor determines the mix of
contraceptive methods available to couples or the speed with which new products
are brought to market. While such a conclusion will seem to many readers too
obvious to require stating, in our review we found numerous instances of otherwise
thoughtful and careful people claiming one or another factor was the sole reason
that new contraceptives were not being developed.
Since the first major breakthrough in research on the oral contraceptive in the
1950s, the number of people practicing contraception worldwide has more than
tripled to about a half billion in 1988. Because of a rapidly increasing population
in the reproductive ages and a tremendous growth in contraceptive practice,
concern about side effects and the effectiveness of existing methods and a demand
for safer, more effective, convenient, and affordable contraceptives has never
been greater. The importance of these issues both in He United States and in
other countries is likely to increase even more in the decades to come.
Although not the focus of this report, attention to the factors that would
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OBSTACLES AND OPPORTUNITIES ~53
promote contraceptive use among individuals not seeking to become pregnant is
also important. New birth control methods-even safer and more effective
ones-are of little benefit if they are not accessible, if they are not used, or if they
are used improperly. Motivation to control fertility and the ability to use various
methods effectively come not only from contraceptive research and development
but also from better distribution systems, better education, including education
about human sexuality and reproduction, and more open communication about
sex and birth control.
Finally, we have not compared contraceptive development to other worthy
causes and therefore do not conclude that having a wider variety of contraceptives
outweighs all other social goods. However, the committee believes that developing
a wider array of safe and effective contraceptives is highly desirable, valuable,
and for the social good. In the committee's judgment, increasing funding and
other resources devoted to contraceptive development will have an important
positive effect, even though the precise scientific and technological breakthroughs
cannot be predicted with certainty.
We should move to develop better contraceptives and to work to ensure more
appropriate patterns of contraceptive use. New methods can change peoples'
motivation to practice contraception. Unless steps are taken now to change public
policy related to contraceptive development, contraceptive choice in the next
century will not be appreciably different from what it is today.
The continuation of contraceptive research and development by U.S. companies
and research institutions is important to the health and well-being of people in the
United States and around the world. Encouragement and financial support for
American research organizations to initiate, resume, or expand their contraceptive
development efforts, as well as reevaluation of and changes in the FDA's
mechanisms of assessment of the risks and benefits of contraceptives, and changes
in products liability rules will speed the development and introduction of safer,
more effective, and more acceptable new contraceptives for the twenty-first
century.
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Representative terms from entire chapter:
contraceptive methods
