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A global overview of ethical issues in women’s health
International Journal of Gynecology & Obstetrics 70 Ž2000. 165᎐172
A global overview of ethical issues in women’s health J.M. Cain FIGO Committee for the Ethical Aspects of Human Reproduction and Women’s Health, FIGO Secretariat, London, UK
Abstract The fundamental denial of basic human rights to reproductive choice, freedom from violence, and economic and educational development for women remains the major underpinning ethical issue in worldwide women’s healthcare. The ability to choose when to have children, whether to have prenatal diagnosis or to make uncoerced choices at the end of life all hinge on the independence of each woman’s ability to make choices about their own healthcare within the constraints of the health resources available to them. Technologic advances increase the complexity of assuring that the rights and best interest of the woman, the fetus or child, and society itself are balanced equitably in both the healthcare setting as well as the development of national or international policies and standards. The obstetricianrgynecologist, as an advocate for women’s health worldwide, has an ethical obligation to assure human rights are extended to women and the obligation to assure that the care received is the best available. 䊚 2000 International Federation of Gynecology and Obstetrics. Keywords: Women’s health; Medical ethics; Violence; Reproductive choice; Maternalrfetal
1. Introduction The discipline of obstetrics and gynecology covers just a small part of women’s health, but the ethical quandaries that arise from the discipline cover the broadest range of any medical discipline. These quandaries span interactions from individual health practitioners with individual women to public health issues about distribution of scarce resources and control of socially sanctioned but injurious health behaviors. The global social and economic disenfranchisement of women continues to impede health im-
provements for women w1x. The social and political invisibility of the health and well-being of women that results from disenfranchisement presents a tremendous barrier to improvements in health status. The simple denial, in some settings, of their most basic ethical and human rights makes the simplest of medical ethics axioms ᎏ prevention of harm ᎏ virtually impossible. Daily, intended harm in the form of sexual violence particularly in areas of military conflict, continues to strip women of the right to freedom from bodily harm. The psychological and reproductive health consequences of abrogation of women’s
0020-7292r00r$20.00 䊚 2000 International Federation of Gynecology and Obstetrics. PII: S 0 0 2 0 - 7 2 9 2 Ž 0 0 . 0 0 2 2 9 - 0
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J.M. Cain r International Journal of Gynecology and Obstetrics 70 (2000) 165᎐172
human rights through such war crimes or simply cultural norms will impact the health of women and families for generations to come. Every minute that passes, women and their children continue to die from preventable complications of pregnancy and childbirth because of the failure of individual nations to accord this most basic step in human existence enough importance to provide healthcare support. Nothing could be a more fundamental ethical obligation for societies than securing the health of mothers and future generations of citizens, yet this remains a distant and unobtainable dream in many areas of the world. Linking the value of family health status to the low status and low value of women worldwide results in the diminution of attention to this vital area of the future for governments and yet directly impinges on their future economic development w2x. The failure of governments to attend to the safety and health of women results in both short- and longterm harm to their own economic and political stability and health, yet it remains a remarkably low priority for many nations. This is an obstacle that the medical profession must overcome. It is one of the ethical obligations of a learned profession, such as medicine, to educate and to advocate for an improved future. Making visible this link between the economic and social status of women worldwide with women’s and their family’s health is an ethical obligation of the learned profession of medicine, and a key to improvement of women’s health. This advocacy is part of the fiduciary role that physicians must play in the best interests of their patients, in this case in the best interests of women’s health worldwide. Each physician is obligated to speak up in their own medical organizations, in their interactions with those who set health policy in their own countries, and in informing and networking with others who can act to improve the status of women in their own country and throughout the world.
2. Ethical advocacy issues Two specific health issues that link cultural roles and status of women with negative medical
outcomes have held center stage in global medical ethics, and remain obstacles to health. They serve as striking examples of the multiple relationships between ethical issues, religious and cultural norms, and health rights for women. The first example is female genital mutilation w3x; 120 million women have undergone female genital mutilation and another 2 million are at risk every year w4x. Regardless of cultural differences, worldwide the most fundamental ethical principle of medicine is benefiting those we treat. Since there is no scientific basis for a benefit from the procedure, and well documented harm, involvement of physicians in the performance of such procedures is ethically unacceptable. Advocacy for elimination of the procedure, condemnation of those who persist, pressure to assure that existing laws prohibiting the practice are enforced, education regarding the medical effects, and knowledgeable and sensitive care for women who have already undergone such procedures are the appropriate ethical stance of the obstetrician ᎐ gynecologist w3x. The second culturally influenced health issue is related to the rampant spread of HIV in women because they are unable because of sexual violence, low social status, poverty, and cultural expectations of subservience to refuse coitus or assure protected intercourse by demanding use of condoms. Approximately 10 million women are living with HIVrAIDS worldwide who were infected primarily through unprotected intercourse, and the number continues to grow w4x. While the right of women ‘to ha¨ e control o¨ er and decide freely and responsibly on matters related to their sexuality, including sexual and reproducti¨ e health, free of coercion, discrimination and ¨ iolence’ w5x have been internationally recognized, we are still far from the goal. Continuing development of economic opportunities for women that result in decreasing their vulnerability to sexual economic coercion and raising their social standing should be part of the advocacy role of medical professionals within their countries and internationally. Raising awareness of the critical role ᎏ the ability to make reproductive choices ᎏ has in the spread of HIV, is also, a fiduciary and therefore ethical duty of physicians.
J.M. Cain r International Journal of Gynecology and Obstetrics 70 (2000) 165᎐172
3. Issues of research in underdeveloped countries The stark need for healthcare in developing areas of the world, particularly for the devastating effects of HIV infection, along with educational deficits and low status of women may make them more vulnerable to exploitation with clinical research carried out in those countries w6x. Two examples of the potential for coercion and harm as a result of the desperate need for access to any healthcare are the now completed HIV transmission trials and reproductive control trials. The just distribution of the burdens Žexposure to risks. and the benefits Žability to benefit from the resulting products or techniques . for the population of women studied is of concern in regard to both these examples. Sub-Saharan Africa has been particularly impacted by maternal transmission of HIV to children, comprising ) 85% of children infected by this route worldwide w4x. Given the overwhelming need for protection, the desperation of women seeking care makes it likely that they would accept ANY risk in order to receive any care. Exposure of neonates to the virus in a placebo arm of a study when the potential for decrease in transmission had been identified in other studies was an issue in the design of transmission studies in underdeveloped countries. The actual strength of protection as well as the minimum treatment required for protection were unknown, and rapid identification of the best strategy was felt to offer the greatest good to the greatest number. The significant decrease in time to answers that a placebo arm added to the study potentially decreased the time to adoption of the best and most cost-effective strategy emerging from the study. This rapid access argument used in the study design, however, is valid only if the beneficial treatment identified by the study is available to the same populations that were studied. If not, then such an argument has no ethical basis. The answer to this question will depend on the ability of the information to benefit the population it was studied in, and the jury is still out. The consequences of such risks to women and neonates are significant w7x. International organizations and physician groups must audit the long-
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term availability of care in order to assure that the vulnerability of women in underdeveloped areas is not taken advantage of for the benefit of developed countries. Worldwide, more than 350 million couples lack access to contraceptive options that would improve their ability to space or limit pregnancies w4x. The ethical issues that are raised for contraceptive studies done in underdeveloped countries are similar to those with HIV transmission studies, as future availability of the contraceptives tested on the populations are rarely assured. Research studies carried out in developing countries have significant secondary benefits for individual women that are important ᎏ particularly access to health that would otherwise not be available. Yet this secondary good may not adequately counter the harms of bearing risks with untested protocols and untested drugs and devices. The balance between potential risk and immediate benefit or future benefit must be clear to everyone involved in the study ᎏ the researcher, the participant, and the community the study is carried out in. The achievement of answers to study questions that benefit monetarily the industrial sponsor and individuals in developed countries without a corresponding commitment to sharing those same benefits with the population that provided the answers is unacceptable. Failure to share the benefits of the research with the women that bore the risk through substantial continuing financial and even infrastructure support to make successful drugs or interventions available places the ethics of the original research in question. The basic principles outlined by the Council for International Organizations of Medical Sciences provide guidelines for establishing or participating in such research. They point out that research should not be done in underdeveloped communities that can be carried out in developed communities so the burdens and the benefits to the population are proportionate. Furthermore, proposed research needs to address issues of concern, with sensitivity to the local cultures, in the community in which it is carried out. Finally, attention to the setting and the information communicated during the informed consent process is crit-
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J.M. Cain r International Journal of Gynecology and Obstetrics 70 (2000) 165᎐172
ically important to research in developing countries in order to prevent the potential of coercion, economically or otherwise. Oversight and advocacy is required from organizations and individual members of the international community of obstetricians and gynecologists. Oversight has the potential for assuring that the benefits of research are available to the women who have carried the burden, will assure that coercive or culturally insensitive research does not occur, and that beneficial research and follow-up is extended to developing as well as developed countries.
4. Conflicts of interest that impact maternal and fetal interests While many countries struggle to provide even basic healthcare, in developing and developed countries the production of high order multiple fetuses with the use of assisted reproductive technology is pitting economic and personal interests against fetal and maternal well being w8,9x. The ability to induce ovulation has resulted in an increased risk of multiple pregnancies, primarily twins. Criteria being set by multiple international and national organizations w10᎐12x provide guidance for canceling cycles if evidence of hyperstimulation is present. In addition, there are best practice guidelines for transfer of embryos with in vitro fertilization techniques. These guidelines are intended to assure a low level of multiple births because of the consequent risks to mother Žpregnancy-induced hypertension, HELLP syndrome, hemorrhage, death. and fetus Žprematurity, lifelong neurologic or other sequel, death. of high order births. Guidelines must result in the limitation of the number of high order gestations in order to protect maternal and fetal health w13x. However, there are powerful conflicts of interest that act in opposition to such guidelines and expertise. The desire for infertility centers to demonstrate high ‘success’ rates often promotes transfer of a higher number of embryos as well as completing rather than canceling hyperstimulated cycles. Parents may also apply pressure on their health caregivers to complete cycles or achieve
‘maximal’ results with such an expensive technology. The desire to achieve a high success rate, the financial costs, and personal desires for offspring have the potential of overshadowing a full consideration of the potential short- and longterm risks to the mother and the fetus. Clearly, the primary ethical obligation of the obstetricianrgynecologist remains the responsible and informed care of the woman undergoing infertility treatment. Hyperstimulation itself can be a deadly side effect of the stimulating drugs. Multifetal pregnancy raises the risks for the mother and the fetuses w8x. Mutifetal reduction may not be an option for individual patients in their cultural or religious context and only further complicates the picture. The obstetricianrgynecologist must assure that the patient is informed of all the potential risks prior to beginning any assisted reproductive care and must assure that the interests of the mother’s health ᎏ including avoiding high order multifetal pregnancy ᎏ guides all aspects of in vitro fertilization or ovarian stimulation that they initiate.
5. Prenatal genetic screening and screening for predisposition to disease processes The variety of testing available for genetically based diseases or predisposition to disease grows daily. While the majority of testing is done prenatally, there is increasing pressure to test children as well as adults for predisposition to genes such as the breast and ovarian cancer associated ŽBRCA. genes. All such testing fundamentally changes issues of informed consent as well as raising unique issues of benefit and harm. All genetic testing inherently involves not only the pregnancy or individual being tested, but results in information that has bearing on the genetic makeup of parents, siblings, cousins, and children. The importance of assessing the potential harm such genetic information may bring to others in the family kindred is not present in the usual physicianrpatient interaction regarding health choices but is required in genetic based testing. Prenatal testing for genetic mutations assumes that the information gained will be used to de-
J.M. Cain r International Journal of Gynecology and Obstetrics 70 (2000) 165᎐172
termine actions of parents regarding significant fetal and neonatal health issues. Testing for uniformly fatal conditions in the neonatal period allows parents to weigh their choices about the maternal risk of carrying the pregnancy against the fatal nature of fetal disease. As noted by Botkin w14x, ‘ . . . the more severe the condition is for the child, generally the greater the harm will be to the parents. The parent’s harms . . . include emotional pain and suffering, loss of a child, loss of opportunities, loss of freedom, isolation, loneliness, fear guilt, stigmatization, and financial expenses’. As the condition being tested for becomes increasingly less fatal from Down Syndrome to genes for predisposition to such things as obesity, the right of the parent to choose to acquire such knowledge and make choices for the fetus or child becomes increasingly questionable. Down Syndrome, with its potential for congenital anomalies and mental retardation, is generally regarded as information that parents might need to make choices within their own framework regarding their ability to care for such a child given their other burdens and economic issues. The choice to offer genetic counseling for this variably severe disease is not without criticism, however, as some authors have claimed that giving information that would lead to abortion of a Down affected fetus is a strongly negative cultural statement about the value of handicapped individuals in society. Demands for testing for predisposition genes such as obesity, heart disease or even breast cancer in the prenatal period go beyond this questionable area. In these circumstances, the issue no longer is the diagnosis of a significant and usually fatal genetically linked disease process but diagnosis of a potential risk that may be ameliorated by behaviors and choices of the child or adult as well as continuing changes in therapy. Testing fetuses or children, however, removes a shield of genetic privacy that prevents potential life-long discrimination ᎏ something parents do not have the right to choose for fetuses or children. While such testing is increasingly possible, it is not the parent’s purview to make the choice in the prenatal period about the value to the child
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or adult that he or she will become of the information. It is even less justifiable to make choices about continuing pregnancy based on these predisposition genes. There are no significant harms to be averted or benefits to be achieved by such testing in the prenatal period for the parents or the fetus. This, along with the potential for stigma or discrimination based on the presence of only a predisposing genetic configuration, is a strong argument for an absolute prohibition of testing for such predisposing genes in either the prenatal or childhood setting w15x. Finally, prenatal testing for sex selection except for serious sex-linked disorders must be regarded as ethically unacceptable. Testing for gender motivated by a desire to sex select male fetuses promotes continuation of the social devaluation of the female gender. That both sex-selective abortions and neglect of female neonates still exist is documented by the 60 million ‘missing’ girls who should statistically exist in populations w4x. Occasional identification of gender for sex-linked, serious andror fatal conditions that has no other genetic marker still has a role. However, any other use reinforces cultural devaluing and no obstetricianrgynecologist should engage in this practice w16,17x.
6. Cesarian section on demand In addition to circumstances where patients request medical interventions that have potential social harm, such as sex selection, there are many medical settings in which patients request interventions that have either no medical benefit or the potential for medical harm. Physicians may encounter requests from women or families for cesarian section because of individual beliefs about potential later influences on pelvic relaxation and the problems of incontinence, beliefs about differences in outcome of delivery for the fetus, or for their own convenience ᎏ all medically questionable viewpoints in the circumstance of normally progressing pregnancies. The ethical principle of supporting the right of patients to make choices regarding their own healthcare Žau-
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tonomy. was never intended to address primary choices that have more potential for harm than beneficial consequences. There is no obligation for physicians to comply with patient ‘wishes’, particularly where there is no medical benefit associated with the intervention. In addition, the conflict with the greater ‘convenience’ of scheduled cesarian sections for the patient and the physician, despite greater risks, warrants close scrutiny of such approaches. Primary cesarian section on demand for non-medical reasons is to be avoided w17x.
r 7. The obligations of the obstetricianr gynecologist in end of life care While care at the end of life is not a majority of the healthcare provided by obstetricianrgynecologists worldwide, they are involved in the care of women who will die either from consequences of maternal diseases during pregnancy or from gynecologic malignancies. The role that the obstetricianrgynecologist can play both in clarifying the changing goals of treatment from curative to palliative when death is inevitable and maintaining a supportive role for the patient and her family is significant. Physicians are equally obligated to assuring excellence of palliative care, particularly access to adequate pain control at the end of life, as they are to assuring excellence of curative or maintenance care. The individual patient must be the decision maker, choosing which interventions she will accept or not accept Žmechanical ventilation or cesarian section for example. in her dying process. As Ramsey put it w18x, ‘ . . . the description of human acts of caring for the dying . . . terminates in the person who is the patient of these ministrations and not in the disease or diseases he has’. The disease Žfor example ovarian cancer. may suggest one sort of palliative treatment, but the woman must decide for herself whether this treatment is appropriate or acceptable for her. Adequate palliative care requires an iterative process of shared decision making between health caregivers and the patient w19x. The need to assure
that an individual understands the terminal nature of the disease process is critical to such choice, and as such the patient must be told the truth about the nature and the progression of their disease. In many cultures certain diagnoses or prognoses, particularly cancer diagnoses, are withheld from the patient while other relatives make the overriding decisions about their care. Such protectionism rarely hides the true facts of the patient’s circumstances from the patient. It further creates a harmful barrier of deception and silence that inhibits discussions with family and friends that could bring closure and meaning to her end of life. Withholding medical information from a dying patient is contradictory to both the ethical principles of beneficence Žso harm in useless treatment or failure to adequately treat pain is avoided. and autonomy Žso they can make choices about treatment as well as what to do during their remaining time.. Failure to achieve adequate palliative care or lack of access to end of life care is of particular concern for women, who are more likely to be impoverished or attempt to prevent the impoverishment of their family that would be required to provide access to the level of care required. This economic and social vulnerability at the end of life may compel women to choose assisted suicide or euthanasia as the only means towards adequate control of their pain. Leaving women with death as the only choice for relief of pain and suffering makes a travesty of the goals of society and communities to bring dignity to the lives of their citizens. Adequate care at the end of life, especially adequate pain control, is a part of human dignity and the obstetricianrgynecologist is equally obligated to advocate for such care as they are for adequate care at the beginning of life for mother and child.
8. Issues of new technologies It is a basic human trait to attempt to improve our circumstances in life. Our advancing use of genetic knowledge in every sphere from oocyte cytoplasm transfers to use of new knowledge re-
J.M. Cain r International Journal of Gynecology and Obstetrics 70 (2000) 165᎐172
garding oncogenes and tumor suppressor genes to treat cancer offers hopes of new opportunities to improve life circumstances. Cloning cells, nuclear transfer cloning to produce human cell lines or tissues, offers great hope for a wide range of problems from providing new skin for burn victims to cancer therapy. Cloning human cells, along with many of the genome based technologies, fundamentally changes the way humankind understand the nature of being human. The potential for genetic engineering both prior to birth and after birth opens the door to a variety of uses that could be both beneficial but also harmful to individuals as well as societies. Setting up guidelines, internationally, that can accept the potential positive uses and limit the harmful uses is exceptionally difficult as the nature of these technologies challenges not only the legal and ethical standards already in place, but the very nature of the social and cultural context of families and societies w20x. Reproductive cloning, nuclear transfer cloning or embryo splitting to produce human beings may well have strong biologic reasons for not pursuing in humans. As Eisenberg notes, ‘cloning would select for traits that have been successful in the past but that will not necessarily be adaptive to an unpredictable future’ w21x. Beyond the issue of decreasing genetic diversity in the human species, the issue of objectification of human beings creates a circumstance where the value of human identity and individuality could be diminished. The opinion of the Committee for the Study of Ethical Aspects of Reproduction and Women’s Health of FIGO suggested further considerations in the reproductive use of cloning, ‘although most people do not wish to see cloning permitted, there will be pressure favoring human reproductive cloning arising from specific personal and financial interests. In setting policy, these pressures should not be allowed to override the larger community’s interests’ w21x. The area of women’s healthcare will continue to be one of ethical concern as it reaches from conception through death and from circumstances that cross all of the world’s social and economic environments. The discipline of obstet-
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rics and gynecology, and each individual physician, carry a significant responsibility to assure that the ethical issues that arise in the healthcare of women throughout their life cycle and in every country of the world are addressed and that the human rights of women are promoted. References w1x United Nations Population Fund ŽUNFPA.. The state of the world population 1997. UNFPA: ISGN 0-89714-409-0 New York, New York 1998. w2x Kabira WM, Gachukia EW, Matiangi FO. The effect of women’s role on health: the paradox. Int J Gynecol Obstet 1997;58:23᎐34. w3x ACOG Committee Opinion. Female genital mutilation. In 1999 Compendium of selected publications. American College of Obstetricians Gynecologists, Washington DC, 1998. w4x United Nations Population Fund. The state of world population, 1997. New York, New York, 1998. w5x United Nations. Report of the Fourth World Conference on Women. Document. ArConf. 177r20, New York, New York, 1995. w6x Glantz LH, Annas GJ, Grodin MA, Mariner WK. Research in developing countries: taking ‘benefit’ seriously. Hastings Center Rep 1998;28:38᎐42. w7x Levine C. Placebos and HIV: lessons learned. Hastings Center Rep 1998;28:43᎐48. w8x Keith L, Oleszczuk J. Iatrogenic multiple births, multiple pregnancy, and assisted reproductive technologies. Int J Obstet Gynecol 1999;64:11᎐25. w9x Klotzko AJ. Medical miracle or medical mischief? The saga of the McCaughey septuplets. Hastings Center Rep 1998;23:5᎐8. w10x British Fertility Society. Ovulation induction 1997: human repro 12:83᎐87. w11x British Fertility Society. Embryo transfer 1997: human repro 12:88᎐92. w12x Barri P, Cohen J, et al. Assisted procreation. International Federation of Fertility Societies. IFFS: Montpellier, France, 1998. w13x Templeton A, Morris JK. Reducing the risk of multiple births by transferring two embryos after in vitro fertilization. N Engl J Med 1998;339:573᎐577. w14x Botkin J. Fetal privacy and confidentiality. Hastings Center Rep 1995;25:32᎐39. w15x Rothstein M. Genetic privacy and confidentiality: why they are so hard to protect. J Law Med Ethics 1998;26:198᎐204. w16x United Nations. Population and development, vol. 1: programme of action adopted at the International con-
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ference on Population and Development ŽCairo, 5013 September 1994.. New York: United Nations, 1995: 20᎐21. w17x Shushan A, Schenker JG. Prenatal sex determination and selection. Hum Reprod 1993;8:1545᎐1549. w18x Ramsey P. On caring for the dying. The patient as person: explorations in medical ethics. New Haven, Connecticut, USA: Yale University Press, 1970:113᎐144.
w19x Committee on Ethics, ACOG. End of life decision making: understanding the goals of care ACOG 1995. 噛 156. Washington, D.C., USA. w20x Robertson J. Oocyte cytoplasm transfers and the ethics of germ-line intervention. J Law Med Ethics 1998; 26:211᎐220. w21x Eisenberg L. Would cloned humans really be like sheep? N Engl J Med 1999;340:471᎐475.
A global overview of ethical issues in women’s health J.M. Cain FIGO Committee for the Ethical Aspects of Human Reproduction and Women’s Health, FIGO Secretariat, London, UK
Abstract The fundamental denial of basic human rights to reproductive choice, freedom from violence, and economic and educational development for women remains the major underpinning ethical issue in worldwide women’s healthcare. The ability to choose when to have children, whether to have prenatal diagnosis or to make uncoerced choices at the end of life all hinge on the independence of each woman’s ability to make choices about their own healthcare within the constraints of the health resources available to them. Technologic advances increase the complexity of assuring that the rights and best interest of the woman, the fetus or child, and society itself are balanced equitably in both the healthcare setting as well as the development of national or international policies and standards. The obstetricianrgynecologist, as an advocate for women’s health worldwide, has an ethical obligation to assure human rights are extended to women and the obligation to assure that the care received is the best available. 䊚 2000 International Federation of Gynecology and Obstetrics. Keywords: Women’s health; Medical ethics; Violence; Reproductive choice; Maternalrfetal
1. Introduction The discipline of obstetrics and gynecology covers just a small part of women’s health, but the ethical quandaries that arise from the discipline cover the broadest range of any medical discipline. These quandaries span interactions from individual health practitioners with individual women to public health issues about distribution of scarce resources and control of socially sanctioned but injurious health behaviors. The global social and economic disenfranchisement of women continues to impede health im-
provements for women w1x. The social and political invisibility of the health and well-being of women that results from disenfranchisement presents a tremendous barrier to improvements in health status. The simple denial, in some settings, of their most basic ethical and human rights makes the simplest of medical ethics axioms ᎏ prevention of harm ᎏ virtually impossible. Daily, intended harm in the form of sexual violence particularly in areas of military conflict, continues to strip women of the right to freedom from bodily harm. The psychological and reproductive health consequences of abrogation of women’s
0020-7292r00r$20.00 䊚 2000 International Federation of Gynecology and Obstetrics. PII: S 0 0 2 0 - 7 2 9 2 Ž 0 0 . 0 0 2 2 9 - 0
166
J.M. Cain r International Journal of Gynecology and Obstetrics 70 (2000) 165᎐172
human rights through such war crimes or simply cultural norms will impact the health of women and families for generations to come. Every minute that passes, women and their children continue to die from preventable complications of pregnancy and childbirth because of the failure of individual nations to accord this most basic step in human existence enough importance to provide healthcare support. Nothing could be a more fundamental ethical obligation for societies than securing the health of mothers and future generations of citizens, yet this remains a distant and unobtainable dream in many areas of the world. Linking the value of family health status to the low status and low value of women worldwide results in the diminution of attention to this vital area of the future for governments and yet directly impinges on their future economic development w2x. The failure of governments to attend to the safety and health of women results in both short- and longterm harm to their own economic and political stability and health, yet it remains a remarkably low priority for many nations. This is an obstacle that the medical profession must overcome. It is one of the ethical obligations of a learned profession, such as medicine, to educate and to advocate for an improved future. Making visible this link between the economic and social status of women worldwide with women’s and their family’s health is an ethical obligation of the learned profession of medicine, and a key to improvement of women’s health. This advocacy is part of the fiduciary role that physicians must play in the best interests of their patients, in this case in the best interests of women’s health worldwide. Each physician is obligated to speak up in their own medical organizations, in their interactions with those who set health policy in their own countries, and in informing and networking with others who can act to improve the status of women in their own country and throughout the world.
2. Ethical advocacy issues Two specific health issues that link cultural roles and status of women with negative medical
outcomes have held center stage in global medical ethics, and remain obstacles to health. They serve as striking examples of the multiple relationships between ethical issues, religious and cultural norms, and health rights for women. The first example is female genital mutilation w3x; 120 million women have undergone female genital mutilation and another 2 million are at risk every year w4x. Regardless of cultural differences, worldwide the most fundamental ethical principle of medicine is benefiting those we treat. Since there is no scientific basis for a benefit from the procedure, and well documented harm, involvement of physicians in the performance of such procedures is ethically unacceptable. Advocacy for elimination of the procedure, condemnation of those who persist, pressure to assure that existing laws prohibiting the practice are enforced, education regarding the medical effects, and knowledgeable and sensitive care for women who have already undergone such procedures are the appropriate ethical stance of the obstetrician ᎐ gynecologist w3x. The second culturally influenced health issue is related to the rampant spread of HIV in women because they are unable because of sexual violence, low social status, poverty, and cultural expectations of subservience to refuse coitus or assure protected intercourse by demanding use of condoms. Approximately 10 million women are living with HIVrAIDS worldwide who were infected primarily through unprotected intercourse, and the number continues to grow w4x. While the right of women ‘to ha¨ e control o¨ er and decide freely and responsibly on matters related to their sexuality, including sexual and reproducti¨ e health, free of coercion, discrimination and ¨ iolence’ w5x have been internationally recognized, we are still far from the goal. Continuing development of economic opportunities for women that result in decreasing their vulnerability to sexual economic coercion and raising their social standing should be part of the advocacy role of medical professionals within their countries and internationally. Raising awareness of the critical role ᎏ the ability to make reproductive choices ᎏ has in the spread of HIV, is also, a fiduciary and therefore ethical duty of physicians.
J.M. Cain r International Journal of Gynecology and Obstetrics 70 (2000) 165᎐172
3. Issues of research in underdeveloped countries The stark need for healthcare in developing areas of the world, particularly for the devastating effects of HIV infection, along with educational deficits and low status of women may make them more vulnerable to exploitation with clinical research carried out in those countries w6x. Two examples of the potential for coercion and harm as a result of the desperate need for access to any healthcare are the now completed HIV transmission trials and reproductive control trials. The just distribution of the burdens Žexposure to risks. and the benefits Žability to benefit from the resulting products or techniques . for the population of women studied is of concern in regard to both these examples. Sub-Saharan Africa has been particularly impacted by maternal transmission of HIV to children, comprising ) 85% of children infected by this route worldwide w4x. Given the overwhelming need for protection, the desperation of women seeking care makes it likely that they would accept ANY risk in order to receive any care. Exposure of neonates to the virus in a placebo arm of a study when the potential for decrease in transmission had been identified in other studies was an issue in the design of transmission studies in underdeveloped countries. The actual strength of protection as well as the minimum treatment required for protection were unknown, and rapid identification of the best strategy was felt to offer the greatest good to the greatest number. The significant decrease in time to answers that a placebo arm added to the study potentially decreased the time to adoption of the best and most cost-effective strategy emerging from the study. This rapid access argument used in the study design, however, is valid only if the beneficial treatment identified by the study is available to the same populations that were studied. If not, then such an argument has no ethical basis. The answer to this question will depend on the ability of the information to benefit the population it was studied in, and the jury is still out. The consequences of such risks to women and neonates are significant w7x. International organizations and physician groups must audit the long-
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term availability of care in order to assure that the vulnerability of women in underdeveloped areas is not taken advantage of for the benefit of developed countries. Worldwide, more than 350 million couples lack access to contraceptive options that would improve their ability to space or limit pregnancies w4x. The ethical issues that are raised for contraceptive studies done in underdeveloped countries are similar to those with HIV transmission studies, as future availability of the contraceptives tested on the populations are rarely assured. Research studies carried out in developing countries have significant secondary benefits for individual women that are important ᎏ particularly access to health that would otherwise not be available. Yet this secondary good may not adequately counter the harms of bearing risks with untested protocols and untested drugs and devices. The balance between potential risk and immediate benefit or future benefit must be clear to everyone involved in the study ᎏ the researcher, the participant, and the community the study is carried out in. The achievement of answers to study questions that benefit monetarily the industrial sponsor and individuals in developed countries without a corresponding commitment to sharing those same benefits with the population that provided the answers is unacceptable. Failure to share the benefits of the research with the women that bore the risk through substantial continuing financial and even infrastructure support to make successful drugs or interventions available places the ethics of the original research in question. The basic principles outlined by the Council for International Organizations of Medical Sciences provide guidelines for establishing or participating in such research. They point out that research should not be done in underdeveloped communities that can be carried out in developed communities so the burdens and the benefits to the population are proportionate. Furthermore, proposed research needs to address issues of concern, with sensitivity to the local cultures, in the community in which it is carried out. Finally, attention to the setting and the information communicated during the informed consent process is crit-
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ically important to research in developing countries in order to prevent the potential of coercion, economically or otherwise. Oversight and advocacy is required from organizations and individual members of the international community of obstetricians and gynecologists. Oversight has the potential for assuring that the benefits of research are available to the women who have carried the burden, will assure that coercive or culturally insensitive research does not occur, and that beneficial research and follow-up is extended to developing as well as developed countries.
4. Conflicts of interest that impact maternal and fetal interests While many countries struggle to provide even basic healthcare, in developing and developed countries the production of high order multiple fetuses with the use of assisted reproductive technology is pitting economic and personal interests against fetal and maternal well being w8,9x. The ability to induce ovulation has resulted in an increased risk of multiple pregnancies, primarily twins. Criteria being set by multiple international and national organizations w10᎐12x provide guidance for canceling cycles if evidence of hyperstimulation is present. In addition, there are best practice guidelines for transfer of embryos with in vitro fertilization techniques. These guidelines are intended to assure a low level of multiple births because of the consequent risks to mother Žpregnancy-induced hypertension, HELLP syndrome, hemorrhage, death. and fetus Žprematurity, lifelong neurologic or other sequel, death. of high order births. Guidelines must result in the limitation of the number of high order gestations in order to protect maternal and fetal health w13x. However, there are powerful conflicts of interest that act in opposition to such guidelines and expertise. The desire for infertility centers to demonstrate high ‘success’ rates often promotes transfer of a higher number of embryos as well as completing rather than canceling hyperstimulated cycles. Parents may also apply pressure on their health caregivers to complete cycles or achieve
‘maximal’ results with such an expensive technology. The desire to achieve a high success rate, the financial costs, and personal desires for offspring have the potential of overshadowing a full consideration of the potential short- and longterm risks to the mother and the fetus. Clearly, the primary ethical obligation of the obstetricianrgynecologist remains the responsible and informed care of the woman undergoing infertility treatment. Hyperstimulation itself can be a deadly side effect of the stimulating drugs. Multifetal pregnancy raises the risks for the mother and the fetuses w8x. Mutifetal reduction may not be an option for individual patients in their cultural or religious context and only further complicates the picture. The obstetricianrgynecologist must assure that the patient is informed of all the potential risks prior to beginning any assisted reproductive care and must assure that the interests of the mother’s health ᎏ including avoiding high order multifetal pregnancy ᎏ guides all aspects of in vitro fertilization or ovarian stimulation that they initiate.
5. Prenatal genetic screening and screening for predisposition to disease processes The variety of testing available for genetically based diseases or predisposition to disease grows daily. While the majority of testing is done prenatally, there is increasing pressure to test children as well as adults for predisposition to genes such as the breast and ovarian cancer associated ŽBRCA. genes. All such testing fundamentally changes issues of informed consent as well as raising unique issues of benefit and harm. All genetic testing inherently involves not only the pregnancy or individual being tested, but results in information that has bearing on the genetic makeup of parents, siblings, cousins, and children. The importance of assessing the potential harm such genetic information may bring to others in the family kindred is not present in the usual physicianrpatient interaction regarding health choices but is required in genetic based testing. Prenatal testing for genetic mutations assumes that the information gained will be used to de-
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termine actions of parents regarding significant fetal and neonatal health issues. Testing for uniformly fatal conditions in the neonatal period allows parents to weigh their choices about the maternal risk of carrying the pregnancy against the fatal nature of fetal disease. As noted by Botkin w14x, ‘ . . . the more severe the condition is for the child, generally the greater the harm will be to the parents. The parent’s harms . . . include emotional pain and suffering, loss of a child, loss of opportunities, loss of freedom, isolation, loneliness, fear guilt, stigmatization, and financial expenses’. As the condition being tested for becomes increasingly less fatal from Down Syndrome to genes for predisposition to such things as obesity, the right of the parent to choose to acquire such knowledge and make choices for the fetus or child becomes increasingly questionable. Down Syndrome, with its potential for congenital anomalies and mental retardation, is generally regarded as information that parents might need to make choices within their own framework regarding their ability to care for such a child given their other burdens and economic issues. The choice to offer genetic counseling for this variably severe disease is not without criticism, however, as some authors have claimed that giving information that would lead to abortion of a Down affected fetus is a strongly negative cultural statement about the value of handicapped individuals in society. Demands for testing for predisposition genes such as obesity, heart disease or even breast cancer in the prenatal period go beyond this questionable area. In these circumstances, the issue no longer is the diagnosis of a significant and usually fatal genetically linked disease process but diagnosis of a potential risk that may be ameliorated by behaviors and choices of the child or adult as well as continuing changes in therapy. Testing fetuses or children, however, removes a shield of genetic privacy that prevents potential life-long discrimination ᎏ something parents do not have the right to choose for fetuses or children. While such testing is increasingly possible, it is not the parent’s purview to make the choice in the prenatal period about the value to the child
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or adult that he or she will become of the information. It is even less justifiable to make choices about continuing pregnancy based on these predisposition genes. There are no significant harms to be averted or benefits to be achieved by such testing in the prenatal period for the parents or the fetus. This, along with the potential for stigma or discrimination based on the presence of only a predisposing genetic configuration, is a strong argument for an absolute prohibition of testing for such predisposing genes in either the prenatal or childhood setting w15x. Finally, prenatal testing for sex selection except for serious sex-linked disorders must be regarded as ethically unacceptable. Testing for gender motivated by a desire to sex select male fetuses promotes continuation of the social devaluation of the female gender. That both sex-selective abortions and neglect of female neonates still exist is documented by the 60 million ‘missing’ girls who should statistically exist in populations w4x. Occasional identification of gender for sex-linked, serious andror fatal conditions that has no other genetic marker still has a role. However, any other use reinforces cultural devaluing and no obstetricianrgynecologist should engage in this practice w16,17x.
6. Cesarian section on demand In addition to circumstances where patients request medical interventions that have potential social harm, such as sex selection, there are many medical settings in which patients request interventions that have either no medical benefit or the potential for medical harm. Physicians may encounter requests from women or families for cesarian section because of individual beliefs about potential later influences on pelvic relaxation and the problems of incontinence, beliefs about differences in outcome of delivery for the fetus, or for their own convenience ᎏ all medically questionable viewpoints in the circumstance of normally progressing pregnancies. The ethical principle of supporting the right of patients to make choices regarding their own healthcare Žau-
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tonomy. was never intended to address primary choices that have more potential for harm than beneficial consequences. There is no obligation for physicians to comply with patient ‘wishes’, particularly where there is no medical benefit associated with the intervention. In addition, the conflict with the greater ‘convenience’ of scheduled cesarian sections for the patient and the physician, despite greater risks, warrants close scrutiny of such approaches. Primary cesarian section on demand for non-medical reasons is to be avoided w17x.
r 7. The obligations of the obstetricianr gynecologist in end of life care While care at the end of life is not a majority of the healthcare provided by obstetricianrgynecologists worldwide, they are involved in the care of women who will die either from consequences of maternal diseases during pregnancy or from gynecologic malignancies. The role that the obstetricianrgynecologist can play both in clarifying the changing goals of treatment from curative to palliative when death is inevitable and maintaining a supportive role for the patient and her family is significant. Physicians are equally obligated to assuring excellence of palliative care, particularly access to adequate pain control at the end of life, as they are to assuring excellence of curative or maintenance care. The individual patient must be the decision maker, choosing which interventions she will accept or not accept Žmechanical ventilation or cesarian section for example. in her dying process. As Ramsey put it w18x, ‘ . . . the description of human acts of caring for the dying . . . terminates in the person who is the patient of these ministrations and not in the disease or diseases he has’. The disease Žfor example ovarian cancer. may suggest one sort of palliative treatment, but the woman must decide for herself whether this treatment is appropriate or acceptable for her. Adequate palliative care requires an iterative process of shared decision making between health caregivers and the patient w19x. The need to assure
that an individual understands the terminal nature of the disease process is critical to such choice, and as such the patient must be told the truth about the nature and the progression of their disease. In many cultures certain diagnoses or prognoses, particularly cancer diagnoses, are withheld from the patient while other relatives make the overriding decisions about their care. Such protectionism rarely hides the true facts of the patient’s circumstances from the patient. It further creates a harmful barrier of deception and silence that inhibits discussions with family and friends that could bring closure and meaning to her end of life. Withholding medical information from a dying patient is contradictory to both the ethical principles of beneficence Žso harm in useless treatment or failure to adequately treat pain is avoided. and autonomy Žso they can make choices about treatment as well as what to do during their remaining time.. Failure to achieve adequate palliative care or lack of access to end of life care is of particular concern for women, who are more likely to be impoverished or attempt to prevent the impoverishment of their family that would be required to provide access to the level of care required. This economic and social vulnerability at the end of life may compel women to choose assisted suicide or euthanasia as the only means towards adequate control of their pain. Leaving women with death as the only choice for relief of pain and suffering makes a travesty of the goals of society and communities to bring dignity to the lives of their citizens. Adequate care at the end of life, especially adequate pain control, is a part of human dignity and the obstetricianrgynecologist is equally obligated to advocate for such care as they are for adequate care at the beginning of life for mother and child.
8. Issues of new technologies It is a basic human trait to attempt to improve our circumstances in life. Our advancing use of genetic knowledge in every sphere from oocyte cytoplasm transfers to use of new knowledge re-
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garding oncogenes and tumor suppressor genes to treat cancer offers hopes of new opportunities to improve life circumstances. Cloning cells, nuclear transfer cloning to produce human cell lines or tissues, offers great hope for a wide range of problems from providing new skin for burn victims to cancer therapy. Cloning human cells, along with many of the genome based technologies, fundamentally changes the way humankind understand the nature of being human. The potential for genetic engineering both prior to birth and after birth opens the door to a variety of uses that could be both beneficial but also harmful to individuals as well as societies. Setting up guidelines, internationally, that can accept the potential positive uses and limit the harmful uses is exceptionally difficult as the nature of these technologies challenges not only the legal and ethical standards already in place, but the very nature of the social and cultural context of families and societies w20x. Reproductive cloning, nuclear transfer cloning or embryo splitting to produce human beings may well have strong biologic reasons for not pursuing in humans. As Eisenberg notes, ‘cloning would select for traits that have been successful in the past but that will not necessarily be adaptive to an unpredictable future’ w21x. Beyond the issue of decreasing genetic diversity in the human species, the issue of objectification of human beings creates a circumstance where the value of human identity and individuality could be diminished. The opinion of the Committee for the Study of Ethical Aspects of Reproduction and Women’s Health of FIGO suggested further considerations in the reproductive use of cloning, ‘although most people do not wish to see cloning permitted, there will be pressure favoring human reproductive cloning arising from specific personal and financial interests. In setting policy, these pressures should not be allowed to override the larger community’s interests’ w21x. The area of women’s healthcare will continue to be one of ethical concern as it reaches from conception through death and from circumstances that cross all of the world’s social and economic environments. The discipline of obstet-
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rics and gynecology, and each individual physician, carry a significant responsibility to assure that the ethical issues that arise in the healthcare of women throughout their life cycle and in every country of the world are addressed and that the human rights of women are promoted. References w1x United Nations Population Fund ŽUNFPA.. The state of the world population 1997. UNFPA: ISGN 0-89714-409-0 New York, New York 1998. w2x Kabira WM, Gachukia EW, Matiangi FO. The effect of women’s role on health: the paradox. Int J Gynecol Obstet 1997;58:23᎐34. w3x ACOG Committee Opinion. Female genital mutilation. In 1999 Compendium of selected publications. American College of Obstetricians Gynecologists, Washington DC, 1998. w4x United Nations Population Fund. The state of world population, 1997. New York, New York, 1998. w5x United Nations. Report of the Fourth World Conference on Women. Document. ArConf. 177r20, New York, New York, 1995. w6x Glantz LH, Annas GJ, Grodin MA, Mariner WK. Research in developing countries: taking ‘benefit’ seriously. Hastings Center Rep 1998;28:38᎐42. w7x Levine C. Placebos and HIV: lessons learned. Hastings Center Rep 1998;28:43᎐48. w8x Keith L, Oleszczuk J. Iatrogenic multiple births, multiple pregnancy, and assisted reproductive technologies. Int J Obstet Gynecol 1999;64:11᎐25. w9x Klotzko AJ. Medical miracle or medical mischief? The saga of the McCaughey septuplets. Hastings Center Rep 1998;23:5᎐8. w10x British Fertility Society. Ovulation induction 1997: human repro 12:83᎐87. w11x British Fertility Society. Embryo transfer 1997: human repro 12:88᎐92. w12x Barri P, Cohen J, et al. Assisted procreation. International Federation of Fertility Societies. IFFS: Montpellier, France, 1998. w13x Templeton A, Morris JK. Reducing the risk of multiple births by transferring two embryos after in vitro fertilization. N Engl J Med 1998;339:573᎐577. w14x Botkin J. Fetal privacy and confidentiality. Hastings Center Rep 1995;25:32᎐39. w15x Rothstein M. Genetic privacy and confidentiality: why they are so hard to protect. J Law Med Ethics 1998;26:198᎐204. w16x United Nations. Population and development, vol. 1: programme of action adopted at the International con-
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ference on Population and Development ŽCairo, 5013 September 1994.. New York: United Nations, 1995: 20᎐21. w17x Shushan A, Schenker JG. Prenatal sex determination and selection. Hum Reprod 1993;8:1545᎐1549. w18x Ramsey P. On caring for the dying. The patient as person: explorations in medical ethics. New Haven, Connecticut, USA: Yale University Press, 1970:113᎐144.
w19x Committee on Ethics, ACOG. End of life decision making: understanding the goals of care ACOG 1995. 噛 156. Washington, D.C., USA. w20x Robertson J. Oocyte cytoplasm transfers and the ethics of germ-line intervention. J Law Med Ethics 1998; 26:211᎐220. w21x Eisenberg L. Would cloned humans really be like sheep? N Engl J Med 1999;340:471᎐475.