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A HEALTHCARE REFORM PRIORITY AN ATTEMPT TO DEFINE PREVENTION OF BREAST CANCER by Arne N. GJORGOV, M.D., PH.D.
(2ND, EXPANDED VERSION)
Macedonian Information Centre
Vol. VII, Special Edition
AnAlyses of MAcedoniAn Politics, econoMy And society
Analyses of Macedonian Politics, Economy and Society
Skopje, February 2010 Vol. VII, Special Edition
HEALTH OF WOMEN
A HEALTHCARE REFORM PRIORITY AN ATTEMPT TO DEFINE PREVENTION OF BREAST CANCER by Arne N. GJORGOV, M.D., PH.D.
(2ND, EXPANDED VERSION)
Macedonian Information Centre
MACEdonIAn AffAIrS Analyses of Macedonian Politics, Economy and Society february 2010, Vol. VII, Special Edition Please, send manuscripts and letters to the editor to: The Macedonian Affairs Editor, Address: Macedonian Information Centre, Naum Naumovski Borce 73 1000 Skopje, Republic of Macedonia Tel./Fax: + 389 (0)2 311-78-76 + 389 (0)2 311-78-34 Internet: www.micnews.com.mk e-mail: email@example.com, firstname.lastname@example.org Submission guidelines available on request. For subscription inquiries or resolving subscription problems call: +389 (0)2 322-18-42
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1. A HEALTHCARE REFORM PRIORITY AN ATTEMPT TO DEFINE PREVENTION OF BREAST CANCER .................................................................... 5 ANORExIA - BuLIMIA NERVOSA AND BARRIER CONTRACEPTIVE PRACTICE IN YOuNg FEMALE PATIENTS ................................... 25
A P EN D EX ES : BREAST CANCER DEATH OF EMPRESS THEODORA, WIFE OF JuSTINIAN I OF BYZANTINE, IN THE SIxTH CENTuRY .............. 55 A REVIEW OF THE OSTEOPOROSIS IN WOMEN: AND A NEW HYPOTHESIS FOR TESTINg ....................65 TO BBC EDITOR: REPLY TO SuSIE ORBACH’S ANORExIA DEBATE “THE FIgHT FOR OuR BODIES,” ......................................81 EARLY REPRODuCTIVE EVENTS AND BREAST CANCER ..............................................................83 RE: FAREWELL TO CHEMICAL PREVENTION OF BREAST CANCER ..................................................................93
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HEALTH OF WOMEN - 5
HEALTH OF WOMEN:
A HEALTHCARE REFORM PRIORITY AN ATTEMPT TO DEFINE PREVENTION OF BREAST CANCER
Arne N. GJORGOV, M.D., Ph.D. Man’s love is of man’s life a part; it is a woman’s whole existence.” Lord Byron
ABSTRACT BACKGROUND. On the evidence-based information of breast cancer as a preventable disease, an attempt is made for definition of primary, non-chemical prevention of the epidemic breast cancer. The battle over healthcare reform is revolving around women’s issues and health protection. AIM. To add to the knowledge and to advance the tested concept of the potential for primary (non-chemical) prevention of breast cancer as an epidemic disease. Ultimately, to present from a medical point of view the attempted definition of a preventive contraception against the epidemic breast cancer (on Table 1). JUSTIFICATION. The number of cases and the incidence of breast cancer is in a steady increase worldwide and in our country, Macedonia, (with more than 800 cases, or 76.2 crude rate per 100,000 female population, in 2008), followed by great expenses in human lives, individual and familial disasters, and material resources. It could
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be assessed that no healthcare reform could be achieved as long as the half of the population, women of all ages, is threatened by a real risk of breast cancer as an epidemic disease. The changes in the biological micro-environment and ecosystem of the intimate (sexual) woman-man relations, which is still unknown, reflect gravely upon the health and lives of people, especially women of all ages. PREVENTION of breast cancer is neither mentioned nor considered in the ongoing debate of healthcare reform, in the scientific literature, and at the conference meeting. EVIDENCE AND DISCUSSION. The results of the initial field study and other ecological and experimental studies showed and corroborated the evidence that the mass condomization of women’s sexuality is the root cause of the perplexing emergence and rapid rise of the breast cancer epidemic all over the world along with the occurence of the AIDS epidemic, after 1981. Prevention of breast cancer rather than programs of mass mammographic screening for early detection of cases of the disease are discussed. The views on contraception and marriage of the main religious denominations in the Western world, which were relevant to the aim of this study, are briefly presented. The negative consequences of early detection of the disease and the recent debate of questioning the breast screening programs is discussed. CONCLUSION. From a medical standpoint, to achieve the suggested primary prevention of the breast cancer epidemic it is necessary to eliminate completely the barrier devices and methods of contraception, the condom use and withdrawal practice. Instead of use of barrier methods, a replacement is to be done by shifting to use of other, non-barrier methods and techniques for fertility-control and family-planning purposes during the reproductive life-span of women, which include: abstention, rhythm, IUDs, OC pills, and tubal ligation. Key words. Breast cancer, Healthcare reform, Condomization, Sexuality, Barrier devices and techniques, Contraception, Religious views, Non-barrier methods and devices, Primary (non-chemical) prevention, Enclosed: Table 1.
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INTRODUCTION The battle over healthcare reform is revolving around women’s issues and health protection against the widespread, specific female diseases, including breast cancer. The changes in the intimate (sexual) biological micro-environment and affected ecosystem in woman-man relations, imposed by specific technological force, whose consequences still remain unknown, reflected gravelly upon the health and lives of people, especially upon women of all ages. The results of the initial research study and the other, subsequent ecologic studies and an experimental trial corroborated and confirmed the evidence of the mass condomization of women’s sexuality as the root cause of the perplexing and rapid emergence of the breast cancer epidemic worldwide accompanied by other tumors and lesions on the female reproductive system The interest and debate about the struggle against breast cancer is increasing in intensity in our country, with certain belated awareness. At a Breast cancer conference in Skopje (Republic of Macedonia), in the beginning of March, 2009, a post stamp (of about $0.25) was promoted as a financial help in the war on breast cancer. It was a copy of the American stamp of a stylized woman’s head, with the same logo “Fund the Fight. Find a Cure,” issued previously by the American Post office on behalf of the breast cancer organizations. The epidemic rise and extent of the current breast cancer crisis worldwide was emphasized, by quoting the number of about 800 cases of the disease, or crude incidence rate of 76.2 per 100,000 female population in the country in 2008, and the heavy human and material burden of the rising breast cancer epidemic. In average, the direct costs of clinical treatment of a breast cancer case was estimated to be around €55,000, “aside the cost of the operation” which was close to the cost of the post-operative treatments, with a bottom line of more than €100,000 expenses per a case, similar to the direct costs and expenses per a breast cancer case on a global extent. Like everywhere, the indirect costs of a breast cancer case in advanced countries were quoted to be threefold greater than the direct (medical) costs (1). The imperative for nationally based screening programs for ‘early detection’ of the disease in women by mammography, between 40 and 65 years of age, and provision of more advanced mammographs and sonographs, were emphasized as indispensable in the struggle against the expected increase of the breast
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cancer epidemic in the future. The potential of prevention of breast cancer as an epidemic disease was neither mention nor discussed at the conference. In the published interview with one of the experts and promoters of the post-stamp, the answer to the question “is there any way of avoiding the danger of breast cancer?” responded explicitly that “There are no methods of prevention of this disease” (2). Contrary to this confident assertion, this study is attempting to espouse the evidence that the epidemic breast cancer is a preventable disease. The sudden and unprecedented epidemic of malignant disease (cancer) of the breast emerged as a collateral, twin outbreak at the same time and all along with the unexpected emergence of the AIDS epidemic, at the beginning of 1980s and ever since. The objective of this study is to emphasize both the need to implement primary prevention and protection against the epidemic forms of breast cancer (along with the accompanying neoplastic diseases in women), and to attempt to define the preventive means to be practiced during everyday lives of women of all ages. RESULTS OF THE ETIOLOGY OF THE EPIDEMIC CANCER OF THE BREAST The results of the initial, hypothesis-testing study of etiology and prevention of breast cancer (3-6) provided evidence and inferences which showed to be new and different from the widely and routinely accepted conceptions about the women’s health and ill-health. It was indicated that there is an association at a significant level between the use of condoms and the development of breast cancer in American and other married women. The etiological link between the use of condom and breast cancer, corroborated in a field study, was subsequently confirmed in a dramatic way by the (explicitly predicted) rapid natural experiment of surprising breast cancer outbreak / epidemic, following the mass condomization campaign for prophylaxis of the suddenly emerged epidemic infections of AIDS, after 1981. Among the other inferences of the evidence-based results of the study was the new perception that the marriage, sexuality and love construct a profound biological marital union, with a strong
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physiological impact upon the spouses, particularly on woman, besides the traditionally acknowledged ‘definition’ of marriage as a social, psychological, economic and legal unit between a woman and a man. The biological plausibility of the purported causal link of the use of barrier methods of contraception (condoms and/or withdrawal - coitus interruptus) to breast cancer in American women has been elaborated elsewhere (3, 6). The causality of breast cancer exposure to condom use was defined in the research study as an INVERSE ecological risk factor due to the absence, elimination or reduction of certain protective biological factors in the seminal fluid (the prostaglandins?), thus inducing technical effects of absolute male sterility in the prime and primordial biological woman-man communications of sexuality. It has also been observed that the dichotomy of sexuality and procreative function of the female is much more complex than it has been presumed. Although intertwined, the distinct sexuality and reproduction capacities in women might offer a ‘window of opportunity’ to act coherently in achieving contemporary imperatives of both, to control the individual fertility and the global population growth, and to prevent the threat of breast cancer as an epidemic disease. In historical (and pre-historic) prospective, it was inferred that marriage in homo sapiens societies has been and remained an institution primarily for protection of the woman and her biological needs and changes, cyclical periods and natural functions, such as menstruations, pregnancies, deliveries, raising children, breast-feeding, and guarding all her functions subject to vulnerable episodes and exposures to outside threats. The unspoken notion at the woman’s biological needs as the main reason for marriage and the central figure of woman in the family structure seems hinted in the Bible, but virtually abandoned to a great extent in the modern civilization today. The alienation from the traditional family values has been escalating in parallel with the emergence of new technological appliances and machines which substituted and alleviated the heavy domestic duties/work of women (7). Among the technological advances for help to women are certainly the high-tech devices for false protection and control of their sexuality, including condoms and the variety of other contraceptive methods.
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Although the attention and concern was focused mainly on the ‘hormonal’ oral pills for birth-control, the condom use and the uncritical campaigns for its use in the mainstream population(s) resulted in grave consequences on health and lives of women of all ages, in terms of the on-going breast cancer epidemic. Even though the use of condoms dates for more than one century (in England at least), the condoms have been totally overlooked as the possible cause of the widespread ill-effects and morbid consequences in women. The introduction of mass condomization of female sexuality has completely corrupted and destroyed the micro-environment of intimate (sexual) human ecosystem, by creating technical effects of sterile mating and unphysiological primordial woman-man relations and cohabitation. The unspoken ideas and intuitive popular knowledge of sex and sexuality as necessary part of life, health and survival of woman in marriage, and maybe of her beauty, was replaced by a conceptual vacuum of sex and sexuality as a trivial, ‘recreational’ gender activity. PREVENTION OF BREAST CANCER INSTEAD THE ‘EARLY DETECTION’ PROGRAMS Emphasis in the battle against the breast cancer epidemic has been given and still is on the so-called ‘early detection’ of breast cancer cases. Some of the controversial issues of the exclusive strategy of early detection, including the in-situ cases, are: • The programs of early detection of breast cancer, which started in earnest in North America and Europe in 1988, as a “preventive approach” to the disease, after the first breast cancer outbreak, pointed out to a new reality that the ‘downstream” healthcare activities (screening and extensive clinical treatments) did not have any effect, nor solution for decline of the on-going breast cancer epidemic. Screening was inefficient to stop the breast cancer epidemic in the community; did not define the cause(s) of the excessive spread of the epidemic, and did not determine any preventive potential for elimination of the breast cancer epidemic or of the carcinogenic risk factors of the disease in the population(s); • The cancer of the breast, which in medicine is considered a systemic disease, could not be successfully treated with interventions on the local lesions only, for the risk of recurrences and distant metastases is always present even with ‘early detection’ and aggressive clinical
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treatments; The issue of the in-situ cases of the disease is challenging the concept of early-detection because of their uncertain end-results; • The campaign for national mammography screening programs is based on the premise of continuous rise and extension of the epidemic breast cancer into eternity. In the past three decades, there have been not less than six to eight million women afflicted with breast cancer, with about a quarter of them perished, in the U.S., since the early years of 1980s. In addition, breast screening programs have long been used for a denial of and falsifying the real rise of the perplexing and expanding breast cancer epidemic in the developed world and, later on, in the developing world as well; • The triumphant claim that “screening saves lives” is unsubstantiated as well, since the non-screened breast cancer cases have the similar rate of survival as the screened women; the survival may have depended on the frequent collateral surgical interventions of the tumors and lesions which usually accompany breast cancer in younger, premenopausal women, such as hysterectomy with or without oophorectomy, thus resulting protective effect similar to that of tubal legation and OC pills; • The deterrence and obviating the evidence for primary prevention of the on-going breast cancer epidemic, rather than screening, is perhaps the greatest damage done to every society by the planned mass mammography screening campaigns, cloaked in scientific rhetoric as “preventive health-care” programs, and yet effectively excluding the women and couples from the information of preventability of breast cancer as an epidemic disease. By opposing public health option for implementing a primary (non-profit, non-chemical) prevention of the current breast cancer epidemic, the suppressive policy resulted in ‘holocausting’ millions of women of all ages.. Breast cancer is a preventable disease. Evidence of the potential for primary (non-chemical) prevention of the epidemic form of breast cancer along with the accompanying gynecological malignant tumors and other lesions is based on scientific studies and tests (3,6), together with experimental trial and other ecological investigations and other indicators of the epidemiology of breast cancer worldwide (8-11). The last development of a flurry of questioning negative consequences of the breast screening programs (12-14) seems to be
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attempts of stopping the meltdown of a long-time misconceived policy in the battle against breast cancer. CONTRACEPTIVE METHODS: ARGUMENTS AND POTENTIALS FOR BREAST CANCER PREVENTION Contraception is an indispensable and inseparable part of the technological transition and living in the contemporary civilization. And yet, due to imperfect understanding of the physiological effects, the contraception is a part of certain gruesome consequences in women, such as breast cancer. Paradox is that both the threat and the solution of the health of women and control of her fecundity are to be supposedly found in contraception and family planning. Many aspects in woman’s personal and family life are reflected on her health and fate. The fertility is a natural capacity necessary to preserve it within the contraceptive practices, instead of the tendency to suppress or destroy this vital innate value because of ignorance or wrong device, methods and techniques of contraception. In order to be applicable and acceptable to the consumers in biological, social and ethical sense, a viable contraception has to have at least three capacities: (i) to protect the life, health and sexuality of the woman, (ii) to protect against unwanted pregnancy, and (iii) to permit ‘normal’ sexual relations. Violation of any of those requirements introduces a risk for fast destruction of the health and lives of women and their families. It is an almost inconceivable fact that the errors in prevention of unwanted pregnancy (with condoms), is reflected to and associated with multitude of signs of ill health in women, including breast cancer and accompanying lesions on their reproductive system. For a natural protection against breast cancer, it has been empirically estimated that a woman has to have experience of eight or more full-term pregnancies (15), together with multiple, relatively short breast-feeding periods of about six months average time for each child, what is obviously impractical to achieve and maintain in the contemporary demographic situation. Conclusion has been that a woman could be able to try to protect herself against all, the unwanted pregnancies and grave abortions, as well as of devastating consequences of breast cancer, including anorexia-bulimia disorders in teenage girls by abandoning barrier contraceptive methods in favor of use of adequate, non-barrier contraceptive methods and techniques.
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AN ATTEMPT FOR DEFINITION OF PRIMARY PREVENTION OF BREAST CANCER The question remains how to prevent breast cancer and other sex- (gender-) specific diseases and disorders in women? Given the available evidence, the most likely answer would be the elimination of the exposure to the use of the barrier contraception methods (condom devices and withdrawal practice), and instead to use non-barrier contraceptive methods and techniques (Table 1). The known professor of gynecology and obstetrics and Dean of the School of Medicine of the University of Dundee, Scotland, Dr. P.W. Howie, has vividly portrayed at the outset (in 1981) the uncertainties which exist among women-users of contraceptives (16): “As the risks of the pill, the coil and sterilization receive increasing attention in the media, one must have sympathy for bewildered contraceptive users because it looks as if the condom is about to get it in the neck as well.” The legitimate fear and dilemmas about contraception should be reassessed and redefined within the framework of the new scientific attainments. The basic idea which is hereto presented in the Table 1 is the evidence-based knowledge for an absolute elimination of the barrier devices and techniques of ‘contraception’ (condoms and withdrawal) and the need for practical shift to certain non-barrier methods and techniques, which could be alternatively used during the reproductiveage span of a woman. The non-barrier methods for contraception ale listed in table 1, as follows: Abstinence, as a temporary measure for underage and teenage girls; NFP (rhythm) methods; Diaphragm, IUDs, Oral contraceptive pills, and Tubal ligation. From medical point of view, the concept of preventive contraception of breast cancer takes into consideration three basic parameters: (1) the reproductive experience and status, (2) motivation for family planning, and (3) the (approximate) age of any reproductive event(s) of the woman and family. The contraceptive alternative methods, such as, ‘Morning after” steroid shots or pills, and the so-called “Plan B,” for accidental and unprotected sexual contact, are not included in the list of preventive contraception against breast cancer, since the controversies of their possible risk of and association with breast cancer. The surgical
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interventions of the (so-called) “prophylactic” mastectomy, hysterectomy, and oophorectomy (one- or double-sided), are also excluded from table 1, because of the common conclusion and logic that the surgical interventions cannot be considered justified for a routine public health approach to breast-cancer prevention. DISCUSSION It was not an easy task to assess the risk-benefit balance of particular contraceptive methods. Uncertainty about the health of women on long-term use of contraceptive methods is present not only with the consumers but with the professionals as well. Until 1930s, all religious denominations strongly forbade contraception as “always considerably evil.” After the Great War of 1914-1918 (WWI), a new social order built-up in the aftermath of the war, initially in the industrialized Western-European countries. The social changes in the industrialized societies developed most likely as a result of several good causes that, among which, firstly, entire generations of young men-soldiers who died at the frontlines did not return home; secondly, the young women who worked at the defense industries as replacement to the recruited male work force in the military, did not return home as well, for housework and family life only, but remained employed in the industries and services; and thirdly, the discussions and scientific studies about the post-war social changes, marital issues and women’s rights along with demands for birth control and contraceptive information grew intensely. Among the early authors with scientific and professional credentials was Dr. Th. van de Velde, a gynecologist and researcher from Belgium, with his trilogy “Ideal Marriage: Physiology and Techniques,” which after 1926 justifiably drew much interest in issues of marital life, sexuality, and liberalized contraception, With no pretention for a theological approach to interpretation of the subject matters, perhaps it may be justified to assume at a lay but informed view at the steadily growing interest in the socially and culturally changed post-war populations in the West as the main cause which prompted the Conference of the Anglican Church, at Lambet, in 1930, to reconsider and declare contraception as a “lesser evil” than
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the unwanted pregnancy and abortion. Thus, the Anglican Church Declaration of permissibility of contraception broke the ranks with the other Christian churches for the first time on the subject matter. All contraceptive methods (including condoms) were permitted for use in Great Britain, without much debate about possible adverse effects. The Catholic Church responded to the popular challenge on contraception in the same 1930 with an Encyclical from Pope Pie XI (Casti Connubii), with instructions for better understanding of procreation in marriage and sexuality of the believers. A clear understanding of the Catholic Church centuries-long tradition of condemning contraception seems well summed up in the following explanation:: "since... the conjugal act is designed of its very nature for the generation of children, those who, in performing it, deliberately deprive it of its natural power and capacity, act against nature and commit a deed which is shameful and intrinsically immoral." The global Catholic congregation, Vatican II, in the 1960s, held a long and in-dept debate and considerations about family planning and contraception. Among the wide considerations about the “control of nature” was the inference at the congregation that “Experience will show what is good or what is evil…” in the realm of birth control and contraception (17). In 1968, Pope Paul VI produced the far-reaching Humanae Vitae encyclical letter, which was perceived as an answer to the new social needs and scientific reality related to marital life and birth control. Together with elaborated details of the moral, psychological and health aspects of the ‘artificial’ contraception and its potential for seriously damaging the values of the holly sacrament of the marital institution, the Papal Letter highlighted its concern for the unknown hazard to the health of mother and child. The use of the ‘natural family planning’ (NFP or, so-called, Ogino-Knaus, or ‘rhythm’ method), was the only birth-control technique permitted to the Catholic couples to practice. Except the rhythm method, strong prohibition was proclaimed against the use of all other methods, such as: the oral contraceptive pills (the method which was most marketed at that time), because of containing steroids in various concentrations to be given to healthy women, and assumed threat and danger to the moral and fidelity in marriage and increase of promiscuity; the intra-uterine devices (IUDs, because of the threat to potential abortion and uterine infections and sepsis); the diaphragms, condoms, and sterilization (of both male and female, as one category) and other methods (17). Because of unknown and
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assumed adverse effects of contraception (all as one, inclusive grouping), grave consequences on the health and life on woman, the child and the family were anticipated by a Catholic scholar, Prof. P.G.D. Riley, as an unidentified but impending global calamity (18). The gloomy predictions were materialized and vindicated to a great extent with the appearance of the perplexing, suddenly emerged and rapidly rising breast cancer as an unprecedented, for the first time in medical history, epidemic of malignant disease(s) (3, 6) instead of the ‘familiar’ epidemics and pandemics of communicable, infectious diseases. Besides the strict restrictions of contraceptive methods in the Humanae Vitae (1968), in the same Papal Letter there was a far-sighted stipulation, if correctly understood by a medical layman in a biomedical context, that the Catholic teaching seemed to consent in the Chapter 15, “Licitness of therapeutical means,” to the use of artificialcontraceptive methods as possible therapeutic methods, as quoted: “The Church, on the contrary, does not at all consider illicit the use of those therapeutical means truly necessary to cure diseases of the organism, even if an impediment to procreation…” (17). More than 40 years ago the attention was focused mainly on the steroidal oral contraceptive pills and their potentially carcinogenic, harmful and other adverse effects and infections of the reproductive organs and fertility of women. No reprieve was made, however, in the persistent condemnation of condoms as “unnatural interference” in the nature of marital sex. With the new information of the significant condom-use association with the breast cancer development, the answer to the epidemic and its steadily rising threat of malignant diseases in women, a therapeutical contraceptive adjustment with some nonbarrier contraceptive methods and techniques, seems unrecognized. The contraceptive adjustment is an attempt to eliminate both the past exposure to breast cancer risks, and a primary prevention against exposure to breast cancer risk in women of all ages. The envisioned objective of the ‘therapeutical contraception’ is the elimination (‘eradication’ to occurrence of few, scattered cases) of the current, excess breast cancer epidemic worldwide to a low incidence of the disease(s) at personal, familial, and national levels. The Judaism has always had precautionary views concerning marriage, woman, committed sexuality and methods for prevention of
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pregnancy. First and foremost, the withdrawal (coitus interruptus) has never been part of a ‘contraceptive’ list of method, and presumed as totally forbidden in the Judaism. For, the threat of capital punishment, as it happened to Onan, due to the mortal sin of spilling the seed on the ground in sexual relations with his levirate, second wife. One of the interpretations was that the Creator is forbidding sterile mating. With regard to modern contraceptive methods, Judaism seems to have shown more tolerant position than other religions. The Responsa classification of eight contraceptive techniques graded from “the most to the list” favored methods, according to the degree of a direct “interference with the generative act and organs,” starting with the OC pills and IUDs (as #1), female sterilization (#2), douche, cervical cap, spermicides and tampon (#3-5), diaphragm (#6), IUDs, again, if leading to abortion (as #7), and ending with male condom (#8). It was a rare reference of condom use, perhaps the only one in the religious literature, with recommendation to its followers, in 1960s and 1970s, that “the male condom be used only in extreme cases of acute danger, and only if other means are unavailable” (19). The Orthodox Christian Churches, with multiple centers in the world, were in accord with the doctrine of the Catholic Church in terms of prohibition of contraception and abortion as an evil. In practice, however, the Orthodox Church allowed the decision for prevention of pregnancy to be done as individual choice (20). The Orthodox Churches believe that the significance of marriage and marital sex has at least four purposes: 1) the birth and care of children, 2) mutual aid of the couple, 3) the satisfaction of the sexual drive, and 4) growth in mutuality and oneness, i.e., love (21). It looks as though the extended Orthodox teaching of the purpose of marriage differs from the Catholic Church which considers marriage as an institution only for twin marital purposes, unitive of the spouses and procreative for children (21). Referring to old Christian sources and theological authorities (of St. Thomas Aquinas and St. John Chrysostom), the Orthodox Church looks at the sexual drive / thirst as the prime purpose of and reason for marriage among a woman and a man, and also for “enjoying sexual relations of husband and wife for their own sake and mutual love” (21). In the teaching of the Orthodox Church there is “an absence of any commitment against contraception,” and “a reliance upon medical profession to supply further information on the issues” of birth control methods (22).
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Islam also prohibits contraception, sterilization, abortion, and infanticide (20). Islam, however, seems neutral about withdrawal (coitus interruptus), known and called ‘azl’ in Arabic, for being an ineffective means of controlling or limiting the traditionally high-parity Muslim families. “Whether there is azl or not, the children will come” is an old saying. Islam vigorously condemns condoms, though. “Virtue, not condoms!” was an official proclamation in Kuwait at a global Conference against AIDS, 1993. Neither the oral contraceptive pills, nor IUDs, or diaphragms produced epidemic emergence of certain female diseases, particularly not epidemics of malignant diseases, such as cancers of the breast, ovaries and other reproductive organs. In use of more than one century, the condoms have always been accepted in England and in other places in Western civilization for granted as a social benefit. Although at the turn of the 20th Century there were some voices of concern in the art and literature about the use of “rubber sheath” as a “prophylactic suppression and barrier” and “a mechanical device to frustrate the sacred end of nature,” (23) the concerns about adverse effects were soon forgotten, and the utterly incomplete understanding of and lack of interest in the grave hazards of “condomization” upon female sexuality prevailed ever since. An in-depth historical review by the scholar H. Ratner (24) of the “salutary effects of absorbed semen” during sexual act, the loss of wellbeing because of absence of the “built-in prescription of Mother Nature for wellness,” the link of condom to breast cancer and preeclampsia, and the saying of M.Stopes, London 1918, that “[I]t is a fact that many women suffer intensely when in their sex relations they are deprived of the semen, either by the practice of coitus interruptus or through the use of a condom” were presented. The strong condemnation of the OC pills by the Catholic Church, after 1960s, was justified by the concern of potential endocrinological or any other damage exacted on healthy a woman, as well as on the fetus in case of pregnancy. Condom was generally prohibited in the list of ‘artificial’ contraceptive methods, with neither specific fear of physical or other harm on woman, marriage and love among spouses, nor breast cancer as a lethal consequence of its (condom’s) use. Because of the lack of research in the area of biological ill effects of condom
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use, no evidence of the grave outcomes of condomized sex on woman’s health was available or tested. For a long time after the evidence of the condom-use link to breast-cancer development was tested and corroborated (in mid-1970s), the use of condoms was still officially promoted, particularly in the past three decades, since the beginning of 1980s, to be “with no known consequences” and as a “safe” device for fertility-control and family-planning purposes. The evidence of life-threatening effects of use of condoms, the breast cancer epidemic, due to technically induced absolute male sterility in marital relations, was presented and subsequently confirmed, almost 10 years after the “Humanae Vitae” 1968 Encyclical letter, in which the issue of the OC pills was the central point of debate and concern of birth control throughout the 1960s and 1970s. Another extensive study which opposed condom use on social and moral grounds (25), showed to be one-sided as well, because it failed to take into consideration the biological issues of condomization of female sexuality, the carcinogenic effects and other ill-health consequences plaguing women and girls. Surprisingly, the new phenomenon of mass condomization of female sexuality, corrupting the basic tenets of marital communication and destroying the intimate (sexual) inter-human bio-system, and resulting in the unprecedented, global appearance of carcinogenic effects on health and lives of women, breast cancer as an epidemic malignant disease and rampant anorexia-bulimia disorders in schoolgirls and other young women, has not been recognized / addressed even in the most recent documents of Christian thought (26). A supportive argument is the historical fact of the sudden emergence of the epidemic of breast cancer in the beginning of the 1980s, as an (explicitly predicted) natural experiment, resulting from the campaigns for promotion of condoms for universal double use, prophylaxis against AIDS transmission and prevention of unwanted pregnancy. The breast cancer epidemic did not appear in the prior two decades of 1960s and 1970s when the attention, choice and the use of oral contraceptive pills (‘anti-baby’) was in focus of marketing, with negligent use of the other methods such as diaphragms and IUDs. The heuristic studies in the voluminous literature of condoms have always investigated only the technical failure, or efficacy of the impermeability to seminal and germ contents (HIV/AIDS virus and
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other ‘sexually transmitted diseases’ - STDs). The condoms have been steadily referred to as a ‘safe’ and an ‘ideal,’ modern contraceptive method and device, with no known harmful consequences, thus promoting a “safe-sex” and condom-related “reproductive freedom” culture. All condom-use studies have been absolutely oblivious to the on-going breast cancer epidemic and the other widespread diseases (anorexia-bulimia disorders) plaguing teenage girls and other young women (27). Given the fact that condom-use has not been assessed in the context of carcinogenic and other devastating biological effects in women of all ages (breast cancer, anorexia-bulimia disorders), it remains unclear as to why the condom has adamantly been prohibited and condemned by the religious authorities. In practical terms, the female sexuality and her reproductive life have shown to be in a delicate biological balance, subjective to disturbances and consequences of ill health, from girlhood through womanhood and long afterwards, most likely in menopause and senior age (28). The woman’s life span, from menarche and menopause (in duration of about 35 years, or approximately 420 months, from 15 to 54 years of age) is beset with anxious worry for protection with contraception of intermittent episodes of pregnancy, abortions, and reproductive-system related sicknesses (15). On the other side, a recent report of the results of the “Improved Therapy of Breast Cancer,” cited the statement of Prof. C. Coombes, the Principal Investigators, from the Cancer Research UK, London, saying that there is cause of optimism: “The more we understand how these cells behave, the more likely we are to understand what happens with breast cancer. That revolution is ongoing. We are going, I think, to be looking at improved results over the next 20 or 30 years” (29). After the fiasco of the community trials for chemo-prevention of the breast cancer epidemic, by employing Tamoxifen pills to healthy women in certain countries in Europe and regions in the U.S., in the mid-1990s, in duration of five and more years (30), other initiatives for prevention of breast cancer did not appear, and the idea of primary prevention of breast cancer and other accompanying lesions (ovarian cancer) seems entirely abandoned. The potential of primary (non-chemical) prevention of the breast cancer epidemic remains an answer and hope for solution of the fatal
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malignant diseases to women in the today’s modern world. This assay is an attempt to try to help alleviate the hidden and intensive, deeply ingrained, intimate concerns of women for prevention of breast cancer as an epidemic disease and protection of their health, sexuality and families. Skopje, January, 2010 REFERENCES 1. Chirikos, Thomas K. 2001. Economic impact of the growing population of breast cancer survivors. Cancer Control, March/April; 8(2): 177-183. Web: http://www.moffitt.org/CCJRoot/v8n2/pdf/177. pdf 2. Kolevska, Gordana. 2009. (With a post stamp in battle against breast cancer). TEA MODERNA Magazine (Skopje) 6 mart, vol. 10, pp. 34-35. (in Macedonian) 3. Gjorgov, Arne N. 1980. Barrier Contraception and Breast Cancer. S.Karger, Basel-New York: x+164. 4. Gjorgov AN. 1991. Breast cancer death rates in Yugoslavia, 1979-1987: An attempt to explain the new rising trends. The Journal of the Medical Association of Macedonia. 45(3-4): 67-73. (In Macedonian. Summary in English). 5. Gjorgov AN. 1994. Rising breast cancer incidence worldwide, 1990-1990: A potential for prevention. The Journal of the Medical Association of Macedonia 48(1-2): 118-123. (In Macedonian. Summary in English). 6. Gjorgov AN. 1996. Breast Cancer: Rationale for an Etiologic Hypothesis. A Reappraisal of the Clinical, Experimental, and Theoretical Aspects of Neoplastic Processes, Pseudopregnancy Complex, and the Possible Role of the Seminal Prostaglandins. University of Pennsylvania School of Medicine, Philadelphia, PA, 1980, and Matica Makedonska Publ., Skopje, 1996. 7. Farrell, Christofer. 2004. How tech helps liberate women. Business Week, October 18. Web: http://www.businessweek.com/ bwdaily/dnflash/oct2004/nf20041018_8340_db013.htm 8. Gjorgov AN, Junaid TA, Burns GR, Temmim L. 1999. Efficacy of preventive prostaglandin treatment of malignant mammary lesions in rats. An experimental trial. J-BUON (Journal of the Balkan Union of Oncology, Athens), 4: 295-306. (Grant from Kuwait University,
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1988-1993). Abstract: European J of Cancer Prevention (London) 1996; 5(Suppl 2): 104. 9. Gjorgov AN. 2003. Breast Cancer: Primary Prevention Versus the Current Policy of Rescue. A Case for Cultural Interaction. New Balkan Politics, Skopje, vol. 6-7, pp. 143-169.Web: http://www. newbalkanpolitics.org.mk/issue6.asp 10. Gjorgov AN. 2003. Primary Prevention of Breast Cancer versus the Current Policy of Salvage Treatment: Update of Evidence and the Proposition. Macedonian Journal of Medicine (Skopje) 49(1-2): 15-26. 11. Gjorgov AN. 2006, 4 March. Prevention of Breast Cancer Rather than Screening. Correspondence. British Med J, 332: 540. Web: http://www.bmj.com/cgi/eletters/332/7540/499#130703 12. Esserman, Laura; Shieh Y, Thompson I. 2009, Oct. 21. Rethinking screening for breast cancer and prostate cancer. JAMA 302(15): 1685-92. Web: www.jamaarchiescme.com and questions on p. 1710 13. Patnick, Julietta. 2009. Breast screening info ‘misleads.’ BBC News. 19 February. Web: http://news.bbc.co.uk/2/hi/7898830.stm 14. Goetzsche, Peter C; Hartling, Ole J; Nielsen, Margerethe; Broderse, John; Jorgense, Karsten Juhl. 2009. Breast screening: the facts—or maybe not. BMJ 2009;338:b96. Web: http://www.bmj.com/ cge/content/full/338/jan27_2/b86 15. Gjorgov AN. 2009. Breast cancer risk assessment to barrier contraception exposure. A new approach. Contributions Soc Biol Med Sci MASA, XXX, 1: pp. 217-232. Web: http://e20.manu.edu.mk/ prilozi/16ag.pdf 16. Howie, Petar W. 1981. Barrier Contraception and Breast Cancer: Book Review. British Journal of Obstetrics and Gynaecology, March, 88: 333. 17. Hoyt, Robert G. 1968. The Birth Control Debate. Interim History from the Pages of National Catholic Reporter. Kansas City, pp. 224 18. Riley, Patrick G.D. 2005. Contraception: A worldwide calamity? Internet, Web: http://catholicsocialscientists.org/cssr/Archival/2005/Riley_319323.pdf 19. Jakobovits, Emmanuel, Chief Rabbi UK. 1978. Judaism. In: Encyclopedia of Bioethics, vol. 2, pp. 791-802
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20. O’Grady, Kathleen. 1999. Contraception and Religion. A short history. Web: http://www.mum.org/contrace.htm 21. Harakas, Stanley S. 2009. For the Health of Body and Soul: An Eastern Orthodox Introduction to Bioethics. Greek Orthodox Archidiocese of America. Web: http://www.goarch.org/ourfaith/ ourfaith8076 22. Zaphiris, Chrysostom 1974. The Morality of Contraception: An Eastern Orthodox Opinion. Journal of Ecumenical Studies Vol. 11(4): 677-690. Orthodox Church of America. Web: http:// jonathanscorner.com/contraception/contraception15.html 23. Rice, Thomas Jackson. 2004. “Condoms, Conrad, and Joyce.” In: Twenty-First Joyce. Morris Beja and Carol Jones, Eds. University of Florida Press, Gainesville, pp. 219-238. 24. Ratner, Herbert. 1990. Semen and Health. The condom condemned. Child and Family (Oak Ridge, IL), Vol. 20:275-282 (Part 1) and Vol. 21:90-96 (Part 2.). Web: http://www.virusmyth.com/aids/ hiv/hrsemen.com. 25. Trujillo, Alfonso I. 2003. Family values versus safe sex. Lifeissues.net: clear thinking about crucial issues. Web: http://www. lifeissues.net/writers/tru/tru_01familysafesex1.html 26. George, P. Robert; George, Timothy; Colson, Chuck. 2009, Manhattan Declaration & Signers. A Call of Christian Conscience. November 20. Web: http://www.demossnewws.com/ manhattandeclaration/press_kit/manhattan_declaration_signers 27. Gjorgov AN. 2009. Anorexia and bulimia nervosa in young female patients and barrier contraceptive practice. ASKLEPIOS International Annual of History and Philosophy of Medicine (Sofia), Vol. III (XXII), pp. 97-108. 28. Gjorgov AN. 2006. A review of the osteoporosis in women: A new hypothesis for testing. Macedonian Journal of Medicine (Skopje) 52(1-2): 5-21. 29. BBC News. 2009. Improving treatment for Breast Cancer (Prof. Charles Coombes). January 30. Web: http://news.bbc.co.uk/go/ pr/fr/-/2/hi/health/3244315.stm 30. U.S. Preventive Services Task Force. 2002. Chemo-prevention of breast cancer: Recommendations and Rationale. Annals of the Internal Medicine, July 2; 137(1): 56-58. Web: http://www.annals.org/ cgi/contents/full/137/1/56
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Attempt for definition of prevention / protection against breast cancer and other gynecological and accompanying tumors and diseases: Non-barrier methods, devices and techniques for fertility-control and family planning purposes, according to the reproductive status, motivation for family planning, and (approximate) age-span at the reproductive event
LEGEND: * Diaphragm, without bactericides or other creams ••• or •• Considered the best or effective methods of prevention of breast / gynecological cancers / lesions • Considered less effective / appropriate methods of prevention of breast gynecological cancers / tumors (•) Considered least effective methods of prevention of breast / gynecological cancers and other diseases (••) Unconfirmed or ineffective (?) / methods/techniques of prevention of breast / gynecological cancers / diseases NOTE: - The Condoms and/or Withdrawal are entirely excluded, as considered ‘non-contraceptive’ device / technique, due to the evidence-based carcinogenic and other ill-health effects; - Controversial ‘Prophylactic Mastectomy, Hysterectomy and/or Oophorectomy,’ not considered preventive, because of lack of justification and grave moral and ethical objections for routine practice; - For incidental, unprotected sexual contacts, the ‘Morning After’ injections / pills (Plan B), are not considered protective contraceptive hormonal methods against breast / gynecological cancers.
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ANORExIA - BuLIMIA NERVOSA AND BARRIER CONTRACEPTIVE PRACTICE IN YOuNg FEMALE PATIENTS
“I am crying over the elusive nature of love” Elizabeth Wurtzel, PROZAC NATION, 1994
ABSTRACT Purpose. The number of new cases of anorexia and bulimia nervosa rose rapidly worldwide in the past two decades, 1980s and 1990s, and the rampant condition is rising ever since, continuing its rise in the 2000s, especially in the developed West, such as, the U.S. and the E.U. Objective. The research is to investigate the etiological risk factors in anorexia nervosa in young female patients, by focusing on exposure to barrier contraceptive methods, specifically, to the condom use and withdrawal practice, as postulated risk factors inducing the physiological and psychological malfunctions in girls and young women of anorexiabulimia disorders. Material and methods. The population under study included 34 consecutive young, female patients, aged 15-35, treated for anorexiabulimia at the Psychiatric outpatient clinic at the Faculty of Medicine of the University St. Cyril and Methodius, in Skopje, Macedonia, between the Fall of 2004 and the Spring of 2005. Personal interviews with pre-structured questionnaire were conducted by two attending physicians-psychiatrists. Results. The mean age of the participating young women was 22.3 years (SD=3.2); while the mean age of 25 singles was 20.6 years
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(SD=3.1), with minimum at 15 and maximum at 25 years of age, and the mean age of 9 ever married patients was 27 years (SD=4.4), with minimum at 24 and maximum at 35 years. Assessed were the barrier methods (condom use and/or withdrawal practice) along with the use of non-barrier (the oral contraceptive pills and other methods), all quantified in months and years of exposure. The main results indicated that the anorexia-bulimia patients overwhelmingly used the condom device and practiced withdrawal technique for contraceptive purposes during most of their young reproductive lives, as opposed to the negligible use of the OC pills. The average duration of condom use (exposure to) was 30.4 months, for withdrawal 22.2 months, and the total mean value of barrier use was 56.7 months (or 4.7 years), all statistically significant: t=6.737, p<.0001, (95%CI 39.4-73.8), as opposed to not statistically significant mean value of the OC pill use which was of 1.55 months of duration, t=2.722, p>.05, (95%CI -0.20-20.6). The duration of exposure to barrier contraception was greater in older, married women (86.2 months) than in the singles (45.8 months).The mean age at first sexual contact was 17.3 years (SD=1.6) for the singles, and at the older age of 19.9 (SD=2.0) for the married patients. The mean age at menarche was 12.6 years (SD=1.3). Virtually the entire sexual experience of the studied young women was covered by barrier contraception use (exposure to sterile mating). In a number of tables are presented the studied characteristics of an array of categorical reproductive and social variables and strata controlled for by contraceptive methods, in mean values. Conclusion. The results presented evidence and corroborated the (sub-)hypothesis that the condomization of the nascent sexuality of young girls / women is a risk factor of anorexia-bulimia disorders. The results justify the initiative for temporary sexual abstinence of schoolgirls and other underage women as a potentially preventive measure against the rampant disorder in the community. The results support the elimination of condom-promoting sexual education, in favor of abstinence. Key words: Anorexia, Bulimia, New Hypothesis, Barriers contraception, Condomization, Withdrawal (Coitus interruptus), OC Pills, Exposure, Symptoms, Abstinence
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Background and Justification The literature of the etiology and epidemiology of ANOREXIA nervosa and BULIMIA nervosa is rather extensive. The etiology of anorexia/bulimia condition is unknown. There are a number of organizations of parent, students, teachers and health professionals, concerned with the life-threatening condition(s) of anorexia and bulimia, usually defined and referred to as “eating disorders,” and “anxiety disorders.” (1,2). In the United States, the prevalence of Anorexia nervosa is estimated at about 10 percent of girls and young women, which frequency is five times greater than the number of HIV/AIDS cases in the country. The estimate of deaths due to anorexia and bulimia (“eating disorders”) has been set up at 50,000 young women, in the U.S., annually (3). In the professional group of female ballet dancers, the incidence of anorexia is almost 100 percent! Approximately, 60 percent of anorexic women develop bulimia (4). It is well-known fact that many of celebrities, young actresses, and even royal princesses (5,6), along with the immigrant girls of all races (7) are being affected by anorexia-bulimia disorders, which figuratively hauls them as a “devil” (8). In a study of 42 cases of anorexia-bulimia in Denmark, in the 1990s, it was found that the incidence of the disorder(s) was 181 per 100,000 in females of 10 to 24 years of age, and the prevalence was estimated at 312 per 100,000 within the same population of young women (9) The mortality rate of anorexia is quite high, and is estimated to be up to 20 percent of the effected women (4). In a recent clinical study in Los Angeles, CA, it was pointed out that one in seven (14%) of patients afflicted with anorexia die of the disorder (10). The condition of anorexia disorders is often defined as an illness of the spirit (mind) and of the body (11). Some anorexia advocacy groups emphasize their mission to raising awareness “that eating disorders are NOT about food and weight; they are just the symptoms of something deeper going on, inside” (12). Major depressive symptoms, suicide and attempted suicide in anorexia patients with depression, and phobias and anxiety have also been reported (13). An anorexic girl is diagnosed by having a body weight 20 percent below the expected body weight of a healthy person at same age and
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height. Some older records of health screening in schools document that the frequency of anorexia nervosa in schoolgirls at that time (a couple decades ago) was much lower and almost non-existent. Anorexia as an epidemic disorder is a truly modern phenomenon (14). The underlying understanding of the causative factors for the condition has persistently been the so called, “three D’s”: body dissatisfaction, dieting, and drive for thinness. (3). In addition, in professional and in popular knowledge as well, the condition is perceived as a result of a ‘culture of thinness’ and dangerous ‘dieting.’ Anorexia is emerging even in traditional cultures (such as Egypt) that did not have such morbidity in the past (15); the new condition was attributed by the author as a result of the “globalization of culture by virtue of the media.” It has been known that the women with anorexia were sexually active, whose activity as usual has been taken for granted, explainable enough as a common activity (as in the rest of the population), and has never been fully investigated. It was shown that women with anorexia nervosa carry a significant variety of (accompanying) morbidity and mortality (16). Among the manifested consequences of anorexia include reports of osteoporosis in young age (2,17,18), which does not improve and remains at a declined bone density rate after the therapy (19), and failure of normal growth and irregular heartbeat. It has been reported that anorexia is also related to the breast cancer development. (20,21). A number of morphological changes of ovaries and uterus along with systemic and hormonal dysfunctions were reported in girls with anorexia nervosa, in terms of menstrual irregularities, the ovaries and uterus were found smaller than expected norms with regression of the organs to prepubertal age, abnormally low estradiol levels and disturbed regulation of gonadotropin secretion, and severe weight loss (22). The fact remains, that the therapy of anorexia-bulimia patients is palliative, non-specific, and with no known curative approach (16). Despite frequent therapeutic sessions, the young women-patients with anorexia-bulimia have a high rate of relapse of 48%, or 17.8 times higher return of the disorder than expected (23), that is, the clients with anorexia-bulimia keep coming back for extended treatment. No treatment or diagnosis of anorexia could relay on the results of molecular genetic studies (24), which further confirms the assumption
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that cultural rather than genetic factors cause anorexia/bulimia in women. Recently, a number of deaths due to anorexia were reported of some fashion models in various countries. The reports of deadly outcomes in young anorexia women prompted a swift revision of the criteria for participation of young women, by applying the body mass index (BMI) into the fashion industry. Young women who did not satisfy the limit of 17.5 BMI index were not eligible to be exposed to their modeling profession. The French Parliament recently initiated a legislative act against encouraging anorexia along with punitive measures against fashion agencies who promote “extreme thinness” in female models (25). A number of recent studies reported devastating effects of the anorexia-bulimia disorders of the whole body functions. Aside from the body-mind symptoms, the signs in patients with “eating” disorders indicated to the existence of a condition known as pseudopregnancy (pseudocyesis), with manifested signs of striae distense, hyperpigmentation, amenorrhea, lanugo, acne, petechiae, pellagra, nail fragility and others (26) Cases of pseudopregnancy in teenagers have been also reported (27) The incomplete knowledge and unsatisfactory therapy of the anorexia-bulimia disorder(s) prompted a new research approach, in order to try to test an alternative, a priori hypothesis of possible association between the barrier contraceptive practice (specifically, the use of condoms and/or withdrawal practice) with the development of anorexia / bulimia in schoolgirls, teenagers, and other young women. Aim and Objectives The main aim of the proposed study is to test alternative, new risk factors to anorexia in young women and to assess their association with the development of the disorder, in order to define the need for change of a faulty cultural infrastructure, the condomization of the nascent sexuality of schoolgirls and other young women, for prevention of anorexia in women.
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The short-term objectives of the research study were: - to assess new risk factors of use of barrier contraceptive methods on female sexuality, - to test a hypothesis of the postulated association of barrier contraceptive practice with anorexia/bulimia in schoolgirls, teenagers, and other young women, aged 15-30, single or married, and - to determine the purported etiologic risk of condom use, for defining a potential of primary prevention and protection against the rampant anorexia/bulimia, as the ultimate objective of the study. The hypothesis to be tested was as follows: Ho: Pr and mean values of condom/barriers users = Pr of OC pill users, versus HA: Pr and mean values of condom/barriers users > Pr of OC pill users. (Note: Ho = Null hypothesis; HA = Alternative hypothesis; Pr stands for proportion – in percentages.) Population under Study and Methods The population under study included all consecutive female patients seeking help and diagnosed as anorexia or bulimia nervosa at the Psychiatric outpatient clinic, Faculty of Medicine of the University ‘St. Cyril and Methodius’ in Skopje, Macedonia. The target group consisted of 34 young women, aged 15 to 35 years, single or married, of all nationalities, and urban/rural residence, between the Fall of 2004 and Spring of 2005. Diagnosis with treatment was the only criteria for inclusion / exclusion of the patient in the study. All participant cases were personally interviewed by the attending therapists, two female psychiatrists, by using a structured questionnaire along with other routine clinical records. (The interviews were conducted by Dozent Dr. V. Vujovic, Ph.D. and Dr. S. Gajdasic-Knezevic, both psychotherapists.) Since the adolescent girls with anorexia / bulimia were coming to the Psychiatry clinic with their parents, the consent was requested from both parties for an extended interview. The interviews were carried out with the young patients only, in a separate room and in a relaxed atmosphere.
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The study instrument, the confidential questionnaire, consisted of a series of anthropologic data (date of birth, education, age at menarche, profession of the client and her parents, height, weight, and others), and history of contraceptive use and reproductive experience (age at first sexual contact, marital status, number of children, menstrual irregularities, cigarette smoking, alcohol and drug use, age of the partner or husband, and knowledge and beliefs about the present health problem). Emphasis in the research and hypothesis testing was given on the types of contraception and the duration of use (exposure), in months and years, of any declared contraceptive method/technique. A composite variable, ‘barrier contraception,’ was computed by adding the number of cases and their duration of exposures to condoms and those with withdrawal practice, in order to be tested with the OC pill (non-barrier) exposure. (Appendix) The characteristics of this patient population (at the time of diagnosis) were described in aggregate numbers, categorical variables in and mean values (averages, standard deviations-SDs, median and mode, minimum and maximum) of most of the studied variables. Continuous variables of all used contraceptive methods were controlled for a number of categorical variables. Composite variables of body mass index (BMI), as one of the acknowledged criterion of anorexia, were computed according to the conventional equation of weight / height2. The BMI was computed according to the present, measured height and weight in the office and, in addition, of the lowest and the highest weight in the past year time, according to the reported patient’s recall. The statistical significance of the differences or lack of it between the means of contraceptive exposures and demographic values were tested by the SPSS-12 procedures. Results Thirty-four patients, age 15-35 years, were diagnosed and treated for anorexia-bulimia conditions were included in the study. (Table 1) The results of the study indicated that the studied young women with anorexia-bulimia disorder have overwhelmingly used condom device and withdrawal technique for fertility-control and family-planning purposes, as opposed to the negligible use of OC contraceptive pills. For the entire group of women, the average use of condoms was 30.37
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months, for withdrawal was 22.21 months, and the total barrier methods 56.07 months (or, 4.7 years), all statistically significant: t=6.737, p<.0001, (95%CI 39.4-73.8), as opposed to the insignificant use of non-barrier contraceptive methods (OC pills) of 1.55 months: t=2.722, p>.05 (95%CI -0.20-20.6). By informed observations and scant data, the condom use seems virtually unknown in the local population. [The withdrawal, however, is well known and is widely practiced under the popular metaphor of “my husband/partner takes care of me” (“mazhot me pazi”)]. The mean age of women was 22.29 years (SD=4.43); the mean age of the 25 singles was 20.6 years (SD=3.1), with a range between 15 and 25 years of age, and the mean age of 9 married (ever) patients was 27 years (SD=4.4), with a range between 24 and 35 years. The mean age at menarche was 12.6 years (SD=1.3, with a range between the minimum age of 11 years and maximum age of 15 years). (Table 2) The mean age at first sexual contact was 17.7 years (SD=1.7, with min. of 15 years, and max. of 22 years). The mean age of the single women’s partners was 24.8 years (SD=3.2, of minimum 18 and maximum 30 years of age), while the mean age of the husbands (of eight married women) was 31 age (SD=3.2, of min. 25 and max. 38 years). The group of husbands was older than the single-women partners for 6.2 years average. The mean duration of the marriages was 6.12 years (74.44 months), with SD=4.8 years and min. of less than one year to max. 11 years. The mean age difference between spouses was 3.8 years (SD=0.53, of min. one and max. 9 years) in favor of husbands. Most of the patients declared intimate (sexual) relations, practiced contraception, and majority (25) were single / never married (73.5 percent), while only nine women were married (26.5%). One patient was a self-declared virgin with no history of contraceptive practice. All patients were educated, out of which 31 (91.2%) women with high school to professional schools and; in particular, 12 (or 35.3%) were highly educated university / college young women (Tables 2A and 2B)
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The condom use reported 24 anorexia patients, with mean exposure of 40.5 months (more than 3.4 years) each or, as a group of 34 patients, average of 30.4 months (more than 2.5 years), that is, technically induced absolute, male-related sterile exposure. The condom use was the most frequent contraceptive method in the studied group of anorexia patients, thus corroborating the working hypothesis. Withdrawal technique (Coitus interruptus) practiced 23 patients, with average of 31.52 months each (more than 2.6 years of sterile exposure), or as entire group, average of 22.21 months (or more than 1.8 years on average) exposure to male sterility. A number of patients practiced both condom use and withdrawal practice intermittently. Practically, the entire sexual experience of the studied young women was covered by barrier contraception use (exposure to sterile mating). The main risk factor, exposure to “barrier methods” of fertilitycontrol, or sterile mating, was composed by adding the sum of the exposures of both condom use and withdrawal practice. The barrier methods were practiced by 30 anorexia patients, with average of 56.67 months (more than 4.7 years), or as a group of 53.03 months (more than 4.4 years) of sterile exposure and sterile sexual stimulation. (For one patient, practicing masturbation, the data of contraceptive experience were missing.) The use of oral contraception (OC pills) was quite infrequent: only five young patients used OC pills as a fertility-control and birthcontrol method. The mean duration of OC pill use was 10.2 months (less than 1 year) for the OC pill users only, or for the entire study group the average duration was 1.55 months. The difference between the means of exposures to barrier methods and OC pills, as well as to separate condom use and withdrawal practice with OC pill exposures, were all statistically significant (p<.001). According to categorical values and strata (of subgroups of the demographic, social, educational and marital variables, the highest average exposure to barrier practice, of 83.25 months (or, almost 7 years) struggle with sterile mating, was found in the ‘oldest’ age group, 25-35 years; OC pill use was recorded in the middle strata, 20-24
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years, while the youngest age group, 15-19 years, did not use OC pills whatsoever. The duration of exposure to barrier contraception was almost twice as greater in older, married women (86.2 months) than in the singles (45.8 months), perhaps because of age differences. The mean age at first sexual contact was 17.3 years (SD=1.6) for the singles, and at the older age of 19.9 (SD=2.0) for the married patients. The mean age at menarche was equal for both singles and married women 12.6 years (SD=1.3). (Table 3) The Macedonian women with anorexia were exposed to barrier methods for 57.19 months (4.8 years), not far from the Albanian women (46 months, or 3.8 years). Besides barrier methods, the Turkish women used 12 months OC pills, the Albanian women experimented, with average of 2 months non-barrier, i.e., pill use, while the Macedonian apparently tried for less than a month with the OC pills for contraceptive purposes. The lack of gradients of the contraceptive choice between women of different nationalities and religion affiliation (Orthodox Christian and Muslim) may indicate that neither ethnicity nor the religion played a significant role in the choice of contraceptive methods/techniques. Education and the profession of the patients seem to have had some impact on the choice and duration of the contraceptive method: there is a clear increasing gradient in the use of both barrier and nonbarrier methods by the level of schooling and economic status. The lowest average number of months of barrier contraception was seen in women with lowest education (10 months, with no use of non-barrier pills), while women with highest education had the longest exposure to barriers (around 61 months, or 5 years) along with more than 3 months of OC pill use. However, the increasing gradient of both barrier and non-barrier methods may have been confounded by the increasing age of the patients associated with the increasing level of education and career building. According to the age at menarche, the data did not indicated a clear pattern for interpretation. The averages of exposures to both barrier and non-barrier methods were close to each age stratum, which may indicate a random choice of the contraceptive knowledge and practice.
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Women with older age of husbands were exposed to condom use and total barrier methods more frequently than women of younger age (condoms 48 vs. 78 months, respectively), while the use of OC pills was 24 months in one woman and 4.5 months on average in women of older age. Similar distribution of contraceptive exposure was also observed in single women with older/younger partners. With regard to age differences between spouses, the results seem to indicated an equal, high exposure to condom use (of 78 months) regardless of the age differences, but much longer duration of exposure to withdrawal and total barrier practice when greater the age differences; the use of OC pills, of 15 vs. 3 months, did not showed to be a significant indicator, perhaps because of small sample size. Duration of marriage was not predictive of contraceptive use choice as well. Women who did not smoke cigarettes had the highest exposure to barrier methods (almost 62 months, or 5.2 years), while smokers showed a lower level of exposure (of 46.4 months) and the occasional smokers showed the lowest level of condom/withdrawal practice. On the other hand, the non-smoking women showed the highest use of OC pills (3.27 months on average). The average exposure to barrier methods did not significantly differ between women who did not use alcohol and women who moderately used alcohol. No drug (mis)use was reported by any participant in the study. One young woman only, age 21 years, reported masturbation in duration of about eight years (96 months), in addition to five years (60 months) of condom use, perhaps practicing simultaneously. The selfinflicted sterile sexual stimulation reportedly stretched for almost all years of her feminine maturity after menarche at 11 years of age. (The condom use was viewed in this study as mutual masturbation rather than a biologically sexual exposure.) According to the three-level strata of age at first sexual contact, the younger the age of sexual experience the higher the average exposure to barrier contraception (around 62 months, or 5.2 years), and inversely, the older the age the higher use of non-barrier, OC pills (3.3 months). (Table 4)
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The menstrual irregularities were reciprocally associated with both barrier and non-barrier contraception. The women who did not have menstrual irregularity, or had rare menstrual problems, had the lowest frequencies of barrier contraceptive exposure (28.8 and 53.0 months, respectively) along with higher use of OC pills (of 2.45 and 1.5 months, respectively), while the women who declared more frequent or frequent menstrual irregularities had higher levels of exposures to barrier methods (84 and 65.7 average months, respectively) along with the lowest (one month only) or none use of non-barrier, OC pills. Lack of gradient relations was evident throughout the strata of the factors of height and weight (present, lowest and highest) and the exposures to both barrier and non-barrier methods. Similar lack of gradient was detected of use of barrier or non-barrier methods and the strata of body mass indexes (BMI) The cohort of the studied group of 34 women diagnosed and treated for anorexia-bulimia showed to be with a low fertility rate. Only three children were reported in nine marriages. No married case had breast-feeding experience. One case, a recently immigrated schoolgirl, of 17, was a self-declared virgin, with admittedly no contraceptive experience. Heavy petting was indicated. Two women reported having spontaneous abortion, and two additional women reported having artificial abortion. A relatively long duration of condom use was found in both cases with abortion (59.4 and 42.4 months, respectively), in contrast to quite minimal use of OC pills (1.5 to zero months, respectively). Almost all participants denied any concern or fear of social stigma, shame, guilt, or social verdict concerning their love/sexual relations, and did not consider their intimate relations as secretive or unconventional (“dangerous”). The family atmosphere (‘good’ or ‘not good’), the stress in the family (no / yes), any problems with the partner (no / yes), and fear of pregnancy/abortion (no / yes), did not make much difference to the choice of exposure/duration to barrier contraception. Again, the use of OC pills was negligible in all psychological and socially-related
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variables. In response to the question of pregnancy, “what to do?” five girls out of 29 (17.2%) responded that they were going “to deliver” the baby, and the same number of girls responded that they would “abort” the pregnancy. Fourteen girls (48.3%) have not yet made up their minds. (Not presented in the tables.) Only 12 women out of 32 (37.5%), thought that nutrition/diet might be cause of their condition (“eating disorder”), while majority, of 20 (62.5%) did not believe that diet has anything to do with their anorexia. With regard to the profession and education of the father, as a surrogate assessment of the social and economic background, the fathers of 23 (72%) women out of 32, were highly educated professionals (physicians, lawyers, engineers, university professors, clerks, private businessmen); only 7 (22%) had their fathers unemployed or common workers. The overwhelming use of condoms/barriers was similar to all levels. Similar inferences could be drawn from the mother’s educational and professional levels, with one exception, however, that four daughters of the category of mothers as “housewives” used OC pills for almost one year in average. The results seem to confirm to a certain degree the well-known fact in the literature that anorexia girls come predominantly from economically / socially well-to-do families. Discussion The current study describes a cohort of 34 young women-patients, 15-35 years, diagnosed with anorexia nervosa, treated in a single institution, their profiles at diagnosis, and the association of a variety of their strata characteristics controlled for exposure to (use of ) both barrier contraceptive methods (condom device and/or withdrawal practice) and non-barrier oral contraceptive (OC) pills. For most of their young reproductive period of time, the women endured a sterile sexual stimulation, a postulated kind of biological torture, leading to the known but neglected condition of false pregnancy (Gjorgov 1980, and 1995). It seems that 4.7 years of life of sterile mating in a 20-22 year young women is a big part of life.
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A corroboration of the working hypothesis, that the ‘eating disorder’ in women is linked to the “frustrated” and condomized female sexuality, rather than to diet and nutrition, may offer a new ground for an adequate public health policy for prevention of and protection against anorexia nervosa for millions of schoolgirls, unmarried teenagers, and married young and other women in the U.S., Europe and beyond. The evidence of this exploratory study which attempted to test a hypothesis of condom exposure as the main risk factor of anorexia-bulimia nervosa seems to be in line with the expected results. Attempts were made, first, to assess and test the a priori hypothesis of the culture-health (or, ill health) relationship, and second, to provide evidence for suggesting a technical change in the cultural environment (which is a mystery), for solving the huge social and medical burden of anorexia/bulimia and to greatly reduce and practically ‘eradicate’ its epidemic disorders of suffering and death in young women to levels of sporadic cases in the community. It seems that even a hint or suggestion of condomized sex, rather than diet, as a primary cause of anorexia-bulimia nervosa as a rampant disease in young women is getting attention. Since young women’s lives are at stake, elimination of the putative cause, condomized sex relations, a precautionary measure could be attempted as a basic family therapy against the epidemic extent of anorexia-bulimia disorders in schoolgirls and other young women. Such an attempt was made almost 10 years ago, to the Swedish Royal Family (4,5), for a severe case of “eating disorder,” with the following communication: “To the Spokeswoman of the Royal Palace, Stockholm, Sweden, December 10, 1997 Dear Madam: This is a humble attempt to address, as a physician and researcher, the reported news in the media of a heavy body-weight loss of Her Royal Highness Princess Victoria, and to try to suggest a new possible approach to the efforts for solving this worrisome situation. In my opinion, the heavy body-weight loss, so called Anorexia nervosa, is secondarily related to the problems of nutrition and diet.
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Rather, there is circumstantial evidence, that the life-threatening condition of Anorexia nervosa is perhaps causally related to the demands of reproductive and intimate life and to its applied technical barriers. The alternative hypothesis about the nature of Anorexia nervosa was deducted from a “byproduct” observation in my long research of the developmental processes in the field of breast cancer. Furthermore, the frequent condition of a prior excess body loss (and gain) in the affected, young, reproductive-aged women with breast cancer was controlled for and partially tested as a sub-hypothesis in my hypothesis-testing study of barrier contraception (the condom use and withdrawal practice) as an etiological risk factor associated to breast cancer in married American women. During my field and ecological studies of breast cancer, it became obvious that the condom use in your country has been quite prevalent, with all the postulated subsequent consequences of the misconception that ‘the use of condom has no side effects.’ On the other hand, breast cancer in Sweden has been reported and registered as one the highest in the world, and still rising, mainly because of the widespread and long-term condom use in the general population, as postulated. In my separate study of the epidemiology of breast cancer in Sweden, in 1992, the potential for prevention and control of the current breast cancer epidemic in the country was further elaborated and suggested. Because the study could not be published, copies of the study were sent from Kuwait University to a number of health and political authorities and institutions in Sweden, as a personal communication. Based on my research experience, I do believe that the exposure to the condom use (i.e., to technically induced sterile stimulation) induces some devastating effects to a normal, young, vivacious, healthy woman, among which the life-threatening response of Anorexia nervosa seems to be one of the most frequent condition in the advanced countries, such as Sweden. The assessment of H.H. the Princess’ condition is done on incomplete information (in the media) and on certain assumptions, which may not be correct. Nevertheless, the possible way out of the anorexic danger for such a young lady, in my opinion, would be the absolute elimination of the condom as a fertilitycontrol device, by reverting to any of the non-barrier contraceptive methods (the pills, diaphragm, rhythm, IUDs, cream-jellies), in order
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to be able to preserve the healthy reproductive and inter-human life, and to prevent neoplastic phenomena. Respectfully submitted,Arne N. Gjorgov, M.D., Ph.D.” (The message was acknowledged with thanks for its “thoughtfulness and willingness to help.”) Notes on the biological plausibility of the tested hypothesis: The use of barriers (condom device and/or withdrawal practice) for contraceptive purposes was defined in the initial breast cancer study as an ‘INVERSE’ environmental factor, for the resultant elimination, reduction, or absence of the putative protective ‘semen factors’ (the Prostaglandins?) in the inter-human ecosystem and micro-environment of intimate (sexual) relations. The resulting semen-factor ‘deficiency’ in repeated sterile mating seem to be compounded by some unknown immediate and protracted adverse effects on the subtle, inner hormonal (im)balance in female, evident in a variety of processes or conditions, including breast cancer and postulated anorexia-bulimia disorders (20,21). In professional and in the popular knowledge, anorexia has been perceived as a result of a ‘culture of thinness’ and dangerous dieting. Now anorexia is emerging even in Muslim countries (Egypt) that did not have such morbidity in the past (15). Although it has been known and elicited as confidential information by the psychologists and psychiatrists, that the girls and other young women with anorexiabulimia are sexually active, their sexual, albeit illicit relations have been always taken for granted as a normal and common activity, and has never been further investigated. Some sexual aspects in girls with anorexia nervosa have been attempted to investigate. The approach to the sexual aspects in girls with anorexia seems to have been considered mostly in a “feministic” framework, of sexual abuse and sexual violence and conflicts, and rarely as willing participants of many schoolgirls in nascent peer sexual relations. No wonder that the results showed to be ambiguous and with (authors’) suggestion to be viewed with caution (28). Furthermore, unspecific ‘disturbances of sexual self-identification’ along with phobias and anxiety were found to be prevalent in anorexic girls.
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The euphemistic concept of “eating disorders” in anorexia-bulimia nervosa is well entrenched in medical guidelines and literature (29). The disease is usually defined as a very complex condition, and is understood as a result of dieting to a reduced body weight as a voluntary behavior, unreasonable reduction of food intake or severe overeating, peer pressure, cultural practices, extreme concern about “body image,” feeling of distress, and a treatable medical illness with maladaptive pattern of eating and other psychiatric disorders such as depression and anxiety disorders (2,30). Despite the availability of abundant and increasing funds for research in the fields of mental health (of approximately $1.4 billion a year), into which fields anorexia is being coded as a psychiatric illness, the agency did not find the way to venture into innovative research areas and/or to define or postulate strategies for prevention and therapy, and to reassess of what may be proved to be a fatal misconception. Consequently, no practical solution was determined so far of the rampant, life-threatening disorders of anorexiabulimia in adolescent girls and other women, young and mature, single or married. The literature about anorexia-bulimia is excessive and rapidly growing. In lack of specific hypotheses on anorexia, a number of clinical randomized trials (CRTs) have been attempted to test composite hypotheses of several observed (“known”) risk factors of the disorders, mostly in the realm of psychotherapy (history of depression, suicide attempts, feeling of ineffectiveness, poor perception, alcohol and drug abuse, and family history of anorexia nervosa) and in pharmacotherapy (31,32). The results of the clinical trials were inconclusive. Nutrition remained as the basic approach to treatment of the disorders (33). Anorexia-Bulimia seems to have affected many ‘celebrities,’ and the anorexia issue reflected in popular culture, the best one known was the ‘Prozac Nation’ 2001 film (34). (Prozac, an antidepressant used for treatment of ‘eating’ disorders; syn.: Zoloft, Paxil and other.) A recent report by a college psychiatrist (10) revealed a professional bias and ignorance about female sexuality of the so-called “helping” profession on university campuses. The false security of the notion of “safer sex” of the widespread “hooking up” (promiscuity in ‘friendly’ relations), and the fact that so many unprotected students suffered from
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depression, anxiety, eating disorder, and self abuse, were emphasized. In addition, a passing reference was made about the entrenched overestimation of condoms as a device for prevention of both STDs and pregnancy. (The report was initially published by an “Anonymous” author.) In a personal communication (on January 15, 2007, which was acknowledged with thanks and interest), an alternative experience was conveyed to the author that “the obvious underlying problem of the college (female) students on the campus revolved around the use of condoms…” namely, that “the obscure sex information and politics of promotion of condomization of female sexuality is turning the campus environment literally into self-toxic one…” (in physiological terms), that “the evidence of a significant link between condom use and breast cancer corroborating the partially tested observation of the association with anorexia and other phenomena in young women…is important not only for marriage and motherhood, as was rightly assessed, but also for their survival…” The weakness of the study for the lack of a comparative group could be alleviated perhaps to a certain degree by data of contraceptive practice in five European countries (France, Germany, Italy, Spain, and the United Kingdom) and in a relatively comparative period of time, Spring of 2003 (35). The OC pills use was found to be the main method of contraception for adult as well as adolescent females (up to 75%). Reportedly, the condom was not used “after having sexual intercourse for the first time.” This experience in contraception practices seems quite opposite to the presented results of the study, in which the anorexic girls almost never used (the non-barrier) OC pills. Perhaps it was by no accident that the U.S. President, possibly acting on extra information, enforced a bold paradigm shift of the condom-promotion campaign, in favor of anti-condom reproductive policy, since 2002, thus effectively ceasing the previous indiscriminate condom-promotion policy, cutting off financial funds for all the condom promoting and condom distributing (and producing) agencies on global scale, and what is most relevant, terminating the so-called “comprehensive sex education” (based on condom promotion model), the “safe teen sex” fallacy and the deadly “condom culture” tendency, at least to the schoolchildren, unmarried teenagers, and other young people, the cornerstone generation of the population. Furthermore, the
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President proclaimed abstinence as the preferred and most likely the most reasonable behavior for schoolchildren and other students in the given contingency of condomized society, backed up with appropriate and long-term financial support. Thus, although unannounced, a practical change of a faulty social infrastructure, the condom use for contraceptive purposes, was initiated by the American President. In this study, temporary abstinence during girlhood and adolescence is identified as a practical attitude for potential prevention and protection against the triple hazards of the rampant anorexia-bulimia disorders by avoiding (condomized and illicit) sexual relations, unwanted pregnancy, and sexually transmitted diseases (STDs) in schoolchildren and other young women. The current cultural matrix of the West is mainly centered on the promoted condom-related “reproductive freedom” fallacy and the erroneous belief in the “safe sex” delusion. Reporting of “noncompliance” of condom use is meant a switch to OC pills use by adolescents. Usage of long-acting hormonal methods of Depo-Provera or Norplant by adolescents is claimed “safe contraception.’ In a metaphorical way, the conclusion was that the condom is the best choice for the adolescents, by emphasizing: “It is no longer diamonds. Now, condoms are a girl’s best friend” (36). It seems that parents and schools teachers know very little about the lives and behaviors of their children and pupils (students). Little is known in science as well about the health impact of condomization of female sexuality, and of the reaction of female to persistent sterile mating. In addition, the protracted effects of anorexia in young agespan in life of women remain as a variety of sequels throughout the rest of reproductive age and postmenopausal life, as studies of osteoporosis and breast cancer seem to indicate. The message of possible condom to anorexia link, first published in 1979 and 1980, was aimed at both the policymakers and contraceptive users, for introducing new public health policy and preventive potentials in reproductive and contraceptive matters, to married and other couples and to young women in the mainstream population. This study, although exploratory in scope, was an attempt to test and explore the gap in knowledge about a faulty social infrastructure, for solving the political crisis and huge public health burden of the young population, for elimination of the anorexia
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epidemic at personal, familial and community levels. The evidence is proving that condom is neither “contraception” nor a “method.” Faced with the reality of lack of treatment efficacy, “therapeutic nihilism” and demoralization of doctors (37), considerations emerged of the justifiable need to better understand and name with other name the “eating” disorders (38). The good news seems to be that, the first initiative for abstinence education of schoolchildren came from the American President, a few years ago. Faced with a considerable resistance from certain interest groups for a “comprehensive sex education” in schools, meaning condom promotion as an option to underage girls, the parents in the U.S., organized in a National Abstinence Education Association, started a ‘Parents for Truth Campaign’ for sex education in schools focusing on abstinence. The main message of the project is intended to be the empowerment of the schoolgirls and other young women with the information of the temporary abstinence until marriage is the best possible protection against anorexia and other diseases in school and adult age. References 1. Abella E, Feliu E, Granada I et (7) al. Bone marrow changes in Anorexia Nervosa are correlated with the amount of weight loss and not with other clinical findings. American J Clinical Pathology 2002;118(4):582-88. 2. National Institute of Mental Health. Eating Disorders: Facts about eating disorders and the search for solutions. February 17, 2006. Web: http://nimh.nih,gov/publicat/eatingdisorders.cfm. (02/17/2006). 3. Hartine, Christine. Eating Disorder Awareness Week. Internet: Something Fishy, January 17, 2007. 4. “Kristi”. The incidence rate of Anorexia in ballet dancers. Internet: Something Fishy, Jan. 17, 2002. 5. Hubbard, Kim. Slip of a girl: Princess Victoria, heir to Sweden’s throne, falls victim to anorexia. People Weekly, Dec. 1, 1998. Web: http://www.theroyalforums.com/forums/130577-post28.html. 6. Anonymous. Girls’ ill health in the Western world (Sweden). The Demon: Anorexia. Nova Makedonija (Skopje), April 4-5, 1998.
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7. Wax, Emily. Immigrant girls suffer from Anorexia. Washington Post, March 12, 2000. Internet. 8. Yatorola C. Anorexia and the devil. Observer (London), October 2, 2007. 9. Pagsberger AK, Wang AR. Epidemiology of anorexia nervosa and bulimia nervosa in Bornholm County, Denmark, 1970-1989. Acta Psychiatrica Scandinavica 90(4): 259-63, Octobar.1994. 10. Grossman JB. Demystifying anorexia nervosa: an optimistic guide to understanding and healing? American J Psychiatry 2005 (January);162: 202-206. 11. Pop-Jordanova, Nada. Anorexia–Disease of the Spirit and Body. Dnevnik 19, Skopje, Aug. 29, 2004. 12. Something-fishy.org. Anorexia nervosa. Web: http://www. something-fishy.org (2002). 13. Pompili M, Mancinelli I, Girardi P et (3) al. Suicide and attempted suicide in anorexia nervosa and bulimia nervosa. Ann Ist Super Sanita. 2003;39(2):275-81. (Abstract). 14. Brumberg JJ. FASTING GIRLS: THE EMERGENCE OF ANOREXIA NERVOSA AS A MODERN DISEASE. Harvard University Press, Cambridge, MA, and London, UK. 1988. 15. Nasser M. Screening for abnormal eating attitudes in population of Egyptian secondary school girls. Social Psychiatry Epidemiology 1994;29(1):25-30. 16. Kay WH et al. An open trial of fluoxetine in patients with Anorexia nervosa. Journal of Clinical Psychiatry 1991;5:464-71. 17. Rigotti NA et al. The clinical course of osteoporosis in anorexia nervosa. JAMA 1991;265:1133-8 18. Miller KK, Lee EE, Lawson EA at (7) al. Determinant of skeletal loss and recovery in Anorexia nervosa. J Clinical Endocrinology & Metabolism 2006;91(8):2931-37. 19. Baker D, Roberts R, Towel T. Factors predictive of bone mineral density in eating-disordered women: a longitudinal study. International J Eating Disorders 27(1): 29-35 (January 2002). 20. Gjorgov AN. BARRIER CONTRACEPTION AND BREAST CANCER. S.Karger, Basel-New York: 1980: x+164. 21. Gjorgov AN. BREAST CANCER: RATIONALE FOR AN ETIOLOGICAL HYPOTHESIS. A Reappraisal of the Clinical,
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Experimental, and Theoretical Aspects of Neoplastic Processes, Pseudopregnancy Complex, and the Possible Role of the Seminal Prostaglandins. University of Pennsylvania, Philadelphia, PA, 1980, and Matica Makedonska, Skopje, 1995. (Submitted to Library of the U.S. Congress, 1996.) 22. Vignjevic D, Jurcic Z, Stipancic G et (4) al. Morphologic changes of uterus and ovaries in childhood onset of anorexia nervosa. Gynaecologia et Perinatologia (Zagreb) 1997;6(1-2):1-5. 23. Norring CE, Sohlberg SS. Outcome, recovery, relapse and mortality across six years in patients with clinical eating disorders. Acta Psyciatrica Scandinavica 1993;87:437-444. 24. Hinney A et al. Genetic risk factors in eating disorders. Am J Pharmacogenomics 2004;4:209-23. 25. Lauter, Deborah. France may make it illegal to promote extreme thinness. Washington Post (April 15, 2008). http://www.washingtonpost. com/wp-dyn/content/article/2008/04/15/AR200804150090... 26. Strumia, Renata. Dermatologic signs in patients with eating disorders. American J of Clinical Dermatology 2005;6(3):165-173. 27. Ayakannu T, Wordsworth S, Smith R, Raghunandan R, Vine S. Pseudocyesis in a teenager using long-term contraception. J of Obstetrics and Gynaecology 2007 April;27(3):322-323 (April). 28. Oleinikov AN. Specific factors of sex behavior in patients with anorexia nervosa and bulimia Zhurnal Nevrologii i Psikhiatrii 2000;100(5):9-22. 29. American Psychiatric Association. DIAGNOSTIC AND STATISTICAL MANUAL OF MENTAL DISORDERS. Fourth Edition (DSM-IV), May 15, 2002. http://allpsych.com/disorders/ dsn.html. 30. Urbick S. Anorexia – Killing America’s Youth. Editorial, March 3, 2006. Web: http://www.buzzle.com/editorial/9-3-2006-197477. asp. 31. McIntosh VW, Jordan J, Carter FA et (5) al. Three psychotherapies for anorexia nervosa: A randomized controlled trial. American J Psychiatry 2005;162:741-47. 32. Taylor CB, Bryson S, Luce KH et (7) al. Prevention of eating disorders. Arch Gen Psychiatry 2006;63(8):881-8.
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33. American Dietetic Association. POSITION OF THE AMERICAN DIETETIC ASSOCIATION: Nutrition intervention in the treatment of anorexia-bulimia nervosa, and other eating disorders. J Am Diet Assoc 2006;106(12):2073-82. 34. Anon. PROZAC NATION Film 2001. http://www.hollywood. com/celebrity/Christina_Ricci/189919. 35. Skouby SO. Contraceptive use and behavior in the 21st Century: a comprehensive study across five European countries. The European J of Contraception and Reproductive Care 2004;9:57-68. 36. Kaunitz Am. Contraception for the adolescent patient. Int’l J Fert Women’s Med 1997;42(1):30-39 37. Russell J. Management of anorexia nervosa. Revisited. Editorial. BMJ 2004 (Feb 28);328:479-80 38. Liu, Aimee. Let’s give eating disorders a new name. Blog, February 25, 2008: Web: http://www.huffingtonpost.com/aimee-liu/ lets-give-eating-disorde_b_88388?view=print
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BREAST CANCER DEATH OF EMPRESS THEODORA, WIFE OF JuSTINIAN I OF BYZANTINE, IN THE SIxTH CENTuRY
ABSTrACT Empress Theodora (503-548 AD) comes from deprived parents daughter of a bear-keeper in the dens of the Hippodrome in Constantinople. As a stage dancer, hetera and courtesan, she became a follower, wife and adviser to Emperor Justinian I (482-565 AD). She died of breast cancer at her 45 years of age (after 27 years of marital fidelity to Justinian). The destiny and the life story of Theodora have always hoisted curiosity and interest in both historical and popular literature. In the study, an attempt was made to shed additional light upon certain aspects of her marital life. The objective of the investigation was to explore and to reassess the intimate environment, life's events, and the postulated etiological cause in connection with her rare disease, cancer of the breast, and its relevance to the present day breast cancer epidemic. The investigation focuses its attention to the risk factors and the conditions conducive to the development of breast cancer in married women, in order to corroborate the potential of primary prevention of the disease in the community. INTRODUCTION The destiny and the amazing history of Theodora (503-548 AD), Byzantine Empress, as the wife of Emperor Justinian I (482-565 AD), has always produced curiosity and interest in the historic and popular literature as a famous woman and a successful empress. Stretching from the meager beginnings of the dens and stages of the Hippodrome, in Constantinople, and reaching the majesting heights and imperial throne of Byzantium, her life story entered the realm of legends. Even during her life, she had been an object of intrigue, jealousy and gossip, which
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episodes were collected by Procopius of Cesarea, a historian of the emperor's palace, a contemporary and eyewitness, in a written account, "Secret History" or "Anecdota" (1). In this and other works of Procopius there are many detailed passages, some of them offensive and harsh, about the personal mentality of Justinian and Theodora, related to state, religion, family and health matters. In a passing reference, it was mentioned that "Theodora died of breast cancer, on June 29, 548, at age of 45," after a long and tortuous disease. In the available literature, her death seems not fully elaborated either by Procopius or by the other historians or writers (2). The cause of her breast-cancer death is reviewed here within the framework of the latest, tested postulates and knowledge in the etiology of breast cancer (3, 4). Breast cancer, although known from the biblical times, has been a relatively rare disease throughout history. Until recently, in most regions of the Middle East and Far East, where breast cancer was only known to appear in the harems of Oriental rulers, the females of the general populations were virtually free of this malignant disease (5). The aim of this study was to appraise the evidence and assumptions in the literature of the events in the life of Empress Theodora, both before and after marriage, in order to try to assess and explain the consistency of the conditions conducive to and the putative cause of her breast cancer in accord with the postulated and tested cause of the epidemic rise and proportions of the disease in (married) women of the contemporary world (3, 4). SOURCES, BACKGROUND AND METHODOLOGY A great deal of the narrative of the Secret History of Procopius (1) is devoted to the youth and life of the future Empress Theodora, in retrospect. All works of Procopius (The Wars, in eight divisions, about the Persian, Vandal and Gothic Wars, Secret History, and Buildings) are the main and often the only historical source (2) for the reign of Justinian I (527-565 AD), at the down and the foundations of the Byzantine Empire. The work Secret History was written with virulent attacks on the "demonic nature" of Justinian and Theodora and containing explicit sexual description, which has been judged by many historians as biased and untrustworthy evidence. Apparently, the author was hiding
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his work, which remained unfinished when he died (in 550 AD), and a few people in the Empire seems had ever known about it. The manuscript of the Secret History has survived, however, and was discovered in the Vatican Library in 1623, almost 1,100 years after it was written, and the death of Procopius. In a relevant event, a case-control study was conducted at the University of North Carolina, at Chapel Hill, NC, and at the University of Pennsylvania, in Philadelphia, PA, USA, between 1974 and 1978, in order to test the hypothesis that a reduced exposure to human seminal factors in the reproductive lives of women is a risk factor of breast cancer in married American women (3, 4). In terms of human reproduction, the semen-factor hypothesis was defined in terms of married women who have been exposed to barrier contraceptive methods (specifically, the use of condoms or withdrawal practice) and women who have been living in infertile marriages due to male infertility. The results of the study corroborated the tested hypothesis and provided evidence of a strong relationship between the long-term use of condoms and the risk of breast cancer in married women. The extended reduction/elimination or absence of the seminal factors (prostaglandins?), rather than reduced fertility (childbearing) of the contemporary marriages, was found to be the possible risk factor accounting for the rise of the incidence and the epidemic spread of breast cancer in the U.S. and most of the advanced countries of the West. The practical application of the confirmed semen-factor hypothesis was the potential for prevention of breast cancer as an epidemic disease in the community. The unforeseen developments of promoted indiscriminate condom use (as technically induced effects of total male sterility on an unprecedented scale in the community) in the 1980s and until recently, further confirmed the condom-breast cancer association and the postulated potential for primary prevention of the disease (6-9). During the course of a prior post-graduate study in International Health Development, at the Royal Tropical Institute, in Amsterdam, The Netherlands, in 1968, in the sessions of Epidemiology, it was discussed that breast cancer was frequent in Catholic nuns (10), with a passing remark, however, that cancer of the uterine cervix was frequent in prostitutes of Amsterdam. Although the topic was not further elaborated, an idea was personally deducted: the semen! The idea being of lack of exposure to human semen in the former, and of excessive, unclean exposure to semen in the latter category of women. The gestating idea of the role of male, seminal factors in women's illnesses was not forgotten, until the chance to test it as an
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explicit hypothesis of a possible cause of breast cancer, a disease of high priority in the U.S., during the 1970s, and long ever since. Besides the assessment of the breast cancer death of Empress Theodora, the aim of the study was extended to a limited appraisal of Emperor Justinian I, for both reasons, as the husband of Theodora, for 27 years, and as a compatriot, and founder of Justinian Prima, near Skopje, as the place of his birth and youth, the region renamed and known as such in the Sixth Century. Justinian I became emperor of Byzantine in 527 and ruled until his death in 656. He was born in 482, near Skopje, Macedonia, between the villages of Bader and Taor (11). The villages still exist and are inhabited under the same names (with an area, called "Gradishte," or palace ruins, in between). As a relative of the childless Emperor Justin, Justinian was taken to the imperial palace in Constantinople, changed his (Slavic?) name from Upravdin (12,13) to romanized Justinian, and was educated and groomed to inherit the throne of the Byzantium. As a great emperor, Justinian I was one of the most important of the Byzantine emperors (14). He launched three ambitious projects (15). First, he tried, but failed, to reunite the Eastern and Western Roman Empires. However, trade helped spread the great culture of the advanced civilization of Byzantium to Italy and to Western Europe. Second, Emperor Justinian I ordered his lawyers and other scholars to organize, simplify and systematize the laws of ancient Rome into the voluminous Corpus Iuris Civilis (Body of Civil Law), written in Roman and later in Greek language. The Corpus remained the basic law for most of the European states until 18th Century. Third, he undertook a massive building program in Constantinople and across the empire. In the capital, he built the magnificent church Haggia Sophia. In his birth place, today's Skopje, he built a new city, Justiniana Prima, as an administrative and religious center of the same province, with extensive infrastructures and buildings (16-19). Figure 1. Justinian's aqueduct of Justiniana Prima at the Contemporary City of Skopje, Macedonia Considerations about the premature breast-cancer death of Theodora and the circumstantial evidence of her marital life with Justinian cannot go beyond Procopius' and other historical facts. Only the efforts in interpreting the evidence may differ from the conventional views
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on the matter, in accordance with the tested semen-factor (deficiency) hypothesis in breast cancer. EVIDENCE AND OBSERVATIONS According to Procopius, Theodora was born in 503 AD, in the dens of the amphitheater of Constantinople, where her father was beastkeeper, and was called the Bearkeeper. The father died soon, leaving three daughters and wife, who soon remarried. Along with her two sisters, Comito, the older, and Anastasia, the younger, Theodora was exposed to begging at a very early age, at eight years, and was introduced to the stages of the theater, as hetera, in her adolescent years. She was exposed to all kinds of "unnatural violence of the corrupt slaves following the masters in the theater." Her mother has set the stage for her public exposure and Theodora "instantly became a courtesan, or as the old Greeks called, an ordinary whore… She did not play flute, nor she danced; she was only showing her youth to everybody, entirely consenting… She was not embarrassed and could not be surprised by anything, and no role was scandalous enough to make her blush." She attracted everybody, especially the younger males, and became very mean, like a scorpion. A number of abortions and the birth of a daughter during that time were alleged by Procopius. At an early age she got married to an official, and followed him to Alexandria, in Egypt, where she divorced him soon. But when she returned to Constantinople, by practicing prostitution all along the way back, Justinian wildly fell in love with her. Theodora was beautiful and had a captivating personality as a dancer and entertainer. At first, Theodora was mistress until he elevated her to the position of a noblewoman. According to the old laws, Justinian as a senator and heir apparent could not marry a prostitute. However, after the death of his uncle, the Emperor Justin, and his aunt the Empress, who objected strongly to Justinian's wedding plans, he cancelled the old laws and regulations and inaugurated a new one which allowed him to marry Theodora, and everybody else to marry a prostitute as well. The wedding ceremony in full imperial splendor took place in the Haggia Sophia cathedral, three days before Christmas, in 542 AD. Procopius called Emperor Justinian and Empress Theodora not a husband and wife, but "brother and sister" and "friends in human form." Some historian consider this statements as a further "extreme view by a biased historian" (14), although in all possibility, Procopius
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discreetly indicated an absence of intimate, physical love of the married couple. There is no reason, whatsoever, to doubt the text. Other cited sources of the Justinian's time (2) refer to Empress Theodora as woman "from the brothel" and "formerly shameless but later chaste." Justinian was 21 years senior of Theodora, and married her at the age of 45. During the courtship, Justinian fell gravely ill and thought he may die, according to the Procopius account. As an empress, Theodora showed to be, or has developed an iron will, letting nothing to stand in the way of her ambition. She was cruel, and she wanted and held power, sharing absolute power loyally with Justinian. He always consulted her on major matters of state or church before reaching a joint decision (9). Procopius makes some unpleasant parallel of Theodora to other woman in her entourage, Antonina, leveling accusations of their sexual lives: both women are said to have given births in their depraved days, abortions, infanticide, and lack of maternal feelings. Theodora had an illegitimate daughter and a son of her first marriage. He further reports that as empress, Theodora often intervened to help individual girls and women in distress, founded a famous Monastery of Repentance for reformed prostitutes, and was a fierce supporter of marital fidelity. However, Procopius who was hostile to Theodora from the beginning never accused her of sexual infidelities after the marriage to Justinian, neither of promiscuity nor of adultery. Accordingly, Theodora may have fulfilled 27 years of marital fidelity to Justinian. In a bizarre episode, Theodora ordered a cruel and brutal flagellation, in front of her eyes, of a favorite, young and good-looking slave, to whom, reportedly, she was emotionally attached and pleasant previously. No temptations. Justinian was described by Procopius as weak, subjective, jealous, and dominated by a powerful wife. Procopius emphasizes the long fasting practices of Justinian, especially his self-depravations and extreme asceticism, as signs of holiness. The couple was described as "demons in human forms," but Procopius never accused Justinian as he did Theodora of sexual excesses in his life. Justinian was troubled by a notable lack of sleep, with nocturnal wanderings around the Place, and habitual underweight. The evidence given by Procopius and other historical sources indicate a possibility of a long-time sexual abstinence in the crowned imperial couple, and a brave endurance and true sacrifice of Theodora in this regard, most probably for the sake of her imperial prestige and dignity. Obviously, sacrifice of sexual life to an accomplished woman like Theodora must have been agonizing and consciously painful.
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Theodora died in 548, at the age of 45, after a long battle and suffering from breast cancer. She may have developed and discovered the breast malignant growth early in her 40s, during her relatively young reproductive age. Her sad likeness can be seen in the sixth-century mosaic, beside the one of her husband, in the church of San Vitale in Ravena, Italy (Figure 2). The mosaic has been described vividly: "Over the pale slight figure of Theodora hangs the glamour of early death and a sorrowing imperial husband" (2). This mosaic, in a church distant from Byzantine, testifies to Theodora's enormous influence on the Eastern Roman Empire and beyond. Figure 2. The mosaic of the famous Empress Theodora of Byzantine (503548) in the basilica San Vitale in Ravena, Italy DISCUSSION AND CONCLUSION Theodora should be evaluated and judged more favorably in history. At least, with her courage she was instrumental in saving the existence of the empire and probably the life of the emperor during the bloody "Nika" riot at the Hippodrome, in Constantinople, in 532, at the expense of more than 30,000 citizen's deaths. Theodora was absolutely determined to remain empress, to struggle like an empress, and to die as an empress (20). Nothing else mattered to her but the imperial power. Justinian could hardly be able to humanly carry out his monumental and ambitious projects had his bellowed wife, Theodora, not always been committed and sensible to him, with loyalty, political support, religious consensus and, presumably, consenting to long sexual abstinence. She might have been aware of the pains of her protracted intimate sacrifice. The Scriptures give ground for debates of sexual relations, human seed, marriage, love, conception, the "sin against nature" of sterile acts (coitus interruptus), prostitution, adultery, and the polemic that "husbands are the chief persons responsible for dissipation of their wives" (21). The early serious ailments in the life of Justinian, as well as his affliction and unexpected survival within the (first) plague epidemic in Constantinople, 514-542 (22, 23), were recorded in the Procopius works. Perhaps the truth could not be violated if it is assumed that the evidence about the lack of fitness, ill health, and excessive asceticism of Justinian
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provide information for assessing the cause for and fault of their infertile marriage. Theodora's death of breast cancer, not of cervical cancer (as observed in courtesans), seems a kind of testimony to and is consistent with the tested semen-factor hypothesis in the etiology and epidemiology of breast cancer. In accord with the aims of the study, it seems that the historic breast cancer, developed early in Theodora's life, may further help explain and corroborate the conditions conducive to breast cancer, by the postulated long-term marital exposure to sterile mating, because of barriers to insemination, or condom use, and the potential for prevention of breast cancer as an epidemic disease in women of the contemporary world. REFERENCES: 1. Procopius. Secret History (Tajna Historija). Stvarnost, Zagreb, 1988. 2. Cameron, Averil. Procopius and the Sixth Century. Routledge, London & New York, 1996. 3. Gjorgov AN. Barrier contraceptive practice and male infertility as related factors to breast cancer in married women. Preliminary results. Oncology (Minich) 1978; 35: 97-100, and Medical Hypotheses (Montreal, Canada) 1978; 4(2): 79-88. Abstract: http://www.sementherapy. com/mirror/sciencedirect.com.002.htm. 4. Gjorgov AN. Barrier Contraception and Breast Cancer. S.Karger Med. Publ., Basel-New York, 1980: x+164. http://www.ncbi.nlm.nih. gov/entrez/query.fcgi?CDM=Display&DB=PubMed 5. Gjorgov AN. Breast cancer in Kuwait, 1974-1983. An epidemiological study. Journal of the Kuwaiti Medical Association 1986; 20: 75-88. 6. Gjorgov AN. 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. 7. Gjorgov AN. Stop the natural experimental trial in breast cancer because of rising incidence: Summarizing the evidence. European Journal of Cancer Prevention (London) 1995; 4: 97-103. 8. Gjorgov AN. Worldwide breast cancer incidence: Ecological rising trends and the potential for prevention. The possible carcinogenic effects of condom use. Speculations in Science and Technology (London) 1995; 18: 16-27. 9. Gjorgov AN. Breast cancer risk from use of condom: Interim evi-
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dence of an unplanned natural experiment. Child & Family (Oak Park, Illinois, USA) 1990; 21: 97-101. 10. Mustachi P. Ramazzini and Rigoni-Stern on parity and breast cancer. Archives of Internal Medicine 1961; 108: 639-642. 11. Anonymous. Iustinian. In: Encyclopedia "Bulgaria" Vol. 7: 554. BAN, Sofia, 1996. 12. Wellman, Paul I. Theodora (The Female, 1955). Progress-Epoha, Zagreb, 1966. (Translation by V. Krmpotic and D. Sucic.) 13. Boscowich, Yoseph Rudzer. Journal d'un Voyage de Constantinopole et Pologne. Grasset, Lausanne, 1772. (Translation by M. Todorova: Dnevnik na edno patuvane. Sofia, 1975.) 14. Leinwand, Gerard. The Pagent of World History, Ch. 7. Allyn & Bacon, Inc., Newton, Mass. 1995: 161. 15. Kreiger LS, Neill K, Jantzen SI, Swebson L. World History: Perspectives of the Past, Ch. 8. D.C. Health & Co., Lexington, Mass. 1994: 181. 16. Shoukarova, Ana. Justiniana Prima. Institute of National History and Matica Makedonska, Skopje, 1994: 150 pp (in Macedonian). 17. Petrov, Konstantin. Aqueduct near Skopje and the problem of its dating. Annual of the Philosophical Faculty of Skopje, 1962; 13: 5-22 (in Macedonian). 18. Kostic, Zorica. Sur les divisions administratives de la Macedoine vers la fin de l'antique. Recuel des travaux de l'Institut d'etudes Byzantines, No. XXXv, Beograd, 1996. 19. Urankar, Pavle. Historical importance of the City of Skopje. "Vasilij Dimitrijevic" Publisher, Skopje, 1930: 1-24 (in Serbian). 20. Mutafchiev P. Lessons in History of Byzantine, Vol. 1. Anubis, Sofia, 1995: pp 161-250. 21. Fladrin, Jean-Louis. Contraception, Marriage and Sexual Relations in the Christian West. In: R. Forest and O. Ranum, Eds: Biology of Man in History, Ch. 1. Selections from: Annales Economies, Societes et Civilisations. The Johns Hopkins University Press, Baltimore and London, 1975: 23-47. 22. Biraben, J-N & LeGoff, Jaques. The Plague in the Early Middle Ages. In: R. Forest and O. Ranum, Eds: Biology of Man in History, Ch. 1. Selections from: Annales Economies, Societes et Civilisations. The Johns Hopkins University Press, Baltimore and London, 1975: 48-80. 23. Allen, Pauline. The "Justinianic" plague. Byzantion (Brussels) 1979; 49: 5-20.
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In: ASKLEPIOS, International Journal of History and General Theory of Medicine, 1997/1998, Vol. XI, pp. 117-121 Arne N. Gjorgov, MD, MPH, PhD (UNC-SPH, Chapel Hill, NC) Skopje, Republic of Macedonia, E-mail: email@example.com
Figure 1. Justinian’s aqueduct of Justiniana Prima at the City of Skopje, Macedonia
Figure 2. Detail of a Byzantine mosaic of the famous Empress Theodora of Byzantine (503-548) in Basilica of San Vitale, Ravenna, Italy
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A REVIEW OF THE OSTEOPOROSIS IN WOMEN: AND A NEW HYPOTHESIS FOR TESTINg
A great mistake we make is that we always think of cause as being close to the effect. J. W. Goethe
Abstract The proposed hypothesis of Osteoporosis etiology and prevention in women postulates that osteoporosis is a late, delayed or prolonged consequence of exposure to (use of ) barrier methods of contraception (specifically, condoms and/or withdrawal, and male /marital infertility) experienced during reproductive, premenopausal life span of married women. The new hypothesis of osteoporosis in women is designed for testing a preventive intervention with non-barrier contraceptive methods in a community / clinical trial. The hypothesis was deducted from a previous hypothesis-testing study which provided evidence of a significant relationship between use of barrier methods and the breast cancer in American married women. The review underlined certain epidemiological features of osteoporosis in women, as an epidemic disease, still rising in frequencies, and the lack of knowledge for control, treatment and prevention of the disease. Within the framework of the U.N. Bone and Joint Decade 2000-2010, the submitted project proposal for an interdisciplinary study is an attempt to try to fill the etiological gap and to try to determine a potential of primary prevention of osteoporosis in women. BACKGROUND, IMPORTANCE AND JUSTIFICATION Purpose. To review and implement a population- and community-based interventional trial for primary prevention of osteoporosis in middleaged women, by testing a new hypothesis of etiologic risk factor(s) of
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the disease. The review and the hypothesis are in response to the UN initiative “Bone and Joint Decade 2000-2010,” the stipulations of the recent Surgeon General Report “Bone Health and Osteoporosis,” 2004 (1), requested by the U.S. Congress, and the mission of the National Institute of Arthritis and Musculoskeletal Diseases (NIAMS) for prevention and applicable knowledge of the disease. The proposed research will be focused on primary prevention of osteoporosis in women. The new HYPOTHESIS postulates that the osteoporosis is a late, delayed or prolonged consequence of the marital exposure to (use of ) barrier forms of contraception (specifically, condoms and/or withdrawal, and situations of male/marital infertility), during the reproductive, premenopausal, middle-ages of women. The hypothesis for testing was deducted into a new concept of osteoporosis and the like bone ill-health conditions in women, during the long-tem research and observations in the fields', ecologic and experimental evidence and observations in breast cancer etiology and prevention, by reassessing the same, tested and corroborated risk factor(s) known to be associated with breast cancer (2-5). Epidemiology. The literature on Osteoporosis is rather extensive. In most industrialized countries, the ever-increasing epidemic of osteoporosis and diagnosed new cases far exceed in frequency (incidence and prevalence) all gynecological malignancies combined in the females, each year (6-10). The ever-rising numbers of osteoporosis are expected to rise even more significantly in the future (1). During the past two decades, since the early 1980s, osteoporosis and its sequels rapidly rose and continued its unabated rise, reaching excess epidemic proportions (10). A "silent epidemic" (11,12) and vastly underreported condition (13), osteoporosis has become highly prevalent disease, becoming an immense clinical and societal burden and an increasing and “tremendous” public health problem of highest priority (1), especially in the affluent North American, European and other communities. In the UK and throughout Europe 10 years ago, osteoporosis was not a public health concern, and was generally perceived as "a normal process of ageing…about which nothing could be done" (14). A systemic disease, affecting 10 million women with osteoporosis, and another 34 million with osteopenia (low bone mass loss, or, "mild osteoporosis") are diagnosed in the U.S. annually (1-10), and many more worldwide. More than 80 percent of all osteoporosis cases are in females. In the U.S. and Europe, 1 in 3 women over 50 years of age will develop the disease, with a probability of having a hip fracture 14 percent (one in seven) (8, 15, 16). An estimated 35 percent of post-menopausal white women in
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the U.S. have osteoporosis of the hip, spine, or distal forearm, and the prevalence in women could rise up to 47 million until 2020 (1). In the U.K., it was estimated that about 3 million people suffer from osteoporosis annually (17). In the past 25 years, it was shown that osteoporosis developed in more and more young, premenopausal women (1, 18, 19). The annual direct cost of osteoporosis with its sequels of fractures amounts $12-$18 billion to the US healthcare systems, and indirect costs in additional billions of dollars, with a conclusion that “these costs could double or triple in the coming decades.” The overall conclusion about the downward spiral in physical and mental ill health due to osteoporosis was that "unless preventive measures are taken a catastrophic global epidemic of osteoporosis seems inevitable" (1, 20). According to the Report (1), “there is a widespread lack of knowledge about prevention” of osteoporosis and the need was emphasized for innovative interventions in community projects against the disease, which situation has been referred to as “the Nation’s at-risk bone status.” Osteoporosis is a major public health problem in the Republic of Macedonia as well. It was estimated that Osteoporosis is widespread in women in the population, and that around 6,000 menopausal women have evident signs of osteoporosis in the country (21). A fraction of 555 hospitalized patients with arthritis-related conditions, were reported in the year 2000, out of which 76.2% were women (with F/M ratio = 3.2 : 1), with about 10,000 hospital days, or 18 days of hospital treatment in average, and at great financial cost. It is assumed that the prevalence of osteoporosis in women of the country is not less than 10 percent. Definitions. Bone mineral density (BMD) is used as a proxy measure of bone strength. Osteoporosis is diagnosed by low bone mass and steadily deteriorating BMD, leading to bone fragility and increased fracture risk. The World Health Organization, 1993 (22), definition of osteoporosis in women is the BMD that is -2.5 SD (standard deviation), below the mean of the BMD in young white adult females. The T-scores of 0 to -1 are meant normal; -1 to -2.5 SDs indicates osteopenia; and -2.5 or lower, is diagnosed as osteoporosis. The U.S. National Institutes of Health Consensus Conference (6) definition is that osteoporosis is "a skeletal disorder characterized by compromised bone strength, predisposing to an increased risk of fracture." The broadened NIH definition of Osteoporosis included factors other than BMD: the bone strength, consisting of two additional features: bone density and bone quality. The bone density is defined in grams of mineral/area (volume); and bone quality includes into the equation the factors of bone architec-
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ture, turnover, damage accumulation, and mineralization, suggesting that factors other than BMD are involved in the etiology of Osteoporosis. Critical information about the research of osteoporosis in women. Presently, there are no etiological hypotheses how to treat or prevent the osteoporosis (1). The current theories of vitamin D and calcium deficiency (23), high animal protein consumption, and other macro-environmental factors had little effect on the osteoporosis rates, treatment and prevention in women. The clinical research in treatment of osteoporosis is relaying mainly on testing new chemical drugs (24) and on nutritional interventions (25, 26). The evidence of the current therapy, including the HRT (hormone replacement therapy) seems insufficient and did not justify their use (27). It seems that the common feature of the research in Osteoporosis today is the fact that women have been investigated in one-sided and highly isolated way, taken out of context of their natural and marital life. Little interest was hoisted about their/ her aspects of reproduction, (barrier-) contraceptive use, and marital/ male fertility (28). The widespread malignant or benign conditions of women, specifically cancer of the breast and tumors of other organs of the reproductive system, have been usually taken as passing references, have not been defined in terms of possible cause-and-effect sequence, and have never related to the distant, prior conditions or experience in the lives of women (28-30). Reproductive issues, mentioned briefly in the Surgeon’s General Report (1) were limited to two conditions of integral health and fertility, concluding that “pregnancy and lactation generally do not harm the skeleton of healthy adult women.” The analogous epidemiological features of breast cancer and osteoporosis have rarely been investigated, if at all, as a common etiology in the potential of their risk factors, prevention and control. The traditional and doctrinaire approaches of research in reproductive issues have neither identified the etiological causes of the osteoporosis epidemic nor defined the ways of preventing the disease in the community and at individual and family levels (31). Besides the biomedical model of osteoporosis, there have been factors associated with the development of the disease, such as, postmenopausal age, protective effect of the African-American race (32), "the confounding mystery" of culture (33), psychological state (34), and others. The idea of osteoporosis screening was found to be unfeasible, until an ap-
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propriate treatment can be determined and a better knowledge of etiology and prevention is identified (35). The development of osteoporosis in women is found to be associated with certain forms of malignancies (36), most notably with breast cancer (29, 37-42), endometrial cancer (43) as well as with certain sex- (gender-) specific diseases, such as increasing rates of Anorexia nervosa (with lethality 18-20%), hyperthyroidism and endometriosis (17, 44, 45), and steroid treatments (46). The evidence of such interrelated conditions and a possible common cause is rather consistent with the proposed new osteoporosis hypothesis. In fact, besides the routine calcium-vitamin D hypothesis, which appeared ineffective for treatment of (future) fractures (47), no other hypothesis on osteoporosis seems to have emerged so far. Many aspects of osteoporosis and related diseases, their treatment and protection against, have remained without answer about their biomedical mechanisms and etiology. The present paradigm of "lack of understanding" of the causes of bone dynamics and bone health alterations, and the widely assumed unsuitable ("experimental") treatment strategies of osteoporosis call for an urgent shift of the unsuccessful paradigm (48). As an attempt to contribute to the “Bone and Joint Decade 20002010”, a global initiative endorsed by the UN (49, 50), and proclaimed by the U.S. President George W. Bush “Decade of the Bone and Joint, 2002-2011” (1), with the mission to "promote cost-effective prevention and treatment" of musculoskeletal disorders, the submitted project proposal is planned to test a new, a priori hypothesis of a postulated etiological association between the barrier contraception during childbearing age and osteoporosis development in women. CONCEPTUAL FRAMEWORK OF THE PROPOSED POPULATION-BASED INTERVENTION Population: Women under investigation will consist of patients of reproductive, premenopausal age, 30-50 years, coming for examination and treatment to the outpatient Clinic and Hospital Department of Rheumatology. Eligibility: women with arthritic pain, swellings, back pain, bone fractures, attending Osteoporosis clinical center; age eligibility, limited to 30 to 50 years of age; Duration of the trial: Short-term, three- to (eventually) extended, fiveyear time period, for completion of the bone health (change) assessment.
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Clinical Methods: Assessment of the patient's profiles, along with interview with structured questionnaire of the types and intensity of contraceptive practice (in years and months, between 15-50 y/a), and measurements and quantification of the individual's bone density, at the baseline, with follow-up, periodical check-ups to the end-point results, in eligible women, aged 30 to 50 years. Measurements of bone heath: Bone mineral density (BMD) will be used as a measure of bone strength, and the WHO scale of bone changes will be applied. Among the techniques available to measure BMD, will be DEXA, quantitative ultrasound (QUS), the high precision 3D Quantitative CT (3D QCT). The 3DQCT is the best method that provides volumetric measurement of the BMD that is capable of distinguishing between the exterior cortical bone and the interior trabecular bone. The changes of the latter are the most reliable indicator of the bone health. Objectives: To test both (i) the purported etiological risk factors, specifically the exposure to condoms and other barrier conditions, during the women's reproductive (pre-menopausal) ages, 15-50, and (ii) the potential of primary prevention of osteoporosis in women at the individual, family and community levels, and (iii) to assess the potential of reverse process of the bone loss into bone gain in young women. Ultimately, to try to justify (iv) a strategy for change of a faulty contraceptive and cultural practice (shift of the condom paradigm), by reassessing the same tested risk factors known to be associated with other sex- (gender-) related disease(s), such as, breast cancer and pelvic lesions. In addition, the trial will (v) try to estimate the prospects for clinical (medical) treatment of refractory cases of the disease. It is expected that there will be enough ground of the proposed research to render older women beneficiaries as well, by critically extrapolating the evidence and the experience to many millions of women in North America, Europe, and other advanced countries everywhere. HYPOTHESIS TO BE TESTED: The elimination of the exposure to barrier methods of contraception (condoms and/or withdrawal practice), with replacement to non-barrier methods, is to significantly reduce, prevent, and reverse the process of bone loss (in prevalence rates and T scores of mean values and standard deviations SD statistics): SAMPLE SIZE determination: Three hundred women in a participating center, computed at: a=.01, b=.01, at relative risk R=2.5 and prevalence P1=.10 = 304 [with a ® type I error, and b ® type II error] (51);
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RESEARCH STRATEGY: A population-based intervention is designed as a two-phase prevention trial, a PRE-TEST -- POST-TEST experimental study with baseline phase and intervention, follow-up phase, with repeated, at least four times, clinical check-ups and bone measurements in women participating in the community trial. The strategy will be a Historical Cohort with Intervention, as a multidisciplinary and multi-institutional clinical/community trial, without randomization and without placebo treatment. Two other strategic approaches were under consideration, but were found less advantageous for fulfilling the objectives of the trial, to assess the etiological risk factor(s) of osteoporosis, to assess the changes in the bone density during the intervention, in terms of bone-density loss and a possible bone-density gain, and to try to define the potential of primary prevention of osteoporosis in women, at individual, familial and community levels. The first alternative approach under consideration was the strategy of a randomized clinical trial (RCT) with placebo, by which the women using condoms would be followed up until osteoporosis and its sequels could become manifest. The drawbacks with this approach are of practical and ethical concerns. There is a strong conviction in the highly negative impact of the continuing condom use upon various aspects of women’s ill health. The subject matter of unjustifiably withdrawn information remains unanswered. Furthermore, such a randomized trial may not be a superior strategy to the proposed population-based intervention objectives. It seemed that the RTC with placebo could not be able to assess the possible reverse process of bone-loss into expected bone-gain process, which is one of the main objectives of the trial. While the levels of significance of the differences of condom use in the bone loss process could be fairly assessed, the changes of the bone density in terms of reduced loss or maybe gains could not be assessed by the RTC-placebo approach. In addition, the randomized placebo trial would require longer period of assessment than the initial three-year time, along with a higher budget. A second alternative approach which might be implemented was a comparative community preventive trial between two similar communities, with measurements of the frequencies of osteoporosis and its sequels. Besides the higher expenses, organization and required long-term period of time for carrying out such a community trial, there was the problem of potentially compromised macro “placebo” treatment. The
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additional and prevailing obstacles was the fact that the community preventive trials, although good in theory, are very difficult to implement, in controlling for publicity bias, the acceptance of the purpose of the trial, unknown interchange of information (and rumors), compliance of the intervention factors, and perhaps some loss of data and self-selection in the clinical assessment of end results. Reliability Assessment: A sample of 10 percent of the participating patients (30) will be reinterviewed in order to assess the reliability of the reported information of the contraceptive practice, devices and methods, and duration of their use (in years and months). • Clinical examination: Baseline phase with Interview, physical check up, measurement of bone density mass with BMD index, ultrasound measurements of BDM: Completion of Baseline phase will be done with quantitative risk analysis of the cross-sectional data of the cohort, in terms of prevalence and duration, in years and months. These aggregate and mean data are expected to be robust. For collecting the data, a modified 'Life History Approach' questionnaire (UNC-School of Public Health, Chapel Hill) is to be employed, along with a number of other clinical records about BMD and other bone density/health determinants. The INTERVENTION (to be carried out in the follow-up phase): • Advice for changes in the lifestyles, for conversion of the barrier contraceptive methods (condoms and/or coitus interruptus/withdrawal) into non-barrier contraceptive methods, for achieving the objectives of the trial. The advice will be according to a Table of non-barrier contraceptive practice, according to marital and reproductive status of women, motivations for family planning in terms of child spacing or completed family size, and age group. • Distribution of non-barrier contraceptive devices, such as IUDs, diaphragm, OC pills, rhythm method, tubal ligation, free of charge to the registered participants. (The cases of pregnancies, although not a part of the preventive intervention strategy, will be accepted as such.) In addition, the data of male or marital sterility/infertility will be assessed by previous records, followed up and recorded as routine procedures, but with no intervention. The cases of vasectomies will also be collected and followed up, recorded and dealt with likewise, but will be excluded from the risk analysis (no hypothesis!) from either “barrier” or “nonbarrier” methods of contraception.
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• Follow-ups: End-result phase, with clinical check-ups, once a year, in duration of the trial, until the end-result phase; with sequential analysis, compliance checks, and comparison of the end-result data with the baseline ones; • Cut-off point: Measures of the bone mineral density (BMD) by Dual Energy X-Ray Absorptiometry test (DEXA), quantitative ultrasound (QUS) and comparison of the values between the baseline, periodical and the end-result data. • Intermediate results and Criteria for early termination of the trial. An early termination of the trial may be considered in situations such as: Attrition of the sample; sequential analysis repeatedly showing no appreciable differences in the results of the intervention (p>.05); and a consensus about the end-results showing too obvious success or failure of the intervention, indicating no good reason for continuing the trial. • Progress reports, periodical and final, with recommendations for further action and possible publication. ETHICAL ISSUES: The population-based intervention, an Historical Cohort strategy with intervention, rather than a RCT (Randomized Clinical Trial with placebo), has been preferred as the appropriate research strategy for certain reasons. The justification for not using placebo in this cohort of young women would be as follows: first, because of the fact that the data of the used fertility-control methods and devices up to the enrollment in the trial by the women-participants cannot be randomized; second, because of the possibility to extend and offer the assumed benefit to all (young) participants in the trial; third, for eliminating any ethical conflict of knowingly exposing women to continued usage of harmful condoms (the purported distant cause of the osteoporosis), by withdrawing condom-causality information; fourth, less secretive approach by reducing the sources of guess and rumors about the preventive goals, which may help the compliance in the use of the non-barrier methods; and fifth, and perhaps one of the most important, the assessment and quantification of the changes and expected signs of reversibility of the of the bone loss, if any, according to the baseline history and profiles of previous contraceptive practice. Furthermore, in view of the fact that potential controversy may emerge about the use of some methods of contraception, the proposed population intervention with non-barrier methods of contraception and fertility control will be conducted for preventive and therapeutic purposes only in the trial, to participating patients. Written consent form will be requested and
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signed by women prior to enrolling into the trial and interventions. BLIND EVALUATION: In order to avoid any possible bias of subjective reading, two independent raters (experts in the field) will be continually performed of the technical findings, both baseline and endresults. An additional test of the reliability of the findings of the two raters will also be conducted. CONFIDENTIALITY AND VISIBILITY: Results to be strictly confidential, and will be used for scientific and therapeutic purposes only; transparency of the procedures. BIOLOGICAL PLAUSIBILITY (partially tested): The use of condoms (barriers) as an 'inverse' environmental factor, compounded by the unknown immediate and lingering adverse effects of repeated absolute sterile mating and barren female stimulation on the subtle, inner hormonal (im)balance in females, evident in a variety of processes or conditions, including osteoporosis and breast cancer. Barrier contraception, specifically, the use of condoms and/or withdrawal practice, is defined as an INVERSE environmental factor, for the introduced elimination, reduction or absence of the putative protective semen factors (the prostaglandins?) in the inter-human, intimate (sexual) ecosystem, during the reproductive ages of married women. For the purposes of the trial, the non-barrier contraceptives are defined as: the OC pills, diaphragm, IUDs, tubal ligation. (The vasectomy data will be recorded and followed-up, but will be neither included in the intervention procedures nor in the analysis of either type of barrier or non-barrier methods.) EXPECTED OUTPUTS: Corroboration of the working hypothesis, at a significant level (p<.01), that (i) the young women in the trial who have been using barrier methods (condoms) for contraceptive purposes to have a lower BMD than the women with history of non-barrier practice, and vice versa, women who have been using non-barrier methods in their marriages to have a higher BMD than the women with condom-use history; (ii) the process of bone loss to be considerably reduced and stopped (and to be lower in studied women) after intervention to non-barrier methods of contraception, and (iii) to observe an inverse process of bone-gain after the intervention. A dose-response relationship is expected to be found in bone processes. MULTIDISCIPLINARY AND MULTI-INSTITUTIONAL COL-
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LABORATION: Settings: The outpatient Center of osteoporosis and the Clinic and hospital units of the Department of Rheumatology, Director Prof. Dr. M. Grlichkov, of the Faculty of Medicine Clinical Center at the University St. Cyril and Methodius in Skopje, Republic of Macedonia, and other participating centers. International Collaboration and Implementing Partners: Still looking for international cooperation with other medical centers, and consultations with experts in Obstetrics & Gynecology, Rheumatology, Surgery, and other disciplines, especially in the United States and in the countries of European Union and the Balkans (Sofia, Belgrade). Necessary Equipment: Dual Energy X-Ray Absorptiometry (DEXA); Ultrasound. Timeframe, by months: [Between July 1, 2006 till September 30, 20092011 (estimation)]. First version: August 9, 2004 Revised (final) version: June 24, 2005 REFERENCES: 1. U.S. Department of Health and Human Services. Bone Health and Osteoporosis. A Report of the Surgeon General. Rockville, MD: DHHS, Office of the Surgeon General, 2004. (http://www.surgeongeneral.gov/library). 2. Gjorgov AN. Barrier Contraception and Breast Cancer. S.Karger, Basel-New York, 1980: x+164. 3. Gjorgov AN. Breast Cancer: Rationale for an Etiologic Hypothesis. A Reappraisal of the Clinical, Experimental, and Theoretical Aspects of Neoplastic Processes, Pseudopregnancy Complex, and the Possible Role of the Seminal Prostaglandins. Matica Mak., Skopje, 1995. 4. Gjorgov AN, Junaid TA, Burns GR, Temmim L, Efficacy of preventive prostaglandin treatment of malignant mammary lesions in rats. An experimental trial. Journal of the Balkan Union of Oncology (JBUON) (Athens) 1999; 4: 295-306. Abstract in: European J Cancer Prev 1996; 5(Suppl 2): 104. 5. Gjorgov AN. Breast Cancer: Primary prevention versus t he current policy of rescue. New Balkan
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Politics 2003; 6-7: 143-169. Web: http://www.newbalkanpolitics.org. mk/issue6.asp 6. National Institutes of Health (NIH). Osteoporosis Prevention, Diagnosis, and Therapy. NIH Consensus Statement 2000, March 27-29; 17(1): 1-36. 7. American Medical Women's Association (AMWA). Position Statement on Osteoporosis. Web: http://www.amwa-doc.org/publications/ Position_Papers/osteoporosis.htm; 5/11/2000. 8. CDC. Prevalence of Arthritic conditions - United States, 1987. MMWR February 16, 1990, 39(6): 99-102. 9. Miller PD, Canalis E, Gass MLS. Osteoporosis: A New Era in Recognition and Treatment (6 parts), 2004.Web: http://www.medscape. com/viewarticle/461563_1. 10. Read M (Chairman). International Osteoporosis Foundation. Osteoporosis in the European Community: A Call for Action. An audit of policy since 1998. IOF, Brussels, 4 Dec 2001. Web: http://www. osteofound.org. 11. Delmas PD, Fraser M (International Osteoporosis Foundation). EU challenges member states to fight the 'Silent Epidemic' of Osteoporosis. Eurohealth, Autumn 1998; 4(4): 27-30. 12. Jackson, Caroline (Member of the European Parliament). Putting osteoporosis on the agenda. Eurohealth, Autumn 1998; 4(4): 26-27. 13. Vestergaard F, Reinmark L, Moseklide L. Osteoporosis is markedly underdiagnosed: a nationwide study in Denmark. Osteoporosis Int. 2004 June 12. Web: www.ncbi.nlm.gov80/entrez/ query?CDM=Text&DB=pubmed. 14. Edwards L, Frazer M. How do we increase awareness of osteoporosis? Bailliers Clin Rheumatol 1997 August; 11(3): 631-44 (Abstract). 15. Lawrence RC, Hochberg MC, Kelsey JL, et al. Estimates of the prevalence of selected arthritic and musculoskeletal diseases in the U.S. J Rheumatol 1989; 16(4): 427-41. 16. Imaginis A. Osteoporosis: Introduction. Web: http://www.imagines.com/osteoporosis; 06.02.2004. 17. National Osteoporosis Society Online-UK. What is Osteoporosis? Web: http://www.nos.org.uk/osteo2.asp. 18. Woznicki, Katrina. Young women vulnerable to bone loss. Report from the World Congress on Osteoporosis, Chicago, June 2000. Web: http://onhealth.com/women/ briefs/item,92892.asp.
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19. Kannus P, Palvanen M, Niemi S, et al. Epidemiology of osteoporotic pelvic fractures in elderly people in Finland: Sharp increase in 19701997 and alarming projections for the new millennium. Osteoporosis International 2000; 11(5): 443-448. 20. Riggs BL, Melton LJ. The worldwide problem of osteoporosis: insights afforded by epidemiology. Bone 1995 Nov; 17(5 Suppl): 505S511S (Abstract). 21. Karevski L, Grlichkov M. Densitometry (DEXA-Method) - precondition for diagnosis and treatment of Osteoporosis. Vox Medici, Skopje, June 2004: 12(43): 24-25. 22. WHO Consensus Development Conference on Osteoporosis. Hong Kong, 1-2 April 1993. Am J Med 1993; 95 (Suppl): 1S-87S. 23. Henneman A, Boekner L. Nutrition and Osteoporosis. PowerPoint information 2004. Internet. 24. National Osteoporosis Foundation. Prevention. (Medications for Prevention and treatment.) Internet, 2004. 25. Rigs L, Melton LJ. The prevention and treatment of osteoporosis. New Engl J Med 1992; 327(9): 620-627. 26. DeBoer E (Dutch Osteoporosis Foundation). OBGYN.net: Osteoporosis case of the month, 2004. 27. Seeman E, Eisman JA. Treatment of osteoporosis: why, whom, when and how to treat. The single most important consideration is the individual's absolute risk of fracture. Med J Aust 2004 March 15; 180(6): 298-303. 28. World Health Organization. Guidelines for Preclinical Evaluation and Clinical Trials in Osteoporosis. WHO, Geneva, 1998: vi+68. 29. Axley M. Osteoporosis and breast cancer: A link? Report. CBS Health Watch and the J Nat Cancer Inst, June 20, 2001. Web: http://cbshealthwatch.medscape.com/cx/ viewarticle/403083. 30. Chlebowski RT. Hormonal treatment of breast cancer: Managing bone loss in patientswith earlystage breast cancer, 2004. Web: http://www.medscape.com/ viewarticle/477666. 31. Lappe JM, Tinley ST. Prevention of osteoporosis in women treated for hereditary breast and ovarian carcinoma. A need that is overlooked. Cancer, September 1, 1998; 83(5): 830-34. 32. Bohannon AD. Osteoporosis and African-American women. J Womens Health Gender- Based Med. 1999 June; 8(5): 609-615 (Ab-
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stract). 33. Eisele S. Cultural differences and their effects on rates of Osteoporosis. 2004. Internet. 34. Dyer KA. Psychoneuroimmunology-PNI (MindBody-Spirit Medicine). Web: http://www.journeyofhearts.org/jofh/ translation/pni_art. 35. Fogelman I. Screening for osteoporosis. No point until we have resolved issues about long-term treatment. (Editorial) BMJ 30 October 1999; 319: 1148-1149. 36. Valeriano, Joanne. Malignancy and rheumatic disease. Malignancy and rheumatic disease are interrelated in multiple ways. Cancer Control J, May-June 1997; 4(3). Internet. 37. Utz JP, Melton LJ, Kan SH, Riggs BL. Risk of osteoporotic fractures in women with breast cancer: a population-based cohort study. J Chron Dis 1987; 40(2): 105-13. 38. Zhang Y, Kiel DP, Kreger BE, et al. Bone mass and the risk of breast cancer among postmenopausal women. New Engl J Med, Feb. 27, 1997; 336(9): 611-17. 39. Hinrichs J, ISL Consulting Co. 2003. Breast cancer & bone loss. The link between breast cancer and Osteoporosis. Web: http://health.yahoo.com/health/centers/bone_ health/_909.html. 40. Ramaswami B, Shapiro CL. Osteopenia and osteoporosis in women with breast cancer. Semin Oncol 2003 December; 30(6): 763-75. 41. Rosen L, Hortobagyi GH. Bone complications in breast cancer. Webcast transcripts 2004: Web: http://bcrfcure.healthology.com/ printer_friendly.asp?f=breast_cancer&c=breast_bonec… 42. Fontanges E, Fontana A, Delmas P. Osteoporosis and breast cancer. Joint Bone Spine, 2004 March; 71:102-10. 43. Newcomb PA, Trentham-Diez A, Egan KM et al. Fracture history and risk of breast and endometrial cancer. Am J Epidemiol 2001; 153(11): 1071-78. 44. Passo R. Adolescents with eating disorders are significantly increasing their risk of Osteoporosis -- A devastating chronic condition. Massachusetts Department of Public Health, Boston, April 20, 2000. Internet. 45. Chen Z, et al. Fracture risk among breast cancer survivors. Arch Intern Med 2005 ; 165 : 552-558 . 46. Imaginis(B). Osteoporosis: Risk factors and symptoms of osteoporosis. 06.02.2004. Web: http://www.imagines.com/osteoporosis/osteo_affectswhom.asp.
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47. The RECORD Trial Group. Oral vitamin D3 and calcium for secondary prevention of low-trauma fractures in elderly people (Randomized Evaluation of Calcium Or Vitamin D, RECORD) : a randomized placebo-controlled trial. Lancet 2005 May 7, 365 : 1621-1600. 48. Dieppe P. Osteoarthritis: time to shift the paradigm. Editorial. BMJ 15 May 1999; 318: 1299-1230. 49. Lidgren, Lars (Chairman). The Fourth Prevention and Treatment of Musculoskeletal Disorders. Internet - Web: http://www.boneandjointdecade.org. 50. Leong AL, Euler-Ziegler L. Patient advocacy and arthritis: moving forward. Bull WHO Feb. 2004; 82(2). 51. Schlesselman JJ. Sample size requirements in cohort and casecontrol studies of diseases. Am J Epidemiol 1974; 99(6): 381-84, and Tables, by the National Institute of Child Health and Human Development, 1974. (CORRECT REFERENCES) Macedonian Journal of Medicine 2006; 52(1-2): 5-21 Printed in Republic of Macedonia
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TO BBC EDITOR: REPLY TO SuSIE ORBACH’S ANORExIA DEBATE “THE FIgHT FOR OuR BODIES,”
December 24, 2006 To BBC Editor Interactive Anorexia Debate E-mail: Message Box Cc: firstname.lastname@example.org Skopje, Macedonia, December 24, 2006 Dear Madam, Re: Susie Orbach’s Anorexia Debate “The Fight for Our Bodies” – Reply and commentary The debate about Anorexia seems overconfident in blaming (pointing out) to diet, diet, dieting in all variations and occasionally (lack of ) physical exercise. Do we really know enough of what “our bodies want”? Do we really know enough about our children as well, especially the schoolgirls, who are at the highest and real risk of anorexia and other accompanying or equivalent phenomena? Perhaps the debate should try to turn its attention to other underlying demons, like the devastating physical and mental effects of the illicit condomization of the nascent sexuality of girls and other young women. As admitted in the debate, we (the humans) “metabolically differ very little (if at all, my remark) from our stone age ancestors,” then we should also admit that the Mother Nature has not adjusted any species, including the humans, to sterile mating, what the condom use actually is. Given the evidence that a persistent condom use is
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significantly associated with breast cancer development (in married women),* it is amazing that the response of Mother Nature looks so cruel to girls with anorexia or breast cancer in young, reproductiveaged women, for being mislead into “safe” fertility-control allure (the hi-tech condom device), the promoted “reproductive freedom” fallacy and “condom culture” misconception. In my informed view, besides the inner “physiologic breakdown” in women with Anorexia nervosa, the misnomer of “eating disorder” is, most likely, a secondary manifestation of impending and consequential suffering. What the British condom industry along with “Government and the NHS are not telling us,” about the diet, as you mentioned, pale in comparison of what has not been officially informed about the scientific evidence of the devastating and carcinogenic effects of consistent exposure to condom use for contraceptive purposes, even as a precaution measure or public awareness for protection of women’s health. (No wonder that the Twiggy fashion of anorexic look originated in the UK, long before the twin epidemics of Aids and Breast cancer ever emerged.) Abstinence, as imposed to American schoolgirls and children, seems the best albeit temporary solution in the circumstances. Arne N. Gjorgov, M.D., Ph.D. (UNC-SPH, Chapel Hill, NC) Skopje, Republic of Macedonia Author of *Barrier Contraception and Breast Cancer, 1980: x+164,
“History of the condom: the overlooked adverse effects.” Journal of the Royal Society of Medicine 1994; 87: 570.
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EARLY REPRODuCTIVE EVENTS AND BREAST CANCER
Comments on Report of Workshop, to the NCI Director, A.C. von Eschenbach, March 23, 2003 Andrew C. von Eschenbach, M.D. Director, National Cancer Institute, Bethesda, MD 20892 Skopje, March 26, 2003 Dear Director von Eschenbach: Re: COMMENTS ON THE SUMMARY REPORT ON EARLY REPRODUCTIVE EVENTS AND BREAST CANCER WORKSHOP In continuation to my previous communications to you, on Dec. 30, 2002 and March 13, 2003, and the response of your NCI Staff, I like to take the liberty of making the following strong comments on the Summary Report on Early Reproductive Events and Breast Cancer Workshop, February 24-26, 2003, as invited. As a long-term physician and researcher in the field of breast cancer and women's health, I was pleased that the old, routine investigations in breast cancer (diet, chemical toxins, and other factors) have been rather abandoned, and replaced by the interest in the reproductive and biological aspects of women during their reproductive periods. However, it seems that most of the issues in the Summary Report have been addressed or considered at the Workshop as though for the first time in the breast cancer research. No reference has been made to an American, hypothesis-testing study which investigated, identified the main risk factor of breast cancer in American women, and defined a potential of primary (non-chemical) prevention of breast cancer at family and individual levels along with an immediate and substantial health gain in the community. Many of the relevant breast cancer factors and
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issues, as listed in the Workshop Summary Report, I do believe, were answered in the published monograph of the aforementioned hypothesis-testing study, more than 25 years ago, entitled, "BARRIER CONTRACEPTION AND BREAST CANCER," S. Karger, Basel-New York, 1980: pp. x+164. In particular, I like to make my comments on most issues raised in all sections of the Summary Report: EPIDEMIOLOGICAL FINDINGS: - It is patently incorrect to conclude that the early age at first term birth is related to lifetime decrease in breast cancer risk. Many studies disputed this McMahon's conclusion, because no contraceptive method was taken into the controlling for secondary factors analysis. The evidence in my study suggested that the highest risk of breast cancer is found in women of early age at first live birth who limit their marital fertility by the means of a single and specific contraceptive method, the condom. The risk of developing breast cancer in such women has been shown to be more than 12 (twelve) times greater than in married women with the same characteristics--early age at first birth and one full and one full pregnancy only--who used other, non-barrier contraceptive techniques, such as, diaphragm, OC pills, IUDs, tubal ligation. (Additional ref: Eur J Cancer Clin Oncol 1985; 21: 267-268.) - Increasing parity is associated with reduction of breast cancer, but conditionally again. Even high parity, perhaps four or less children, is not protective if the woman (the married couple) has been using barrier contraceptive methods, specifically condoms or withdrawal technique after the completion of the desired family size, or between the pregnancies. Let's assume that the reproductive ages of women, between 15 to 50 years of age, consist of 35 years, or 420 months. Woman with high parity of five children would have had 45 months of pregnancy, which is about 11 percent of her reproductive age without practicing any kind of contraception. Lactation excluded for a moment, it may open a period of about 375 months for practicing family planning. If the woman has been lucky enough to use non-barrier methods then she will be protected against breast cancer and a number of other accompanying diseases and phenomena. However, if the woman has been exposed to the "safe" and "modern" methods of condom use, then the chances of getting breast cancer are almost certain, as the evidence and the observations indicated. With the lower parity, the risk of breast cancer
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increases in those (married) women with condom-use history. Parity by itself, as an event, is not a lone protective factor against breast cancer but rather the manifold exposure to the semen factors of the healthy partner (husband). Since the high parity is not a modern population objective, the basic requirement for a primary prevention of breast cancer is the consistent use of non-barrier contraceptive methods during the reproductive ages of women. - The "long-term protective effect of young age at subsequent term pregnancies is not so strong." This may partly explain the observation that category of young age and FTNP is limited, because of the corruption of the reproductive potential in many women with the inappropriate and misconceived barrier contraception practice, i.e., the marital exposure to condoms and its induction of physiologically unknown carcinogenic effects. - Induced abortion is not associated with an increase in breast cancer risk, as concluded in the Report. In my breast cancer study (1980) the issue of abortion and breast cancer link was tested with an explicit subhypothesis. It was corroborated that the induced abortion, which indicated a fertility of the couple, was not related to breast cancer. To the contrary, the spontaneous abortion or abortions, which clearly indicate a marital (male?) sub- fertility or sterility, were expected to be associated with the increased breast cancer. The study indicated that it may be true, but the association did not reach statistical significance. In this regard, it is not by chance that the category "full term birth pregnancy" excludes the pregnancy failures, such as the spontaneous abortions, or even worse, the iatrogenic "missed" abortions, which indicate marital infertility, associated with breast cancer. Although the participating author of the induced abortion and breast cancer link hypothesis has placed a dissenting comment, defending it, I still believe that it is not correct. The hypothesis is not substantiated by the subsequent evidence, and is obviously missing the medical experience and clinical observations in women's health. It is widely acknowledged that abortion is a very emotional, deeply stressful and soul-searching experience to the mother, which experience should be avoided in the future by all possible contraceptive means. Since the 1980s, however, the "best," the "safe" and "modern" available contraceptive method, offering "reproductive freedom," was the promoted use of condoms. The women and couples of the mainstream population have been trained to persistent condom use for contraceptive purposes, converting in actual fact their
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marriages and husbands into absolutely sterile male partners, and thus inducing the greatest risk of breast cancer development in women in a relatively short latent period of two-and-a-half to five years. In this regard, by persistent exposure to condoms, the post-abortion women did not differ from other women in the community in developing breast cancer. The risk of breast cancer is personal and individual in the community and the family. - Lactation may provide "a small" reduction in breast cancer risk, as mentioned in the Summary Report, but it might be your assumption rather than your evidence. Lactation is nevertheless a secondary protective factor, in my view and tested observation. In the Arab world (Kuwait), the lactation was customarily long, 18-24 months for every newborn child! Who in the Western world can afford such a long lactation any more? - I must point out that the semen-factor (deficiency) hypothesis that was tested in my breast cancer study (1980), the exposure to "exogenous" hormonal factors (the DES and other composites in new glossary) was defined as a risk factor to breast cancer. A long period passed since the mid-1970s, when the study was initiated, supported by and completed jointly at the University of North Carolina School of Public Health, at Chapel Hill, NC, and at the University of Pennsylvania School of Medicine and Hospital, in Philadelphia, PA, during which I was concerned about the ill-effects of the extensive and widespread "replacement" hormonal treatments on American and other women, until the recent termination of the breast cancer inducing HRT. EPIDEMIOLOGICAL GAPS: - The issue of the mechanism of the "pregnancy at early age" in protection against breast cancer? The issue has been partially addressed in my breast cancer study (1980). Instead of "pregnancy" as the main protective factor, as repeatedly mentioned in the Summary Report, I preferred to consider the mechanism of the semen-factors in the protection of breast cancer. Pregnancy by itself was found to have NO separate protective effect against the disease. However, two sections of the breast cancer study (1980), trying to interpret the possible mechanisms and processes of the breast cancer developments due to condom exposure, had to be taken out of the dissertation at that time. The two excluded sections of the report of the study (1980) were subsequently published,
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under the title: Gjorgov AN. BREAST CANCER: RATIONALE FOR AN ETIOLOGICAL HYPOTHESIS. A Reappraisal of the Clinical, Experimental, and Theoretical Aspects of Neoplastic Processes, Pseudopregnancy Complex, and the Possible Role of the Seminal Prostaglandins. Matica Makedonska, Skopje, 1995: pp 84. The book has been submitted to the National Library of the US Congress, and I believe that it may be still available there. - Radiation-induced breast cancer is controversial rather than certain. I have addressed the issue in my breast cancer study (1980), along with the atomic-bomb consequences in Hiroshima and Nagasaki. It is not a long story (hypothesis) to be repeated here, about the evidence that the breast cancer was not increased in some age categories of women there, but I believe it could be better to read about it in the full context of the study. - The association between pre-eclampsia and condom use was investigated by Klanoff-Cohen H, et al: An epidemiological study of contraception and pre-eclampsia. JAMA 1989; 262: 3143-47. The study corroborated the association between the condom use and the pre-eclampsia in pregnant women. The study was carried out at the same School of Public Health of the University of North Carolina at Chapel Hill, NC, where I completed my study of breast cancer and condom exposure association previously. CLINICAL FINDINGS: In my view, the issues of mammographic density, changes in breast histology, and hormonal changes after pregnancy, might be of academic interest but are not necessarily important in the search of the causes of the breast cancer epidemic and the ways of prevention of its unabated explosion in American women and worldwide. CLINICAL GAPS: Again, the issues of "pregnancy-related" histological and hormonal changes, the "precise nature" (?) of pregnancy related changes, aspects of "ductal lavage findings," procedures of assessing of "breast composition," molecular and histological changes in the breast "during and after pregnancy," immune systems in breast cancer and pregnancy, and non-hormonal metabolic changes in breast cancer risk, might be of in-
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terest to many, but may also be a deviation from the efforts to respond to the current breast cancer contingency. I do believe that many of the issues listed in the NCI Summary Report may become redundant after the current breast cancer epidemic is reduced to sporadic cases of the disease. ANIMAL MODEL FINDINGS: - It is not news that pregnancy protects against "chemical carcinogeninduced breast cancer in rats and mice." Are there such women that are or might be exposed to such a crude impact of toxic chemicals that develop breast cancer? Nowhere. May I humbly suggest to you my experimental study in which the breast cancer was induced in small laboratory animals by sterile mating only. No chemical or physical agents, or radiation, were used for provoking the predetermined mammary cancer in the female animals. The term "mimicking pregnancy" seems blurred and poorly defined; most likely, it reflects a deep hormonal imbalance in the female animals, and in my experience, might be present in women as well. I do not have a full answer to these phenomena but, contrary to the postulates of certain researchers whose fallacious assessments are reflected in the Summary Report, that the "mimicking pregnancy" is "protective for carcinogen-induced cancer in rats," I strongly believe and have observed during the testing that the mystery of the breast cancer development may be located in this hormonal dysfunction, including for women. By default, I have alternatively used the term "PSEUDOPREGNANCY COMPLEX" in my studies in order to denote the process of a long-term hormonal imbalance in the development of breast cancer in human female along with neoplastic tumors of the endometrium, ovary, thyroid gland, and other conditions. Obviously, during its long evolution Nature has not adjusted the species to sterile mating, including the humans. The chaotic and dysfunctional inner response in females to the sterile sexual stimulation, ostensibly conducive to carcinogenic changes in the breasts and other organs of the reproductive system, is the most likely CONDITION that we have ignored to see and acknowledge, as researchers and medical professionals. Ref.: Gjorgov AN, Junaid TA, Burns GR, Temmim L. Efficacy of preventive prostaglandin treatment of malignant mammary lesions in rats. An experimental trial. Journal of the Balkan Union of Oncology (J-BUON) (Athens) 1999; 4: 295-306. (Kuwait University Faculty of Medicine and the Kuwait Cancer Control Centre - KCCC). Abstract in: European J Cancer Prevention 1996; 5(Suppl 2): 104, along with
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the aforementioned publications of 1980 and 1995. ANIMAL MODEL GAPS: It seems that gaps are more than the three ones mentioned in the Report. I would suggest that "chemical carcinogen exposure" in experimental animals is not necessary anymore and other (non-chemical) models should be developed. In addition, non-chemical models in breast cancer should be tried in laboratory experiments before or after in "pseudopregnancy" rather than in "pregnancy". FUTURE RESEARCH DIRECTIONS: - Animal and treatment models. I believe that we have attempted already an innovative experimental model in breast cancer etiology and preventive treatment with Prostaglandins 15 years ago, as mentioned above. The experimental trial in animals was a laboratory test of the previously completed studies in the potential of primary, non-chemical and sustainable prevention of breast cancer, before a clinical / community preventive trial of breast cancer prevention in women is suggested, submitted, justified and eventually funded. - It is hard to comment on the issues of "hormone-induced protection." I believe that the practice of hormonal manipulations in the field in breast cancer could hardly be justified at present. Let the geneticists test their postulates of BRCA1 and BRCA2 mutations within the framework of the semen-factor hypothesis in breast cancer. - To pursue descriptive (only? why not comparative, retrospective and prospective also) and international studies in order to develop hypotheses and new hypotheses in breast cancer. This research hypothesis-developing direction in breast cancer touched me personally. My breast cancer study was based on a specific hypothesis in the development of breast cancer in American women, and was tested at two prestigious universities in the United States (of North Carolina and of Pennsylvania), in the mid-1970. It has provided a viable ANSWER to the breast cancer problem in the country and beyond, defined a potential of primary prevention of breast cancer, and explicitly predicted, at the outset, of an imminent breast cancer upsurge as a natural experiment resulting from increased prevalence and the promotion of an indiscriminate and persistent condom use as a prophylaxis against the AIDS
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transmission in the mainstream American population. The study has became a non-existent entity, effectively banned from public view and professional scrutiny, unknown for generations of researchers, excluded from debates for prevention of breast cancer as a public health policy, and the author followed the fate of the study and the published book. I do wonder about what kind of "new hypotheses" in breast cancer are sought for protection from the dreaded disease of the present and future young women and their families, when a study in breast cancer prevention, such as my study, "BARRIER CONTRACEPTION AND BREAST CANCER" (1980) is still suppressed and censored. [Alternatively, the study may be available in dissertation form, at the University of Michigan Dissertation International (1979), Ann Arbor, MI 48106; UMI publication # 79 14352, pp 325.] At the present, it is of no surprise that the word "prevention" of breast cancer is absent or wrongly equated with the downstream salvage treatment activities of the breast cancer, early-detection and mass screening campaigns, failed and misconceived chemo-prevention with Tamoxifen and other toxic chemicals, acclaimed "prophylactic" triple surgery and defeminizing mastectomy and oophorectomy of healthy and young women as the only protection against the disease, and aggressive treatment of the breast cancer affected women. - Surrogate markers. No comments. (Why after pregnancy only?) - Translate knowledge about "protective effects of pregnancy" into intervention trials with human populations. To my knowledge and experience in the breast cancer prevention and women's health fields, the protective effects of pregnancy could not be translated into a viable basis for a public health policy in prevention of breast cancer on a population base. An ecological study, based on official IARC and WHO data, further corroborated at significant level of correlation the association between the breast cancer incidence rates and the prevalence rates of condom use in 166 countries of the world. [Ref.: Ecological breastcancer incidence differentials and condom-use prevalence worldwide, 1983-1987: Corroboration of the potential for primary prevention. Archives of the Balkan Medical Union (Bucharest) 1998; 33 (3): 111123.] Conversely, I am convinced that the application of the variety of non-barrier contraceptive methods, rather than pregnancy, could be implemented as a basis for intervention trials in human populations, for achieving a sustainable, sizeable elimination (perhaps up to 80 percent) of the present-day breast cancer epidemics (i.e., into the level
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of sporadic breast cancer cases). Such an interventional trial may be needed before the women and their partners (husbands) are EMPOWERED with the INFORMATION of the main hazards of developing breast cancer, and of the way to prevent through their personal decisions about the options for protection against the dreaded biological terror and real threat of the disease(s) during their reproductive lives. Namely, at it is known, the information is more powerful than legislation in the public health work, including the breast cancer prevention and protection. The manuscript of the research proposal for an interdisciplinary and collaborative intervention trial, in duration of three to five years, is ready to be submitted. The intervention trial is titled: "PRIMARY PREVENTION OF BREAST CANCER IN THE COMMUNITY: NEOPLASTIC DISEASES ASSOCIATED WITH BARRIER CONTRACEPTIVE RISK FACTORS. PROJECT PROPOSAL" - "Promote interactions among epidemiologists, clinicians, and basic scientists," and "funding interdisciplinary research" concerning breast cancer and reproductive dysfunctions. Fine. That is what is really needed. I know personally (from conferences) or by correspondence a number of participants at the Early Reproductive Events and Breast Cancer Workshop, who are familiar with the main concept, results and conclusions of my initial breast cancer study. However, it seems to me that the content of the study, and the other publications and communications related to the primary breast cancer prevention, etiology and epidemiology, was obviously not mentioned it at the meeting. Requesting their reactions and opinion from the participants about the suggested new approach in the elimination of the current breast cancer epidemic might prove valuable. For your information and record, I would like to refer you to two more studies: Gjorgov AN: Continuing rise of the breast cancer epidemic worldwide, in the 1990s: Further evidence and corroboration of the potential for primary prevention. Contributions of the Section of Biological & Medical Sciences of the Macedonian Academy of Sciences and Arts (MASA), Skopje, 2000, Vol. XXI, No. 1-2, pp 41-63; and Gjorgov AN: Breast Cancer: Primary Prevention Versus the Current Policy of Rescue. A Case for Socio-Cultural Interaction. New Balkan Politics, Skopje, 2003, vol. 6-7, pp. 143-169. Internet: http://www.newbalkanpolitics.org.mk/issue6.asp
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BOARDS' RESPONSE: I do believe that the additional gap in our LACK of clinical and biological understanding of breast cancer, rather than understanding of pregnancy (?) only, could be identified soon, I believe, which might help guide the future institutionalized research agenda in primary breast cancer prevention. No wonder that the President George W. Bush has undertaken an energetic campaign against the condom use and education in the American schools, and thus effectively terminating the very foundations of a universal and lethal condom culture. No matter what the intentions, the struggle against the condoms is the struggle against the breast cancer epidemic in the country and beyond. I would greatly appreciate if my comments and suggestions about the potential breast cancer prevention and the proposed intervention trial in the community could be communicated to the NCI Board of Scientific Advisors and Board of Scientific Counselors, for their considerations. Thanking you for your attention, I shall be looking forward to hearing from you. Respectfully yours, Arne N. Gjorgov, M.D., Ph.D. (UNC-SPH, Chapel Hill, NC) Author of “Barrier Contraception and Breast Cancer,” 1980, x+164 Active Member of the New York Academy of Sciences
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RE: FAREWELL TO CHEMICAL PREVENTION OF BREAST CANCER
Letter to Dr. Andrew C. Eschenbach, Director of the NIH, April 2006 Dr. Andrew C. von Eschenbach Director of the National Cancer Institute, NIH, Commissioner of the Food and Drug Administration 9000 Rockville Pike, Bethesda, MD. 20082 Skopje, April 30, 2006, E-mailed and Airmailed Dear Sir: Re: FAREWELL TO CHEMICAL PREVENTION OF BREAST CANCER Referring to the unending debate about the chemical prevention of breast cancer, as featured at the 28th Annual San Antonio Breast Cancer Symposium (SABCS), in December 2005, of a renewed Study of Tamoxifen and Raloxifene (STAR), as the ‘new option’ for breast cancer prevention, I like to convey to you my critical reaction and comments. The big display about the supposed Raloxifene and Tamoxifen breast cancer prevention in healthy women seems a continuing attempt by some (American and British) pharmaceutical industries and some concerned scientist to carry out an arbitrary chemical prevention of breast cancer in the general population. The effort to commercially advance the drug [“with fewer serious side effects” than Tamoxifen (?)] is based on the assumption of and is clearly implying that there is something biologically wrong with the American women, whose ‘inadequacy’ should be corrected by administering the toxic drugs. The early-terminated project (STAR) is also being claimed “for benefit” in some prestigious medical journals (JAMA) as well as in some prestigious daily newspapers (NY Times) as drugs “recommended for breast cancer prevention.” One may wonder whether the breast cancer specialists, advocates, and
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policy makers were well-informed to consider the possibility that there is nothing biologically abnormal with the American (and other) women who should be swayed to take the drugs. A really new option for primary prevention against the ever-rising breast cancer epidemic in the country and worldwide would be to find out what causes the subtle, delicate balance of the inner environment of women to deteriorate, and to generate condition(s) conducive to the development of breast cancer along with other diseases of the reproductive system and other phenomena. In my informed opinion, true prevention of the current breast cancer epidemic could only be done from tested and corroborated findings of determined etiological causal factor(s) and evidence-based prevention potential. A necessary shift of the conceptual framework about the etiology, the risks, and the potential of prevention of the epidemic disease of breast cancer may offer a viable ANSWER to the present breast cancer contingency. The alternative approach to the chemical intervention has been postulated in an American study long ago that suggested an evidence-based potential for primary prevention of the epidemic extent of breast cancer (to the level of sporadic cases). However, the alternative option, for a change, has neither been considered at the SABCS, nor at the highest policy-decision and public health maker levels. Hopefully, the United States along with some E.U. countries will not justify repetition of the highly controversial, costly and harmful community-based ‘chemo-prevention’ experiments of breast cancer, no matter authorized or elective. Given the fact that many human lives are at stake, that the disease is rampant, and the feelings of urgency abound, it seems that it is not the best time to delay a primary prevention action, or to pretend ignorance about of potential prevention option of the current breast cancer epidemic in the United States and other advanced and affluent countries of the West. There seems no help, I believe, but to bid a long overdue FAREWELL to the risky breast cancer chemo-prevention allure. The critical comments are based on research evidence, observations and inferences presented in the enclosed (in the text) Breast Cancer Conceptual Framework Shift (Table 1), with the hope you might be interested in.
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Respectfully submitted, Arne N. Gjorgov, M.D., M.P.H., Ph.D. (UNC-SPH, Chapel Hill, NC) Author of the “Barrier Contraception and Breast Cancer Study,” published in the distant 1980: x+164 G. Hadzi-Panzov Street, No. 2; 1000 Skopje, Republic of Macedonia; Phone & fax: 00389-2-317 8568; E-mail: email@example.com Enclosure 1
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