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Has family planning a future ?
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HAS FAMILY PLANNING A FUTURE ? Egon Diczfalusy,
M.D.
Reproductive Endocrinology Research Unit Karolinska sjukhuset, Box 60500 S-104 01 Stockholm, Sweden
"None of our beliefs are quite true; all have at least a penumbra of vagueness and error". Bertrand Russell (18) The classical assertion in the comedy "Phormio" by Publius Terentius, "Quot homines tot sententiae; suo quoque mos" (So many men, so many opinions; his own a law to each) (22) is more than 2000 years old but truly reflects the human condition even to-day. Just as in former times, human beings to-day greatly differ in their assessment of relative good and evil. And whereas people and their governments might agree that population growth is one of the many serious issues confronting mankind at present, they may (and do) disagree on the likely consequences of this growth on the future availability of some basic necessities, such as food, drinking water, shelter, energy, education, health services and employment, or on the impact of population growth on the future extent of desertification, deforestation and soil erosion (14, 15, 24). Even more controversial might be the assessment of some basic issues related to ethics and human values in connection with population limitation and family planning (2). As rightly stated by the World Bank, "Population is a subject that touches issues central to the human condition,including personal freedom and the very definition of economic and social progress" (27). Hence it is understandable that people and their governments may have a wide range of views on this and related subjects. Population Growth and its Implications An old Chinese proverb says that "Every truth has its sect, and each sect has its truth", but irrespective of our personal views on these - admittedly - complex issues, it may be worth remembering a short sentence from Bertrand Russell's Sceptical Reprinted by permission from Ares Serono Symposia on behalf of Raven Press from Diczfalusy, E. and Bygdeman, M. (Eds.): Fertility Regulation Today and Tomorrow (1987)
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Essays, which I have selected as a motto for this presentation: "None of our beliefs are quite true; all have at least a penumbra of vagueness and error" (18). Such a vagueness characterizes the condition of mankind, including its origin and final destination, both of which are submerged in the big ocean of ignoramus. Whether the formative period of Homo sapiens was 300,000 years, or much longer, is still subject to cons-e uncertainty. However, it is established, and with a fairly high degree of certainty, that the global population reached the size of one billion soon after 1800, and before 1850. Furthermore, decadal estimates between 1920 and 1950 and quinquennial estimates thereafter indicate that it took some 120 years to reach the second billion, 33 years to add the third, and 14 years (between 1960 and 1974) to reach the fourth billion (3). Whether the fifth billion has already been reached, as suggested by the World Population Institute (36), or will be reached some time next year, as predicted by the United Nations Population Division (25) and the World Bank (27, 28), is most probably within the limits of error, at least for the time being. Hence the scenario depicted in Table 1 represents the demographic events of the last two centuries with an increasing degree of certainty from the beginning of the 19th to the last decades of the 20th century. Table 1.
The global demographic change during the 19th and 20th century
Population (BiTlions)
Year
1 2 3 4 5
1807 1927 1960 1974 1987
What about future growth? A great deal of thought has been given to various models for the proper extrapolation of the available data; the different methods of projection are discussed by Demeny (3). The balance of evidence strongly suggests future growth along a logistic curve, resembling an oblongated letter "S" tilted to the right. There is also essential agreement that the world population will continue to grow, albeit at a progressively slower pace, for another 100-150 years; it is projected to reach 6.1 billion by the year 2000, 8.2 billion by 2025, and it is expected to stabilize between 10 and 11 billion around the end of the 21st century (3, 25, 27). Approximately 90% of this future growth of the global population will occur in countries which are to-day considered as developing. Indeed, already in the year 2050, six times more people will live in developing than in developed countries compared to the present ratio of 3:l.
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Demographic processes are characterized by both significant biological regularities and behavioural inertia that provide longer range projections of past trends with considerable expected accuracy. Hence - barring catastrophic developments - it is difficult to challenge the above forecasts without rejecting the underlying global mortality and fertility rates and projections (3). The long-term implication of present mortality and fertility trends can also be illustrated by the calculation of the hypothetical size of the stationary populations, examples of which are indicated in Table 2. Table 2. Hypothetical size of the stationary populations of the most populous countries
Country
Population (Millions) Mid-1984
Stationary population (Millions)
India
749
1,700
China
1,029
1,600
96
528
USSR
275
375
Indonesia
159
361
Pakistan
92
353
Bangladesh
98
310
Brazil
133
293
USA
237
288
Nigeria
Adapted from the World Development Report,
1986.
Although such estimates are highly speculative, they do suggest what might happen if present growth rates remain fairly stable. Accepting the unanimous prediction that by the end of the 21st century some 10 billion human beings will pursue their happiness on this Earth and that sustaining a global population of this size will require a very high level of technical civilization and an intimately interconnected world economy, the obvious issue is the impact of rapid population growth on economic development and quality of life in the developing world, and the impact of family planning in slowing down population growth and thus improving the prospects for a more rapid economic development. As Mr. A.W.Clausen said it in the Foreword to the World Development Report 1984, "Population growth does not provide the drama of financial crisis or political upheaval, but as this
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Report shows, its significance for shaping the world of our children and grandchildren is at least as great"(27). A few months later, at the International Conference on Population in Mexico City, he added that "The evidence is overwhelming that rapid population growth impedes efforts to raise living standards in most of the developing world" ?.. One could not and must not bequeath to future generations a world in which the most spectacular growth was that in numbers of people living in absolute poverty. "Therefore", he said, "over the coming five years, the Bank would finance more than 20 projects for population and health in Sub-Saharan Africa. It would also consider supporting international efforts in contraceptive research to make simple and safe techniques available" (24). Even - what I consider - a revisionist look at population and growth by the National Research Council of the USA admits that rapid population growth is .., more likely to impede progress than to promote it (15) and concludes that, even if the economic grounds for family planning are not as compelling as some maintain (italics are mine), it is amply justified on thebasis of individual family health and welfare. The Role of Family Planning Of course, it would be nai‘ve to think that family planning alone can solve the problems of developing countries. But it would seem to be equally naTve to believe that these problems can be solved without some family planning. This has been gradually recognized by developing countries; in the early sixties, only seven governments provided family planning programmes; in the early eighties, over 120 governments supported such programmes, directly or indirectly (23). However, it cannot be overemphasized that the impact of family planning goes far beyond the issues of population growth and economic development; it is an important tool to improve the health status of populations, especially in developing countries. The effective use of family planning will delay the age at first pregnancy and space further births; when integrated into primary health care, both of these factors will lower infant, child and maternal morbidity and mortality and significantly reduce illegal abortions and their health hazards. Some maternal, infant and child mortality rates in selected countries are presented in Table 3. WHO calculates that, in certain developing countries, each time a woman becomes pregnant, she runs a 200 times greater risk of dying than if she had lived in a developed country. Failure to time and space pregnancies augments the risks of complications and death. Deprived of the means to plan their childbearing, women risk their lives to end undesired pregnancies; in Latin America, for example, half of all deaths among pregnant women are due to illegal abortions. Moreover, in some areas of Africa, 5% of the young adolescent girls die when they become pregnant. Effective family planning could avoid suchs deaths (32, 34). 4
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Table 3 Maternal, infant and child mortality
in selected countries Child death rate3)
Country
India
700
118
11
Bangladesh
700
105
18
Pakistan
700
94
16
Indonesia
300
a7
12
Mexico
103
38
3
Brazil
97
57
6
China
46
38
2
Japan
19
6
1
USA
10
11
1
6
6
1
Sweden
')Per 100,000 live births (WHO 1985). 2) Per 1,000 live births (U.N.Pop.Div. 1985). 3) Per 1,000 children aged l-4 years (World Development 1986).
Report
What the data of Table 3 do not show, is that 85% of the world's births take place in developing countries, but that these same countries suffer 95% of the world's infant deaths and 99% of all maternal deaths (33). Studies carried out in 21 countries indicate some of the reasons why over half a million women in developing countries die each year in pregnancy and childbirth, leaving at least one million children motherless: poor coverage of the health care system (more than half of the births in developing countries - a total of 58 million - are unattended births (32, 35)), lack of transport and facilities for dealing with emergencies, lack of family planning to avoid too frequent, closely spaced births and births at unfavourable ages, unwanted pregnancies and the associated risks of illegal abortions, and conditions related to malnutrition and poverty (33, 34). Of the annual half million maternal deaths, at least 20% are attributable to illegal abortion attempts (30, 34). It is difficult to provide an estimate of the world-wide morbidity rates due to abortion and the global number of illegal and legal abortions. However, fairly reliable national data (shown in Table 4) indicate the magnitude of the problem in four
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countries as different as India, China, Japan and the USA (21). Table 4.
Percentage Distribution Pregnancy First order
Japan -__-19
of All Pregnancies India
China
USA
19
37
31
Second
"
18
16
20
24
Third
'
8
42
16
19
55
23
27
26
33
30
6.0
Abortion Total
(millions) 3.5
Modified from : Segal (21). Hence, irrespective of whether the global estimate of abortions is put at 30 or 60 million per year, it is easy to see that abortion represents a public health issue of considerable dimension, especially in developing countries. Effective family planning could drastically reduce these figures. The importance of spacing is underlined i.a. by the fact that children born less than one year after the end of their mother's last pregnancy are more than twice as likely to die as children born after an interval of two years, or more. Estimates for developing countries show that if all births were spaced at least two years apart, infant mortality could be reduced by 10% and child death rate (aged l-4 years) by 16% (31). What is, again, needed, is more effective family planning. The contraceptive prevalence and the crude birth rate in selected countries are presented in Table 5. It has been pointed out by the WHO that if women the worTd over were able to have the children they say they want, the crude birth rate would range between 16 and 28 per thousand, rather than the present range of 28 and 40 (31). Indeed, the data of Table 5 indicate that in several African countries, contraception is hardly accepted and that the crude birth rate varies between 41 and 50 per thousand. However, the data also indicate that even in countries with well developed family planning systems, such as USA, China, Indonesia and India, 24-50% of couples in the fertile age do not use any method of fertilityeregulation at all, and the data of Table 6 show that in the same countries, the proportion of the couples who do not use any modern method of fertility regulation is higher and varies betwemand 68 per cent (cf. 4) of the total in the fertile age bracket. The magnitude of the problem can be illuminated by additional figures: In 1980-81, 68 per cent of married women of reproductive age were using a contraceptive method in developed countries, as contrasted to 38 per cent in developing countries; usage varied from 69 per cent in East Asia to 17 per cent in Africa; 6
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even to-day, approximately 300 million couples who do not want more children are not using any method of family planning (34). Table 5 Percentage of married women of childbearing age using cgntraception, and the crude birth rate in selected countriesa' Country
Percentage contraceptorsb) (1983)
Crude birth rate per thousand (1984)
Population (millions) (mid-1984)
Ethiopia
2
41
42
Zaire
3
45
30
Nigeria
5
50
97
Pakistan
11
42
92
Bangladesh
25
41
98
India
35
33
749
Mexico
48
33
77
Indonesia
50
33
159
Brazil
50
30
133
Japan
56
13
120
China
71
19
1029
USA
76
16
237
a) Adapted and modified from the World Development b)
Report 1986.
Women aged 15-49, who are practising, or whose husbands are practising any form of contraception, such as female and male sterilization, injectable and oral contraceptives, intrauterine devices, diaphragms, condoms, spermicidal agents, rhythm, withdrawal and abstinence. What are the Conclusions?
From the foregoing it appears that family planning has a tremendous potential to significantly improve the quality of iife by drastically reducing maternal and infant mortality. However, it also appears that a very large number of couples in the fertile age are not using as yet any method of family planning, and the question is, why not? One reason is that available methods and services of family planning fail to meet as yet the demands of developing countries.This is strongly suggested by the number of unwanted births and by the high discontinuation reported with all modern methods, and by the persistent high
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number of induced abortions
(7). Table 6
Fertility regulation
in India, Indonesia, China and the USA
Choice of various methods: percentage figures India
Indonesia
China
USA
None
68
43
31
31
Pill
2
32
6
14
Injectables
6 3
15
35
5
Sterilization (Female)
IUD
ID
2
18
24
Sterilization (Male)
11
7
10
3
16
Conventional
8
2
Sources
(10, 20,
21).
There s another reason, perhaps even more fundamental. As the economist Keynes emphasized in another context, "The difficulty lies, not in the new ideas, but in escaping the old ones, which ramify . . into every corner of our minds" (11). Intellectually, it may be relatively easy to see that excessive population growth poses critical dangers to the future of the species, the ecosystem, individual liberty and welfare, and perhaps even to the structure of social life. However, since the middle Pleistocene, human beings struggle to survive as individuals, families, Hence, traditionally, procreatribes, communities and nations. tion has a deep emotional value (Z), the general revision of which may prove to be more complicated than originally believed. Immediate
Needs
The logical conclusion seems to be that there is a need for a much wider variety of safe and effective methods of fertility regulation that will suit the individual situation, the socioeconomic condition and the cultural and religious values of different couples. This need is further accentuated by the continued momentum of population growth in developing countries, which by the year 2025 will double the number of women in the childbearing age from the present figure of 875 million, or more (19). There is an even more urgent need for a better understanding of the psychosocial and behavioural factors influencing the acceptability and continuation rates of various methods, and the matrix of interactions that link the user, the service provider
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and the delivery system. This latter is of paramount importance, since recent progress in the development of improved and new fertility regulating agents has not been matched by universal access, acceptability and compliance in their use. Furthermore, there is a need for a much wider variety of fertility regulating agents than the limited choice available at present, because the choice of fertility regulating methods in various populations shows marked differences (cf. Table 6 and 10, 20, 21), and because there are equally marked differences in family formation patterns, attitudes, perceptions and user preferences. The more than 100 developing countries greatly differ from each other in these respects. Indeed, the experience gained during the past 15 years indicates that the acceptability and delivery of various methods of fertility regulation is more often than not specific to a given country, locality and culture (5). The Role of Research To develop new and safe methods and to provide answers to the questions posed, research is needed. Yes, but what are the research needs in more specific terms? Several examples can be given. For instance, no pill for men, or a completely reversible method of male sterilization has as yet been developed. There is no post-coital agent, or efficient chemical method for female sterilization, and the most advanced leads of birth control vaccines have just reached the stage of the first clinical assessment; other leads are many years behind in development. Firm answers to the major safety issues under debate to-day will require continued large-scale investigations in many more developing countries during several decades to come. Answers are also lacking to the prevention and/or treatment of seemingly minor adverse effects of modern contraceptive methods, like bleeding irregularities. Sometimes these are described as being only of "nuisance value", but in reality bleeding problems represent by far the most important reason for discontinuation in the overwhelming majority of published studies (5). Moreover, the diagnosis, prevention and treatment of infertility is an integral part of family planning care, but progress in this area is disappointingly slow. Currently used diagnostic procedures and preventive measures are unsatisfactory, and the value of available methods of treatment (particularly in the male) is questionable, whereas the need is increasing, especially in the developing world (5). Last, but not least, there is a major research need in the field of social sciences to identify incompletely comprehended factors affecting the use of existing and new methods of fertility regulation, such as the complex social, economic, cultural and psychological factors influencing contraceptive choice and decision-making in relation to family formation and fertility limitation. Other examples in this area of research are the effects of community dynamics on the adoption
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of fertility regulating practices, the influence of gender roles and status on reproductive behaviour, and the social and economic costs and benefits of fertility regulation,especially as perceived by couples in developing countries. Obstacles Confronting
Research
Why do we not go ahead then with research in a really big way? I see seven cardinal elements negatively affecting greatly needed research and development efforts at present: insufficient funding, hostile philosophies, liability issues, the drug regulatory climate, shortage in manpower, relative paucity of new ideas, and gaps in communication. Insufficient funding Funding of research on human reproduction and fertility regulation has never been sufficient. In fact, it has only been close to 1% of the global expenditures on health research and has steadily declined in real terms during this decade. Recommendation No. 69, reached by consensus of 146 participating Member States at the Population Conference in Mexico City (24), "Governments and funding agencies are urged to allocate increased resources for research in human reproduction and fertility,regulation ,.. ' has not had an impact on the financial support to the field, at least not yet. Hostile philosophies We are witnessing in these days a re-awakening of an aggressive anti-abortion and anti-family planning philosophy, characteristically enough in some developed countries. This re-awakening originated with a debate on ethical and moral values with regard to medical termination of pregnancy, but has now been extended to family planning. Since a few economically powerful developed country governments are sympathetic to these views, the funding of international and national research activities is also suffering. Liability issues Could Konrad Lorenz rewrite his book "The eight mortal sins of civilized mankind' (13) to-day, I am convinced that he would change the title from 8 to 9 mortal sins, in order to include liability suits American style. The private industry of the developed world is more and more discouraged by the threat of costly product liability suits and the consequent difficulty in obtaining liability insurance for the development of contraceptive methods. The withdrawal of several intrauterine devices from the US market - although these products are safe and effective and remain acceptable by the FDA of the USA - is only an example in this respect (1). Non-profit institutions engaged in such research are also threatened. The over-all result is that the number and volume of active research programmes on fertility regulation in the private sector is rapidly shrinking at the time when all possible forms of research
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support would be required to meet the urgent needs of the developing countries. Drug regulatory problems Recommendation No. 69 of the International Conference on Population, quoted above in connection with funding problems, also states that "Modernization and updating of the official requirements for the preclinical and clinical assessment of new fertility regulating agents and a strengthening of the research capabilities of developing countries in these areas are also urgently needed" (24). As an example,there is disagreement among national Drug Regulatory Bodies whether or not the beagle dog is a suitable toxicological model for the preclinical assessment of the safety of contraceptive steroids (6); the FDA of the USA still requests such testing, whereas the Regulatory Agencies of the United Kingdom, the Federal Republic of Germany and Sweden, and the Toxicology Review Panel of the WHO Special Programme in Human Reproduction (29) do not consider the beagle dog a suitable toxicological model.for the preclinical assessment of the longterm safety of steroidal contraceptives. Because seven-year studies in this species (in conjunction with a ten-year study in monkeys) are very costly and time-consuming and yield results difficult to interpret, several pharmaceutical companies feel discouraged to underwrite the expenses of such studies with new Since there are a number steroidal contraceptive formulations. of other major issues to be resolved, or at least to discuss, the World Health Organization in collaboration with the Government of India is organizing a Symposium on this subject in New Delhi in February 1987. On this occasion, WHO will also present recommendations for new guidelines. Shortage in manpower fhe world-wide scarcity of investigators in reproductive research was recognized by the Population Council and by the Rockefeller Foundation already in the early fifties. From the early sixties, the Ford Foundation joined them in a significant way to support training in this field also outside the United States (8). From the early seventies, the WHO Special Programme in Human Reproduction assumed a dominant role in this area (5). Since in many developing countries there was (and still is) a great shortage in scientists with a competence in the biomedical, social, behavioural and management aspects of fertility regulation, and in proper institutional resources for such research, during the past 15 years the Programme has carried out a major strengthening of the research resources of the developing countries by building up multidisciplinary research facilities, awarding more than 900 Research Training and Visiting Scientists Grants and providing equipment, supplies, etc. in a total value exceeding 40 million US dollars (5). This is, however, just the very beginning of a very expensive and time-consuming, but absolutely essential long-term process to assist developing
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countries to achieve self-reliance in a field of critical importance. The special importance of the still existing shortage in research manpower is underlined by the marked differences among developing countries with respect to the acceptability of various methods of fertility regulation. Seen in a global perspective, the shortage of manpower in both developing and developed countries is definitely a factor interfering with rapid progress. Relative paucity of new ideas ff merelv for orofessional reasons alone. active scientists and science-administrators may violently disagree with this last point; however, a comparison of the leads pursued in clinical studies to-day and ten years ago would seem to support the view that there is an urgent need for more innovative leads in order to speed up the development in certain areas of mission-orientated research. Examples in question: the development of methods for the regulation of male fertility and for the diagnosis and treatment of male infertility, for post-coital contraception and for the solution of the problem of endometrial bleeding. A sufficient number of new leads will only be generated by fundamental, basic, research, and when support to basic research is diminished (like it happened in the seventies), the long-term consequences of this on mission-orientated research and developmental efforts are predictable. Indeed, the state of art in the areas indicated suggests that a strong case could be made for a massive support of fundamental research in these and related areas, if our principal aim is to intensify the development of new and improved fertility regulating agents. Communication gaps Answers concerning the long-term safety of fertility regulating agents require time and, in the case of a slightly increased risk of cancer, a very long time, perhaps 20-25 years, during which the agent must be used extensively by a large enough population. By the time sufficient evidence is available, the agent in question may have become obsolete. An example is the earlier use of oral contraceptives with a high estrogen content, which by now have been replaced with modern low-dose formulations. Hence time will be required aoain before a possibly increased risk can be established with the new formulati ns. However, in the public debate, "single issue groups"' 7
1)
This expression was used in a speech by former US President Jimmy Carter to denote a special group of individuals, subscribaccording to which all the evils ing to a simplistic philosophy, of this world could be rectified by resolving a special - rather limited - issue. Judging from the proverb, "cave ab homine unius libri" (beware of the man of one book), the syndrome was not unknown to the ancient Romans.
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sceotics ,opponents of family planning and the overanxious may (and do) demand "absolute" proof and "absolute" guarantee of long-term safety. The ensuing debate - which more often than not is loaded with emotions - may create an atmosphere which will negatively influence further research, particularly large-scale long-term human studies. An example in question is the DMPA debate (6, 29). The type of circular argument which arises in this way was illustrated by Sir Alan Parkes more than 15 years ago: " .. . no woman should be kept on the Pill for 20 years until, in fact, a sufficient number have been kept on the Pill for 20 years" (16). Since under the thin veil of factual arguments a deep conflict of emotional values is hidden, it is understandable that the opponents of family planning are unwilling to wait 20 years for answers and that they are unwilling and/or unable to argue in probabilistic terms. Hence the origin of the communication gap is in part emotional. How did Lichtenberg say it about 200 years ago? "Often we think we believe a thing and yet do not believe it. Nothing is more impenetrable than the motivation of our actions" (12). The autoportrait of the scientist and his modus operandi was masterly depicted by Bertrand Russell: "For it is not enough to recognize that all our knowledge is, in a greater or less degree, uncertain and vague; it is necessary, at the same time, to learn to act upon the best hypothesis without dogmatically believing it" (17). One of our major problems is how to explain to the public, to mass media and to decision-makers in simple, but accurate, terms, which answers, when, how and with what type of certainty can be provided by science in given situation. Will the concept of 95% confidence limits ever penetrate the public mind? The complexity of modern research is constantly increasing and so is the communication gap between scientists and the rest of the world. However, whereas the only panacea proposed by the scientific community is always more and more research, it is essential that this research should also embrace communication with the scientifically untrained majority of mankind. Has then Family Planning a Future? This question may appear somewhat rhetoric, but after some reflection, our answer must be strongly affirmative, irrespective of whether we think that its demographic or health aspects represent the key issue. Family planning has come to stay with us for many generations, because in an interconnected and interdependent world, it is extremely difficult, if not impossible, for pressure groups, or even for governments to ignore, or stop technical progress, or permanently to enforce a life in a technical isolation and hope in this way to escape the irreversible consequences of a global scientific development. And in spite of some technical shortcomings, family planning and fertility regulation already to-day represent an indispensable modern tool for improving the quality of life of numerous
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couples in a large number of countries. However, what also becomes obvious, is the increasing need for further research in a number of areas, be it reproductive physiology, the development of new methods of fertility regulation, more studies on safety, the diagnosis and treatment of infertility, or the psychosocial, behavioural and service aspects of family planning. Last, but not least, further strengthening of the human and institutional resources for research on family planning in developing countries remains an issue of very high priority. Of course, expanded and intensified research will require a substantially increased support both at the international and at the national level, and - at first glance at least - the past and present experience in this context does not inspire too much optimism. Pessimists sometimes quote the almost 200 years old views of Hegel in this respect: "What experience and history teach is this - that people and governments never have learned anything from history, or acted on principles deduced from it" (9). This may be true in describing the past, but hardly valid in predicting the future. As Wittgenstein says, "That the sun will rise tomorrow is an hypothesis; and that means that we do not know whether it will rise" (26). How do we then know that the attitudes of people and of governments with respect to massive support to research may not change overnight, for instance, in former developing countries? What "experience and history" also teach is that what was impossible yesterday is commonplace to-day. Indeed, a change for the better in future research support is not only possible, it is highly probable, since it represents only a quantitative change in an already widely adopted policy by many governments. Furthermore, nothing would be more unjustified than to consider Hegel as a cynic; in his Introduction quoted above, he also says: "We may affirm absolutely that nothing great in the world has been accomplished without passion" (9). If so, the combination of passion and compassion must be an irresistible approach to the improvement of the human condition. Therefore, what is needed now is that mankind shows a little more generosity towards itself and invests a bit more into research in family planning. Experience and history also indicate that research is a cost-effective investment in many areas. To invest into research in family planning means to invest into a brighter future. REFERENCES 1. American College of Obstetricians and Gynecologists: Statement on Searle's removal of IUDs, January 31, 1986. 2. Callahan, D. (1972): Ethics and population limitation. Science 175:3-16. 3. Demeny, P. (1985): The world demographic situation. Center for Policy Studies, The Population Council, Working paper No. 121, December 1985. 14
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4. Diczfalusy, E. (1985): New developments in oral, injectable and implantable contraceptives, vaginal rings and intrauterine devices; A Review. Contraception 33:7-22. 5. Diczfalusy, E. (1986): The first Contraceotion: l-119.
fifteen years; A review.
Fertilitatskontrolle im 21. Jahrhundert: 6. Diczfalusy, E (1986): Haben wir noch eine Zukunft? In: 25 Jahre hormonale Kontrazeptiva aus Berlin. Hammerstein, J., Ed. Excerpta Medica (Amst.). 7. Fathalla, M-F. (1983): A synthesis of various experiences and problems encountered with available methods of fertility regulation in developiong countries. In: Research on the Regulation of Human Fertility; Needs of Developing Countries and Priorities for the Future. (Diczfalusy, E. and Diczfalusy, A. Eds.). Scriptor, Copenhagen, p. 76. 8. Greep, R.O., Koblinsky, M.A.and Jaffe, F.S. (1976): Reproduction and Human Welfare; A Challenge to Research. The MIT Press, Cambridge, Mass. 9. Hegel, G.W.F. (1832): Introduction to The Philosophy History. Translated by J. Sibree. 10.
of
H.M. and Sumbung, P.P. (1985): The National Family Planning Program in Indonesia; Role of the intrauterine Intrauterine Contraception, contraceptive device. In: (Zatuchni, G.I., Goldsmith, A. Advances and Future ProPsects and Sciarra, J.J., Eds.). Harper & Row, Philadelphia,PP 15-24.
Judono,
Il. Keynes, J.M. (1942): Address to the Royal Society Club. In: Mackay, A.L.: Scientific Quotations: The Harvest of a Quiet Eye. Crane, Russak & Company, Inc., New York, p.87, 1977. 12. Lichtenberg, G.C. (1799): Reflexions. cf. Requadt, P.:Lichtenberg, Aphorismen, Briefe, Schriften. Third impression. Alfred Krijner Verlag, Stuttgart, 1953. 13. Lorenz, K. (1973): DieauhtTodsUnden der zivilisierten heit. R.Piper & Co. Verlag, MUnchen.
Mensch-
14. National Academy of Sciences (1971): Rapid Population Growth: Consequences and Policy Implications. Johns Hopkins University Press, Baltimore, Md. 15. National Research Council (1986): Population Growth and Economic Development: Policy Questions. National Academy Press, Washington, D.C. 16. Parkes, A.S. quoted by Mackay, A.L.: Scientific Quotations: The l-lamest of a Quiet Eye, p.116. Crane, Russak & Co. Inc. New York, 1977. 17. Russell, B. (1951): Unpopular essays, p.43. Second impression. George Allen& Unwin Ltd., London.
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18. Russell, 6. (1952): Sceptical essays, p. 151. Fifth impression. George Allen & Unwin Ltd., London. 19. Salas, R.M. (1984): Population: The Mexico Conference and the Future. Opening address to the United Nations Conference on Population, Mexico City, 6 August 1984. UNFPA/ICP/84/E/2500. 20. Saxena, R.N. (1983): Experience and problems encountered with available methods in family planning programmes in India. Research on the Regulation of Human Fertility; Needs Of In: Developing Countries and Priorities for the Future (Diczfalusy, E. and Diczfalusy, A., Eds.). Scripter, Copenhagen, PP. 35-53. 21. Segal, S.J. (1984): Seeking better contraceptives. Populi 11:24-30. 22. Terentius, P.: Phormio, Act II,Sc.4, Line 14. Transl. Henry Thomas Riley; cf. The Oxford Dictionary of Quotations, Second edition, Oxford University Press, p.542, 1953. 23. United Nations Department of International Economic and Social Affairs, Population Division (1981): Report on monitoring of population policies. Working Papers No. 69, U.N. Population Division, New York. 24. United Nations Department of Technical Co-operation for Development: Report of the International Conference on Population (1984). E/CONF. 76/19. United Nations Publication, Sales No. E.84.XIII.8, New York, 1984. 25. United Nations Population Division (1984): World Population Prospects: Estimates and Projections as Assessed in 1982. To be published (1986). Data reproduced in the Review and Appraisal of the World Population Plan of Action, Report of the Secretary General, United Nations International Conference on Population, Mexico City, August 1984; E/CONF. 76/4 Corr. 1. - 26 July 1984, pp. 29-30. 26. Wittgenstein, L. (1922): Tractatus Logico-philosophicus. Sixth impression (1955), p.181. Routledge & Kegan Paul Ltd. London. 27. World Development Report (1984). Published for the World Bank by Oxford University Press, London. ISBN o-19-520460-3. 28. World Development Report (1986). Published for the World Bank by Oxford University Press, London. ISBN O-19-520518-9. 29. World Health Organization (1982): Facts about injectable Bull.WHO 60:199-210. contraceptives. 30. Family Health Division, Wopld Health Organization Unpublished estimates. 31. World Health Organization 16
(1985):
(1984): Health and fdmily
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In point of fact, No. 23. 32. World Health Oraanization, Media Service Health. In point of fact , No. 27.
(1985): Women and
33. World Health Organization, Media Service (1985): Prevention of maternal mortality. WHO Features No. 99, December. 34. World Health Organization, Media Service (1986): The health of mothers and children. In point of fact, No. 33. 35. World Health Organization Annual, Geneva.
(1985): World Health Statistics
36. World Population Institute (1986): Quoted by the International Herald Tribune, July 7th, 1986.
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HAS FAMILY PLANNING A FUTURE ? Egon Diczfalusy,
M.D.
Reproductive Endocrinology Research Unit Karolinska sjukhuset, Box 60500 S-104 01 Stockholm, Sweden
"None of our beliefs are quite true; all have at least a penumbra of vagueness and error". Bertrand Russell (18) The classical assertion in the comedy "Phormio" by Publius Terentius, "Quot homines tot sententiae; suo quoque mos" (So many men, so many opinions; his own a law to each) (22) is more than 2000 years old but truly reflects the human condition even to-day. Just as in former times, human beings to-day greatly differ in their assessment of relative good and evil. And whereas people and their governments might agree that population growth is one of the many serious issues confronting mankind at present, they may (and do) disagree on the likely consequences of this growth on the future availability of some basic necessities, such as food, drinking water, shelter, energy, education, health services and employment, or on the impact of population growth on the future extent of desertification, deforestation and soil erosion (14, 15, 24). Even more controversial might be the assessment of some basic issues related to ethics and human values in connection with population limitation and family planning (2). As rightly stated by the World Bank, "Population is a subject that touches issues central to the human condition,including personal freedom and the very definition of economic and social progress" (27). Hence it is understandable that people and their governments may have a wide range of views on this and related subjects. Population Growth and its Implications An old Chinese proverb says that "Every truth has its sect, and each sect has its truth", but irrespective of our personal views on these - admittedly - complex issues, it may be worth remembering a short sentence from Bertrand Russell's Sceptical Reprinted by permission from Ares Serono Symposia on behalf of Raven Press from Diczfalusy, E. and Bygdeman, M. (Eds.): Fertility Regulation Today and Tomorrow (1987)
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Essays, which I have selected as a motto for this presentation: "None of our beliefs are quite true; all have at least a penumbra of vagueness and error" (18). Such a vagueness characterizes the condition of mankind, including its origin and final destination, both of which are submerged in the big ocean of ignoramus. Whether the formative period of Homo sapiens was 300,000 years, or much longer, is still subject to cons-e uncertainty. However, it is established, and with a fairly high degree of certainty, that the global population reached the size of one billion soon after 1800, and before 1850. Furthermore, decadal estimates between 1920 and 1950 and quinquennial estimates thereafter indicate that it took some 120 years to reach the second billion, 33 years to add the third, and 14 years (between 1960 and 1974) to reach the fourth billion (3). Whether the fifth billion has already been reached, as suggested by the World Population Institute (36), or will be reached some time next year, as predicted by the United Nations Population Division (25) and the World Bank (27, 28), is most probably within the limits of error, at least for the time being. Hence the scenario depicted in Table 1 represents the demographic events of the last two centuries with an increasing degree of certainty from the beginning of the 19th to the last decades of the 20th century. Table 1.
The global demographic change during the 19th and 20th century
Population (BiTlions)
Year
1 2 3 4 5
1807 1927 1960 1974 1987
What about future growth? A great deal of thought has been given to various models for the proper extrapolation of the available data; the different methods of projection are discussed by Demeny (3). The balance of evidence strongly suggests future growth along a logistic curve, resembling an oblongated letter "S" tilted to the right. There is also essential agreement that the world population will continue to grow, albeit at a progressively slower pace, for another 100-150 years; it is projected to reach 6.1 billion by the year 2000, 8.2 billion by 2025, and it is expected to stabilize between 10 and 11 billion around the end of the 21st century (3, 25, 27). Approximately 90% of this future growth of the global population will occur in countries which are to-day considered as developing. Indeed, already in the year 2050, six times more people will live in developing than in developed countries compared to the present ratio of 3:l.
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Demographic processes are characterized by both significant biological regularities and behavioural inertia that provide longer range projections of past trends with considerable expected accuracy. Hence - barring catastrophic developments - it is difficult to challenge the above forecasts without rejecting the underlying global mortality and fertility rates and projections (3). The long-term implication of present mortality and fertility trends can also be illustrated by the calculation of the hypothetical size of the stationary populations, examples of which are indicated in Table 2. Table 2. Hypothetical size of the stationary populations of the most populous countries
Country
Population (Millions) Mid-1984
Stationary population (Millions)
India
749
1,700
China
1,029
1,600
96
528
USSR
275
375
Indonesia
159
361
Pakistan
92
353
Bangladesh
98
310
Brazil
133
293
USA
237
288
Nigeria
Adapted from the World Development Report,
1986.
Although such estimates are highly speculative, they do suggest what might happen if present growth rates remain fairly stable. Accepting the unanimous prediction that by the end of the 21st century some 10 billion human beings will pursue their happiness on this Earth and that sustaining a global population of this size will require a very high level of technical civilization and an intimately interconnected world economy, the obvious issue is the impact of rapid population growth on economic development and quality of life in the developing world, and the impact of family planning in slowing down population growth and thus improving the prospects for a more rapid economic development. As Mr. A.W.Clausen said it in the Foreword to the World Development Report 1984, "Population growth does not provide the drama of financial crisis or political upheaval, but as this
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Report shows, its significance for shaping the world of our children and grandchildren is at least as great"(27). A few months later, at the International Conference on Population in Mexico City, he added that "The evidence is overwhelming that rapid population growth impedes efforts to raise living standards in most of the developing world" ?.. One could not and must not bequeath to future generations a world in which the most spectacular growth was that in numbers of people living in absolute poverty. "Therefore", he said, "over the coming five years, the Bank would finance more than 20 projects for population and health in Sub-Saharan Africa. It would also consider supporting international efforts in contraceptive research to make simple and safe techniques available" (24). Even - what I consider - a revisionist look at population and growth by the National Research Council of the USA admits that rapid population growth is .., more likely to impede progress than to promote it (15) and concludes that, even if the economic grounds for family planning are not as compelling as some maintain (italics are mine), it is amply justified on thebasis of individual family health and welfare. The Role of Family Planning Of course, it would be nai‘ve to think that family planning alone can solve the problems of developing countries. But it would seem to be equally naTve to believe that these problems can be solved without some family planning. This has been gradually recognized by developing countries; in the early sixties, only seven governments provided family planning programmes; in the early eighties, over 120 governments supported such programmes, directly or indirectly (23). However, it cannot be overemphasized that the impact of family planning goes far beyond the issues of population growth and economic development; it is an important tool to improve the health status of populations, especially in developing countries. The effective use of family planning will delay the age at first pregnancy and space further births; when integrated into primary health care, both of these factors will lower infant, child and maternal morbidity and mortality and significantly reduce illegal abortions and their health hazards. Some maternal, infant and child mortality rates in selected countries are presented in Table 3. WHO calculates that, in certain developing countries, each time a woman becomes pregnant, she runs a 200 times greater risk of dying than if she had lived in a developed country. Failure to time and space pregnancies augments the risks of complications and death. Deprived of the means to plan their childbearing, women risk their lives to end undesired pregnancies; in Latin America, for example, half of all deaths among pregnant women are due to illegal abortions. Moreover, in some areas of Africa, 5% of the young adolescent girls die when they become pregnant. Effective family planning could avoid suchs deaths (32, 34). 4
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Table 3 Maternal, infant and child mortality
in selected countries Child death rate3)
Country
India
700
118
11
Bangladesh
700
105
18
Pakistan
700
94
16
Indonesia
300
a7
12
Mexico
103
38
3
Brazil
97
57
6
China
46
38
2
Japan
19
6
1
USA
10
11
1
6
6
1
Sweden
')Per 100,000 live births (WHO 1985). 2) Per 1,000 live births (U.N.Pop.Div. 1985). 3) Per 1,000 children aged l-4 years (World Development 1986).
Report
What the data of Table 3 do not show, is that 85% of the world's births take place in developing countries, but that these same countries suffer 95% of the world's infant deaths and 99% of all maternal deaths (33). Studies carried out in 21 countries indicate some of the reasons why over half a million women in developing countries die each year in pregnancy and childbirth, leaving at least one million children motherless: poor coverage of the health care system (more than half of the births in developing countries - a total of 58 million - are unattended births (32, 35)), lack of transport and facilities for dealing with emergencies, lack of family planning to avoid too frequent, closely spaced births and births at unfavourable ages, unwanted pregnancies and the associated risks of illegal abortions, and conditions related to malnutrition and poverty (33, 34). Of the annual half million maternal deaths, at least 20% are attributable to illegal abortion attempts (30, 34). It is difficult to provide an estimate of the world-wide morbidity rates due to abortion and the global number of illegal and legal abortions. However, fairly reliable national data (shown in Table 4) indicate the magnitude of the problem in four
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countries as different as India, China, Japan and the USA (21). Table 4.
Percentage Distribution Pregnancy First order
Japan -__-19
of All Pregnancies India
China
USA
19
37
31
Second
"
18
16
20
24
Third
'
8
42
16
19
55
23
27
26
33
30
6.0
Abortion Total
(millions) 3.5
Modified from : Segal (21). Hence, irrespective of whether the global estimate of abortions is put at 30 or 60 million per year, it is easy to see that abortion represents a public health issue of considerable dimension, especially in developing countries. Effective family planning could drastically reduce these figures. The importance of spacing is underlined i.a. by the fact that children born less than one year after the end of their mother's last pregnancy are more than twice as likely to die as children born after an interval of two years, or more. Estimates for developing countries show that if all births were spaced at least two years apart, infant mortality could be reduced by 10% and child death rate (aged l-4 years) by 16% (31). What is, again, needed, is more effective family planning. The contraceptive prevalence and the crude birth rate in selected countries are presented in Table 5. It has been pointed out by the WHO that if women the worTd over were able to have the children they say they want, the crude birth rate would range between 16 and 28 per thousand, rather than the present range of 28 and 40 (31). Indeed, the data of Table 5 indicate that in several African countries, contraception is hardly accepted and that the crude birth rate varies between 41 and 50 per thousand. However, the data also indicate that even in countries with well developed family planning systems, such as USA, China, Indonesia and India, 24-50% of couples in the fertile age do not use any method of fertilityeregulation at all, and the data of Table 6 show that in the same countries, the proportion of the couples who do not use any modern method of fertility regulation is higher and varies betwemand 68 per cent (cf. 4) of the total in the fertile age bracket. The magnitude of the problem can be illuminated by additional figures: In 1980-81, 68 per cent of married women of reproductive age were using a contraceptive method in developed countries, as contrasted to 38 per cent in developing countries; usage varied from 69 per cent in East Asia to 17 per cent in Africa; 6
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even to-day, approximately 300 million couples who do not want more children are not using any method of family planning (34). Table 5 Percentage of married women of childbearing age using cgntraception, and the crude birth rate in selected countriesa' Country
Percentage contraceptorsb) (1983)
Crude birth rate per thousand (1984)
Population (millions) (mid-1984)
Ethiopia
2
41
42
Zaire
3
45
30
Nigeria
5
50
97
Pakistan
11
42
92
Bangladesh
25
41
98
India
35
33
749
Mexico
48
33
77
Indonesia
50
33
159
Brazil
50
30
133
Japan
56
13
120
China
71
19
1029
USA
76
16
237
a) Adapted and modified from the World Development b)
Report 1986.
Women aged 15-49, who are practising, or whose husbands are practising any form of contraception, such as female and male sterilization, injectable and oral contraceptives, intrauterine devices, diaphragms, condoms, spermicidal agents, rhythm, withdrawal and abstinence. What are the Conclusions?
From the foregoing it appears that family planning has a tremendous potential to significantly improve the quality of iife by drastically reducing maternal and infant mortality. However, it also appears that a very large number of couples in the fertile age are not using as yet any method of family planning, and the question is, why not? One reason is that available methods and services of family planning fail to meet as yet the demands of developing countries.This is strongly suggested by the number of unwanted births and by the high discontinuation reported with all modern methods, and by the persistent high
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number of induced abortions
(7). Table 6
Fertility regulation
in India, Indonesia, China and the USA
Choice of various methods: percentage figures India
Indonesia
China
USA
None
68
43
31
31
Pill
2
32
6
14
Injectables
6 3
15
35
5
Sterilization (Female)
IUD
ID
2
18
24
Sterilization (Male)
11
7
10
3
16
Conventional
8
2
Sources
(10, 20,
21).
There s another reason, perhaps even more fundamental. As the economist Keynes emphasized in another context, "The difficulty lies, not in the new ideas, but in escaping the old ones, which ramify . . into every corner of our minds" (11). Intellectually, it may be relatively easy to see that excessive population growth poses critical dangers to the future of the species, the ecosystem, individual liberty and welfare, and perhaps even to the structure of social life. However, since the middle Pleistocene, human beings struggle to survive as individuals, families, Hence, traditionally, procreatribes, communities and nations. tion has a deep emotional value (Z), the general revision of which may prove to be more complicated than originally believed. Immediate
Needs
The logical conclusion seems to be that there is a need for a much wider variety of safe and effective methods of fertility regulation that will suit the individual situation, the socioeconomic condition and the cultural and religious values of different couples. This need is further accentuated by the continued momentum of population growth in developing countries, which by the year 2025 will double the number of women in the childbearing age from the present figure of 875 million, or more (19). There is an even more urgent need for a better understanding of the psychosocial and behavioural factors influencing the acceptability and continuation rates of various methods, and the matrix of interactions that link the user, the service provider
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and the delivery system. This latter is of paramount importance, since recent progress in the development of improved and new fertility regulating agents has not been matched by universal access, acceptability and compliance in their use. Furthermore, there is a need for a much wider variety of fertility regulating agents than the limited choice available at present, because the choice of fertility regulating methods in various populations shows marked differences (cf. Table 6 and 10, 20, 21), and because there are equally marked differences in family formation patterns, attitudes, perceptions and user preferences. The more than 100 developing countries greatly differ from each other in these respects. Indeed, the experience gained during the past 15 years indicates that the acceptability and delivery of various methods of fertility regulation is more often than not specific to a given country, locality and culture (5). The Role of Research To develop new and safe methods and to provide answers to the questions posed, research is needed. Yes, but what are the research needs in more specific terms? Several examples can be given. For instance, no pill for men, or a completely reversible method of male sterilization has as yet been developed. There is no post-coital agent, or efficient chemical method for female sterilization, and the most advanced leads of birth control vaccines have just reached the stage of the first clinical assessment; other leads are many years behind in development. Firm answers to the major safety issues under debate to-day will require continued large-scale investigations in many more developing countries during several decades to come. Answers are also lacking to the prevention and/or treatment of seemingly minor adverse effects of modern contraceptive methods, like bleeding irregularities. Sometimes these are described as being only of "nuisance value", but in reality bleeding problems represent by far the most important reason for discontinuation in the overwhelming majority of published studies (5). Moreover, the diagnosis, prevention and treatment of infertility is an integral part of family planning care, but progress in this area is disappointingly slow. Currently used diagnostic procedures and preventive measures are unsatisfactory, and the value of available methods of treatment (particularly in the male) is questionable, whereas the need is increasing, especially in the developing world (5). Last, but not least, there is a major research need in the field of social sciences to identify incompletely comprehended factors affecting the use of existing and new methods of fertility regulation, such as the complex social, economic, cultural and psychological factors influencing contraceptive choice and decision-making in relation to family formation and fertility limitation. Other examples in this area of research are the effects of community dynamics on the adoption
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of fertility regulating practices, the influence of gender roles and status on reproductive behaviour, and the social and economic costs and benefits of fertility regulation,especially as perceived by couples in developing countries. Obstacles Confronting
Research
Why do we not go ahead then with research in a really big way? I see seven cardinal elements negatively affecting greatly needed research and development efforts at present: insufficient funding, hostile philosophies, liability issues, the drug regulatory climate, shortage in manpower, relative paucity of new ideas, and gaps in communication. Insufficient funding Funding of research on human reproduction and fertility regulation has never been sufficient. In fact, it has only been close to 1% of the global expenditures on health research and has steadily declined in real terms during this decade. Recommendation No. 69, reached by consensus of 146 participating Member States at the Population Conference in Mexico City (24), "Governments and funding agencies are urged to allocate increased resources for research in human reproduction and fertility,regulation ,.. ' has not had an impact on the financial support to the field, at least not yet. Hostile philosophies We are witnessing in these days a re-awakening of an aggressive anti-abortion and anti-family planning philosophy, characteristically enough in some developed countries. This re-awakening originated with a debate on ethical and moral values with regard to medical termination of pregnancy, but has now been extended to family planning. Since a few economically powerful developed country governments are sympathetic to these views, the funding of international and national research activities is also suffering. Liability issues Could Konrad Lorenz rewrite his book "The eight mortal sins of civilized mankind' (13) to-day, I am convinced that he would change the title from 8 to 9 mortal sins, in order to include liability suits American style. The private industry of the developed world is more and more discouraged by the threat of costly product liability suits and the consequent difficulty in obtaining liability insurance for the development of contraceptive methods. The withdrawal of several intrauterine devices from the US market - although these products are safe and effective and remain acceptable by the FDA of the USA - is only an example in this respect (1). Non-profit institutions engaged in such research are also threatened. The over-all result is that the number and volume of active research programmes on fertility regulation in the private sector is rapidly shrinking at the time when all possible forms of research
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support would be required to meet the urgent needs of the developing countries. Drug regulatory problems Recommendation No. 69 of the International Conference on Population, quoted above in connection with funding problems, also states that "Modernization and updating of the official requirements for the preclinical and clinical assessment of new fertility regulating agents and a strengthening of the research capabilities of developing countries in these areas are also urgently needed" (24). As an example,there is disagreement among national Drug Regulatory Bodies whether or not the beagle dog is a suitable toxicological model for the preclinical assessment of the safety of contraceptive steroids (6); the FDA of the USA still requests such testing, whereas the Regulatory Agencies of the United Kingdom, the Federal Republic of Germany and Sweden, and the Toxicology Review Panel of the WHO Special Programme in Human Reproduction (29) do not consider the beagle dog a suitable toxicological model.for the preclinical assessment of the longterm safety of steroidal contraceptives. Because seven-year studies in this species (in conjunction with a ten-year study in monkeys) are very costly and time-consuming and yield results difficult to interpret, several pharmaceutical companies feel discouraged to underwrite the expenses of such studies with new Since there are a number steroidal contraceptive formulations. of other major issues to be resolved, or at least to discuss, the World Health Organization in collaboration with the Government of India is organizing a Symposium on this subject in New Delhi in February 1987. On this occasion, WHO will also present recommendations for new guidelines. Shortage in manpower fhe world-wide scarcity of investigators in reproductive research was recognized by the Population Council and by the Rockefeller Foundation already in the early fifties. From the early sixties, the Ford Foundation joined them in a significant way to support training in this field also outside the United States (8). From the early seventies, the WHO Special Programme in Human Reproduction assumed a dominant role in this area (5). Since in many developing countries there was (and still is) a great shortage in scientists with a competence in the biomedical, social, behavioural and management aspects of fertility regulation, and in proper institutional resources for such research, during the past 15 years the Programme has carried out a major strengthening of the research resources of the developing countries by building up multidisciplinary research facilities, awarding more than 900 Research Training and Visiting Scientists Grants and providing equipment, supplies, etc. in a total value exceeding 40 million US dollars (5). This is, however, just the very beginning of a very expensive and time-consuming, but absolutely essential long-term process to assist developing
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countries to achieve self-reliance in a field of critical importance. The special importance of the still existing shortage in research manpower is underlined by the marked differences among developing countries with respect to the acceptability of various methods of fertility regulation. Seen in a global perspective, the shortage of manpower in both developing and developed countries is definitely a factor interfering with rapid progress. Relative paucity of new ideas ff merelv for orofessional reasons alone. active scientists and science-administrators may violently disagree with this last point; however, a comparison of the leads pursued in clinical studies to-day and ten years ago would seem to support the view that there is an urgent need for more innovative leads in order to speed up the development in certain areas of mission-orientated research. Examples in question: the development of methods for the regulation of male fertility and for the diagnosis and treatment of male infertility, for post-coital contraception and for the solution of the problem of endometrial bleeding. A sufficient number of new leads will only be generated by fundamental, basic, research, and when support to basic research is diminished (like it happened in the seventies), the long-term consequences of this on mission-orientated research and developmental efforts are predictable. Indeed, the state of art in the areas indicated suggests that a strong case could be made for a massive support of fundamental research in these and related areas, if our principal aim is to intensify the development of new and improved fertility regulating agents. Communication gaps Answers concerning the long-term safety of fertility regulating agents require time and, in the case of a slightly increased risk of cancer, a very long time, perhaps 20-25 years, during which the agent must be used extensively by a large enough population. By the time sufficient evidence is available, the agent in question may have become obsolete. An example is the earlier use of oral contraceptives with a high estrogen content, which by now have been replaced with modern low-dose formulations. Hence time will be required aoain before a possibly increased risk can be established with the new formulati ns. However, in the public debate, "single issue groups"' 7
1)
This expression was used in a speech by former US President Jimmy Carter to denote a special group of individuals, subscribaccording to which all the evils ing to a simplistic philosophy, of this world could be rectified by resolving a special - rather limited - issue. Judging from the proverb, "cave ab homine unius libri" (beware of the man of one book), the syndrome was not unknown to the ancient Romans.
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sceotics ,opponents of family planning and the overanxious may (and do) demand "absolute" proof and "absolute" guarantee of long-term safety. The ensuing debate - which more often than not is loaded with emotions - may create an atmosphere which will negatively influence further research, particularly large-scale long-term human studies. An example in question is the DMPA debate (6, 29). The type of circular argument which arises in this way was illustrated by Sir Alan Parkes more than 15 years ago: " .. . no woman should be kept on the Pill for 20 years until, in fact, a sufficient number have been kept on the Pill for 20 years" (16). Since under the thin veil of factual arguments a deep conflict of emotional values is hidden, it is understandable that the opponents of family planning are unwilling to wait 20 years for answers and that they are unwilling and/or unable to argue in probabilistic terms. Hence the origin of the communication gap is in part emotional. How did Lichtenberg say it about 200 years ago? "Often we think we believe a thing and yet do not believe it. Nothing is more impenetrable than the motivation of our actions" (12). The autoportrait of the scientist and his modus operandi was masterly depicted by Bertrand Russell: "For it is not enough to recognize that all our knowledge is, in a greater or less degree, uncertain and vague; it is necessary, at the same time, to learn to act upon the best hypothesis without dogmatically believing it" (17). One of our major problems is how to explain to the public, to mass media and to decision-makers in simple, but accurate, terms, which answers, when, how and with what type of certainty can be provided by science in given situation. Will the concept of 95% confidence limits ever penetrate the public mind? The complexity of modern research is constantly increasing and so is the communication gap between scientists and the rest of the world. However, whereas the only panacea proposed by the scientific community is always more and more research, it is essential that this research should also embrace communication with the scientifically untrained majority of mankind. Has then Family Planning a Future? This question may appear somewhat rhetoric, but after some reflection, our answer must be strongly affirmative, irrespective of whether we think that its demographic or health aspects represent the key issue. Family planning has come to stay with us for many generations, because in an interconnected and interdependent world, it is extremely difficult, if not impossible, for pressure groups, or even for governments to ignore, or stop technical progress, or permanently to enforce a life in a technical isolation and hope in this way to escape the irreversible consequences of a global scientific development. And in spite of some technical shortcomings, family planning and fertility regulation already to-day represent an indispensable modern tool for improving the quality of life of numerous
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couples in a large number of countries. However, what also becomes obvious, is the increasing need for further research in a number of areas, be it reproductive physiology, the development of new methods of fertility regulation, more studies on safety, the diagnosis and treatment of infertility, or the psychosocial, behavioural and service aspects of family planning. Last, but not least, further strengthening of the human and institutional resources for research on family planning in developing countries remains an issue of very high priority. Of course, expanded and intensified research will require a substantially increased support both at the international and at the national level, and - at first glance at least - the past and present experience in this context does not inspire too much optimism. Pessimists sometimes quote the almost 200 years old views of Hegel in this respect: "What experience and history teach is this - that people and governments never have learned anything from history, or acted on principles deduced from it" (9). This may be true in describing the past, but hardly valid in predicting the future. As Wittgenstein says, "That the sun will rise tomorrow is an hypothesis; and that means that we do not know whether it will rise" (26). How do we then know that the attitudes of people and of governments with respect to massive support to research may not change overnight, for instance, in former developing countries? What "experience and history" also teach is that what was impossible yesterday is commonplace to-day. Indeed, a change for the better in future research support is not only possible, it is highly probable, since it represents only a quantitative change in an already widely adopted policy by many governments. Furthermore, nothing would be more unjustified than to consider Hegel as a cynic; in his Introduction quoted above, he also says: "We may affirm absolutely that nothing great in the world has been accomplished without passion" (9). If so, the combination of passion and compassion must be an irresistible approach to the improvement of the human condition. Therefore, what is needed now is that mankind shows a little more generosity towards itself and invests a bit more into research in family planning. Experience and history also indicate that research is a cost-effective investment in many areas. To invest into research in family planning means to invest into a brighter future. REFERENCES 1. American College of Obstetricians and Gynecologists: Statement on Searle's removal of IUDs, January 31, 1986. 2. Callahan, D. (1972): Ethics and population limitation. Science 175:3-16. 3. Demeny, P. (1985): The world demographic situation. Center for Policy Studies, The Population Council, Working paper No. 121, December 1985. 14
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4. Diczfalusy, E. (1985): New developments in oral, injectable and implantable contraceptives, vaginal rings and intrauterine devices; A Review. Contraception 33:7-22. 5. Diczfalusy, E. (1986): The first Contraceotion: l-119.
fifteen years; A review.
Fertilitatskontrolle im 21. Jahrhundert: 6. Diczfalusy, E (1986): Haben wir noch eine Zukunft? In: 25 Jahre hormonale Kontrazeptiva aus Berlin. Hammerstein, J., Ed. Excerpta Medica (Amst.). 7. Fathalla, M-F. (1983): A synthesis of various experiences and problems encountered with available methods of fertility regulation in developiong countries. In: Research on the Regulation of Human Fertility; Needs of Developing Countries and Priorities for the Future. (Diczfalusy, E. and Diczfalusy, A. Eds.). Scriptor, Copenhagen, p. 76. 8. Greep, R.O., Koblinsky, M.A.and Jaffe, F.S. (1976): Reproduction and Human Welfare; A Challenge to Research. The MIT Press, Cambridge, Mass. 9. Hegel, G.W.F. (1832): Introduction to The Philosophy History. Translated by J. Sibree. 10.
of
H.M. and Sumbung, P.P. (1985): The National Family Planning Program in Indonesia; Role of the intrauterine Intrauterine Contraception, contraceptive device. In: (Zatuchni, G.I., Goldsmith, A. Advances and Future ProPsects and Sciarra, J.J., Eds.). Harper & Row, Philadelphia,PP 15-24.
Judono,
Il. Keynes, J.M. (1942): Address to the Royal Society Club. In: Mackay, A.L.: Scientific Quotations: The Harvest of a Quiet Eye. Crane, Russak & Company, Inc., New York, p.87, 1977. 12. Lichtenberg, G.C. (1799): Reflexions. cf. Requadt, P.:Lichtenberg, Aphorismen, Briefe, Schriften. Third impression. Alfred Krijner Verlag, Stuttgart, 1953. 13. Lorenz, K. (1973): DieauhtTodsUnden der zivilisierten heit. R.Piper & Co. Verlag, MUnchen.
Mensch-
14. National Academy of Sciences (1971): Rapid Population Growth: Consequences and Policy Implications. Johns Hopkins University Press, Baltimore, Md. 15. National Research Council (1986): Population Growth and Economic Development: Policy Questions. National Academy Press, Washington, D.C. 16. Parkes, A.S. quoted by Mackay, A.L.: Scientific Quotations: The l-lamest of a Quiet Eye, p.116. Crane, Russak & Co. Inc. New York, 1977. 17. Russell, B. (1951): Unpopular essays, p.43. Second impression. George Allen& Unwin Ltd., London.
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18. Russell, 6. (1952): Sceptical essays, p. 151. Fifth impression. George Allen & Unwin Ltd., London. 19. Salas, R.M. (1984): Population: The Mexico Conference and the Future. Opening address to the United Nations Conference on Population, Mexico City, 6 August 1984. UNFPA/ICP/84/E/2500. 20. Saxena, R.N. (1983): Experience and problems encountered with available methods in family planning programmes in India. Research on the Regulation of Human Fertility; Needs Of In: Developing Countries and Priorities for the Future (Diczfalusy, E. and Diczfalusy, A., Eds.). Scripter, Copenhagen, PP. 35-53. 21. Segal, S.J. (1984): Seeking better contraceptives. Populi 11:24-30. 22. Terentius, P.: Phormio, Act II,Sc.4, Line 14. Transl. Henry Thomas Riley; cf. The Oxford Dictionary of Quotations, Second edition, Oxford University Press, p.542, 1953. 23. United Nations Department of International Economic and Social Affairs, Population Division (1981): Report on monitoring of population policies. Working Papers No. 69, U.N. Population Division, New York. 24. United Nations Department of Technical Co-operation for Development: Report of the International Conference on Population (1984). E/CONF. 76/19. United Nations Publication, Sales No. E.84.XIII.8, New York, 1984. 25. United Nations Population Division (1984): World Population Prospects: Estimates and Projections as Assessed in 1982. To be published (1986). Data reproduced in the Review and Appraisal of the World Population Plan of Action, Report of the Secretary General, United Nations International Conference on Population, Mexico City, August 1984; E/CONF. 76/4 Corr. 1. - 26 July 1984, pp. 29-30. 26. Wittgenstein, L. (1922): Tractatus Logico-philosophicus. Sixth impression (1955), p.181. Routledge & Kegan Paul Ltd. London. 27. World Development Report (1984). Published for the World Bank by Oxford University Press, London. ISBN o-19-520460-3. 28. World Development Report (1986). Published for the World Bank by Oxford University Press, London. ISBN O-19-520518-9. 29. World Health Organization (1982): Facts about injectable Bull.WHO 60:199-210. contraceptives. 30. Family Health Division, Wopld Health Organization Unpublished estimates. 31. World Health Organization 16
(1985):
(1984): Health and fdmily
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In point of fact, No. 23. 32. World Health Oraanization, Media Service Health. In point of fact , No. 27.
(1985): Women and
33. World Health Organization, Media Service (1985): Prevention of maternal mortality. WHO Features No. 99, December. 34. World Health Organization, Media Service (1986): The health of mothers and children. In point of fact, No. 33. 35. World Health Organization Annual, Geneva.
(1985): World Health Statistics
36. World Population Institute (1986): Quoted by the International Herald Tribune, July 7th, 1986.
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