ABSTRACT

Breast cancer (BC) rose dramatically in the 1980s and 1990s, reaching epidemic proportions worldwide. Proposal of a national strategy for primary prevention of the present BC epidemic in the community. Objectives: to reduce the BC incidence, to eliminate the BC epidemic, and to test the potential for primary prevention. The sources of the global data of BC incidence for the past 20 years, by countries and populations, taken from the official WHO-IARC editions of "Cancer Incidence in Five Continents." Additional sources: annual and periodical reports of a number of European Cancer Registries, the Internet and other publications, with estimates of BC up to 2002. Population: reproductive-aged women, 18-50 years, with breast diseases, including BC, and healthy, with free access to the Center for Breast Diseases in Skopje, or elsewhere in Europe. Estimated sample size: 2,000 clients. Age eligibility criteria only. Design: community preventive intervention, before-and-after trial, in duration of three-year follow-up. Evidence presented of the rapid and escalating rise of BC epidemic worldwide: 57.7% rise of the incidence rates in the U.S. between 1980 and 1986; the rapid rise of the new breast cases in the U.S., and incidence rates in the UK and Kuwait; natural experiment of the highest ever recorded breast cancer incidence rate, of 209.4, and the lowest rate of 8.1, at the same place and time, in Harare, Africa; autonomous development of breast cancer in Sweden; and the overall epidemiology of the rising BC epidemic in the U.S., 1980-2002.The neoplastic breast diseases assessed in connection with pelvic lesions (tumors of reproductive system: corpus uteri, ovary, adnexa) and possible common risk factors with osteoporosis. The preventive intervention consisting of: (i) Advice for conversion of barrier contraception (condom, withdrawal) into non-barrier contraceptive practice (the OC pills, diaphragm, IUDs, rhythm, tubal ligation); (ii) Distribution of non-barrier contraceptive devices and methods, free of charge; and (iii) Follow-up and hypothesis testing of end-results with baseline data. A non-barrier contraceptive practice as a basic prerequisite for a primary, non-chemical and sustainable prevention of BC in the community. Main outcome measures: tumor’s volume, density index, patterns of breast parenchyma structure, incidence rates, degree of personal satisfaction of women, and bone density and structure. Expected Results. Stopping tumor progression and reversal of the carcinogenic process in patients; immediate health gain in the community, with reduction of the BC epidemic of about 80 percent; evidence of potential of primary prevention of BC. Corroborated “paradigm shift,” from NO-prevention to PRIMARY prevention of BC. Conclusions: BC IS A PREVENTABLE EPIDEMIC DISEASE and public health problem. A case of socio-cultural interchange in primary BC prevention between less-developed to well-developed countries.

Key words: Breast cancer; primary prevention; reproductive-system cancers; condoms; epidemic disease; risk factors; hypothesis testing; ecological survey.

*Accepted for poster presentation at the Second European Breast Cancer Conference (EBCC2), Brussels, Belgium, September 26-30, 2000.

BACKGROUND

"…Everything we shut our eyes to,
Everything we run away from,
Everything we deny, denigrate or despise,
Serves to defeat us in the end…"
Henry Miller: Acceptance

Breast cancer suddenly rose all over the world in the 1980s, reaching unprecedented epidemic proportions, and accelerated its epidemic rise during the 1990s, affecting mainly the advanced countries of the West. Cancer of the breast far exceeds in frequency (incidence and death rates) any other cancer in almost all female populations worldwide, especially in Europe and Americas. The breast cancer incidence rate rose sharply in the United States during the decade of 1980s, for 57 percent in six years, between 1981 and 1986, [1] as well as in many other countries, such as Canada, the UK, France, Sweden, Switzerland, and other.

Initially, a case-control study was conducted in the United States in order to test the hypothesis that a reduced exposure to human seminal factors during the reproductive lives is an etiologic risk factor in the development of breast cancer in married American women.2-5 The study was carried jointly at the University of North Carolina School of Public Health, at Chapel Hill, NC, and at the University of Pennsylvania School and Hospital, in Philadelphia, PA, between 1974 and 1978. The results of the hypothesis-testing study strongly corroborated the postulated association between the barrier-contraceptive risk factors, i.e., the condom use and withdrawal practice, and the development of breast cancer in married women. In addition, the reached evidence indicated a potential of primary (non-chemical) prevention of breast cancer as an epidemic disease in the community. Quantifying the risk, evidence was presented that the women who used condoms and/or practiced withdrawal for extended periods of time in their marriages had a risk of developing breast cancer that was OR = 5.2 times greater risk (95%CI: 3.1 ® 8.7) than the risk of women who used non-barrier contraceptive methods for fertility control and family planning purposes (diaphragm, oral-contraceptive pills, IUDs, rhythm, cream-jellies, tubal ligation). By using Bayes' theorem, it was estimated that 17.4% of women in the general population using condoms or withdrawal would develop breast cancer versus 3.9% of women using non-barrier contraceptive methods. It was indicated that the latent period of breast cancer development was within a period of two-and-a-half to five years, and the carcinogenic effect of thecoitus condomatus and/or coitus interruptus was operative at a frequency of 50% of these methods. Almost 80 percent of the etiologic fraction of the putative causal factor in the study could be attributed to the long-term contraceptive exposure to (use of) condoms and withdrawal in marital relations.

The observed, unforeseen developments in the epidemiology of breast cancer during the past two decades of the 1980s and 1990s, seems to have substantially supported both the evidence of the tested semen-factor hypothesis of a significant breast cancer and condom-use association, and the postulated conclusion of a potential for primary prevention of breast cancer in the community. At the initial time of the indiscriminate condom-use promotion in the general population for dual purposes, indispensable family planning device and AIDS prophylaxis, the predictive power of the tested semen-factor hypothesis was further tested, by its own explicit prediction, of an imminent and anticipated upsurge of breast cancer epidemic as a rare natural experiment.

The ecological studies of breast cancer incidence rates (age-adjusted) in 166 cancer registration centers and demographic situations on five continents, further confirmed the sharp increase of breast cancer worldwide, especially in the developed and affluent world of North America and Europe.6-12 In a number of developed countries (such as Sweden and Canada), the increase of the breast cancer epidemic showed autonomous developments, uplifting trends despite the declining changes of other types of cancer in women. In a number of developing countries (China, Poland), the age distribution of breast cancer shifted dramatically towards young women, of reproductive age 35-49 years. Correlation analyses13,14 of the postulated two cause-and-effect factors, that is, the estimated by the United Nations prevalence rates of condom use (in percentage) and the reported (by the WHO-International Agency for Research on Cancer - IARC) breast cancer incidence rates (age-adjusted) per 100,000, showed high and significant correlation coefficients (p<.001) by global regions, developed-underdeveloped stages, urban-rural settings, and race.

The biological plausibility of the field's tested "semen-factor" hypothesis was further tested in an experimental study on small laboratory animals. 15 The efficacy of the treatment with prostaglandins was found to exhibit preventive effect on 73.7% of the malignant mammary lesions and on the pelvic (ovary, endometrium), thyroid, and pituitary lesions as well in rats. With the new knowledge of a significant relationship between the barrier-contraception risk factors and breast cancer, based on evidence of tested and corroborated field, ecological and experimental studies, it has been postulated that the breast-carcinogenic processes could be reversed, controlled and prevented. The main conclusion is that breast cancer is a preventable health problem.

A project proposal for a community prevention trial of breast cancer has been suggested in order to facilitate evidence based decision for amending the condom policy and for translating the findings into a public health action for primary prevention of breast cancer and humanizing the women's health in the community and beyond.

The AIM of the preventive trial is to eliminate to a significant level the incidence of breast cancer and to help solve the epidemic burden of the disease in the community. The OBJECTIVES of the preventive community trial are to:

(i) establish a baseline body of breast cancer data of the extent of breast cancer by clinical exams and interviews of a group of women (clients) in the community;

(ii) intervene with advice and application (use) of distributed non-barrier devices or methods to the clients with established breast diseases and needs; and

(iii) follow up and test the end-results of the intervention, and quantify the impact of the health gain and the efficacy of the preventive trial.

The ultimate objective of the study is to provide evidence for an attainable and sustainable prevention of breast cancer in the community as well as at the family and individual levels, as a basis of a wide public health action. In addition, to make an attempt to initiate a case of cultural interaction on health matters, and to contribute aspects of a local culture to the rest of western culture specifically in the field of breast cancer prevention.

MATERIAL, SOURCES AND METHODS

Breast cancer in women all over the world is presented in this study, according to countries, age groups, race, and specific populations. For achieving the objectives of the study, several outcome measures were utilized: number of new cases, crude and age-adjusted incidence rates, age-specific rates, and average annual incidence rates, all per 100,000 female population, percentages of temporal and special changes and differences, and other outcome measures. The global data of breast cancer incidence for the past 20 years, by countries and populations, were used from the "Cancer Incidence in Five Continents" (CI5), volumes IV, V, VI, and VII editions of the WHO-International Agency for Research on Cancer (IARC). Those sources provided comprehensive data of international breast cancer incidence between 1973 and 1992. Additional sources of breast cancer data were used from the annual or periodical reports of a number of European Cancer Registries, reaching the period between 1992 till 1995. A very useful source of breast cancer data and figures was found in the Internet and other publications, especially for the United States, filling the gap for the period between 1995 until 2001, and estimates for 2002. Common statistical procedures were used for testing the significance of the results. Correlation analysis was implemented in order to test the statistical significance of the trends of the disease. The SPSS for Windows program 8.0 was used in the analysis.

EVIDENCE

The highest initial upsurge of breast cancer emerged in the United States, between 1981 and 1987. The escalating rise of breast cancer of 57.7 percent in the country in the first six years of the decade, from 80.1, per 100,000, in 1980, to 126.2 in 1986, reached epidemic proportions (Figure 1). The descriptive epidemiology and etiology of breast cancer is to include a satisfactory interpretation of and search for cause of the rapid, unexpected and perplexing upsurge of the disease in order to be able to suggest an answer for its solution, prevention and elimination of the breast cancer epidemic.

Figure 1: United States, 1973-1992: Rapid Rise of Breast Cancer Incidence, Crude Rates, per 100,000

The breast cancer epidemic continued its expansion worldwide. The data of the breast cancer advent in the United States may serve as a model and testimony of the epidemic. The pattern of the breast cancer epidemic showed that it has unique features and is unlike the pattern of any other disease; it showed no cyclical current, and no decline, stepwise or prolonged, after a supposed culmination. The pattern of the breast cancer epidemic showed only a steady increase throughout the 20-th Century, with periodical exacerbations, reaching further culminations. The number of the new breast cancer cases in the United States, reported between 1960 to 1996,16 and completed with reported new cases and estimated in-situ cases from other sources up to 2002, are presented in Figure 2. The number of breast cancer cases split after 1988, however, showing reporting of two types of findings, clinical and of early detection, that is, the findings of the mammography screening campaigns. The mammography screening campaigns started in 1988 and later, as a consequence to the first and perhaps the greatest wave of new breast cancer cases in the communities. However, the new breast cancer cases discovered in the mammography screening campaigns, mostlyin situ ones, have not been reported to the Cancer Registries. In the years after 1988, the proportion of the non-reported screening-discovered new cases were estimated to be around 15-20% in comparison to the clinically diagnosed and reported new breast cancer cases. In 2001, the proportion of the screening-discovered cases to clinically diagnosed (and reported) breast cancer cases was 24%, thus increasing the reported 192,200 new cases by 46,128 screening cases to the total of 238,328 new cases. For 2002, the proportion of the screening-discovered cases was estimated to be 24.5%, or, 49,858 non-reported new cases, thus increasing the estimated number of 203,500 clinically diagnosed new cases into 253,358 new cases.

Figure 2: Number of Breast Cancer Cases in the United States, 196—2002: Reported and Estimated *Estimated in-situ cases)

The remarkable increases of breast cancer incidence in other parts of the world showed consistent patterns of rapid increases like in the U.S. Almost all European countries, including the United Kingdom, Sweden, Switzerland, Finland, Norway, France, Italy, as well as Canada, Australia and New Zealand, were heavily affected by the breast cancer epidemic in a similar, common pattern. The steady increase of breast cancer in Oxford, UK (Figure 3), showed a 28,0% increase in five years, between 1988 and 1992.

Figure 3: Oxford, England, 1968-1992: Breast Cancer Incidence, Average Annual Crude and Age-adjusted Rates, per 100,000

The age-specific rates showed a definite shift of breast cancer towards the younger generations of women. Besides, the greatest increase of breast cancer was found in younger women, of reproductive age. In many populations around the world, the advent of the breast cancer epidemic reflected initially in increased rates in young women, thus creating a new curve of "debut peak effect." In Japan (Figure 4 and Kuwait (Figure 4A), where breast cancer was almost an unknown condition, the younger populations of women (of all nationalities) showed remarkable increases in subsequent short periods of time, between 1979 and 1989. The changing pattern of age-specific rates supported the observation that the reproductive age rather than age per se is such is a risk factor of breast cancer,

   Figure 4: Miyagi, Japan: Breast cancer incidence Figure 4A: Kuwait, 1974-1989: Breast cancer
     shift to younger Women, in five five-year               incidence shift to younger women, in three
     periods. Age-specific Rates, per 100,000                 five-year periods. Age-specific rates/100,000

Perhaps the most noteworthy age-distribution of breast cancer is that in Harare, Zimbabwe, reflecting both the highest incidence rate and the lowest incidence rate of the disease in the world, in European and the African women, respectively, in 1992 (Figure 5). Probably indicating a natural experiment, the highest ever recorded crude incidence rate of breast cancer, of 209.4, per 100,000, was reported for the resident European women, contrasted to the lowest incidence rate, of 8.1 per 100,000, in African women, with a relative ratio of 25.9 : 1. The extraordinary age-specific incidence differential strongly indicated an intense exposure to (the European women) or lack of exposure to (the African women) the breast cancer risk factors, to the postulated condom use. Similar differentials of the breast cancer incidence rates have been noted in other communities living in the same area, time, place and countries, such as Israel, the US, and other.

Figure 5: Harare, Zimbabwe, 1990-1992: Breast cancer Incidence by Race of African and European Women. Age-specific Rates, per 100,000

A correlation analysis of the age-adjusted incidence rates of breast cancer with the category of "rest of the cancers" of the 24 counties in Sweden, in 1994, indicated an autonomous development of breast cancer from the other types of cancer in the country. (The category of "the rest of cancers" was computed by subtracting breast cancer rates from the existing category of all cancers [without skin cancer] in women.) The Figure 6 presents the trends of three categories of cancer in women in Sweden 1994: While breast cancer rose significantly (p<.0001) by 14.2% in 12 months, all cancers increased by a percentage of 2.1% (mainly because of the incorporated breast cancer), but the "rest of cancers" showed a decline of -1.3%. The data of the correlation analysis may indicate that the biology and the etiology, including the risk factors of breast cancer may markedly differ from the characteristics of many other types of cancer.

Figure 6: Breast Cancer Autonomous Trends in Sweden, 1993-1994, in Percentages: (i) New Breast Cancer Cases, (ii) All Cancer Cases*, and (iii) “Rest” of Cancer Cases** Category

The overall epidemiology of the breast cancer epidemic in the United States is presented in the Figure 7. There is again a dual presentation of the curves, of the breast cancer progression in the country in the past two decades, 1980 and 1990. The curve of the age-adjusted rates, which started at 80.1 per 100,000, in 1980, indicated a much lower level of breast cancer incidence in the country, not exceeding 140 per 100,000. The curve of the crude rate, however, including the mammography-screening findings, indicated much higher levels of breast cancer in the country during the same period of two decades, reaching an exceptionally high incidence rate of 172.9 per 100,000, in 2002. (The age-adjusted breast cancer rates were first standardized according to the World Standard Population 1960, then by the Standard USA Population 1970, and since 2001, by the USA population 2000 taking its census as a standard.) In any case, the development of breast cancer from sporadic cases into a massive epidemic in the US is a far cry from the National Cancer Control Program of 1986 in which the objectives for control of breast cancer were envisioned to decline by 21% in the next 15 years, until 2000. Instead of the programmed incidence of 64.0 per 100,000 to be achieved at the end of the Century, the crude incidence rate of breast cancer in the Year 2000 was 159.1 per 100,000, and the age-adjusted incidence rate was 124.1. Contrary to the observed high incidence rates, the postulated primary prevention of breast cancer would have an impact of about 50% decline of the observed level in 1980, or an impact of about 80% decline, according to the etiological fraction of the causal factor in the general population.

Figure 7: Breast Cancer Trends in the U.S., 1980-2002. The Trend Projected by Breast Cancer Control Program of 1986, the Observed Rise of the Incidence Rates (Crude and Age-adjusted), per 100,000, and the Postulated Preventive Impact, in Percentages

Finally, it is worth noting that the breast cancer epidemic has not circumvented the Republic of Macedonia.^7,9 The increased death rates of breast cancer have been observed since the end of the decade of 1980. The sketchy cancer-registry data indicated a gradual increase of the incidence of the disease as well. Thus, from 355 cases of breast cancer in 1994, with an incidence rate of 33.5, the disease continued to rise to 536 cases in 1995, 551 cases in 1996, 570 cases in 1997, and 596 cases in 1998, reaching an incidence rate of 59.5.

COMMUNITY PREVENTION TRIAL

The purpose of the suggested Community Prevention Trial is to provide answer to the present and aggravating breast cancer (BC) epidemic. Despite the enormous work in the field, including the latest international and European breast cancer conferences, the traditional and dogmatic approaches have not identified the etiological causes of the breast cancer epidemic nor have defined the ways of preventing the disease in the community. The proposal is designed as a three-year community trial, both for testing an innovative approach to breast cancer prevention, and for implementing a primary, non-chemical and sustainable prevention of the breast cancer epidemic in the community.

The indiscriminate and persistent promotion of universal condom use for dual purposes of family-planning and AIDS prophylaxis, induced unintended technical effects of (absolute) male sterility in the community on an unprecedented scale. As explicitly predicted and anticipated, the widespread and increasing prevalence of condom-use in the community resulted in an unforeseen, immediate and rapid rise of breast cancer epidemic especially in the EU and other advanced countries. The potential of primary breast cancer prevention was defined on the basis on the tested hypothesis that the long-term exposure to (use of) barrier contraception (condoms) in married American women has acted as an “inverse” environmental risk factor resulting in elimination, reduction or absence of the postulated “semen factors” (possibly the prostaglandins) in the intimate, inter-human (sexual) environment and ecosystem.

Table 1: PRIORITIES, OBJECTIVES AND TARGETS of Primary Breast Cancer Preventive Project

The ecologic hypothesis to be tested is as follows: The elimination of the etiological risk factor of use of condoms as a contraceptive practice in the general population, in order to eliminate the breast cancer epidemic in the community. The suggested community trial is to be amultidisciplinary study with necessary European collaboration. The ultimate social, cultural and scientific objectives of the preventive community trial is to justify a public health action for a primary prevention of breast cancer and help eliminate the ever rising incidence and death rates of breast cancer and incidence of other reproductive-organ neoplastic diseases in the community, and health impact at family and individual levels as well (Table 1).

The research strategy of the community prevention trial would be a "before-and-after trial," based on historical cohort approach, with controlled intervention.Participants would constitute reproductive-aged women, 18-50 years, with breast cancer and other breast and pelvic diseases, and healthy women who like to join the trial. Women of general population of the country (region) with free access to the Center for Breast Diseases at the Medical Faculty of the St. Cyril and Methodius University of Skopje, or elsewhere in Europe. It will be a population-based sample, with estimated sample size of about 2,000 participants. Age eligibility criteria will be applied only for recruitment into the study. The comparative design is to consist of groups of (i) women (and duration) with history of barrier contraceptive use (condoms and withdrawal), and (ii) women (and duration) with history of non-barrier contraceptive use (pills, diaphragms, rhythm, IUD, tubal ligation).

The initial phase of a cross-sectional study will achieve a quantification of the relative and attributable risks of barrier-contraceptive risk factors and will establish the baseline characteristics of the participants. The second phase of the trial will be a follow-up phase with intervention. The neoplastic breast diseases will be assessed in association with pelvic lesions (tumors of reproductive system: corpus uteri, ovary, adnexa), along with signs of osteoporosis, in a search for possible common risk factors.

The community trial of the preventive intervention is to consist of three clinical steps: (1) Advice for conversion of barrier contraception into non-barrier contraceptive practice

(2) Intervention with distribution of non-barrier contraceptive devices and methods, free of charge, along with control of compliance; and

(3) Follow-up with scheduled periodical clinical examinations, and final hypothesis testing by comparison of the end-results with the baseline data. The duration of the follow-up is to be less than three years. In order to assure an unbiased assessment of the findings, a blinded evaluation of the baseline and of the end-results is to be done by two independent raters (experts in the respective fields).

The clinical investigations will take several steps. First, an informed consent before baseline clinical data are recorded is to be required for enrollment into the trial. The assessment of the baseline profiles of all participants is to be done by personal interview, mammography, ultrasound, physical examination, bone-densimetry, body mass index measurements, gene testing and family history, and of a number of other control factors. Cognizant of the potential birth-control controversy, the promotion of the non-barrier contraceptive methods during the community trial is to be used for therapeutic purposes only. An adequate, non-barrier, fertility-control and family-planning practice is considered as a basic prerequisite for a sustainable primary prevention of breast cancer in the community. Cases of male/marital infertility in the study to be assessed recorded and followed up, but no contraceptive intervention will be applied in those women. The pregnancy events along breast-feeding duration, although not recommended as breast cancer prevention in the trial, will be accepted as a part of the intervention nevertheless.

The ethical considerations will be of special consideration. Since randomization will not be done, the historical data of contraceptive practices will be used for comparison of the initial findings with the end-results. Since it is known that randomization is hardly to be fully achieved in community experimental trials, the comparison of the contraceptive history data, a kind of inadvertent self-selection into the groups is to be permitted, in order to avoid exposition of the participants to unnecessary breast cancer  risk factors.

The main outcome measures will consist of: Breast cancer incidence cases, relative and contributable risks of the past contraceptive practice, duration of exposure to contraceptive methods and techniques, tumor’s volume, tumor's density index, patterns of breast parenchyma structure, bone density and structure, and gene testing frequencies according to risk factors, and degree of personal satisfaction of women participants in the study. Contingent upon the outcome, an extension of the follow-up phase for two more years may be considered for a better completion of the osteoporosis end-result assessment.

Expected results: The evidence to be corroborated that BREAST CANCER IS A PREVENTABLE DISEASE, amenable malignant epidemic and solvable public health burden. In addition, a “shift of the conceptual framework” of breast cancer (and other accompanying diseases and phenomena) is expected to be definite, from no-prevention paradigm to primary prevention paradigm (Figure 8).

Figure 8: Shift of the Conceptual Framework of Breast Cancer: From A – NO-PREVENTION Paradigm to B – PRIMARY PREVENTION New Paradigm

Specific added values of the preventive breast cancer community trial are anticipated to be: Firstly, corroboration of the evidence for a life-long, inexpensive, and natural potential of primary prevention of breast cancer and a number of other related conditions and gender-specific diseases and other phenomena (Table 2).

Table 2: Health Belief Model of Primary Breast Cancer Prevention

Secondly, stopping the tumor progression in individual subjects and reversal of the carcinogenic process in participating patients. Thirdly, immediate health gain with reduction of the breast cancer epidemic for about 80 percent of the observed rate and recorded number of new breast cancer cases in the community. And,fourthly , a public health action with application of the new knowledge for empowerment of women and couples of the general population with information of the real hazards of breast cancer, and enabling them to make free choice for prevention of the dreaded biological terror of breast cancer during their reproductive lives. Additional research might be indicated for preventive action, treatment and prevention of osteoporosis in postmenopausal women and, probably, of Anorexia nervosa in girls and young women. 

DISCUSSION

Breast cancer has risen suddenly and rapidly at the beginning of 1980s and continued its unabated, epidemic rise throughout the 1990s. Worldwide, breast cancer rose by 17.1% in the five-year period 1988-1992, or 3.4% annually. The increase of breast cancer is evident, escalating and statistically significant in almost all studied populations, regions, and time periods. The fascinating, unexpected and perplexing rapid rise of breast cancer in the United States could not be explained by any risk factor or theory of the conventional epidemiology, but by the semen-factor (barrier contraception, the condom use) hypothesis. The presented evidence of the breast cancer epidemic worldwide is a part of the accumulated facts of life and other substantiated scientific and professional observations of the biological plausibility of the proposal, in an effort to support the implementation of primary, non-chemical, and sustainable prevention of breast cancer in the community.

The spiraling breast cancer epidemic, associated with cancers of other reproductive organs, showed to be not an ordinary outbreak of a disease. The breast cancer epidemic, maintaining an intolerable biological terror in the communities, has never subsided. The limitations and misconception of the current downstream activity of salvage-oriented strategy, falsely equated with prevention of the disease, disguised the "war" against the hidden, unknown and feared enemy, the breast cancer, into futile public health and clinical activity. It would be extremely unlikely to protect the younger and the current generations of women and their families and partners of the real breast cancer threat, suffering and death by the continuation of the present dogmatic activities of screening, early detection, and aggressive treatments only. In the attitudes of many populations around the Mediterranean Basin and, apparently, elsewhere, 17^,18 a great stigma is attached to the women suffering of breast cancer. The stigma to breast cancer, but not to other diseases, was probably given at the time when no restrictions in reproduction were possible, and it was routine to see the rare condition in views with certain pattern of weakness or sterility in husbands. The undercurrent popular belief, stemming from the ancient times 19^,20 is that the health or ill health of the husband is reflected entirely on women's health and life,21 and breast cancer as a result of problems in the sphere of the unspoken, unconsummated intimate marital (sexual) life. In fact, it seems that the victims and the family members of the patients even in the developed countries where the disease is pretended to be almost a modern lifestyle feel a hidden stigma attitude toward breast cancer.

The fiasco and early termination of the expensive and damaging to women's health Tamoxifen chemo-prevention trials in Europe and the U.S., and discontinuation of the controversial hormone replacement therapy (HRT),22 along with the disappointing (negative) results of the most recent study on environmental and toxic factors on breast cancer causation on Long Island, New York,23^,24 and disputing the hypothesis (postulated by scientists lacking practical clinical experience and observations, especially in the realm of human reproduction) of the "hormone disrupting environmental exposure" in breast cancer etiology,25 brought back to the main political and professional attention the issue of breast cancer and its ongoing devastating and decimating effects on women.

The breast cancer epidemic is not officially recognized as an epidemic. Although the doctors and the public are puzzled by the steady rise in rates and numbers of breast cancer over the last decades, officially, the breast cancer epidemic is nonexistent. Moreover, there has been claim that the "widespread trivialization of breast cancer became a routine part of the breast cancer culture. 26 The issue of breast cancer, however, as the acknowledged most common cancer, is overwhelmingly a concern of a great number of women's and public associations and organizations, and the information about breast cancer is enormous and quite frequent. Disturbing requests appeared at breast conferences, such as, "Break the silence--stop the epidemic: Opening the doors to dialogue around the world, 27 Alarming headlines appeared in the mass media, such as, "Cash and Cancer: An Unholy Alliance," along with the comment that the widespread information about breast cancer has been "inundated with meaningless information," since it repeated the useless knowledge and proclaimed no possibility of prevention. 28 "Breast cancer -- why so many?"29 "Estimated breast cancer incidence skyrockets."30 The elevated levels of breast cancer rates are remarkable and still rising, thus the traditionally defined reasons for the increased risk, such as, delayed childbirth, earlier menarche, diet, dairy products nutrition, lack of exercise, etc., proved to be useless in explaining it and much less in preventing the dreaded disease.31 It was unusual to note that even in the Brussels Declaration of the 2nd European Breast Cancer Conference, 1998, there was absolutely no mention of prevention.32 The American and British breast cancer alliances and advocacy groups tried to emphasize to a certain degree the necessity of prevention, requesting research on "how to stop and prevent the epidemic."33 In a Petition, delivered to the President of the U.S., in October 1993, the breast cancer activists highlight the fact that breast cancer was "far more prevalent than the AIDS epidemic" in the country.34

The effort of the concerned American breast cancer advocates, survivors and activists apparently remained ineffective, since the request had in all probability had to be reviewed and endorsed by an official body for population matters.35 However, it is not for certain that the attitude of everybody involved is to welcome a prevention of breast cancer in the community.36

The breast cancer became a political issue37 of highest public health priority and the prevention of the current epidemic of the malignant disease is to be solved at highest political levels as well. Most probably, no likely solution to the current breast cancer epidemic worldwide, and especially in the advanced and developed countries of the West, could be reached as long as a book in primary breast cancer prevention² is effectively banned from public view, censored for further professional assessment and testing, and barred from considerations as a potential basis of a public health policy in prevention of breast cancer and other accompanying sex-specific diseases and phenomena.

The community preventive trial, as proposed, with retrospective and prospective strategies, will attempt to reassess the efficacy of the non-chemical intervention, i.e., the conversion of the barrier contraceptive practice (the use of condoms and/or withdrawal) to a non-barrier contraceptive practice (the OC pills, diaphragm, IUDs, rhythm, creams-jellies, tubal ligation). The elimination of the use of condoms and withdrawal for fertility-control purposes in the mainstream population is expected and tested to bring about the postulated reduction of breast cancer and other neoplastic lesions in the community, and a new approach in the field of Mastology and the reproductive-organ oncology. In allegorical terms, condom is the most frequent demon in medical history. By removing the cause, the epidemic breast cancer problem will be eliminated.

The breast cancer epidemic, along with the twin epidemic of AIDS, is perhaps one of the last vestiges of the hot Cold War. There is no justification that women should continue paying the deadly tolls of the reproductive bioengineering technologies, in learned ignorance, deceptive participation, denied free choice, and false beliefs that they are protected by the indiscriminately promoted "safe" high-technology methods of "reproductive freedom." The most recent NCI reanalysis showed that "breast cancer rates have not been leveling off during the 1990s, but have actually been rising 0.6% a year since 1987."38 In addition, a NCI call is placed forward for research "to explain the cause of the recent rise in breast cancer," as this study is trying to emphasize a plausible answer of etiology and prevention of the disease. Obviously, the condom culture, the purported cause of the global breast cancer epidemic, has become strong, preponderate, pervasive and self-perpetuating misconception and lifestyle in most of the industrialized world.

The first practical step in primary prevention of breast cancer, however, should be to implement their human rights "to know" and to empower the European and other women and couples with the information about the real hazards of breast cancer, raising the awareness of the possibility of prevention of and protection against the dreaded disease, and emphasizing the necessity of attaining the ability for personal assessment of the risk factors in their life situations. Empowered by a valuable information, no doubt that the women and couples will be able to individually make free choice of, judgment about, and informed biological decisions for their personal health, protection against breast cancer and other accompanying diseases, contraceptive needs, and family well-being.

Implemented potential of primary breast cancer prevention would induce immediate health gain in the European Community and beyond. The European women along with the American women deserve better than the downstream salvage attempts as the only public health policy, because they are among the most affected by the epidemic disease and they do suffer and die needlessly from breast cancer, without any factual help. The case of a socio-cultural interchange and dialogue in prevention of breast cancer would be an uncommon technology transfer from a less-developed region to the well-developed and affluent regions and communities within the common European house.

REFERENCES and Endnotes

[1] Gjorgov, Arne N.. Emerging worldwide trends of breast cancer incidence in the 1970s and 1980s: Data from 23 cancer registration centres. European Journal of Cancer Prevention (London) 1993; 2: 423-440.

2-5 Gjorgov AN. Barrier Contraception and Breast Cancer. S. Karger Medical Publisher, Basel-New York-London-Paris-Munchen-Sydney, 1980: x+164 p.

3. Gjorgov AN. Barrier contraceptive practice and male infertility as related factors to breast cancer in married women. Preliminary results.Oncology (Munich) 1978: 35: 97-100, and Medical Hypotheses (Montreal, Canada) 1978; 4(2): 79-88.

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Published in the “New Balkan Politics. An Academic Quarterly Journal of Politics,” Skopje, 2003, Vol. 6-7, pp.143-169