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Industrial
Strength Marketing: A
Selection From “Contraceptive Research and Development: Looking to the
Future (1996),” pp. 34-37. |
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‘In a MOLT minute’ ~ Dr. Coutinho did not write “Is Menstruation Obsolete?” in a vacuum. What else was going on in the field of contraceptive research at the time? |
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Hey - Know a
journalist reporting on women’s health? This book makes a great gift for them
– and you can help improve the quality of women’s health reporting at the
same time! All for the low price of $37.50 for the PDF version. On an even
tighter budget -- PDF chapters can be had for $4.80 each. What a bargain! Note
to journalists: In reading the following selection, pay attention to the
dates: Could be a story in there, as to the overall contraceptive R&D
environment in which Dr. Coutinho A) Came up with the idea for his book, and
B) Wrote it. Just be sure if you interview Dr. Coutinho, tell him “MOLT sent
ya!” |
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hasslefreeclipart.com |
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THE NEED FOR A SECOND CONTRACEPTIVE
REVOLUTION
By the late 1980s, many of the
factors that had been driving the research agenda of the 1970s and 1980s had
changed drastically. The mission's clarity had become blurred by
the debate about whether it was population growth, or inequitable access to
economic and social opportunity, that was the world's major problem. There was
also the widespread misconception that, with oral contraceptives, the
"problem" had been solved. From the standpoint of the science, the
promise of reproductive endocrinology was diminishing, funding opportunities
were decreased, and new scientists were not being attracted by the field. And,
largely for legal, political, sociocultural, and ultimately economic reasons,
there was relentless retrenchment from the field of contraceptive research by
most major pharmaceutical companies. In the 1960s, a dozen large
pharmaceutical companies had been active in contraceptive research and
development; nine of those were in the United States. By the mid-1980s,
just four such firms continued to have significant contraceptive research and
development programs; three were in Europe, just one in the United States.6
Had it not been for public sector commitment during these years, the field
might well have fallen into utter scientific oblivion (NRC/IOM 1990;
Rockefeller Foundation 1993).
The net effect of this
stalling of the first revolution was that there has been no real scientific
breakthrough in contraceptive technology, for either men or women, in over
three decades. The sole exception has been the antiprogestins, arguably the
greatest breakthrough in fertility regulation technology since the discovery of
oral contraceptives (Brown 1995; IOM 1993b). Modification of hormonal
contraceptive delivery through injectable and implant technologies and dramatic
improvement in intrauterine devices (IUDs) were significant developments, but
they were not significant breakthroughs from the perspective of fundamental
science. Because development of new contraceptive technologies typically takes
10 to 20 years, contraceptive products that are now emerging from the pipeline
tend to fit the earlier demographically driven paradigm and respond only in a
limited way to newer thinking (Brown 1995). Although recent surveys of
contraceptive research and development indicate that there are close to 100
product leads being pursued around the world, most are incremental
improvements—modifications in dosage, form, or delivery—and all but one are
hormonally based (PATH 1993). Such improvements have been important and
necessary but the argument might be made that, absent any shared, coherent set
of priorities, large gaps will persist in contraceptive research and
development. At best, contraceptive needs will be filled erratically and
slowly, impairing wise and effective allocation of resources under conditions
of increasingly probable scarcity (IOM 1993a).
In sum, the advances in
cell and molecular biology and biotechnology that have been opening new
frontiers in other areas of the medical and biological sciences have been
exploited in only limited ways in contraceptive research. There are at least
two possible explanations. One is that the new science, as much as it has
contributed to innovation in other domains, is not, in fact, as applicable to
development of novel contraceptives and the new leads that have been identified
are not scientifically enticing enough to industry. The other is that there
are other historical and current factors, outside the science, that are holding
back contraceptive research. This study explores both possibilities.
The Environment for Contraceptive
Research and Development and the Objectives of this Study
In January 1990, the
Committee on Contraceptive Development of the National Research Council (NRC)
and the Institute of Medicine released a report on two years of analysis of
barriers facing the development of new contraceptive methods.7
The committee concluded that contraceptive development was indeed stalled;
that the most problematic obstacles were the political and ideologic climate in
the United States, the organization of resources available for research, some
of the federal regulatory requirements, and the specter of product liability.
Absent public policy changes that would lower at least some of these obstacles,
the committee predicted that contraceptive choices in the next century would
not be appreciably different than what they were at the time of that study (NRC/IOM
1990).
The present study,
undertaken over five years later, began with the premise that contraceptive
development continues to be largely stalled, but that the factors previously
considered formidable barriers were no longer viewed by the pharmaceutical
industry as the primary deterrents to its involvement in the field. In an
analysis of industry perceptions commissioned by The Rockefeller Foundation as
part of its Contraception 21 initiative, the Program for Appropriate Technology
in Health (PATH) determined that the major obstacles for industry are, instead,
economic (PATH 1995). In general, the analysis concluded, the pharmaceutical
industry does not seem to perceive either sufficiently enticing new product
ideas or an adequately large, interested, and financially rewarding market that
would justify the sizable investments required for development of fundamentally
new contraceptive methods.
It seemed logical, therefore,
to put our study emphasis, first, on fresh leads that might emerge from the
rapid advances in the biomedical sciences and, second, on changes in the
character of the market, in the hope that, together, the science and a
differently perceived market might motivate at least some industrial players to
return to the field. Nonetheless, we must note that, although there have
been some helpful regulatory modifications since the 1990 report, the
political and ideologic climate in the United States continues to be critical
in the domains of law and resource investment and remains, therefore, of high
economic relevance for industry. Although the charge to the committee did
not ask that we analyze that climate, it continues to so influence the field
that we could not justify ignoring it. The matter of the sociopolitical climate
is addressed in Chapter
7 as part of the cluster of reasons that "explains" why industry
perceives engagement in contraceptive research and development as problematic,
a cluster that importantly includes matters of product liability.
Of comparable relevance is
the fact that the technical adequacy of contraceptives does not, in itself,
guarantee wide social acceptance. The decisions to use contraception, plan a
family, or practice safer sex are rarely just pragmatic, intellectual matters
or issues of biologic function. Rather, they are profoundly rooted in personal
identity and sense of control, roles and expectations, feelings about
sexuality, concepts of risk, and peer and partner influences (Hatcher et al.
1994; IOM 1995a). In turn, each of these individual factors is rooted in
religious beliefs, family and group traditions, and values; knowledge and
education; and the contemporary play of larger socioeconomic and cultural
forces. Important among the latter are the ethnic, cultural, regional, and
religious diversity within a growing number of national populations, shifting
as those populations urbanize and are are increasingly linked to global
communications media; the effects of economic variables on fertility,
perceptions of personal opportunity, family structure, and access to
reproductive health care; and divergent views on sexuality and appropriate
sexual behavior, gender roles and relative power, and contraception and
abortion. Within each of these independently weighty variables, there is
contradiction, ambivalence, and volatility which, despite a fair amount of
analysis and despite a sizable literature, is neither systematically or deeply
understood (IOM 1995a). We consider aspects of these variables in Chapter
5 in the context of the women's agenda and attitudes toward
contraception and contraceptive methods.
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