Document 776Kbbm5BLRBGo7MKQ534wxV

Health Policy Advisory Center HEALTH HEALTH HEALTH HEALTH HEALTH HEALTH HEALTH Volume 16, Number 6 PAC BULLETIN WOMEN'S HEALTH ISSUES ISSUES ISSUES ISSUES ISSUES ISSUES ISSUES enthysician ISSUES ISSUES piz Advanced m nal ISSUES age ISSUES High ISSUES risk Ia ISSUES genic copli complications ISSUES ions ISSUES In ISSUES iga ISSUES nal delay ISSUES re ISSUES options ISSUES I e ISSUES informatio ISSUES Shifts ISSUES ideology Roductive ISSUES ght ISSUES ral ISSUES dile ISSUES Medical ISSUES hologies ISSUES Issus ISSUES of ISSUES co ISSUES ol Feminist ISSUES ISSUES ISSUES ISSUES ISSUES Neonatal ISSUES intensive ISSUES c ISSUES ISSUES ISSUES ISSUES ISSUES ISSUES ISSUES Nighk ISSUES Iatrogenic ISSUES Compli ISSUES ons Inustrial ISSUES lo ISSUES More ISSUES optio ISSUES [ore ISSUES info ISSUES ISSUES hifts ISSUES in ISSUES ideology ISSUES Rep ISSUES uctive rights Disab ISSUES. mas ISSUES Medical ISSUES thologies ISSUES ISSUES control ISSUES Fem ISSUES ist sch ISSUES ship Physician ISSUES domina ISSUES tenology ISSUES ISSUES hatal ISSUES inte ISSUES Quality ISSUES of ISSUES fe State ISSUES barent Phi ISSUES dan bias ISSUES A ISSUES tric iccplicati plicatio ISSUES ISSUES ISSUES ISSUES Peer Review National Malpractice Crisis Threatens Birth Alternatives To the editor: The effects on obstetricians of the medical malpractice crisis have been well publicized during the past few years: Y' According to the American College of Obstetricians and Gynecologists, the number of obstetric - related claims has tripled since 1978. Y' Many insurance companies have had difficulty obtaining reinsurance, the coverage needed to protect themselves in the event of multiple claims that exceed their risk projections. And because many states allow the pressing of malpractice claims until the affected child reaches adulthood, accurate risk assessment is often difficult. continued on page 31 This issue of the Bulletin was prepared by the Women's Health Work Group: Debra De Palma, Kathleen Gavin, Dana Hughes, Feygele Jacobs, Judy Lipschutz, Regina Neal, Judith Sackoff, and Diane St. Clair. Health / PAC Bulletin Volume 16, Number 6 August / 1986 Board of Editors Tony Bale Howard Berliner David Kotelchuck Ronda Kotelchuck Carl Blumenthal Arthur Levin Robert Brand Robb Burlage Cheryl Merzel Patricia Moccia Anjean Carter Robert Cohen Regina Neal Hila Richardson Debra De Palma Judith Sackoff Peg Gallagher Herbert Semmel Sally Guttmacher Hal Strelnick Louanne Kennedy On Leave: Michael E. Clark, Steven Meister Executive Editor: Joe Gordon Editor: Kathryn K. Wheeler Staff: David Steinhardt, Loretta Wavra Associates: Des Callan, Mardge Cohen, Barry Ensminger, Kathleen Gavin, Marsha Hurst, Mark Kleiman, Sylvia Law, Alan Levine, Judy Lipschutz, Joanne Lukomnik, Kate Pfordresher, Susan Reverby, Alex Rosen, Diane St. Clair, Gel Stevenson, Ann Umemoto, Rick Zall. MANUSCRIPTS, COMMENTS, LETTERS TO THE EDITOR, AND SUBSCRIPTION ORDERS should be addressed to Health / PAC, 17 Murray St., New York, N.Y. 10007. Subscription rates are 22.50 $ for individuals, $ 45 for institutions. ISSN 0017-9051 1986 Health / PAC. The Health / PAC Bulletin is published four times per year, in June, August, November and December. Second class postage paid at New York, N.Y. Postmaster: Send address changes to Health / PAC Bulletin, 17 Murray St., New York, NY 10007. The Health / PAC Bulletin is distributed to bookstores by Carrier Pigeon, 75 Kneeland St., Room 309, Boston, MA 02111. Design: Three to Make Ready Graphics / 1986 Cover by Maggie Block Typeset by Kells Typography, Inc. Articles in the Bulletin are indexed in the Health Planning and Administration data base of the National Library of Medicine and the Alternative Press Index. Microforms of the Bulletin are available from University Microfilms International, 300 Zeeb Rd., Dept. T.R., Ann Arbor, MI 48106. Contents Vital Si0.g ..n ecs ce. ce. ee e cc eeeeeaes 4 On the Question of Baby Doe sees eeees 5 Two points of view about the decision making - process regarding treatment for infants born with severe and often life threatening - disabilities An interpretation of the Baby Doe Rules and the Child Abuse Amendments of 1984 c c .c ee .10.10 2 Health / PAC Bulletin Like a Boxer Over the Hil2l.0?.0.0 .e .ee e 15 Assessing the Prejudice Against Mid - Life Childbearing The Cervical Cap: Test Case For U.S. Regulatory Politics.. vee 22 Body Eng0.0l .0 ci cc es e cch c ee. nee. see nee " 27 Media Scan ........ 0... cc eee e er cee e een eeee " 28 Know News ... 2... ccc ce cece eee eee e nena ences 30 Bulletin Board. ....- Back Cover Letter from the President Dear Reader, You may have noticed our erratic publication schedule over the past months, a period during which we've been undergoing a trying but exciting reorganization at Health / PAC. We're pleased to announce that, in an effort to consolidate the political analysis and organization that Health / PAC repre- sents, we have created the position of Executive Editor and selected Joe Gordon for this new post. Joe's background makes him well qualified for developing the Bulletin and for building Health / PAC's role as a central locus in the progressive health network. For the last six years, he has worked as a labor journalist for the National Union of Hospital and Health Care Em- ployees, where he served as Associate Editor of the union's monthly magazine, 1199 News. He also helped develop the union's ongoing arts program, the Bread and Roses Cultural Project. We'd also like to thank Kathryn Wheeler for her superb work as consulting editor for this and the previous issue of the Bulletin. Kathy enabled us not only to get through the transi- tion, but also to maintain the quality of the Bulletin. A final word for those of you who read the fine print. The current and last issues of the Bulletin state the actual dates of publication rather than our usual bimonthly sequence, due to a requirement of the U.S. Post Office that we " keep up with the times. " Your September - October and November - Decem- ber, 1985 issues were not lost in the mail, but redesignated as Volume 16, Numbers 5 and 6. This change will not affect the length of your subscription. 0 - Patricia Moccia, President Health / PAC Board Notes & Comment The contemporary women's movement has produced an ex- citing, influential and growing feminist scholarship that has transformed fundamentally the ways in which we understand ourselves and our society. It is a scholarship that calls old. theories and methodologies into question by looking at society from the view of all who constitute it, women and men alike. The new feminist scholarship has provided central reassess- ments of the historical and sociological roles of physicians, medicine, science and technology. It has also looked at women as both the providers and recipients of medical care services. It has challenged some of the most fundamental assumptions about the nature of women held by a range of scientific experts and academic disciplines. And in the process, it has forced us to re evaluate - some very basic concepts; for example, what is gender, what is reproduction, what is technology, what is science? The four articles in this issue of the Bulletin draw on and contribute to this feminist scholarship. They examine critically the relationship among science, technology, medical care, ideology and gender. Adrienne Asch and Barbara Katz Rothman debate the social and political implications of the growth of neonatal intensive care technologies and the consequent emergence of " Baby Doe " rulings. While Rothman and Asch disagree about these rul- ings, they share the understanding that what is at issue is not a scientific question, but a moral dilemma. Asch's argument places the " Baby Doe " debate in the con- text of society's misperceptions and mistreatment of people born with physical disabilities. Her thesis: That newborns with disabilities should be treated, regardless of their parent's Rochelle Kern, PhD, is a Project Director with the American Foundation for the Blind and an Instructor in Sociomedical Sciences at Columbia University School of Public Health. For several years, she has been studying the effects of women's domestic arrangements on their psychological and physical well being - and, in particular, on their risk for depression. wishes, even if that requires state intervention. Since the cen- tral problem, according to Asch, is the oppression of those with disabilities, the solution rests in maximizing opportunities and support for the disabled. This perspective reconceptualizes disability as a normal and natural, though undesirable, occur- rence, and disabled people as a social minority whose rights have been historically denied. In Asch's view, what families of disabled children need are more options, more information and more support. Social ignorance and cultural biases about disability create a context in which parents can too easily decide against allowing a disabled child to live. She sees the decision to treat any par- ticular infant as a social, psychological and political one, and for this reason, she's concerned about parents and doctors who would fail to provide disabled children with treatment. For Rothman, the heroic technologies of neonatology have resulted in a growing number of newborns (extrauterine " fetuses ") being kept alive despite severe physical abnormalities, many without the prospect of anything close to a normal or healthy life, or even long term - survival. At the same time, while medicine presumes the efficacy of its own services (termed " treatments "), parents who question or disagree with medical recommendations are increasingly finding their own trustworthiness and competence challenged by the state. " Baby Doe " rulings remove from parents their legal rights to make decisions about their children's care and well being - . And this, argues Rothman, represents an alarming and dangerous ideo- logical shift in our view of parents- and most notably of mothers as the best protectors of their children's welfare. The debate and issues raised by Asch and Rothman are im- portant and enlightening. We see, among other things, the political consequences and moral dilemmas produced by seem- ingly " neutral " technologies in medicine and science. And we see the inevitable contradictions between the interests of the state, including its support of medicine, and the rights and needs of children and parents. Of particular concern are the continued on page 14 Health / PAC Bulletin 33 Vital Signs Toward a'Healthier ' Federal Budget In 1983, Washington - based public in- terest groups warned that Reagan Ad- ministration policies were having an adverse effect on the health of pregnant women and children in the states. Dr. Edward Brandt, who was then Secretary of Health, dismissed the assertions, claiming they were built on " incomplete data. " However, a recent report by the Children's Defense Fund shows that the warnings were well founded. In its newly published book, The Maternal and Child Health Data Book: The Health of America's Children, CDF documents disturbing trends in maternal and child health. Among the key findings are: * A three percent rise in the postneonatal mortality rate between 1982 and 1983, the largest one year - increase in 18 years. * An increase in the prematurity rate for the third consecutive year. * An increase in the proportion of babies born at low birthweight for the 14th consecutive year. According to the CDF, several factors may have contributed to these trends, especially a dramatic upswing in poverty followed by substantial cuts in health and social services, particularly prenatal care. Despite the evidence of increasing needs, however, the Reagan Administra- tion has proposed further reductions in the health programs serving poor women and children - a funding level for Fiscal Year 1987 that would be $ 26.2 million or 41 percent below the combined appropri- ation level of these programs in FY 1986. In addition, the President would like to reduce Medicaid payments by $ 17 billion between FY 1987 and 1991. Be- cause Medicaid payments account for 55 cents of every public health dollar spent on children, such cuts would have a devastating effect on access to health care for the children of the poor. Fortunately, Congress apparently did some of its homework and has rejected most of Reagan's proposed health care cuts. The approved Congressional bud- get for FY 1987 includes an increase of about $ 75 million for the Maternal and Child Health Block Grant. There is also a sizeable increase in funding for the expansion of Medicaid coverage to preg- nant low income - women, and some additional money for immunization pro- grams, although these increases still fall short of meeting the increased health needs of the poor. Final Congressional budget authoriza- tion and appropriation decisions will probably not be made until October. Therefore, health advocates should use this time to urge elected officials to appropriate the allocated funds, and to remind them that more action is needed to stem the tide of deterioration in the nation's health. 0 A Turn to the Right- And a Little White Lie In the classic romantic ballad " My Blue Heaven, " a turn to the right brings you within view of a little white light that is shining from a lovers'nest where you'll be happy tonight, and presumably for- ever. It is a warm and reassuring picture, and the stuff of dreams. Today, a different turn to the Right can bring you, innocently enough, into ter- rifying proximity to the stuff of night- mares. Across the country, according to an article in the Guardian, a New York City based - newsweekly, there are now some 3000 " bogus clinics " that, on the basis of their names, at least, appear to offer abortion services; in reality, how- ever, they are actually dedicated to pre- venting abortion. Eleanor J. Bader, who wrote the arti- cle, says that most of the clinics are spon- sored by the Catholic church and other religious or Right - to - Life groups. One, the Pearson Foundation, has prepared a 93 page - booklet detailing how to set up and operate such a clinic. To start, most of these clinics have a name that is either " neutral " or clearly misleading as to their real purpose, such Health / PAC Bulletin as Abortion Advice, Women's Help Organization or Pregnancy Problem Center. " The woman who wants an abor- tion may not come to the center if the center appears to be pro - life, " the booklet cautions. The booklet gives highly strategic ad- vice on how to accomplish the clinic's objectives. (Locate at the entrance to a real abortion chamber (sic), and since you have a similar sounding - name, the woman may come in to see you instead.) During an initial examination period, a potential client is subjected to the strongest possible prosyletizing: pictures of buckets - full of dismembered babies and of women in obvious emotional stress, implying that this is how every woman feels after an abortion; in depth - questions about the client's religious practices, and staff prayers for one's soul for even thinking of an abortion; offers of a place to live, clothing and even a job after the baby is born. In addition, the printed materials dis- tributed include frightening and false in- formation such as highly exaggerated statistics about the number of women who need blood transfusions and about the possibility of sterility resulting from abortion. Some states, such as Texas, are begin- ning to fight back. In an effort to close or regulate such clinics, the state's At- torney General is suing such clinics for " infliction of intentional mental harm, and false, deceptive and misleading acts or practices. " Other states, including New York, are planning to publicize the names and addresses of the bogus clin- ics, and to push for separate listings in the Yellow Pages, a common source of referral - one list for abortion providers and one for " abortion alternatives. " Some women's rights activists are pushing regulatory agencies to investi- gate and prosecute bogus clinics for false advertising and for intentional dissemi- nation of medical fallacies, or " practic- ing medicine without a license. " In the meantime, however, Pearson and others are proceding with plans to open new clinics, including, according to one report, some 20 new locations in New York City " within the next several months. " Caveat emptor! O On The Question of Baby Doe In the spring of last year, Health / PAC sponsored a public forum on Reproductive Rights and Disability Rights, brought about by keen interest in the " Baby Doe " cases (see page 10). As a society and as individuals, we have been facing difficult decisions about treatment for infants born with severe and often life threatening - conditions. Health care workers, hospital admin- istrators, lawyers, disabled people and parents have all been engaged in the emotional and often acrimonious debate about the implications of treating - or not treating - these infants. What we had hoped to add to the debate was an understanding of the tension between reproduc- tive rights advocates on one hand and advocates for disabled infants such as Baby Doe on the other. The Baby Doe laws seemed to challenge the very core of the feminist movement - namely, the right of women to control their reproductive functions and to guide the fate of their offspring. In Adrienne Asch and Barbara Katz Rothman we found two dedicated feminists who came down squarely on opposite sides of the treatment issue. In fact, their disagreement was so fundamental that they framed the debate in distinctly different terms. Asch argues that society's overwhelming fear and even loathing of disability and disabled people have prejudiced the debate, and that before all else, these attitudes must be acknowledged and rec- tified. She also believes that the treatment of newborns is not actually a reproductive rights but a child rights issue, based on the premise that newborns are separate beings and should not be discussed in the way that fetuses are. Rothman sees the issue as one of parental control, arguing that parents, and not the state, must have the right to make the difficult decisions about the treatment of infants born with severe disabilities. The different premises of these two advocates led them to stress different aspects of the dilemma, and thus to draw different conclusions about how to resolve it. Some of the positions taken by Asch and Rothman are not necessarily popular ones, but they are well stated and should not be ignored. Those who heard them last year were grateful for the oppor- tunity to re examine - our views in the sympathetic environment of a Health / PAC forum. As you read this condensed version of that forum, prepared especially for this issue of the Bulletin, we hope it will have the same profound effect on you that the original did on us. -Women's Health Work Group Health / PAC Bulletin 150 " Each child including - the child with a disability- has a right to a fair chance at life. If a parent's failure to provide medical treatment denies this right, it is the responsibility of the state to interfere, to protect the child. " by Adrienne Asch Adrienne Asch is an activist and writer on feminism, disability and other social issues. A doctoral candidate in social psychology at Columbia University, Ms. Asch currently serves on the Hastings Center Committee on Ethics and Care of the Imperiled Newborn, the ACLU Committee on Receiving and Withholding Medical Treatment, and the Board of Directors of the National Abortion Rights Action League. 6 Health / PAC Bulletin I b ' believe that newborns with disabilities should be given appropriate medical treatment regardless of their parent's wishes, even if that treatment requires state intervention. Many of my friends and colleagues on the left find this posi- tion disconcerting, because it is usually identified with the right and with the Right - to - Life movement. However, as a socialist- feminist, I believe it to be in keeping with deeply held leftist- progressive politics that champion the cause of the weak, vulnerable, and those in need of protection. Society Takes a Tragic View When nondisabled people think about the rights of newborns with disabilities, and when they suggest that one should abort a fetus diagnosed as having a disability, they take the position that disability is tragic and disastrous - and that to be disabled is inherently unacceptable. Society is generally uninformed and skeptical about the potential of people with impairments, and genuinely terrified of being disabled. As a result, people without impairments find it difficult to imagine a fully human and valuable status for disabled newborns, or one that is poten- tially so for fetuses with disabilities. I believe that life with disability can be worthwhile - if by that one means having the opportunity to appreciate beauty and variety; to learn, and to participate in social activities; to be productive and to feel useful; to care for and be cared about by other people. Almost all disabled people - even those with severe cognitive as well as physical impairments - have some capacity for all these things. And concerned citizens can make life even more worthwhile by helping to change societal attitudes about disability. One of the changes needed is that women must understand the meaning of disability rights in order to deal responsibly with reproductive rights. They must, for example, get better infor- mation about the potential of the disabled in order to make truly informed choices about whether to abort a fetus known to have a disability. Like most feminists and leftists, I distinguish between the moral status of the newborn and the moral status of the fetus. Because the newborn infant is a separate biological being who can live outside another's body, I believe it is entitled to the legal and moral status of a person, and to all the protections that go with such status. Because the fetus is inside the body of another and cannot live outside it, I do not accord it separate status and protection, and therefore accept that the mother re- tains the right to decide whether to carry a fetus to term. However, I also believe there is a significant moral difference continued on page 8 " No one cares more about a baby than the baby's parents. It is the parents, therefore, that should have the right to evaluate and choose those services, medical or other, which they consider to be the most appropriate for their newborn. " by Barbara Katz Rothman Teonatal intensive care has been called the new battle- N ground in the ongoing medical war against death. And perhaps it is. As in any battle, advances are sometimes made and the enemy sometimes retreats. But the costs in human life and suf- fering are unspeakable, and sometimes win or lose, the battle may not be worth the cost. There is a growing consensus in the United States, on every level from - legislation on the living will to the films made for children, that the intensive care unit may not be a place where anyone wants to live. I was struck by the scene in " E.T., " for example, where the lovable " extraterrestrial " lies surrounded by tubes, bottles, wires and monitors in a form of ICU set up in the home of the boy Elliot. As he appears to be dying, E.T. has become an object of scientific interest and curiosity, and the viewer empathizes with Elliot in his desire to scoop him up and get him out of there. Audiences everywhere cheered as Elliot and his friends took over from the doctors and scientists and gave E.T. what he really needed. They sent him home. Parents whose babies are placed in intensive care units sometimes feel very much like Elliot watching E.T. They see their babies wired, strapped, taped and bound, and they are sometimes horrified. Some parents believe it is necessary, that this is what will make the baby well. Some parents are less sure, seeing only slim chances of survival. And among those who think it is the baby's only chance as well as those who think it is no chance at all, there is sometimes a strong feeling that this is not a place where a baby ought to be. Some parents try to " humanize " the environment - - an inter- esting expression. No environment could be more human than that entirely artificial, man made - world in which the baby lies. It is not so much that they wish to humanize the environment, I think, but that they need to declare the humanness of their babies. Parents, nurses and doctors, too, share that concern. Teddy bears are placed in the corners of the boxes the babies occupy. Decals of butterflies and balloons grace the walls here and there. It does not change the essence of the unit, though, or what is happening there. Barbara Katz Rothman, PhD, is Associate Professor of Sociology at Baruch Center of the City University of New York. She is the author of Giving Birth (Penguin 1983) and The Ten- tative Pregnancy: Prenatal Diagnosis and the Future of Motherhood, just published by Viking. NICU: In Whose Interest? Some of us feel that what is happening in these units is not necessarily in the interests of the babies, but in the interests of the people who run them. Some people feel they are run to make money. I spoke to one mother recently who had removed her baby from a neonatal ICU against medical ad- vice. She said that the child never needed to be there, had been perfectly fine, she believed, and now, three years later, she still has no reason to doubt her judgment. So why had he been placed there? Money, she said. She was well insured, and the hospital had run up thousands of dollars in bills, and was un- willing to release the baby while more money could be made. That is her understanding. Others feel the motivations are more complex; not money, perhaps, but knowledge. It is in the interests of scientists and doctors to learn more. It is certainly in their interests in terms of career advancement and professional training. It is even in continued on page II Charles Charles Charles Charles Charles Angrand Angrand Angrand Angrand Angrand Angrand Health / PAC Bulletin 7 continued from page 6 between deciding not to have a child in the first place and deciding that this particular fetus, with its likely set of characteristics (including disabilities), is not wanted. Counseling about disability should begin long before women undergo tests for genetic disability in their fetuses, and should include information about laws and services as well as about individuals who manage with disabilities. Furthermore, honest assessment should focus not on the supposed future quality of life of the disabled child, but rather on what people want from the experience of parenting. No one can know what the life of any child will be like; we can only try to imagine what we want from being parents, and then can search ourselves to see how a child's disability will influence our parenting experience. And if we work to change societal attitudes, arrangements and institutions, we will find that the experience of having a child with a disability might not be a blight on our parenting experience. The'Sick'Model Is Inappropriate To examine this point of view, let's take a closer look at cur- rent attitudes. Up to now, our society has been accustomed to thinking of people with disabilities as people in need of health care, service or charity. They never need charity but they may need health care. They may need rehabilitation and chronic care, in addition to acute care, and some need other suppor- tive services as well, to live independent, productive lives. But the way the disabled are viewed is the way that sick people are viewed; as out of the common activities of life until recovered. Since disabled people - unlike people with flu or broken legs - do not " recover, " this sick role model serves to isolate them. They're often viewed as having no other function, capacity or characteristic than the disability itself. Like the sick person who is supposed to follow a medical regimen, to suspend all decision - making, to do what he or she is told in a passive and compliant way, the disabled person has been viewed as passive and compliant for all time. This image is constantly reinforced by language. Take the phrase " confined to a wheelchair. " It is as though the wheelchair user is in a prison; the wheelchair is interpreted not as a means of mobility but as a means of restraint. People are " tragically deformed " or " damaged, " or they are " victims " and " sufferers, " such terms clearly connoting undesirable, not wished- - to - be - for states of affairs. There is a big difference between saying that disabilities should be prevented or ameliorated and saying that the disabled are damaged, defective and unable to participate in ordinary activities of daily life. The media perpetuate some powerful images of disability. One is that of the heroic individual who climbs mountains despite polio. More often, however, it is the saint - like, passive person contentedly accepting life from a corner; the foolish, incompetent blind person bumping into walls and serving as the butt of other people's jokes; or the poster child who raises millions of dollars by being depicted as a cute, tragic person in need of public aid. Philanthropic agencies in search of money for research use poster children to play on the fear of disability in others, guilt about one's own " good " health, and ignorance about how it is possible to live, love, work and play as a person with a disabil- ity. Thus, they raise vast sums while perpetuating the view of disabled people as basically pathetic, and grateful for anything the public does for them. But the people who really pay are the disabled themselves. The play " Joe Egg " graphically depicts the impact of disability on the nondisabled, and illustrates what people are likely to think when faced with the questions of whether a Baby Doe should be treated or whether the fetus with a disability should be aborted. The play is about the parents of a child with serious dis- abilities, and it's message is that having this child has destroyed their lives. Nothing in the play permits the audience to ques- tion the characters and personalities of the parents or to wonder whether other events might have affected them in similar ways. Nor is there anything in the play to make the audience ask whether these lives would not have been destroyed had society treated people with disabilities differently. Public Issue or Private Problem? The presence of a disability is viewed as a private problem, private trouble, and, ultimately, a private disaster. It is not seen as a public issue remediable by solutions aimed not at " heal- ing " people's disabled bodies or minds but at changing society's ways of dealing with them. It is the latter point of view about people with disabilities that is the core of the disability rights movement: We should ameliorate disability when we can, and ameliorate the negative social consequences of disability when we cannot lessen the impairment itself. The disability rights movement asserts that if disability were to become a genuinely public issue, it would not have to be such a private trouble; that society should accept the care of the disabled as a legitimate responsibility - providing the sup- port services, enforcing civil rights laws, creating an accessible environment for everyone. Then having a disability or raising a child with a disability would not seem to be such a " disaster, " " burden " or " dilemma " as it is now. People with disabilities may need medical care at higher levels and with greater frequency than people without them. They may need support services in the form of interpreters if they are deaf, readers if they are blind, attendants if they are unable to perform manual tasks. They may need particular kinds of structured residences if their intellectual or psychiatric conditions make more typical lifestyles impossible. And the families of people with disabilities need support- emotional, financial and sometimes professional - to assist them in working with and caring for a child who needs physical, occupational, speech or other therapy. If those services existed routinely, and if the society were much more serious about thinking of people with disabilities as genuinely part of the community, then we would be mak- ing decisions about carrying disabled fetuses to term or rais- ing newborns with disabilities in a vastly different climate. Such a climate would convey the message that it is accep- table to be a person with a disability; that it is, in fact, rather normal and natural, if not necessarily a wished - for occurrence. Schools would - in fact as well as in law - educate even severely disabled children alongside their nondisabled classmates, of- fering them the necessary services to ensure the opportunity to maximize their potential. Public transportation would be accessible, and the environment barrier - free so that all buildings and streets could be navigated. Disabled people would expect to find employment for which they are qualified rather than being unemployed as they typically are now. Before the advent of the disability rights movement, people with disabilities were not seen as a political or legal minority. However, thanks to that movement - and to the legislation of the 1970's that created the beginnings of civil rights protection in education, employment and political life disabled - people 080 Health / PAC Bulletin are now coming to be seen as a minority whose problems are more social and environmental than medical. This means that the solutions to those problems are also social and environmental. And how does all this relate to deciding whether a particular disabled infant should be provided with the means to live or permitted to die? That infant might be the Bloomington Baby, who had Down's syndrome and a blocked esophagus that could easily have been corrected by surgery. It might be Baby Jane, whose spina bifida and other disabilities would have been alleviated but not cured by surgery. Or it might be a low birthweight - premature infant who may live after receiving medical intervention but be per- manently disabled in some way. That baby's disabilities could include brain damage, heart and respiratory damage, or sen- sory or neurological and motor impairment. ' Quality'Is Not the Question Barbara Katz Rothman believes that the treatment of these infants does not present a disability rights question. She and others see it as a quality - of - life decision, depending on whether someone else presumably - a parent - thinks that this being should live as a person with some degree of disability, whether slight or severe, known or unknown. But I disagree. I don't think that " quality of life " is a matter for discussion, and that if the infant can live, albeit disabled, then it should be helped to do so. I therefore support state in- tervention in the form of the Child Abuse Amendments of 1984, which provide that neither physician nor parent can withhold beneficial treatment. Parental privacy rights are already limited by law and by societal morality, and parents would be sanctioned for aban- doning or killing newborns deemed healthy or without disabilities. Further, the same people who decry using govern- ment intervention to protect the rights of infants with disabilities would support state intervention when its purpose is to prevent abuse or neglect of healthy children, or discrimination against children based on race or gender. The Child Abuse Amendments (see box on page 10) cut down on the possibility that parents or doctors will fail to pro- vide children the treatment that will permit them to live. Like Ms. Rothman, I do not believe that most parents wish harm to their children, but I do believe that, in a society which is ignorant and terrified of life with disability, parents can easily decide that a new life with impairments is not one worth living. If we retain our belief that a newborn infant is a child who can- not be abused by its parents or by anyone else without state intervention, then we must extend that belief to include the right of state protection to permit the life of the disabled newborn to continue. With Ms. Rothman, I do not believe that infants who will surely die within weeks or months - regardless of what medical technology does should - be forced to undergo treatment. However, as I read the Child Abuse Amendments, they do not mandate treatment in circumstances where the child is known to be dying. They mandate treatment in circumstances where parents and doctors have, in the past, presumed that the level and extent of a child's disabilities meant an " unacceptable " quality of life for the child or parents and that treatment should therefore not be given. It will not do to say that such instances are rare. Murder is not common, but we seek to protect people from it. Some prominent physicians still advocate that children with certain disabilities not be treated because it won't be " worth it " or they " don't fit the guidelines. " For example, if a child has spina bifida and the parents don't have a specified level and kind of resources, then some physicians are saying " don't have the cor- rective surgery. " The Child Abuse Amendments protect infants from such abuse by either the medical establishment or parents. Invasive, painful, futile treatment is abuse; treatment with some reasonable likelihood of permitting a chance at life is not. With Ms. Rothman, I agree that the large number of infants in need of neonatal intensive care could be spared this interven- tion with appropriate attention to prenatal care for the young, frequently poor, minority women who are their mothers. However, not all babies in these units and not all babies who are the subject of the Child Abuse Amendments are the result of inadequate maternal health and care. Ideally, all parents would raise their infants, disabled or not, and for those unable to do so, the state would provide the resources. Whether cared for by natural, adoptive or foster parents, or in a group facility supported by the state, these children deserve to have their needs met. A Chance at Life If we could recognize that all people, disabled or not, have unique as well as " ordinary " needs, and commit ourselves to creating a society in which all people's needs are met, we could cease to view our service to the disabled as a " special " effort that can be eliminated when times are tight. The needs of the disabled must be met simply because they are human beings. The most basic need is the chance at life. If disabled children could be seen as truly valuable, we would not have situations requiring state intervention against parent and doctor; everyone would strive to provide for the lives of all citizens. As disability rights come to be taken more seriously; as disabled people of all kinds participate throughout society to make integration more of a reality; as disabled people come to be seen as fully human and deserving of opportunities for development; as they speak up more in their own behalf, and as others look to them to do so; and as society allocates resources for disabled citizens as well as for nondisabled ones, more women and men may come to see having a child with a disability as something other than a tragedy and a burden. Health / PAC Bulletin 9 But until that time, we can be glad that the state has inter- vened in this matter - as it has had to intervene in other matters of family abuse or of societal discrimination - to protect the least powerful. As politically conscious health workers, concerned about the rights of all patients, readers of the Health / PAC Bulletin are in an important position to influence the thinking and ac- tion taken in behalf of the nation's disabled newborns. Let us work together, not only to interpret and implement the Child Abuse Amendments, but to provide the necessary support to enable disabled people, like all people, to achieve their poten- tial. Y' Baby Doe Reviewed What is now known as the " Baby Doe " issue first came to national attention in April 1982, when a boy was born, in Bloomington, Indiana, with Down's syndrome and an esophageal fistula. The first disability has no known cure; the second is commonly corrected by surgery. Because the baby had Down's syndrome and would have been mentally retarded to some degree, the boy's parents, on advice of the attending physicians, refused to correct the life threatening - condition. Six days later the baby died of starvation and dehydra- tion. In response, the Reagan Administration promul- gated its first set of regulations known as the Baby Doe Rules, stating that hospitals not reporting to child abuse authorities a parent's refusal to consent to appropriate treatment for infants with disabilities were guilty of discrimination against the handicapped under Section 504 of the Rehabilitation Act of 1973. In October 1983, Baby Jane Doe was born with spina bifida, hydrocephalus and microcephaly, in Long Island. The parents were told that their daughter's combined disabilities were likely to include some degree of paralysis, incontinence and retardation. As with Down's syndrome, it is difficult to know at birth the exact level of disability likely to be experienced with spina bifida. Some people with spina bifida have intellectual disabilities as well as physical ones; others do not. Physicians offered two alternative courses of treat- ment: The baby could have surgery to close the open- ing in her spine and to drain the excess fluid in her brain, or she could receive antibiotics, food, and water but no surgery. The parents chose the latter course. A stranger, a prominent anti abortion - attorney, insti- tuted a lawsuit to require surgery, but New York's highest court ruled that the stranger had no legal capacity, and when the state's child abuse agency investigated, it found no improper action by the parents. At the same time, the United States Department of Jus- tice filed suit to obtain the medical records of the infant, to determine whether she had been denied appropriate medical treatment because of her disabilities. The United States Court of Appeals for the Second Circuit ruled that Section 504 and its regulations did not permit the government to examine patient records to determine the appropriateness of medical and family decision- making. - A separate suit was filed by the American Hospital Herbert Semmel is Litigation Director with New York Lawyers for the Public Interest and a member of the Health / PAC Board. Association and the American Medical Association, at- tacking the Section 504 regulations. In Bowen v. American Hospital Association, June 1986, the Supreme Court of the United States, in a divided ruling, found that the 504 regulations were invalid. The Court reasoned that, since parental consent is required before treatment of a child, the hospital was not discriminating based on handicap when it acceded to parental wishes. The issue of the hospitals'obligation to see that dis- abled infants are treated is far from ended by this decision. In the past, many hospitals have instituted legal action, or filed charges, when parents have refused to consent to blood transfusions on religious grounds or, in one famous case, refused conventional chemotherapy and sought to treat cancer with laetrile. The Court indicated that, if a hospital regularly brings proceedings when parents refuse " medically necessary " treatment but fails to do so in the case of a severely disabled child, the inaction by that hospital would appear to constitute illegal discrimination. In addition to the Baby Doe regulations, Congress passed the Child Abuse Amendments of 1984, PL 98-457, requiring that state child abuse agencies act on complaints of failure to provide " medically indicated treatment. " The law states that child abuse is present if hospitals fail to furnish what physicians believe to be the most effective medical treatment to ameliorate or cor- rect life threatening - conditions in infants, regardless of parental wishes. Three exceptions to this mandate exist in the law: 1. The infant is chronically and irreversibly comatose; 2. The provision of such treatment would (a) merely prolong dying, (b) not be effective in ameliorating or correcting all of the infant's life threatening - conditions, or (c) otherwise be futile in terms of the survival of the infant; or 3. The provision of such treatment would be virtually futile in terms of the survival of the infant and the treatment itself under such circumstances would be inhumane. The precise legal and practical effects of this statute on state agencies are unclear. Some states may fail to define child abuse as defined in the federal statute and lose their funding for child abuse programs. On the other hand, some states may be moved to broaden currently narrow definitions and to intervene more often. It is also unclear whether these amendments authorize private citizens (as opposed to state agencies) to bring lawsuits against hospitals or parents. Herb - Semmel arninnitieman eagerness scanning tae buideertnnetrtina -- continued from page 7 the interests of future sick babies for scientists to learn more, to look at the baby in front of them not only in terms of what they can do for it, but what they can learn to help other babies later on. Parents, unlike scientists, have vital concerns only with this particular baby right now, and what this particular baby needs. And not all parents feel their baby needs what medical treat- ment has to offer. Some feel, like Elliot, that they can offer the baby a better chance of survival outside the medical set- ting. And some feel that survival is not the only value - that it is sometimes better for a baby to die in peace than to live in horror. Changing Ideologies When parents make such a decision, there are those who see the choice not as an act of great personal sacrifice and love, but one of selfishness. The parents are accused of behaving not in the child's best interests, but in their own, preferring the death of their baby to the distress and difficulties of raising a child with disabilities, a child who is not now and probably never will be " perfect. " Of course, someone has to make deci- sions in the baby's interests, and some claim that the conflict of rights between parents and child is too great for us to be able to trust parents. Therefore, babies need to be protected against their parents, we are told. It is from this belief- that parents are not trustworthy advo- cates for their babies - that the " Baby Doe " regulations developed. Someone, not the parents, but someone else has to represent the babies. The idea that parents, and particularly that mothers, do not act in the interests of their babies, and most especially their disabled, disfigured and otherwise need- ful babies, represents a significant change in the popular American ideology of motherhood. Earlier ideology portrayed mothers as self sacrificing - , all accepting - , all loving - . Let us turn from the 1980's film " E.T. " to the early 1940's film " Dumbo. " Dumbo is a baby elephant who is grossly dis- figured. His ears trail to the ground so that he trips over them. He is clumsy and foolish, in appearance and in action. Of course, the other elephants laugh, and reject him. Dumbo's is, as they say, a face only a mother could love, and his mother loves him, indeed. When he is humiliated and threatened, she flies into a rage, bringing the circus tent crashing down. Her frilled cap and sweet, maternal smile disappear as she rears up to full elephant size and power. I do not believe that the shifting ideology from mother as protector to mother as potential enemy of her children represents a change in maternal behavior or protectiveness. I believe it represents, among other things, a response to the feminist movement. If women can look out for our own inter- ests, then, some fear, perhaps we cannot be trusted to look out for the interests of our children. It is in the context of this lack of trust that the " Baby Doe " situation must be understood. Neither motherhood nor medi- cine are institutions the society has much faith in these days, although babies are as highly valued as ever, and maybe more So. And it is the context of the changing ideology that makes me so profoundly distrustful of even the most well meaning - and sincere attempts to protect newborns with disabilities. In Defense of Mothers: A Rebuttal In the Health / PAC forum on neonatal care and " Baby Doe " regulations, Adrienne Asch and I discussed these issues. Ms. Asch and I have, I believe, a genuine respect for each other's sincere and good intentions, as well as a genuine concern about the implications of each other's positions. In our discussion, Ms. Asch asserted that: " Newborns with disabilities should be treated, even against the parents'wishes, even if it requires state intervention. " That is a clear statement of the position represented in the " Baby Doe " regulations designed to protect newborns with disabilities. In what follows, I will examine, and challenge, the words and phrases used in her statement. " Newborns With Disabilities.. " Let us begin at the beginning, Ms. Asch's reference to " newborns with disabilities. " Is that the population to be pro- tected by the " Baby Doe " regulations? Somtimes, surely. Some of the " Baby Does " have been full term - infants with evidence of disabling conditions. That, of course, was the case with the 1982 Bloomington, Indiana baby born with Down's syndrome and a blockage of the esophagus, whose parents decided not to treat the blockage. But that is not the case for the majority of the patients in neonatal intensive care. The predominant problem is prema- turity. Had the pregnancy continued to term, we have no reason to expect that most of those babies would have been other than healthy. The longer the pregnancy continued, the better the condition of the baby; conversely, the shorter the period in utero, the greater the chances of death or severe damage. The disabilities are created in the course of continuing what should have been a period of gestation, and the best of neonatal inten- sive care units is a very poor substitute for the mother's body. As the technology of neonatal intensive care becomes more powerful, premature babies are being kept alive at earlier and earlier stages, and at this point, definitions of prematurity are coming to overlap our definitions of miscarriage. The implica- tions of treating a miscarried fetus as a newborn can be devastating; a miscarriage can be prolonged for months or even years as the fetus baby / slowly dies. A poignant, yet Kafkaesque description of this situation can be found in The Long Dying of Baby Andrew, Robert and Peggy Stimpson's journal of the miscarriage of their baby. As she lay in the recovery room following the miscarriage, Ms. Stimpson was shocked to be informed that the " baby " was doing well. The baby, named Andrew, spent six months dying in unremitting agony, as sores ulcerated to the bone, and the bones themselves shattered. The miscarriage was finally completed six months later, as even all the tools of the NICU failed to keep Andrew from dying. Where do such " newborns " or, more accurately, " extrauterine fetuses " come from? Some, like Baby Andrew, appear to be genuine accidents of nature - a poorly placed placenta, a uterine malformation, some other idiosyncratic tragedy. But something far more systematic, and far more sinister, is hap- pening. Prematurity is race- and class linked - . Prematurity is in large measure a problem of poverty. When mothers are not adequately cared for and nurtured, when they are not well fed, when they are stressed beyond endurance, then they cannot continue their pregnancies. If, as a society, we wished to protect babies, we would be wise to begin by protecting mothers. Our failure to do so results in the presence among us of ill, weak and suffering extrauterine fetuses, the newborns with disabilities we only then feel a col- lective need to protect. ".. Should Be Treated.. " " Treated " is a seemingly innocuous word that has come to Health / PAC Bulletin 11 mean medical treatment; in our society, treatment is what doc- tors say it is. Many of us are coming to understand that medical treatment is sometimes inappropriate, sometimes unnecesarily harmful, unnecessarily painful, unnecessarily psychologically distress- ing- and not always the most effective treatment around. There is some evidence to suggest, for example, that one highly effec- tive treatment for prematurity involves wrapping the baby and mother together, and caring for the mother as she cares for the baby. In continuous, skin - to - skin, breast mouth - to - contact, even quite small babies have been shown to do well. In American hospitals, mothers are now more often allowed to be with their babies and children than they were just ten years ago, but more as a visitor than as healer. In cases involving children of all ages, parents'rights to decide on alternative treatments - treatments the parents could choose for themselves - are being overridden in favor of the medically approved treatment. As long as a single professional group maintains the monopoly on defining treatment, any claim that newborns " should be treated " will be a politically loaded sentiment. ".. Even Against the Parents'Wishes... " To refer to the needs of parents to do what they feel necessary for their babies as " wishes " trivializes the depth of their con- cern. I perceive the needs of people to prevent their child's death from being prolonged into months or lives of agony to be something more than " wishes. " While some would have us think that the refusal of medical treatment is always destruc- tive, others of us believe that it is something protective - even if it means choosing death over continued existence. Parents who are sincerely acting to protect their children, to do what they genuinely believe is the right thing for the children, are not acting out of " wishes. " " . Even if It Requires State Interventionsz It is in this single phrase - in the bringing in of state power- that we come to the heart of the matter. For we are now talk- ing not only about the kinds of decision - rules we should develop that is, the direction in which we prefer to err when in doubt - but where the power to make these decision - rules shall reside. I think that we are all wise enough to know that whenever there are difficult questions to be decided, mistakes are going to be made. Some babies, who by almost all standards, should have been allowed to die quickly and well, will be made to die slowly and in pain. And some babies, who by almost all stan- dards should have received medical treatment, will suffer or die needlessly because such treatment was refused. And we must all be wise enough to realize that we may never know whether the right decision was reached in any given case. Those who feel the Bloomington Baby Doe should have been treated say the decision made was clearly in error; with surgery on his esophagus, they believe, the baby would have been well. He would always have Down's syndrome, of course, but his life, they believe, could have been a good one. In Jeff Lyon's fine and thoughtful work, Playing God in the Nursery, he describes that case - and he also describes the seemingly similar case of Brian West. Brian, too, had Down's syndrome and a missing esophagus. He was treated, against his parents'decision and judgment, through five surgeries, none of which solved the problem. He suffered through two long years, never well enough to be at home, sometimes bound hand and foot to prevent him from tearing at his surgical wounds in agony. He died at 26 months, a lifetime from which his parents may well have been right in trying to protect him. Could that same fate have been in store for the other Baby Doe? Who knows? Who could know? Decisions to treat or not to treat are made, and then the babies live -- or do not live - with the consequences. And sometimes we will never know what would have been, what could have been. It is not really a question of whose judgment we trust. We cannot know who will be right, but we do know that, in- evitably, anyone making these decisions will sometimes be wrong. To me, it comes down not to whose judgment we trust, but whose mistakes. Medicine has a long history of mistakes, especially mistakes in matters of disability. It is ironic that the disability rights movement seems so trusting of medical decision - making regarding necessary treatment; there has been so much un- necessary medical treatment to avoid or to repair disability. Medicine has long regarded disability, like death, as a sign of professional failure. The state, too, has a long and horrible history of mistakes on matters of disability. These systematic mistakes of the state can be seen in the history of eugenics in the United States, dreadful as it was, and even more tragically, elsewhere. And what about the mistakes of parents? We know too well that parents make mistakes. They demand too much or too little of, and for, their children. They are too fearful or too trusting of authority. They give up too soon or hang on too long. Yes, parents certainly make mistakes. Why, then, do I trust the idiosyncratic mistakes of parents? Precisely because they are idiosyncratic. The mistakes of medicine and those of the state are systematic, and that alone is reason not to trust. Medicine, and (perhaps even more so) the state, make their decisions in their own interests, in calcula- tions of cost benefit - ratios, in definitions of " salvagability, " in the very drawing of lines. New York, for one, is not a state that has acted consistently in the best interests of children, of mothers, or of disabled people. Parents may not be anywhere near infallible in their judgments, but historically it has been parents - mothers - who have made decisions in the best interests of children, who have acted to protect and to nurture children, who have even been relied on to put the interests of their children before their own. It is mothers, not doctors- and certainly not the state - who have historically demonstrated their trustworthiness (not perfection, just trustworthiness) as advocates for children. Help the Parents Decide If the situation were such that every objective observer who fully understood the facts of the matter would come to the same conclusion regarding treatment for any given newborn, this would be a far simpler matter. Our question would only be: " Who is best equipped to understand all of the facts? " But that is very far from the situation we face. We live in a pluralistic society. People decide such issues - the questions of life and death, the kinds of disabilities and of circumstances that make life no longer worth living, the kinds of treatments that are worth enduring -- in very different ways for themselves. There is genuine disagreement among us as to when life is, and is not, worth living. The increasing acceptance of the " living will " demonstrates our acceptance of individual differences in values and in needs. With the living will, with the situation of people who have led some part of their lives, we ask the state to allow decisions to be made as the individual would have made them. For the 12 Health / PAC Bulletin newborn, for the extrauterine fetus, we have no way of life, no history of values on which to draw. The closest we can come are the values and way of life of the people who would have raised that child. Ultimately, no one wants anyone to have the right to make life death - and - decisions for anyone else. But it is in the nature of parenthood that one accepts responsibility for a new life, and makes decisions as one would have the child make those decisions. Parenthood is always the acceptance of responsibil- ity for a life. . These complex issues of life and its meaning involve much more than a straightforward question of disability rights. This is an economic and social issue, centering on access to prenatal care and nutrition, on poverty and prematurity. This is an issue of the individual's right to say no to the encroachment of medical technology into all areas of our lives and at all costs, and it is an issue of a technology bent on taking over reproduc- tion at earlier and earlier stages. In a system that is cutting back on all the services women need to be good mothers, turning all of this into a disability rights issue is unforgivably naive. This is not a moment to judge parents. Our first priority must be to help parents, to give them what they need, nurturing mothers so that they can bring forth healthy children, nurtur- ing both mothers and fathers so that they have the resources to give of themselves to their children, giving parents the in- formation we want them to have, including information about the meaning and place of disability in the lives of disabled people. And then, I believe, we are going to have to trust the sub- jective decisions and judgments of parents regarding the ap- propriate medical services for their newborns. Because there are no objective answers, and there won't be any in the foreseeable future. C] Wiliam King Health / PAC Bulletin 13 continued from page 3 implications of these contradictions for women - those who bear and most often have primary responsibility for raising children. In another fascinating discussion of the intersection of science, cultural ideology and women's experience, Phyllis Kernoff Mansfield evaluates the long - held and influential medical view that the risks from childbearing increase directly with maternal age. In contradiction to the experiences of many of us who have become " older " mothers or worked as midwives in nontraditional childbirth settings, current medical teachings and practice hold that childbearing should be confined to the years before age 35 and, especially, that women who become mothers after this age are at " high risk. " As Manfield points out, the decision of whether and when to bear children is cen- tral to women's lives, influencing our personal, educational, occupational and political options. Mansfield presents the results of a methodological evalua- tion of U.S. research studies that examined the relationship between " advanced maternal age " and a variety of pregnancy outcomes, classifying these studies in terms of the adequacy of their research design. Significantly, she found that the vast majority of studies are fundamentally flawed in their design, many failing to control for such central factors as parity and socioeconomic status, others omitting any statistical tests for comparing age related - outcomes. Mansfield also found that the stronger a study's research design, the less likely it was that maternal age would influence outcome. In addition, it appears that many complications of older women's pregnancies are actually iatrogenic, produced by the medical services they received as a result of being defined as " high risk. " And so we are left to ask why, in the absence of a strong empirical base, there exists such a widely held bias among physicians against mid - life childbearing. It appears, says Mansfield, that there are strong and old ideological biases against childbirth among older women and that this ideological tradition has been handed down as medical knowledge for literally hundreds of years. Drawing on feminist scholarship, she argues that medical teachings legitimate cultural beliefs about appropriate and desirable behavior among women. These beliefs emerge and change historically as part of broader political, economic and social processes. In the fourth article, Erica Gollub discusses the legislative and regulatory history of the cervical cap in the U.S. as an example of the interrelationship among science, medicine, cor- porate structure and sexist ideology. Despite a 100 year - history of successful contraceptive use in Europe, and an impressive body of clinical evidence about the cap's effectiveness and safety, the FDA has prevented its approval and widespread use by holding it in its current " investigational " status since the late 1970's. Gollub argues that the FDA's treatment of the cervical cap reflects its social and political history - and most particularly its relationship to the women's health movement in this country - as well as the interests and influence of the profit- able pharmaceutical industry. It is only within this context that we can begin to make sense of the FDA's treatment of the cer- vical cap, as well as the differential treatment of the cap ver- sus other more invasive and dangerous forms of contraception, including birth control pills and intrauterine devices. By locating their discussions in the broader context of feminist research and writings, authors Asch, Rothman, Mansfield and Gollub enrich our understanding of the rela- tionship among the state, medical care services, technology, ideology and the sociological significance of gender in our society. Y' - Rochelle Kern What's Happening to Health Care? g The Health / PAC Bulletin shows you. No one else offers independent analysis of health policy issues from prenatal care to hospices for the dying, covers medical carelessness for women and on the job poisoning; offers incisive international reports and lively cbarriee fisn douns tdroy.m estic health developments; and stays on top of the changing trends that are transforming the health If you already know all this and have a subscription, why not do a friend a favor and fill in his or her name on the form below before you run out of 22 stamps? Please enter subscription (s) for the Health / PAC Bulletin Check: 0 Individuals $ 22.50 Y' 2 years $ 42 Y' Institutions 45 $Y ' 2 years $ 70 _ (Foreign subscribers add 8 $ per year) Name Address City . State Zip Y' Bill me (plus postage and handling) Y' Charge: Y' Visa MasterEx piYr'a tion date No. Signature Send your check or money order to Health / PAC Bulletin, 17 Murray St., New York, N.Y. 10007 14 Health / PAC Bulletin Like A Boxer Over the Hill? Assessing the Prejudice Against Mid - Life Childbearing by Phyllis Kernoff Mansfield In the last decade or so, more and more American women have chosen to delay their childbearing until their late twen- ties, thirties or even beyond. First birth - rates for women in their early thirties more than doubled between 1972 and 1982, while rates for women in their late thirties rose 83 percent during this period. Reasons for postponing parenting have included an unprece- dented move into the paid work force by women, a desire to complete their education or to reach a satisfactory rung on the corporate or academic ladder before starting a family, a need to get on top of things financially before the baby's arrival, the postponement of marriage, and a general need to complete cer- tain preparental agendas such as time for growing up and set- tling down before assuming parenting responsibilities. " Whatever the reason for their delay, when such women begin to consider pregnancy and seek medical advice concerning the risks of mid - life parenthood, they discover only contradictions. Current popular books on the subject are generally enthu- siastic, citing stories of successful mid - life pregnancies among contemporary women. Such success has been attributed vaguely but consistently by popular writers to a " unique positive dimension " among older couples today, which endows the older woman's pregnancy with extra energy, permits her to move through her pregnancy experience " with a remarkable degree of composure " and results in a positive outcome. Medical Literature Is Pessimistic The medical literature, on the other hand, is considerably more pessimistic. Since 1958, the Council of the International Federation of Obstetricians and Gynecologists has designated that all first time - mothers over 35 are to be considered high- risk patients, regardless of other personal and health factors that might predict an uncomplicated pregnancy. As health. consumer advocate Barbara Seaman has commented, " You can't expect objectivity from the sort of people whose text- books, in this day and age, refer to women having their first child after 30 as elderly primiparas. " " 4 It appears that such pessimism dates back to " the ancients, " to such remote literature as Mauriceau's 1668 claim that " women a little antiquated suffer more in their first labours than other women, " and that these " honored time - concepts " sug- gesting the dangers of later childbearing have been handed down uncritically over the generations.5 Phyllis Kernoff Mansfield, PhD, is Assistant Professor in the Department of Nursing, College of Human Development, at Pennsylvania State University in University Park, PA. Today, such medical prejudice still prevails. The older first- time mother has been compared by one physician to a " boxer over the hill. " Her muscle tone is not good enough, he says, and neither is her endurance. She knows the words, but can't play the tune. Promoting this kind of prejudice are the medical textbooks, considered by some to be the most potent mechanism by which medical advice is transmitted, often un- critically; today, they still state that the " elderly primigravida is somewhat more likely to encounter complications which are the result of the natural process of growing older. " Is 35 Really Too Old '? The impact of such pessimistic medical advice on women's lives is enormous. Women wishing to delay motherhood in order to first attain other career, educational, financial or per- sonal goals feel pressured by the so called - biological clock which reminds them with each tick that the " safe " age for childbearing ends at age 35. In many cases, these women may forego parenting altogether if they reach 35 before they are ready to become mothers. Other women, in their 30's or early 40's, may decide for the first time that they wish to become parents, or may find themselves in new relationships and wish to start a second family; these women, learning that they are medically at " high risk " for pregnancy and delivery complica- tions, may also abandon their parenting plans. Should an older woman choose to become pregnant, she may experience the " currents of prejudice against older parents in this society " encountered by the author, Price, in researching her popular book, You're Not Too Old to Have a Baby. Feel- ings of being culturally out of step will merge with her con- cerns that somehow her well being - and especially that of her fetus will somehow be adversely affected by her age. The resultant stress from such concerns will detract emotionally from her pregnancy experience and may also have a deleteri- ous biological effect on the pregnancy, since research has begun to document a link between heightened emotionality during pregnancy and a number of adverse outcomes. There is still another way in which the medical tradition against mid - life parenting can influence the pregnancy experi- ence and, indeed, the very outcome for older pregnant parents. Since the medical community believes these women are high- risk patients, they are likely to introduce a number of interven- tions during labor and delivery which, while believed to be necessary and intended as helpful, may actually heighten the older woman's risks. Such iatrogenic, or physician - caused, complications include the increased risk of morbidity or mor- tality of mother and infant from excessive reliance on cesarean Health / PAC Bulletin 15 A -- a wae section deliveries and on drugs during labor and delivery. In summary, medical tradition advising women to confine their childbearing to the years before age 35 has had wide- spread influence on the ordering of major events in their lives, on the decision to become a mother at all, on the emotional experience of pregnancy and even on the pregnancy outcome itself. Because of the far reaching - effects of such a pessimistic outlook, it becomes imperative that the advice be examined for its accuracy. Such an investigation would ask two questions: First, is there sound empirical evidence to support the pessimistic claims, and second, is the evidence generalizable to the present cohort of contemporary, middle - class, healthy postponers. I undertook such an investigation, which is described below. Examining the Evidence For this investigation, a critical review was made of all those research studies performed in the United States that have ex- amined the relationship between advanced maternal age (a medical term defined variously by researchers as motherhood later than 28, 30, 35, 40 or older) and eight pregnancy out- comes. With the exception of one paper presented at a con- ference, all studies were published in academic journals or as government documents. It was important to review all the available studies in order to avoid a selection bias on the part of the investigator, as well as to find the origins of the prejudice against delayed child- bearing and to determine the way this belief has been trans- mitted across time. Eight Pregnancy Outcomes Analyzed The eight pregnancy outcomes I selected were those the 16 Health / PAC Bulletin medical profession most consistently reports as increasing in incidence with advancing maternal age; as such, they probably have been most central to the development of the pessimistic advice. They are: 1. Toxemia - either pre eclampsia - , charac- terized by edema, hypertension and protein in the urine, or eclampsia, an advanced stage of toxemia characterized by con- vulsions and even death (the urine test that is part of each prenatal visit tests for toxemia); 2, 3. Two complications of labor and delivery: prolonged labor, and delivery by cesarean section; 4. Two placental abnormalities: placenta previa, when the placenta implants in the lower uterus instead of the body of the uterus and may block the os, and abruptio placentae, the premature separation of a normally implanted placenta; 5. Maternal mortality; 6. Low birthweight; 7. Perinatal mor- tality, late fetal deaths and stillbirths; 8. Infant mortality, generally defined as infant death up to the age of one year. Other important pregnancy outcomes, such as spina bifida or cleft lip and palate were excluded from the analysis because they have been less consistently linked to advanced maternal age and are therefore less central to the development of the pessimistic view. Regrettably, Down's syndrome studies were also excluded from the critical review, although I did conduct a " state of the art " sampling of studies. It had been assumed that the incon- trovertible link between this outcome and advanced maternal age must be based on strong research evidence. Surprisingly, however, a casual review of this literature revealed a number of methodological weaknesses. For example, while all the studies reported an increased risk of Down's syndrome with advancing maternal age, the precise risks cited varied con- siderably, mostly because of serious problems ascertaining ex- isting Down's cases. Also, this seemed to be another research domain in which the same few studies were cited over and over, even according to a noted researcher in the field. It is in- teresting to note that very recent British data show the safest maternal age with regard to risks for congenital malformations to be between 30-34, probably in some part due to more systematic screening of this age group. In light of the importance of this link in the formulation of the belief that pregnancy over 35 is risky, it would seem to be very important for researchers to systematically review the Down's syndrome literature and to perform well designed - studies that can begin to address the many ambiguities and con- fusions remaining in this area. How the Studies Were Evaluated Each study was evaluated on the basis of certain criteria that were developed after reading selectively in this literature. The studies seemed flawed in two important ways: They attributed differences between age groups to age without eliminating the possibility of alternative explanations (e.g., birth order); and their judgments of differences were open to question, because they made them subjectively (no statistical tests), or the numbers they were comparing were too small, or they failed to include a comparison group in their study. Four criteria were established that a minimally acceptable study would have to meet, and one that did was called " Category One. " Others became " Category Two " or " Three " studies, depending on which criteria were not met. The criteria for each category, as well as the number of studies falling into each category, are shown in the accompanying table. The first criterion, " presence of a comparison group, " may seem to be especially simplistic; after all, if a study is attempt- ing to make comparative statements about the reproductive out- Methodological Criteria Presence of a comparison group Control for parity Adequate sample size Use of statistical tests for comparing older and younger groups Major Flaw (s) Number of Studies Assigned to Each Category (Total = 104) Percentage of Studies Per Rating Category Showing Older Women at Higher Obstetrical Risk Methodological Criteria for Evaluating Studies RATING CATEGORY (See text for full description.) One (Strongest) Two Three (Weakest) Yes Yes Yes / No At Yes Yes Yes / No loenaest Yes Yes Yes / No " No " Yes No No None 11 (10% of total) 28 Comparisons between age groups made subjectively; room for bias 30 (29%) Alternative explanation of findings possible because parity not accounted for; comparisons weak because no comparison groups, small sizes and subjective determination of differences 63 (% 61) 48 37 comes of younger and older mothers, it ought to include groups of both ages to study. However, the literature contains studies in which only older mothers were studied and then guesses made about how the outcomes might compare with some " average. " Any study not meeting this most basic criterion was assigned to Category Three. " Control of parity " -- the number of live births to an individual woman -was a second basic requirement. In fact, most studies comparing older and younger women failed to consider that a variety of other important factors besides age (e.g., socioeconomic status, health history, or how many children the woman has already had) could have explained any observed differences between outcomes. To be liberal, this investiga- tion required only that a study control for parity. Otherwise ( , differences in outcomes could be related to the number of births rather than maternal age per se.) Any study failing to meet this criterion also fell into the weakest category, Three. Since many studies did not employ statistical tests for comparing age related - outcomes, it became critical to have adequate numbers of events with which to make subjective determinations of differences. Many studies tried to determine differences when as few as one or two events were being com- pared. The criterion of " adequate sample size " really refers to a minimum of 10 outcome events per group for studies not employing statistical tests, although most of the studies fail- ing to meet this criterion (also assigned to Category Three) were comparing far fewer than ten events. The use of statistical tests was the criterion separating the strong Category One from the weaker Category Two studies. Without statistics, comparative judgments were entirely sub- jective, and conclusions open to the intentional or unintentional biases of the researchers. For example, this study uncovered evidence of opposite interpretations of the same data set by two different groups of researchers, 10.11 one concluding that low birthweight incidence was age related - , the other that it was not. Depending on the scale points each group chose in plotting the data, either interpretation seemed " reasonable. " In addi- tion, a study without statistics would be unable to simultan- eously assess the influences of multiple factors, an approach shown to be critical in detecting whether age or other related factors were most important in influencing outcomes. 90% of Studies'Scientifically Shaky ' The table shows that only 11 (or 10 percent) of the 104 studies were satisfactory methodologically. Another 30 (29 percent) were methodologically sound but based their conclusions on Health / PAC Bulletin 17 subjective and therefore scientifically shaky grounds. The largest number of studies, 63 (61 percent), were methodologi- cally inadequate, and their flaws raise serious questions about the validity of their conclusions. In every decade up to 1970, poor research studies out- numbered good ones. Not a single Category One study ap- peared until 1957, and only one more before the 1970's. Finally, in the 1970's, computer technology, statistical sophistication and more attention to the development of epidemiologic design skills during medical training combined to create the possibil- ity for the stronger designs we see more often today. Age Less a Factor Than Presumed The stronger the design, the less likely that the study found a maternal age effect. While 37 percent of Category Three and 48 percent of Category Two studies indicated that older. mothers were at higher risk for complications, only 28 per- cent of the studies using sound methodology found this result. The major reason for these differences appears to be the serious confounding problem already mentioned: A number of factors predictive of adverse outcomes are intertwined with the advanced maternal age factor, which alone receives bad press as the cause of complications. These " other " factors in- clude certain pre existing - diseases more prevalent in older women such as diabetes or hypertension; the birth of a tenth or twelfth child to a poor older woman; the birth of an un- planned child late in life; the decision by obstetricians to " safeguard " the long awaited - child of an older mother by order- ing certain interventions such as more drugs in labor and delivery, or more cesarean sections, which themselves become the iatrogenic cause of complications. All may be harmful in- fluences on the outcomes in question, but will remain hidden behind a maternal age effect unless the researchers unscram- ble the factors and examine their independent effects. Many of the well designed - studies did just that and, by and large, found that advanced maternal age became a less impor- tant predictor of outcomes when other age related - factors were controlled statistically or by the design. For example, one of the earliest Category One studies, conducted by Friedman and Sachtleben (1965), 12 found that the slow, second - stage labors observed in their over - 35 group could be entirely accounted for by the excessive amounts of sedatives given to these women. In a study of infant mortality, researchers Shah and Abbey discovered that the maternal age effect they first found disappeared with the simultaneous adjustment of other mater- nal and socioeconomic variables and concluded that age " by itself... showed no effect on neonatal mortality. " " " 13 Such sophisticated methodologies are necessary for sorting out whether age itself or other age related - factors are linked to the particular outcomes in question. Yet we have seen that most studies were simplistic; few employed either a proper research design or the appropriate statistical analyses really called for. What this means, quite simply, is that at least 90 percent of the studies did not employ an adequate methodology for controlling the enormous confounding problem inherent in maternal age research. A second finding of interest concerns the eight individual outcomes studied. With only one or two exceptions, these adverse outcomes were not nearly as consistently linked to ad- vancing maternal age as medical teaching would have us believe. When rating categories were combined, delivery by cesarean section emerged as the only complication to increase with age in more than 50 percent of all studies investigating that relationship. Labor duration increased with mother's age 18 Health / PAC Bulletin in only 12 percent of studies of that outcome; placental com- plications, in 17 percent of studies; infant mortality, in 28 per- cent; maternal mortality, in 36 percent. Perinatal mortality was the only outcome besides cesarean section incidence to show some link with maternal age: In 49 percent of all studies of age related - perinatal mortality, a link was made between older mothers and more perinatal deaths. Rueff Since the 11 Category One studies are those that are methodologically rigorous, it is especially worthwhile to look at the findings of these studies. Once again, only C section - rates regularly increased with maternal age (in 100 percent of studies), while maternal and perinatal mortality rates were found to increase with maternal age in 50 percent of these studies. No other outcomes showed a link with maternal age in these Category One studies. Physician Management Implicated A closer look at the studies, and a familiarity with the history of childbirth in this country, suggest alternatives to a reproductive - aging explanation for these findings. For exam- ple, we know that cesarean sections are not elected for older women solely because they are experiencing labor and delivery complications, but more likely because complications are an- ticipated, since women over 35 are " high - risk " patients. Reviews of patient charts by several researchers show that there have been less restricted indications for cesarean sections among older patients. Some physicians have even admitted to performing C sections - on older patients when it was " likely that many would have delivered vaginally if permitted to do SO. 14 " Physicians have written of their concern that, for elderly primiparas especially, the present birth might be their first and last. Thus, their task has been to safeguard this long awaited - offspring. The " high social value of the child " apparently has influenced physicians to act " with greater alacrity than under ordinary circumstances " 15 to elect a cesarean section for first- time older mothers. The fact that older women experience more C sections - means they will also experience proportionately more side- effects inherent in the procedure. Unfortunately, there are, and always have been, certain risks associated with cesarean sec- tions. It is well established - that more women die following cesarean section than vaginal deliveries. " 16 Also, especially prior to the availability of antibiotics in the 1940's, C section - deliveries were associated with postpartum infection and subsequent maternal death. Another complication of elected cesarean section is " iatrogenic prematurity. " This involves the birth of an immature. infant suffering from respiratory distress syndrome (RDS) because of lung immaturity. RDS is the greatest single cause of perinatal morbidity and death in the United States. 17 Although there is a modern tool for documenting fetal lung maturity, this test was not available prior to the early 1970's, and in any case is still not used prior to all elective C sections - . It is possible to see how all three of the childbirth complica- tions identified by the Category One studies as maternal age- related (sections C - , maternal and perinatal mortality) may ac- tually be related to the special obstetrical management of older women in this country. If older women experience higher rates of C section - , they may also experience higher rates of mater- nal and perinatal mortality. The Transmission of'Honored Time - ' Concepts The scientific literature does not lend support for the degree of prejudice encountered against mid - life childbearing within the medical community, and indeed, within society as a whole. If scientific data do not provide the basis for the prejudice, what then is its source? And how has it persisted, in the face of con- tradictory evidence? One of the very early writers on this subject provides some answers. Spain, a female physician, wrote, back in 1912, that medical students had been taught for generations about the dangers of childbirth for first time - elderly mothers. 18 It is im- portant to note that this teaching was occurring in the United States before any research specifically on this topic had been published in this country. And it is fascinating that Spain, more than 70 years ago, was already challenging such pessimism: " We must conclude that the tradition handed down to us from past generations of the many dangers of childbirth in the elderly primiparae can no longer be maintained unreservedly. " If medical students were being taught in 1912 to fear mid - life childbearing, the warnings could not have been based on re- search studies in this country. There is a suggestion that the earlier scientific literature from France, Germany and Scandi- navia may have formed the basis for the belief. " On the other hand, several writers attribute this teaching to even earlier sources such as Madame Lachapelle, 20 and Mauriceau. 21 The discovery that the source of contemporary medical ad- vice concerning mid - life childbearing probably goes back to ancient writings about " antiquated " women has been one of the surprises of this research. Another has been the steadfastness of that pessimistic view in the face of challenges throughout this century from within the medical community and from ac- tual scientific findings; the early pessimism has persisted, despite conflicting findings and challenges from researchers. For example, a 1932 study reported that older women could " naturally expect " longer labor, more toxemia and a greater likelihood of fetal and maternal morbidity and mortality, although only seven studies of advanced maternal age and pregnancy had been performed in this country by that time, with inconsistent results. By the 1940's, the older first time - mother was declared a " hazard during pregnancy and labor, " 23 and by mid century - , concerns for this mother had, in the words of two physicians, reached " a state approaching hysteria. " 24 In 1957, for example, family planning expert Alan Guttmacher urged a warning against postponing pregnancy to be " emblazoned on the walls of high schools and girls colleges. " 25 Keep in mind that at the time of this frenzy, research findings were anything but con- clusive regarding older women's obstetrical risks. Several writers, from Spain to the present, have suggested that such " honored time - " medical concepts have been transmit- ted through the generations, often uncritically, in medical text- books that are not revised as often as necessary. Indeed, the Chair of the Obstetrics and Gynecology section of the Jour- nal of the American Medical Association stated in 1949 that a medical text is " to a great extent merely a copy of previous books.26 In 1980, a team of medical researchers made a similar observation: " Definite opinions [about pregnancy and labor in older primiparas] are given in textbooks, but no at- tempt is made to compare these truisms with the findings of a controlled study. " 27 ' Nonobjective Science'Validates Myths We have seen that the prevailing prejudice against older motherhood in our culture has its roots in centuries - old teachings that have remained essentially unchanged despite challenges from critics and contradictory evidence from both research studies and from contemporary older women's suc- cessful reproductive experiences. The tenacity with which certain physicians have held onto this teaching is remarkable, even to the extent of discounting Rembrandt Health / PAC Bulletin 19 ean eer wal eee 2 wy ' ee Oe ae soaate Be d Renee on : jedaot demcmet fawn ? - * * er vtenny tet women ot ao yeni sprees, ed infieats ated a ee * ja pla pla pla j tShaineb i ipnakge d t Opreec divaedef dem mrtAanclb e | yy 'ndose hg id cre ctl Ring omen x ot *** tym wilma aparejameis eagle an He 3 one ne. daVinc ** ** ** ** ** ** abe * a cap fang eTehe aBe Lain t vof e#8 Maes Gs 0 ool Spek as* h* o k er, An ae Leonardo # a ee 2 DE a. dea nies aes their own researching findings. Although one pair of re- searchers found that their older mothers experienced un- complicated labors, they nevertheless warned that such findings should be viewed skeptically, lest they engender an unwarranted feeling of optimism.28 While medical prejudice against delayed pregnancy no doubt has stemmed in part from a sincere concern that older mothers will be at higher risk for any number of complications, other motives may also have been in force to sustain a teaching that limits a woman's options for motherhood to her teens and twen- ties. For example, the 1940's and 1950's, decades in which a frenzy of research occurred to document the dangers of post- poning pregnancy, were also the war and post - war years when educated couples, at least, were being asked to put aside birth control, child spacing, or planned parenthood and " not lose sight of the extremely important question of the production of the next generation of our national family. " 29 Coincidentally, these were the years when women were being coaxed back home from the workplace so that the men returning from battle could have their jobs back. 30 What bet- ter way was there to do this than to encourage early and fre- quent childbearing and to warn about the hazards of postponement? There may be other explanations as well, for this research does not stand alone in questioning the scientific wisdom of a routine medical practice. There is a large, growing body of feminist research that now calls into question many other traditions of women's medical care, especially concerning such reproductive events as menstruation, childbirth and meno- pause. This feminist perspective recognizes that medical prac- tices for over a century have been legitimated by a science that is neither objective nor neutral, and which serves instead to validate myths about women's biological nature that reflect 20 Health / PAC Bulletin prevailing cultural values. Examples of such myths include the beliefs that women are inherently fragile and sickly, that most reproductive concerns are of psychosomatic origin, and that older women are sexless, unattractive and reproductively obsolete. If we look at my research findings from this feminist perspective, we can begin to understand why it might be dif- ficult for the medical profession to relinquish its " high - risk " label for pregnant women over 35. To do so, pregnancy and childbirth would have to be viewed as normal and healthy events rather than events fraught with danger; older women who planned a pregnancy would have to be redefined as reproductively and emotionally capable (not to mention sex- ually active!); and physicians would have to relinquish an enor- mous degree of social control over the timing of parenting in women's lives. It has been pointed out that the political and economic interests of dominant elite groups are best served when women are viewed as inherently disadvantaged, biolog- ically. If older women were to be viewed as reproductively capable, these interests could be weakened. We must be extremely skeptical of advice that limits women's options. As scientists studying mid - life pregnancy, we must design studies that are sensitive to and control for the myriad influences on reproductive outcome aside from maternal age. It would be even better to devise a new approach to the study of this subject, one in which women are viewed not as lists of variables to be manipulated but as whole individuals with suc- cessful and unsuccessful pregnancies to be studied and better understood. Feminist research has proposed a new paradigm that incor- porates women's actual experiences within a social and political context. As physicians, women must be on guard against the uncritical transmission of ancient myths as scientific teachings. We must make our criticisms heard, and must alert our col- leagues to what we don't yet know. As social scientists and as feminists, we must be aware of the subtle influences that culture exerts on what appear to be scientific, objective medical teachings. And as health professionals, we must educate other women with accurate facts about the risks they may- or may not encounter - in making the choice to become an older mother. O The material in this article is adapted from a forthcoming book by the author, Pregnancy for Older Women, to be published this year by Praeger. 1. See, for instance, National Center for Health Statistics. " Advance report of final natality statistics, 1982. " Monthly Vital Statistics Report, 33 (6), Supplement, 1984; Dimos, H. " Getting mad and doing something about it. " Ms. May, 1980, pp. 44-49; Kamerman, S.B. Parenting in an unrespon- sive society. New York: The Free Press, 1980; Roland, A. & Harris, B. Career and motherhood: Struggles for a new identity. New York: Human Sciences Press, 1979; National Center for Health Statistics. " Trends in first births to older mothers, 1970-1979. " Monthly Vital Statistics Report, May 1982, 31 (6) Supplement; Westoff, C. " Some speculations on the future of marriage and fertility. " Family Planning Perspectives, 1978, 10, 79-83; Daniels, P. & Weingarten, K. " A new look at the medical risks in late childbearing. " Women and Health, 1979, 4, 5-36. 2. See, for instance, Price, J. You're not too old to have a baby. New York: Farrar, Straus, Giroux, 1977, p. 76; Fabe, M. & Wikler, N. Up against the clock. New York: Warner Books, Inc., 1979; McCauley, C.G. Preg- nancy after 35. New York: Pocket Books, 1976, p. 8. 3. Blum, M. " Is the elderly primipara really at high risk? " Journal of Perinatal Medicine, 1979, 7, 108-112. 4. Berman, V. & Berman, S. " Who runs a higher risk? A consultation about childbearing after 30. " In G.S. Brewer (Ed.), The Pregnancy after 30 workbook. Emmaus, Pennsylvania: Rodale Press, 1978. 5. See, for instance, Randall, L.M. & Taylor, J.C. " Elderly primigravid women. " American Journal of Obstetrics and Gynecology, 1949, 57, 1210-1221; Points, T.C. " The elderly primipara. " Obstetrics and Gynecology, 1957, 9, 348-354; Brewer, T. " Consequences of malnutrition of human pregnancy. " CIBA Review: Perinatal Medicine, 1975, 5-6; Calkins, L.A. Reproduction in the older woman. Journal of the American Medical Association, 1949, 141, 635-638. 6. 6. Price, op. cit., p. 76. 7. Donald, I. Practical obstetric problems. London: Lloyd - Luke Ltd., 1979. 8. 8. Carlson, D.B. & LaBarba, R.D. " Maternal emotionality during pregnancy and reproductive outcome: A review of the literature. " International Jour- nal of Behavioral Development, 1979, 2, 343-376. 9. For a fuller discussion of the methodological problems regarding the study of Down's syndrome, see Mansfield, P. Re evaluating - the medical risks of late childbearing. Women and Health, forthcoming in the Spring- Summer 1986 issue; also Pregnancy for older women, Praeger publishers, forthcoming in 1986. The British data on congenital malformations are reported in New Society, 13 September 1985, p. 393. 10. National Center for Health Statistics. Factors associated with low bir- thweight (Vital and Health Statistics, Series 21, no. 37). Hyattsville, Maryland: U.S. DHEW Public Health Service, 1980. 11. Daniels & Weingarten, op. cit. 12. Friedman, E.A. & Sachtleben, M.R. " Relation of maternal age to the course of labor. " American Journal of Obstetrics and Gynecology, 1965, 91, 915-924. 13. Shah, F.K. & Abbey, H. Effects of some factors on neonatal and post- neonatal mortality. The Millbank Memorial Fund Quarterly, 1971, 49, 33-57. 14. See, for instance, Weisl, B.A.G. " A five year study of elderly primiparas. " American Journal of Obstetrics and Gynecology, 1968, 101, 244-253; O'Sullivan, J.F. " The elderly primigravida. " Journal of Obstetrics and Gynecology of the British Empire, 1960, 67, 265-270; Friedman & Sachtleben, op. cit. 15. See, for instance, Waters, E. & Wager, H. " Pregnancy and labor ex- periences of elderly primigravidas. " American Journal of Obstetrics and Gynecology, 1950, 59, 296-304; Schmitz, H.E., McGowan, L., & Smith, C.J. " Primiparity after age thirty - five. " Obstetrics and Gynecology, 1958, II, 424-429. 16. Varner, M.W., Daly, K.D., Goplerud, C.P., & Keetel, W.C. " Maternal mortality in a major referral hospital. " American Journal of Obstetrics and Gynecology, 1982, 143, 325-339; Wertz, R.W. & Wertz, D.C. Lying - in: A history of childbirth in America. New York: Schocken Books, 1977. 17. Hack, M., Fanaroff, A., Klaus, M., Mendelawitz, B., & Merkatz, I. " Neonatal respiratory distress following elective delivery: A preventable disease? " American Journal of Obstetrics and Gynecology, 1976, 126, 43-47; Goldenberg, R. & Nelson, K. " Iatrogenic respiratory distress syn- drome. " American Journal of Obstetrics and Gynecology, 1976, 124, 617-620. 18. Spain, K.C. " Childbirth in elderly primiparae. " American Journal of Obstetrics, 1912, 65, 421-428. 19. Tew, C.R. & Kuder, K. " Elderly primiparae: A study of 240 cases. " American Journal of Obstetrics and Gynecology, 1938, 35, 773-381. 20. Randall & Taylor, op cit. 21. Points, op. cit. 22. Daichman, I. " Labor in the elderly primipara. " American Journal of Obstetrics and Gynecology, 1932, 24, 127-132. 23. Kuder, K.K. & Johnson, D.G. " The elderly primipara. " American Jour- nal of Obstetrics and Gynecology, 1944, 21, 165-169. 24. Dodge, E.F. & Brown, W.E. " Effect of age upon obstetric complications in the primigravida. " Southern Medical Journal, 1950, 43, 1060-1066. 25. Guttmacher, A. Pregnancy and birth -A book for expectant parents. New York: The Viking Press, 1957. 26. Calkins, op. cit. 27. Kessler, I., Lancet, M., Borenstein, R., & Steinmetz, A. " The problem of the older primipara. " Obstetrics and Gynecology, 1980, 56, 165-169. 28. MacDonald, I.R. & MacLennan, H.R. " A consideration of the treatment of elderly primigravidae. " Journal of Obstetrics and Gynecology of the British Empire, 1960, 67, 443-450. 29. Eastman, N.J. " The effect of the interval between births on maternal and fetal outlook. " American Journal of Obstetrics and Gynecology, 1944, 47, 415-466. 30. Rothman, S.M. Woman's proper place: A history of changing ideals and practices, 1870 to the present. New York: Basic Books, Inc., 1978. 31. The feminist perspective described here is culled from the following im- portant articles: Davis, K. (1984). Women as patients: A problem for sex differences research. Women's Studies International Forum, 7 4 (), 211-217; Fidell, L. (1980). Sex role stereotypes and the American physician. Psychology of Women Quarterly, 4 (3), 313-330; MacPherson, K.I. (1983). Feminist methods: A new paradigm for nursing research. Advances in Nursing Science, 2 3 (), 3-13 and (1985). Osteoporosis and menopause: A feminist analysis of the social construction of a syndrome. Advances in Nursing Science, 7 4 (), 11-22. A System of Scientific Medicine Philanthropic Foundations in the Flexner Era Howard S. Berliner, Columbia University Foreword by Eli Ginzberg " academic... inquiries do not generally enthrall readers, however much they may educate and enlighten. Dr. Howard Berliner's monograph does all three: it educates, enlightens and in so doing, is utterly fascinating. " from the foreword by Eli Ginzberg Using archival materials, diaries, etc., Howard Berliner documents the role of the great philan- thropic foundations, i.e., Carnegie Foundation, in bringing scientific medicine and medical education centered around research into the forefront in the United States. January 1986 190 pp. 0-422-79520-8 # 9822 $ 29.95 / cloth 0-422-79530-5 # 9829 $ paper 12.95 / Also available from Tavistock... Women Physicians Careers, Status, and Power Judith Lorber " A superb addition to the research on women professionals " -Cynthia Fuchs Epstein 1985 160 pp. 0-422-79050-8 # 9013 $ paper 10.50 / Tavistock 29 WEST 35TH STREET, NEW YORK, NY 10001 Health / PAC Bulletin 21 The Cervical Cap Test Case for U.S. Regulatory Politics by Erica Gollub ThThee constant search for safe and effective alternatives in birth control has resulted in the steadily growing recogni- tion of the cervical cap as an attractive option. While American women who have heard about the cap are impressed by its high level of convenience and the potential for long term - wear without risk, another notable aspect of this method is its very long history of use. In fact, the cervical cap may well be the world's oldest birth control method. However, for those who are active in the women's health movement, the excitement of " rediscovering " this simple rub- ber cap, which holds many advantages over the diaphragm for most users, is being overshadowed by a growing cynicism regarding the regulatory status of the device. For five years, the cervical cap has been stuck in a state of " limbo. " It has not been approved by the U.S. Food and Drug Administration, and still requires considerable administrative work on the part of the provider, since the device is only allowed to be fit under an investigational protocol that includes obtaining special per- mission from the FDA. As awareness grows about the cap and its undecided regulatory fate, so does the chorus of questions concerning the reasons for this lengthy delay. Among the many ironies arising from this situation, is the fact that a simple rubber barrier device is probably undergoing the strictest scrutiny of all contraceptives, including newer and significantly more invasive methods such as the oral contracep- tive and the IUD. This is partly due to the timing of the cap's arrival on the regulatory scene, as we shall see. Perhaps more importantly though, the chief proponents of the cap, a collec- tion of individuals and groups within the women's health move- ment, carry far less political and financial clout than the typical lineup of corporate lobbyists familiar to the FDA. These various factors have worked together to throw some complexity into the question of FDA approval for this device. History of the Cap Researchers have found evidence of the use of cervical caps throughout ancient times, constructed of materials including opium and beeswax, formed out of half lemons - (the lemon juice acted as a spermicide) and, later on, manufactured out of metals such as gold, silver and platinum. 1.2 Some of these Erica Gollub is currently a doctoral student in epidemiology at the Columbia University School of Public Health, and also a counselor at Womancap, a cervical cap investigative site in New York City. She has been involved with several cervical cap investigations, and her research concerns benefit / risk evalua- tions for various contraceptives. firm cervical caps were worn for the entire intermenstrual period and removed by a physician at the time of the menses. 34 The modern flexible cervical cap, constructed of rubber, was perfected in 1823 by a German gynecologist named Adolphe Wilde, who first took a wax impression of the woman's cervix to be fit. Simultaneously, a New York physi- cian, E.B. Fotte, also devised a modern rubber cap! The cap never caught on here as well as it did in Europe, probably due to some degree of confusion about the nature of the device, as well as an apparent lack of a U.S. manufacturer to promote it. The current U.S. supplier, Lamberts, Ltd. of London, has been manufacturing caps for a century, calling them " check pessaries. " Both Marie Stopes and Margaret Sanger were involved in popularizing the cap in the 1920's and ' 30's, when it was also known as the " French pessary. " 1.36 The British Family Planning Association currently lists the cap as an approved birth control method, and it is available in a limited number of other European countries as well. Although Ortho Pharmaceuticals manufactured a firm lucite cap in the United States from the 1920's through the 1940's, the cap's failure as a profitable item at the time prompted its discontinuation. 1.2 In the late 1970's, the women's liberation and women's health movements, and, in particular, health ac- tivist and author Barbara Seaman (Women and the Crisis in Sex Hormones, 1977) brought about revived enthusiasm for the cap; then, increasingly, the fitting of the cervical cap became a part of the training and skills of various women's health clinics and self help - groups. Cervical cap imports began to attract the attention and concern of the FDA, which had not yet formally evaluated the device. Cap shipments from England were periodically confiscated until 1979, when the FDA re- quired that they be labeled " for investigational use only. " Fi- nally, in 1980, the agency classified the cap as a " significant risk " device, placing it in the same category as IUD's and pacemakers, and requiring that from 1981 on, providers have an FDA approved - " Investigational Device Exemption " number (IDE) to fit caps. Forty thousand women and five years later, the agency still has not made a decision. Use and Effectiveness as a Contraceptive Women who use the cap as their primary or only contracep- tive method have found it extremely convenient, compared with all other barrier methods; after insertion onto the cer- vix, no extra effort is necessary to avoid pregnancy throughout wear and in the case of the cap, long term - wear for three or four days is not uncommon. Only a miniscule amount of sper- micide is used, no repeat applications being necessary, since 22 Health / PAC Bulletin the spermicide has been found to retain effectiveness for up to seven days. And while it is true that some veteran cap- wearers have dispensed with using spermicide altogether- the concept of the cervical cap at its best - spermicide use is still advised as a general recommendation. Although the cap is held secure around the cervix by suction, it is not internally felt by the wearer, once inserted. Pressure against the bladder or uretha is rarely reported to be a problem, whereas for some diaphragm users, frequent painful urinary tract infections can often be prohibitive. Finally, for the partner as well, the cap seems to be relatively as comfortable as, or more comfortable than, the diaphragm. Since 1981, there have been only a handful of published studies on the cap, although many cap investigation sites have faithfully been compiling their own unpublished statistics. The Feminist Women's Health Centers, for example, in California, Georgia and other locations, have fit more than 20,000 cer- vical caps including those fit before caps were classified as " in- vestigational. " (Estimates of the total number of cervical caps fit in the United States to date range from the FDA's estimates of 20,000 to Greer's estimates of 40,000 or more.) 6.7 Although studies published before 1981 were conducted on firm cervical caps such as those made of lucite, effectiveness data obtained with firm caps are generally regarded as equally applicable to soft caps. The most notable and often quoted - of these early studies was published in 1953 by Tietze, Lehfeldt and Liebmann. Hans Lehfeldt, an Ob Gyn / specialist with a now limited practice in New York City, has authored many arti- cles and studies on the cap, and qualifies as one of its foremost champions in the United States. Dr. Lehfeldt began fitting caps in Berlin in the 1920's, and continues to do so. Another prominent cervical cap researcher, Dr. James Koch, in Boston, published the largest and most detailed study conducted on the cap, in 1982.8.9 Dr. Koch is currently at work modifying the Vimule cervical cap - a type that has cur- rently been suspended for use by the FDA (see below) - for future testing in the United States. Overall, the safety data on the cap have been reassuring. There have been no long term - health risks associated with leav- ing the cap on the cervix for several days. In addition, there is evidence that abnormal pap smears are found less frequently with cap use and that the cap helps clear up certain adverse cervical conditions such as cervical erosions. The cap has been connected with no infections of any type, although some women do report slight cramps if they forget to remove the device for several days, or wear it for longer than usual. Effectiveness data has placed the cap in a position com- parable to the diaphragm, the rates ranging from 80% to 97% protection against pregnancy. 4.9.10.11 Of course, effectiveness rates with any barrier method depend greatly on how reliably and correctly the method was used. Koch's effectiveness study of more than 400 women found a user failure rate of 4.7% and The Disturbing FDA Delay ae This article on the cervical cap outlines its history as i. a contraceptive device; its safety and efficacy; and re- maceuticals, the cap just isn't worth producing given its long life span, and low profitability. H} cent regulatory developments regarding its approval by the Food and Drug Administration FDA (). That this Finally, if the New Right's latest antics set the tone for Reagan Administration regulatory agencies, the FDA device has not yet been approved by the FDA despite its use for more than 100 years in Europe and its clinical will not be in any hurry to approve safe, affordable and accessible contraception for women. The activities last use here in in more than investigational 40,000i nivnevsetsitgiagtaitoinoanla lt rwioamlesn rfeofrl etchtes ,p awset bfeilviee vyee,a rasn underlying disregard for women's health and fertility on fall of Representative Jack Kemp (NY R /) and Senator Orrin Hatch Utah (R /) to cut Title X funds for family planning centers offering abortion counseling would not the part of the U.S. pharmaceutical industry and the have affected women's access to abortion as much as FDA te women's access to family planning services. With this We find it particularly disturbing that a contraception effort,. these so called - " pro - life " forces showed method such as the sponge was approved after tests on only 1,596 women (Health / Puc Bulletin, Vol. 15, No. 5), while the cap has, for so long, moved no closer to approval. We are disturbed - but not surprised. After all, _ themselves for what they really enemies are - of women's ~ equality. For access to contraception is a key ingredient ~ to women's liberation; when women cannot control their ' fertility, they cannot stay in school, in the workplace or the sponge, an over - the - counter product, is more attrac- make their own choices about childbearing. tive to both the pharmaceutical and the medical com- munities. Practitioners do not have to spend time fitting ~ - We see the fight to gain approval for the cervical cap within the larger context of women's battle for control the sponge or teaching women how to use it. On the other hand the, cervical cap is a " intensive provider -" device, requiring time on the part of providers to fit it and to teach women how to use it properly. (It's not surprising, therefore, that most clinics currently providing the cap are women's women's health centers.) In addition, the cap is of their fertility at a time when this right is under con- - stant threat. Today, approx~ imately 50 mi llion women work outside the home, including approximately 70% of women ages 25-54. These women are not going to leave their jobs to become full time - mothers and housewives. The need for women to control their own _ durable, sturdy and requires little spermicide, the item fertility is now as crucial as ever. And safe, affordable that makes the diaphragm profitable for the drug com- panies. And let's not overlook the fact that each " one- birth control is a necessary ingredient for that control 7 rea. lized. to be. a8 Y' tire - use - only " sponge sells for more than $ 1.00, while -Women's Health Work Group the $ 15.00- $ 20.00 cap can last for years. For the phar- Health / PAC Bulletin 23 Gage Suzan a method failure rate of 3.7%, for a cumulative pregnancy rate of 8.4%. Similarly, Tietze, Lehfeldt and Liebmann in 1953 found a user failure rate of 4.3% and a method failure rate of 3.3% with the hard lucite cap.4 New data from an ongoing study at UCLA describing 21,000 woman months - of experi- ence does not differ significantly from these findings.5 Higher failure rates have been reported with less consistent and less correct usage of the cap. 10.11 Lehfeldt and Sivin, for example, reported a net cumulative pregnancy rate of 15.6%. " But in light of the British experience exceeding 100 years, and the convenience, safety and effectiveness data that weigh so heavily in favor of the cap, what is stalling the cap's approval in the United States? The Politics of Contraceptive Regulation Ever since the FDA ruling that placed the cervical cap in the highest risk category, women's health activists have ob- jected to what is seen as extraordinary restrictiveness with the cap compared with a much greater laxity concerning con- traceptives with the proven potential for risky complications. For example, while federal regulations have severely limited. access to the cap, products like IUD's and oral contraceptives, which carry much greater potential risks but were approved before the current rigorous standards went into effect, are not targeted for a thorough safety review by the agency. It should be noted that the cost of product liability litigation, and not regulatory action, has been responsible for the virtual unavailability of IUD's since early this year. This has created a virtual double standard of safety for contraceptives. Charges have also been made that financial and political pressures to stall progress toward cap approval have been brought to bear on the FDA by contraceptive manufacturers. If approved, the cervical cap could threaten both spermicide and diaphragm sales, as well as some part of the market in non- barrier methods. Compared with the diaphragm, for example, far less spermicide is needed, and fewer replacements of the device, if any. But while the charges of pressure are true, they do not tell the whole story. The FDA is essentially structured to be responsive to commercial initiatives. That is, the agency never 24 Health / PAC Bulletin proposes the approval of any product in the absence of a private sponsor. Moreover, the agency possesses neither the resources nor the jurisdiction to conduct any testing of a new product up for approval; it relies completely on the company data that has been submitted. Unfortunately, as regulatory history has shown, especially in the past few years, this system has several weak links. In fact, for the FDA's Office of Device Evaluation, the historical example of the Dalkon Shield seems to weigh as heavily as some of the more recent product liability cases con- nected with the FDA's Center for Drugs and Biologics. The Dalkon Shield was an IUD that was marketed in 1971 without sufficient research, then subsequently withdrawn after serious health hazards (including death) developed for thousands of the women who used it. More recent cases involve Oraflex, an anti arthritic - drug manufactured by Lilly; and Selacryn, an anti hypertensive - by Smith, Kline and French. Both drugs caused deaths not reported to the FDA in requesting approval for U.S. marketing. The upshot has been an increasingly con- servative disposition toward new product approval. What has gradually evolved, therefore, in relation to cervical cap approval, has been a concerted effort by the FDA to " make an example " of the cap by exercising, through the process of regulatory review, the agency's full power of discretion in the face of increasingly publicized abuses connected with the agen- cy. Both to protect its own reputation and to suggest better pro- tection for the American consumer, the FDA is demonstrating its ability to hold up a product indefinitely at the pre approval - level, through the meticulous application of rules that the FDA typically finds burdensome and rarely applies to the letter. The FDA defends this posture toward the cervical cap by alluding to the " lessons of the Dalkon Shield, " although the shield was approved before standards of animal and human experimen- tal trials for new products were well elaborated; moreover, it is a device placed inside the uterus making it considerably more invasive than the cap. There are several ways in which the FDA's disposition is being enforced. One we have already seen is the requirement of an endless supply of data; pooling investigational sites na- tionwide, the number of " woman - years " of experience with the cap now reaches into the hundreds of thousands. 12 Another important component in this strategy has been the decision to approve cervical caps on a one - by - one basis. Cur- rently, for example, three kinds of caps are available through the British manufacturer, each with a 100 year - marketing history. The caps are identical in their mechanism of action and nearly identical in composition (harder and softer varieties of rubber are used) but they vary in shape and size distribu- tions and are thus able to accommodate some of the great diver- sity in women's internal anatomy. The FDA has decided that each variety will require an independent investigational history and application before it can be approved, in contrast with the model of the combination oral contraceptive, for example, where approval for the first high dose - combination ensured ready approval of different combinations thereafter. Banning the Vimule Cap The recent decision to ban one of the three available caps provides yet another illustration of the current FDA agenda. Briefly summarized, a dispute arose in 1984 between the FDA and segments of the women's health community as to the ad- visability of the continued fitting of the Vimule cap, after the discovery of a " nicking " or " grooving " effect from its raw rub- ber edge on the vaginal or cervical tissue of 10% of the sampled users. (It is the only cap of the three types on which the edge is not smoothed down by the manufacturer.) This effect seemed to bear a relationship to the length of time the cap was worn, although the association was neither proven nor disproven, since the Vimule was prohibited by the FDA shortly after the effects were noted. A number of women's health groups, consumer activists and medical professionals rallied to try to make the Vimule cap available to women under altered conditions of use. Shortly before the FDA's hearings on this matter, however, a comment from the National Institute for Child Health and Human Devel- opment (NICHD) seemed to clarify the real issue at hand. A prominent staff member (who did not wish to be identified) of the Contraceptive Development Research branch office of the Center for Population Research at NICHD stated frankly that it was a common belief in NIH FDA - circles that the FDA would insist on the banning of the Vimule cap in exchange for later approval of the more commonly fit Prentif cap, as a demonstration that the agency did not intend to persist in its " lenient " attitude toward the cap. 12 These remarks cast the hearings as more of a show of power than an honest dialogue on risks and benefits. And so far, no cap has been approved. Animal Tests Finally, in what promises to be the most extreme example of the FDA's posturing, the agency has recently decided to re- quire animal tests for the cervical cap before any regulatory decision is made. This new development has sparked both alarm and anger in the women's health community, since animal studies are normally demanded prior to the initiation of human studies with a new device, and normally serve to in- sure the safety of the anticipated human studies. Considering the available human evidence on the cap, the only possible ex- planation for this new requirement is the misdirected wish of the FDA to somehow " complete the necessary records " on the device. The move, both literally and symbolically, represents a real step backward. Compared to the sponge, then, the cervical cap is found lacking in some of the critical elements for unobstructed ap- proval by the FDA. It does not have access to the lobbying efforts of a major drug house that might have altered the FDA's original classification of the cap as a high - risk device. If, for example, the cap had been reclassified under Class II at an early stage, its sponsors (women's health groups) would have been required only to pro- vide written " performance standards " for the device in order to market it. 15 Interestingly, the cap is classified as a Class II device when used for collecting menstrual fluid and in artificial insemination. The justification for this undoubtedly involves the comparatively higher " risk " of pregnancy in the benefit / risk assessment. Neither has the cap been fortunate enough to come by $ 5 million in backing from private investors, the sum Vorhauer received in venture capital and other contributions, 13 in addi- tion to the $ 2 million provided by the Agency for International Development for clinical testing purposes. 14 Finally, the cap constituency has not had the privilege, as Vorhauer did, of paying consultants who are both influential at the government level and who have a clear stake in the ap- proval of the device due to other affiliations, to sit on a " scien- tific " advisory board making recommendations to the FDA. 16 It seems clear that the cap has simply not traveled in the " right " circles. The Cap in the Context of Women's Health and Contraceptive Options What are the implications of these regulatory politics on the cap's accessibility and on its role in women's reproductive health care? Of immediate concern, of course, is the problem of limited access as long as the cap is not approved. Not only do women often not know how to find the cap (there are only about 100 investigational sites nationwide), but they are sometimes not able to find a cap that fits well. Between 10% and 30% of The Cap vs. the Contraceptive Sponge If it could be demonstrated that the FDA was " cracking down " in a universal way, and that other new drugs and devices were similarly being subjected to stepped - up standards in order to pass approval, this analysis would end here. Approval in 1983 of the contraceptive cervical sponge (Today "" sponge) however, clearly pointed up the other critical issue tied to the regulatory inertia of the cervical cap; the lack of a corporate sponsor. While corporate interest in the cap is still very much a future event, based on FDA approval, the " Today " contraceptive sponge was introduced rather directly by a financially fit and well connected - corporate structure, allowing the sponge to sail through the approval procedures once the minimum amount of human testing had been accomplished. (See Health / PAC Bulletin Vol. 15, No. 5.) Bruce Vorhauer, creator of the sponge and of its marketing outfit, VLI Corporation, had complained loudly to the press about the " long delay " between conception and marketing. 13 However, his brainchild was maneuvered efficiently through the approval process after completion of adequate studies on only tenth one - the number of women he claims as his study population. The speedy approval of the sponge had been virtually guaranteed after intervention on behalf of Searle Pharmaceutical Company led to the reclassification of the sponge as a drug, 14 thereby avoiding FDA review. Fallopian Tube { Ovary Uterus Cervix Cervical Cap Health / PAC Bulletin 25 women seeking to try this contraceptive method cannot ob- tain a secure fit, due to limitations in sizes and shapes. While the diaphragm comes in 10 different sizes, the most commonly fit cap, the Prentif, is made in only four. Therefore, given the demand for the cap, it is likely that some women are fit using criteria that are liberal enough to allow for occasional dislodge- ment of the cap from the cervix. In fact, dislodgement and / or unintended pregnancy are the reasons women give most often for leaving this method in search of an alternative. 7.9.10 But dislodgement due to an imperfect fit will continue to be an in- direct outcome of the cap's non approved - status unless variety in caps is somehow disconnected from the issue of regulation. Just as experimentation with different dosages and types of estrogens and progestins has attempted to " tailor " the pill to diverse sets of women's physiological needs and tolerances, design innovation with the cervical cap is much needed to re- spond to the structural diversity of women. The cervical cap, even more than the diaphragm, requires a careful, considered fit; slight differences in the size or shape of a woman's cervix can mean the difference between a " good " fit and a recommen- dation against its use. In this way, the data available now reflect only the qualities of the few, and very old, cervical cap alter- natives we have available for testing. We will not be able to truly assess the impact of the cervical cap as a contraceptive method until much more of its potential has been realized in manufacturing. The chicken - and - egg aspect of this situation is that FDA approval would be the single most influential oc- currence to spur product innovation. For although caps will be scrutinized on a one - by - one basis, the demonstrated profit- ability of the first cap approved will stimulate commercial in- terest in design innovation for future models. Corporate priorities for contraceptive research and development being what they are, this simple, inexpensive contraceptive will most likely just continue in its slow trudge toward FDA approval. Considering the long term -, important work is needed to en- sure a steady and reliable future for the cap. Continued ad- vocacy for access to safe and effective birth control will be critical in the face of an increasingly hostile Administration. In addition, preparing for cap approval will require large - scale education campaigns for the professional community whose responsibility it will probably be to prescribe and fit the cap successfully. Networking between the women's health com- munity and the community of Ob Gyn / practitioners, who generally have little - to - no experience with this method, is essential now. The risk for uninformed and careless cap fit- ting is unfortunately relatively high, since the device requires a new set of skills, both for the practitioner and the user, beyond those needed with the diaphragm. Another important goal of this networking will be to dispel the many continuing myths surrounding the cervical cap- for example, that it causes infertility, ectopic pregnancy, cer- vical erosion and / or dysplasia; or that it must be surgically im- planted or removed. That the threat to reproductive rights in this country will con- tinue under the Reagan Administration appears assured. Con- nected with the fundamental struggle to meet this threat are broad questions concerning the regulation of contraceptives, and, specifically, the approval process for the cervical cap. The case of the cervical cap illustrates that we need to rebuild our regulatory system to ensure both care and vigilance in con- trolling medical or health related - products, and critical respon- siveness in areas where human health need is greatest. We need to incorporate safeguards into this system against profit becom- ing the sole criterion for medical and health related - research. And finally, we need to protect against the purely political uses of our regulatory apparatus in highly controversial areas such as birth control. These issues will be important ones to grap- ple with in the years just ahead. 5 Author's note: Since the writing of this article, notable progress has been made toward attaining cap approval. Results of the official NIH funded - study at UCLA are ex- pected soon. In general, the study has found the cap to be as effective as the diaphragm, with women preferring the cap over the diaphragm. The drawbacks to the cap, as uncovered by the study, include those historically associated with this method, and are not serious: possible dislodgment, occasional partner sensitivi- ty, and occasional odor on long term - wearing for some users. The FDA is still holding out for animal studies; however, the British manufacturer has agreed to have them conducted, and they should not exceed six months in duration. Pending the suc- cessful completion of these studies, the path is apparently now clear for cap approval sometime within the next year. VAINCRE 01 MOURIR 1. Liz King, The Cervical Cap Handbook for Users and Fitters. (unpub- lished), Emma Goldman Clinic for Women, Iowa City, Iowa, 1981. 2. Barbara Seaman and Gideon Seaman, M.D. Women and the Crisis in Sex Hormones. Bantam Books, Inc. New York, 1977. Chapter Fourteen. 3. Mary S. Calderone, M.D. Manual of Family Practice and Contraception. Second Edition. Williams and Wilkins Co., Baltimore, 1970. Chapter by Hans Lehfeldt, M.D.: 368-385. 4. C. Tietze, H. Lehfeldt and H.G. Liebmann, The " Effectiveness of the Cer- vical Cap as a Contraceptive Method. " American Journal of Obstetrics and Gynecology 66, no. 4 (October 1953): 904-908. 5. G.A. Richwald, L.H. Kersey, T.A. Calabro, S. Greenland, R. Potik, M.A. Comas. " The Los Angeles Cervical Cap Study: Effectivenss and Safety of the Cavity - Rim Cervical Cap in 1852 Users " Paper presented at the American Public Health Association 113th Annual Meeting, Washington, DC, 20 November 1985. 6. Germaine Greer, Sex and Destiny: The Politics of Human Fertility. Harper and Row, Publishers, New York, 1984: Chapter Six. 7. Food and Drug Administration (Lillian Yin, Ph.D.) Regulatory Hearing on the Order of Withdrawing the IDE (Vimule), Sept. 13, 1984: Vol. 1. 8. James P. Koch, M.D. " The Prentif Contraceptive Cervical Cap: Accep- tability Aspects and Their Implications for Future Cap Design. " Contracep- tion 25, no. 2 (Feb 1982): 161-173. 9. J.P. Koch, M.D. " The Prentif Contraceptive Cervical Cap: A Contem- porary Study of Its Clinical Safety and Effectiveness. " Contraception 25, no. 2 (Feb 1982): 135-159. 10. Erica Gollub, MPH. " Use of the Cervical Cap Among a Clinic Popula- tion: Aspects of Acceptability and Effectiveness. " (1984, unpublished) 11. H. Lehfeldt and I. Sivin, " Effectiveness Use - of the Prentif Cervical Cap in Private Practice: A Prospective Study. " Contraception 30, no. 4 (Oct 1984): 331-338. 12. Personal communication, 8/10/84. 13. New York Times 4/6/83: 01. 14. Diane St. Clair. " Gyn Game: the FDA and the Contraceptive Sponge. " Health PAC Bulletin Vol. 15, Number 5. 15. Federal Food, Drug and Cosmetic Act, 1976 Amendment. 16. Gwenda Blair, Mop'n'Glow ", " Village Voice, May 1, 1984, p. 1. 26 Health / PAC Bulletin Body English Screening for Better Health by Arthur A. Levin Much of the criticism of modern med- icine has focused on its obsession with curative intervention to the exclusion of health maintenance and disease preven- tion. During the 1950's and 1960's, how- ever, medicine began to promote annual comprehensive physical exams for healthy adults as an example of high quality, responsible primary care. Should Screening Be'Routine '? As more sophisticated technology became available, automated multiphasic screening loomed as the darling of those anxious to reduce ever increasing death rates from the major degenerative di- seases. The reasoning was that if disease was caught early, before symptoms de- veloped, interventions available to medicine could produce positive results. It was noted by proponents of prevention that medicine did not appear able to pro- vide much benefit for those already symptomatically ill with heart disease, cancer, or respiratory illness; in short, the chronic diseases that caused the ma- jority of deaths. Guidelines Suggested Automation made it possible to con- sider screening the entire population on a periodic basis. By the early 1970's, so- called multiphasic screening appeared to be a growing industry. Fortunately, some observers questioned the wisdom of this approach. In the mid 1970's, a number of experts wrote articles that critiqued non- specific screening of people without symptoms. At the very least there was agreement about the following: 1. Specific criteria needed to be developed and met before screening for a disease was justified. 2. The concept of a rationalized lifetime approach to screening was needed. 3. Screening procedures should be sex, age and demographically specific to maximize yield and minimize cost. 4. The health benefits of intervention should outweigh the risks. In 1975, Drs. Frame and Carlson wrote the first critical review of the evidence supporting screening for disease in asymptomatic, healthy people (Journal of Family Practice, 1975). In 1979, the Canadian Task Force on the Periodic Health Examination Canadian ( Medical Association Journal, 1979) published a report of recommended screening pro- grams that included analysis of the qual- ity of scientific support. Other organiza- tions, including the American Cancer Society have issued guidelines, and the U.S. Department of Health and Human Services is planning to publish its own health maintenance recommendations. Medical specialty groups have also pro- moted screening guidelines, although they are sometimes at odds with those of other groups. The development of a rational, selec- tive, lifetime health maintenance pro- gram did not eliminate all of the controversy. There are those who con- tinue to find the potential of greater harm than benefit in some routine screening procedures including annual pap tests and mammography. In future columns, we will review what currently is known about the most common routine screening procedures and what debates are going on. However, since this issue is devoted to women's health, it would seem appropriate to alert readers to a recent article about amniocentesis. The Risks of Amniocentesis Amniocentesis is a screening proce- dure now routinely offered to women at risk of having a child with chromosomal abnormality, neural tube defect or meta- bolic disease. The most common indica- tion for screening, by far, is advanced maternal age. However, a recent journal article from researchers in Denmark (The Lancet, 7 June 1986) points out that growing numbers of young women with- out any known genetic risks are re- questing the procedure. In order to determine the risks of this trend the researchers organized a ran- domized controlled trial to follow the pregnancy outcome of 4,606 low risk - women, ages 25-34 years. The study group had amniocentesis performed. The control group did not have amnio- centesis, but the majority of controls did have ultrasound. Results showed that women having amniocentesis were 2.3 times as likely to have a spontaneous abortion as those that did not. These results differed from three earlier studies in the U.S. and Canada, none of which found this rela- tionship, but confirmed results of a U.K. study that did. In addition, the Danish researchers also found that neonatal respiratory distress syndrome and diagnosis of pneumonia in newborns occurred more frequently when the mother had had am- niocentesis. This replicated the observa- tions of two prior studies. If amniocentesis is a growing trend for young mothers at low risk, then the criteria for evaluating screening pro- cedures outlined previously are not being followed. It is difficult to justify such screening on medical grounds, since benefit is almost nil, but risk is not. Whether the demand for these proce- dures are the result of the technological imperatives created by everyone's desire for a perfect baby is not clear. What is clear is that the dangers of unnecessary use of amniocentesis should be well publicized. O Arthur A. Levin is a member of the Health / PAC Board and Director of the Center for Medical Consumers, pub- lishers of the newsletter Healthfacts. The Center maintains a free medical library for the public at 237 Thompson Street (between West 3rd and West 4th) in New York City. For further information call (212) 674-7105. Health / PAC Bulletin 27 Media Scan The New Our Bodies, Ourselves by the Boston Women's Health Collective, New York: Simon & Schuster, 1984. by Diane St. Clair All books are a reflection of their authors, but very seldom does a reviewer feel an obligation to give both parties equal space. In this case, however, the stories of the book and of the collective authors are intertwined and, indeed, worthy of telling. Just as each edition of Our Bodies, Ourselves has used women's voices and experiences as vital conveyors of health information, so too has the Boston Women's Collective used its continued experience of activism to supply the ongoing context for its books. The Collective has incorporated the principle that women's experiences serve as an important source of information -- a source which " experts " often overlook or deny - into its very structure. For more than ten years the group has retained its collective structure, weathering divorces and attacks from the Moral Majority and celebrating births, weddings, and a best- selling book (the original Our Bodies, Ourselves sold close to three million copies in 12 languages; its royalties finance the Collective's annual budget of more than $ 100,000). The distance the group has travelled is reflected in the new Our Bodies, Ourselves, as well as in the many and varied projects its members are involved in. According to the Collective, this new edition is the work of 90 women, and their efforts are evident in its expanded size and horizons. Although the funda- mental message is the same as in the original - that women have a right to be active, informed participants in their own health care - the scope of this mes- sage is broader, embracing women from more varied backgrounds and more diverse concerns. In this edition, for instance, we hear from prostitutes, les- bians, and the disabled; the older, the fat, and minorities - " voices of women previ- ously unheard, " according to Collective member Norma Swenson. The authors take us on some new paths and ask us to open ourselves to new issues - and admit that there may be no clear - cut correct responses to some of the more difficult among them, such as pornography. The Collective devotes entire chapters to these added areas: * Body image observes that " Women who don't'fit'the ideal image experi- ence painfully negative judgements... which make it hard for nearly every woman in our society to love and ac- cept herself as she is. " * Alcohol, Mood Altering Drugs, and Smoking includes advice on how to get help. * Alternative Medical Care covers biofeedback, visualization, acupunc- ture, and more. * Psychotherapy warns that " Women must approach psychotherapy with caution. " * Environmental and Occupational Health includes tables on the effects of environmental hazards on body sys- tems and common dangers in women's occupations, as well as suggestions on how to organize around these issues. * Violence Against Women discusses rape, battering, sexual harassment, in- cest, and self defense - . * New Reproductive Technologies covers subjects such as donor insemination, surrogate motherhood, and in vitro fertilization. * Women Growing Older comments, " Because older women's concerns are so often overlooked, even in feminist books, it is important to begin. " * Developing an International Aware- ness cites an Asian woman's observa- tion that " American and European feminists, by being uninformed about their sisters in other countries, con- tribute unwittingly to their exploita- tion. " In addition, many of the original chap- ters have been revised to include new health information. The birth control chapter, for example, lists barrier methods as the option of choice, while previous editions put the pill and the IUD first. Cervical caps now receive favorable mention; Depo Provera - and other injectibles are discussed and the abuse of informed consent that can ac- company their use is criticized. Most impressive to me in this edition is a section in the chapter " The Politics of Women and Medical Care " entitled " Myths and Facts. " Here the authors directly challenge and refute five major myths of contemporary medicine which many of us, consciously or uncon- sciously, have come to accept: * American medical care is the best in the world. * Medical care has been responsible for the major improvements in world health. * Medicine is a science. * Medical treatments in current use have proven safe and effective. * Medical care keeps us healthy. Once these misconceptions have been exposed, " health " and " health care " take on new meanings - beyond drugs, technology, and " science " to the broader context in which we live. Again, the tendency to define public health issues in the narrow parameters set by " experts " is directly challenged, as a section on inter- national awareness demonstrates: " Many people see overpopulation as the world's priority issue, believe it causes mass starvation, social disruption, violence and poverty. On the contrary, we believe that it is not overpopulation, but the in- equitable distribution of the world's resources that has led to a cycle of pov- erty and misery for many... the U.S. consumes 1/3 of the world's resources to support six percent of the world's popu- lation. While large populations can put a strain on natural resources, so can high consumption lifestyles. " There is no doubt that The New Our Bodies, Ourselves will be an indispen- sable resource to admirers of the original as well as to younger generations of women. O Diane St. Clair is a member of Health / PAC's Women's Health Work Group. Rueff 28 Health / PAC Bulletin DOUBLE EXPOSURE WOMEN'S HEALTH HAZARDS 4 ON THE JOB AND AT HOME A edited by Wendy Chaykin, M.D. Preface by Eula Bingham + I + S. T DOUBLE EXPOSURE Women's Health Hazards on the Job and at Home edited by Wendy Chavkin Winner of the 1984 American Health Book Award " Double Exposure shatters any remaining assumptions that wom- en's health and workplace hazards are separate issues.... These essays are rich in research, statis- tics, law and critical analysis. The book is scholarly, well edited, yet passionate in its call for concern and informed action. It should be read by managers, policymakers, union leaders, feminists, health activists, and everyone who cares. " -New Directions for Women " Double Exposure's scope is both comprehensive and pre- cise.... With its expert compilation of technical data, Double Expo- sure remains as readable as it is erudite, because Chavkin and her authors consistently highlight the necessity of informed activism. " - - Miriam Frank, In These Times $ 10.00 PB633X (paper) Please add $ 1.50 for the first book, and 25 for each additional book, when ordering by mail. To pay with MasterCard or VISA, designate which card, card number, and expiration date. At your bookstore or directly from MONTHLY REVIEW PRESS 155 W. 23rd St., NY, NY 10011 212-691-2555 Test Tube - Women. Edited by Rita Arditti, Renate Dullea Klein and Shelley Min- den. Pandora Press. London, Boston, Melbourne and Henley, 1984. The Mother Machine by Gena Correa. Harper and Row, New York, 1985. by Tina Dobsevage These two volumes are important reading for anyone concerned with reproductive technology and its impact on our society. Test Tube - Women is a col- lection of 33 essays written by con- tributors from England, Germany, Australia, New Zealand, India and the United States. All are feminist activists from a variety of backgrounds: biologi- cal sciences, midwifery, journalism, the social sciences. The essays explore the meaning of the new reproductive tech- nologies for a woman's decision to have a child or to remain child - free. The Mother Machine is an excellent piece of reportage that outlines the historical development of the new technologies, and then explores their implications for the future of women. The new technologies examined are artificial insemination (AI) (actually not so new, the first reported success occur- ring in 1790), prenatal diagnosis (prin- cipally amniocentesis), and in vitro fertilization (IVF). In The Mother Machine Ms. Correa also points out how the technology developed for IVF may lead to new forms of prenatal diagnosis such as genetic analysis of embryos prior to implantation. Both works briefly dis- cuss prenatal therapy of the fetus with genetic disease, and the research on cloning of mammals. The control of reproduction - that is, conception, pregnancy and birth- through the use of these new technolo- gies might seem, at first, a boon to womankind. Now, women who were for- merly " barren " can conceive, using the sperm of their choice (or is it their choice?) via artificial insemination. There is the opportunity to diagnose genetic disease antenatally and abort a " defective " fetus, provided, of course, that abortion remains a woman's right. There is also the possibility of having biologic children without the bother of pregnancy through the use of IVF tech- niques and surrogate mothers. However, as both books document, these technolo- gies are developed and promoted by men -with women as the targets or objects of reproductive manipulation. And thus they have the potential of enabling men to enslave women. Reading Test Tube - Women and The Mother Machine was a shocking experi- ence, because they present important in- formation which, while not secret, is not widely known. The Mother Machine carefully docu- ments the development of artificial in- semination and IVF, and the techniques of embryo transfer in the cattle industry; then, the application of these techniques to women. We learn of the strong influ- ence of the eugenics movement and how many of the men working in the cattle in- dustry are the same men involved in the development of AI and IVF in women. What is horrifying - and what was so difficult to confront in this book - is not the information about the technology, but the carefully researched and powerful analysis that shows to what extent women have been and could be exploited and oppressed. Test Tube - Women covers many of the same issues raised in The Mother Machine. In addition, it includes essays on disability and motherhood, lesbian mothers, and male sex selection in India. In both books, technical terms are ex- plained well. Test Tube - Women includes a glossary, and The Mother Machine contains a chronology of the develop- ment of IVF beginning in the late 19th century. Both books end on a note of " realistic optimism, " meaning that there exists the possibility of changing the direction of these new technologies. " By clearly articulating the values we want to uphold, and by demonstrating how the technologies impair the well being - of women, " says Correa, we can make them an issue of public concern. Then, once a public concern exists, the possibility of regulation and control emerges. OO Tina Dobsevage, MD, is an internist at the Columbia Presbyterian - Health Ser- vice, an officer of the United Salaried Physicians and Dentists, and a former member of the Health / PAC Board. Health / PAC Bulletin 29 Know News The Women's Health Movement- Lessons for Health Educators by Nick Freudenberg As the women's health movement ap- proaches its 20th anniversary, it is ap- propriate for health educators and other public health professionals to assess what we can learn from these two dec- ades of experience. Few other recent social movements have addressed ques- tions of health and medical care so directly, and few have contributed a prac- tice so relevant to changing health beliefs, health practices and health care institutions. Consciousness Raising One of the most powerful techniques that feminists used to organize women to their cause was the consciousness- raising group. In CR groups, women would share their personal experiences of oppression - around childbirth, sex- uality, sexual violence and other issues. Out of these collective examinations, an understanding of the social and political roots of oppression would often emerge. Individual women realized that their own situation was not unique and that the per- sonal was in fact political. Unlike therapy groups, CR groups made no distinction between healer and patient. Many women found that the sup- port provided by other members of the group gave them the strength needed to confront, for the first time, the causes of their oppression. As a result, many women changed relationships, con- fronted paternalistic doctors, or ex- perienced their sexuality differently. Health Education As a Right The women's health movement also in- sisted on women's right to be educated about their bodies and their health. They followed in the footsteps of Emma Gold- man and Margaret Sanger, who 40 years earlier had argued that accurate and complete information on sexuality and reproduction was a prerequisite for women's liberation. Whether writing a book such as Our Bodies, Ourselves, a volume which has educated a whole generation of women on health and sex- uality, or demonstrating for sterilization guidelines mandating that women must know in detail about that procedure prior to signing a consent form, feminist health activists fought to make health education a fundamental right. Creating Alternatives The women's health movement has also made important contributions in health care delivery. Sidestepping the traditional conflict over whether to con- centrate on transforming mainstream medicine or providing alternative care, some feminist groups did one and some the other. They organized and educated about sexist practitioners, unnecessary sterilizations, hysterectomies and breast cancer surgery, degrading and invasive birthing practices, and dangerous drugs. But they also established feminist clinics, birth centers, battered women's shelters and rape crisis intervention centers. Tens of thousands of women us- ed these new facilities and learned about a different kind of care. By empowering patients and by economic competition, these alternative institutions pushed the established system to change. In the final analysis, the totality of the feminist contribution to public health practice is greater than the sums of its in- dividual parts. Consciousness raising, health education as a right, alternative institutions and a critique of the system are more than separate elements of the women's health movement. Together they combine to offer a vision of a dif- ferent social order where - women and men are equal, where health care and health education are rights, and where making health is a collaborative effort in- volving the individual, society and health care workers. Relevance for Educators What is the relevance of this vision to health educators? First, it provides a way to communi- cate to people the relationships among our different concerns. To stop smoking, clean up the environment or engage in family planning are in themselves impor- tant goals, but our ultimate concern is to help people live healthier, more satisfy- ing and freer lives. Second, this vision helps to resolve one of the central dilemmas health educators face. Some insist that our task is to change individual behavior. Critics reply that too often this approach blames the victims of broader social forces; they argue that health educators must organ- ize to challenge health damaging - institu- tions. The women's health movement provides a rationale for doing both. When women learn to change indivi- dual behavior (e.g. asking their doctors more questions, doing breast self exami- - nation regularly, treating vaginal infec- tions on their own) they do so both to improve their health and to win more autonomy, to be more in control, to be an active participant rather than an ob- ject. And when women organize to safe- guard access to legal abortions, to remove a dangerous intrauterine device from the market or to prevent involun- tary sterilizations, they do so to enable women to make individual choices free of constraint from external forces. This unity and consistency is possible because the women's movement has a vision of the individual and the collective where one can support the other. Finally, the feminists'use of vision demonstrates to health educators how we can tap the deeper concerns of the Amer- ican people. As health care is privatized and health promotion packaged as a commodity, health educators will have to make hard choices as to where we seek our identity. Will the Hospital Corpora- tion of America, General Foods and Equitable Life define the practice of health education? Or will it be the quest of ordinary people for better living con- ditions, healthier communities and de- cent health care? What the women's health movement has demonstrated in the last two decades is that a critical analysis of people's everyday experiences can engender the energy, power and commitment to change behavior, attitudes and institu- tions. O Nick Freudenberg is Director of the Pro- gram in Community Health Education at the Hunter College School of Health Sciences, City University of New York. 30 Health / PAC Bulletin Peer Review continued from page 2 Y' In response, many insurers are either dropping their malpractice coverage or drastically increasing their premiums - and as a result, some obste- tricians have been forced to leave their practice and essentially to abandon their patients. Less well publicized - is the fact that this same crisis is having an even greater impact on certified nurse midwives - (CNM's), and is thus threatening to eliminate low cost -, low risk - birth alternatives. With respect to insurance coverage, all providers of maternity care have been treated the same, without regard for ac- tual practice conditions or experience. This means that certified nurse - mid- wives and birth centers, for example, are being judged in the same way as obstetri- cians and hospitals, who have a much higher risk and greater percentage of lawsuits. Statistics show that only 6 per- cent of all nurse midwives - have ever been sued, in contrast to 73 percent of obstetricians. Because nurse midwives - are not in the same economic league as physicians, we are now suffering in two ways - f- irst, from the difficulty in obtaining any coverage at all; second, from the exag- gerated premiums for whatever is available. We are facing both a crisis of availability and a crisis of cost. In July of last year, the insurance com- pany for the American College of Nurse- Midwives (ACNM) did not renew the coverage held by that professional organization for its members, a move af- fecting about one half - of the nearly 3000 nurse midwives - now practicing in the country (generally, those not practicing in hospitals and therefore not included in their hospital's coverage). In its quest for new coverage, the organization was turned down by 17 companies before it was given temporary coverage, set to ex- pire this fall, by the American Nurses ' Association. Coverage for the Maternity Center Association's Childbearing Center, in- cluding its staff, has been provided for eight of the ten years of the CbC's ex- istence by the Medical Malpractice In- surance Association MMIA () . This is an agency mandated and regulated by the State to cover any physician or health facility licensed under Article 25 that cannot otherwise get coverage. When the ACNM lost its national policy, New York State CNM's per- suaded the state legislature to mandate MMIA coverage for them as well. MMIA's response, however, was to pro- pose a premium of $ 72,300 for CNM's functioning without a physician present for birth - a rate two and half one - times the gross earnings of a CNM and sub- stantially higher than the $ 52,809 pre- mium for obstetricians then in effect! Premiums for individual CNM's under the ACNM policy had been $ 850, and the MCA Childbearing Center has been paying (and still pays, until the Insurance Department accepts a new rate) under $ 1000 for all of its midwifery staff, a total of five and half one - CNM's, based on the number of hours worked. The proposed new MMIA rate would represent for MCA - even with a supplementary rate filing of 85% -a -a 43,000 percent increase in premium to $ 430,000! Although it would be easy to blame the insurance companies for this situation, it is actually a complicated drama with many players. There are providers of care who need to be more patient- oriented; consumers who should be dis- couraged from using litigation as a first means of redressing problems, especi- ally communication problems; insurors who need to be more sensitive to their in- escapable social role; and lawyers who need to consider the enormous economic impact malpractice suits have on health. care as a whole. One beacon of hope in this crisis is a bill currently before the U.S. Congress to amend the Risk Retention Act of 1981, effectively allowing nurse midwives - to self insure - by establishing their own mutual insurance company operating in all fifty states. Of course, MCA is work- ing closely with the National Association of Childbearing Centers and the Ameri- can College of Nurse Midwives - for the passage of this legislation. Birth centers and midwives nurse - of- fer a low cost -, low risk - alternative for patients seeking maternity care. If that choice is eliminated, it is not just those patients who will lose out, but the health care system as a whole. CO Ruth Watson Lubic, General Director Maternity Center Association 48 East 92nd Street New York, N.Y. 10128 July 1986 WO>>>>>>>>>>>>>> bs >>>, A A a a Know A A Your aA A Body A Series for Women A aA a COOOL A A A A iA Gynecological The aAaA GyCnecholeogiccakl Guynpeco logical aA a Revised & Newly Fully Illustrated " Written in clear, everyday language... a valuable self help - " tool for women. " -Barbara Ehrenreich author & women's health activist Each pamphlet gives detailed infor- mation on common health prob. lems and concernsL Y' self care - techniques Y' when to contact a health - care provider Y' your rights as a health - care consumer Y' knowing what's normal for you. * For 1 booklet send sell addressed stamped envelope. lor 2 add 50 orders over $ to 2 $ 5 add 75 orders over $ 5 and $ 1 What Can One Woman Do? (a review of patients nights) Quantity Price Total = $ 50 The Gynecological Checkup 100 $ Infections of the Vagina $ 100 _ Health Story 100 $ (your personal health record) First Trimester Abortion 100 $ Second Trimester Abortion - $ 100 Menopause Breast Cancer Facts A Woman Needs to Know Complete Set of 8 Booklets ADD Postage & Handling " TOTAL AMOUNT - - $ 100 $ 100 6.00 $ = __ a S Please send orders to Health / PAC. 17 Murray Street. New York. N. Y. 10007 Name Address City State Zip Health / PAC Bulletin 31 Bulletin Board Women and Cancer Five reports from a daylong conference on " Women and Cancer, " which was held last fall in New York City are now available for purchase. The conference, which was sponsored by the Center for Medical Consumers and the National Women's Health Network, was attended by more than 375 people, predominantly women. The conference reports, which summarize both lec- tures and workshops on a given topic, cover the follow- ing: Breast Cancer, $ 12; Food and Cancer, Reproductive Cancer, and Medical Practices That Could Cause Cancer, $ 8 each; Living With Cancer, $ 6. The reports can be obtained by sending a check or money order to the Center for Medical Consumers, 237 Thompson Street, New York, NY 10012. Conference on IRB's Public Responsibility in Medicine and Research (PRIM & R), a non profit - organization whose central focus is addressing bioethical issues in biomedical and behavioral research, will sponsor a conference this fall entitled What's " New and Different With Institutional Review Boards? " The meeting will be held on September 29 and 30 at the Park Plaza Hotel in Boston. Topics in- clude panel discussions on " Informed Consent: Sword, Shield or Sham? " " AIDS Research and IRB's, " " In- vestigator / Sponsor Relationships, " and " What is the Role for IRB's in the Allocation of Scare Resources Interleukin II and Beyond. " The panels will be followed by workshops on a variety of issues including privacy and confidentiality, fetal research, the use of tissues and biologics, placebos and clinical trials, and the IRB's role in modifying study design. For further information con- *.: tact PRIM & R at 132 Boylston Street, B or call 617-423-4112 or 617-423-1099. os to n, M A 02 11 6, a - A Different Kind of Tour The People's Medical Society has published an unusual 224 page - volume entitled Take This Book to the Hospital With You. Written in the upbeat style of a travel guide, the soft cover book is intended to an be aid to negotiating the sometimes unfamiliar language and customs of hospital territory. The authors tell you not only how to plan for your trip, but what to expect when you get there, and when you're ready to leave. They give you tips on how to spot billing errors, decipher medical abbreviations, fight for your rights and more. The cost for the guide is $ 9.95 plus $ 2.00 for shipping, and it can be obtained by sending a check or money order to Peo- pElmem'asu sM,e dPicAa l1 8S0o4c9i.e ty, Box WH, 14 East Minor Street, Y' Health / PAC Health Policy Advisory Center 17 Murray Street New York, New York 10007 2nd Class Postage Paid at New York, N.Y. NOTE TO SUBSCRIBERS: If your mailing label says 8511, your subscription expires with this issue.