{"paper_id":"10f6c9a9-aed9-4fac-b655-afe0f1adb46f","body_text":"Caroline de Costa\nThe Abortion Pill\n\nFirst published in 2007  by Boolarong Press\nCopyright      ©      Caroline de Costa\nThis book is copyright. Apart from any fair dealing for the purpose of private \nstudy, research, criticism or review, as permitted under the Copyright Act, \nno part may be reproduced by any process without written permission. \nInquiries should be addressed to the Publishers.\nAll rights reserved.\nde Costa Caroline, 1947 - .\nRU 486.\nISBN 9781921054334 (pbk).\n1. Mifepristone - Australia. 2. Mifepristone - Government\npolicy - Australia. 3. Abortifacients - Australia. I.\n615.766\nBOOLARONG PRESS\n1/655 Toohey Road, Salisbury 4107\nTypeset by Watson Ferguson & Company\nPrinted and Bound by Watson Ferguson & Company\n\n\nACKNOWLEDGEMENTS\nMany people have contributed to my knowledge of medical \nabortion and thus to the preparation of this book: Dr Mike Carrette, \nDr Darren Russell, Naomi de Costa, Senator Jan McLucas and her \nstaff, Senator Claire Moore and her staff, Senator Lyn Allison and \nher staff, Dr Sharman Stone and her staff, Dr Lesley Clark, the staff \nof Cairns Base Hospital Library, Cait Calcutt, Dr Leslie Cannold, \nProfessor David Healy, Dr Sally Cockburn, Dr Michele Moore, \nDr Margaret Sparrow, Dr Carol Shand and Dr Andre Ulmann. I \nalso acknowledge the contributions made to the campaign to bring \nRU486 to Australia by so many women – and men – who for reasons \nof space I have been unable to name.\ni\n\nLIST OF COMMON ABBREVIATIONS \nUSED IN THIS BOOK\nACOG – American College of Obstetricians and Gynecologists\nAMA – Australian Medical Association (also American Medical \nAssociation, abbreviation not used in this book)\nFDA – Food and Drug Administration (United States)\nFIGO – International Federation of Obstetricians and \nGynaecologists\nMIMS - Monthly Index of Medical Supplies\nMJA – Medical Journal of Australia\nNHS – National Health Service (United Kingdom)\nPC – Population Council\nRANZCOG – Royal Australian and New Zealand College of \nObstetricians and Gynaecologists\nRCOG – Royal College of Obstetricians and Gynaecologists\nTGA – Therapeutic Goods Administration\nWHO – World Health Organisation\nii\n\nCONTENTS\n      Acknowledgements                            i      \n      List of common abbreviations used in this book              ii   \n  1. Introduction                             1\n  2. Some basic facts about RU 486                                          6\n  3. Who has abortions in Australia, \n    and what services are currently available for them?          10\n  4. The ‘abortion pill’ and the ‘morning-after pill’ – \n      what’s the difference?                                                        22\n  5. The history of RU486 in Europe \n      and the United States                                                        25\n  6. The many uses of misoprostol                                          37\n  7. Alternatives to mifepristone for medical abortion       46\n  8. Other medical uses of mifepristone                              51\n  9. The side effects, risks and complications\n      of medical abortion                                                     55\n10. The New Zealand experience with RU486                   62\n11. Recent experience with mifepristone in \n      North America, Europe, Asia and elsewhere                   68\n\n12. Medical abortion and Australian law                              75\n13. Early Australian attempts to introduce \n   medical abortion – and the opposition                            85\n14. The Harradine Amendment\n      and the decade 1996-2006                                         89\n15. 2005 – the debate surrounding the \n      Harradine Admendment                                                   96\n16. The Senate Inquiry into the Private Members’ Bill 107\n17. The reversal of the Harradine Amendment 111\n18. The current situation – and the future 122\n      References 128\n      An A-Z of abortion 134\n      References A-Z 169\n      Index 170\n\nINTRODUCTION \nOn a bright winter’s day at the beginning of July, 2006, I walked \nfrom my office in the JCU School of Medicine in Cairns and \nacross the three city blocks to the rooms of my colleague Dr Mike \nCarrette. Waiting for me with Mike was a woman I will call Joanne. \nI had met Joanne the previous week when I had shared a three way \nconsultation with herself and Mike.\nJoanne was 43 years old and had recently discovered that she was \nsix weeks pregnant. The pregnancy was unplanned. In a previous \npregnancy Joanne had suffered an episode of thrombo-embolism \n– a blood clot had formed in her leg and migrated to her lungs. \nFortunately this life-threatening condition had not been fatal for her, \nalthough she required anti-coagulant medication for the ensuing six \nmonths. The physician caring for her at the time had also given her \nsome strongly worded advice – she should avoid further pregnancy, \nwhich posed a serious threat to her life. \nIn addition to her medical problems Joanne, as a divorced single \nmother, felt quite unable to proceed with another pregnancy at \nher age. She had consulted her general practitioner, who talked \nsympathetically with her about all her options.  After thinking long \nand hard, Joanne decided that she should undergo an abortion. She \nwas also interested in the possibility of a medical abortion, in order \nto avoid an anaesthetic.\nAt her first consultation with Mike and myself, the procedure \nof induced medical abortion using the drugs mifepristone (RU486) \nand misoprostol was explained. Joanne brought with her a friend, \nDoreen, to act as support person throughout the process, which \n\nRU 486\n2\nwould take place in Joanne’s home. Exactly what Joanne could \nexpect to feel, the various risks that were involved, and what she \nshould do in any kind of emergency, were all outlined. She was \nsupplied with written information about the world-wide experience \nof medical abortion and a detailed consent form to take home and \nread. The appointment for the following week was pencilled in.\nWe met again as planned. Joanne was quite sure of her decision \nand had brought with her the signed consent form. Mike unwrapped \nthe package of mifepristone and as we both watched Joanne took a \nsip of water and swallowed it down. Would she feel any side effects \nthat afternoon? she asked. Not likely, we replied, RU486 itself has \nfew side effects. But she had contact numbers for both of us in case \nof any problems.\nTwo days later we met for the third time. On this occasion Joanne \nhad four tablets of the drug misoprostol inserted vaginally. She had \nalready been given prescriptions for antibiotics and painkillers. \nShe was driven home by Doreen who stayed in close touch with \nus by phone. Two hours later Doreen reported that Joanne was \nexperiencing some contractions and bleeding; within half an hour \nthe abortion process was complete and bleeding and pain were \nsettling.\nJoanne had just become the first woman in twelve years to \nundergo a legal abortion  using RU486 in Australia, and one of the \nvery few ever to use the drug in this country. \nWhy is this event in any way remarkable? RU486, as mifepristone\n1  \ncontinues to be more widely known, has been available in France \nand Switzerland since 1988, the United Kingdom since 1991, \nmost other European countries since the early-mid 90s, and the \nUnited States since 2000. It is used legally in Russia, India, China, \nIsrael, Turkey, Tunisia and New Zealand, amongst many other \ncountries. In almost all these places its use evokes little in the way \nof controversy. Its actions, side effects and potential risks have been \nwidely studied, and the evidence shows that it is safe, effective, \n1 Throughout this book the names RU 486 and mifepristone will be used \ninterchangeably – they are the same thing.\n\n3\nCAROLINE DE COSTA\nand highly acceptable to women, both for early abortion – usually \nimplying up to nine weeks of pregnancy – and for the much less \ncommon procedure of late abortion. However in Australia the drug, \nafter initial (promising) trials directed by Professor David Healy \nof Monash University, became the focus for political manoeuvring \nthat had nothing to do with the health or human rights of Australian \nwomen. Under an extraordinary piece of legislation known as the \nHarradine Amendment, the use or import of the drug was prohibited \nwithout the personal permission of the Federal Minister of Health. \nThis had the effect of discouraging pharmaceutical companies from \napplying to the Australian Therapeutic Goods Administration \n(TGA) for approval to import and market the drug – which is the \nnormal pathway by which drugs developed and manufactured \noverseas enter the country. It also meant that Australian women \nhave been poorly informed about something quite familiar to their \nsisters in Europe, North America and elsewhere, and denied a \nchoice that is widely available in so many other countries.\nThis situation was partly remedied by the overturning of the \nHarradine Amendment by a conscience vote in both Houses of \nParliament in February 2006. This unique event occurred because \na cross-party group of women senators introduced a Private \nMembers’ Bill in the Senate, which was passed in that House and \na week later in the Lower House, the House of Representatives. \nThe bringing of this piece of legislation to the Parliament, and the \nevents that preceded it, demonstrated an extraordinary unity of \npurpose between women from all shades of the political spectrum \nand from a huge range of different backgrounds.  There was clear \nrecognition from these women- and of course from many men – \nthat access to safe, legal abortion must be a fundamental right of \nAustralian women and that this is the opinion of a majority of the \npopulation. Allowing access to RU486 extends that right, increasing \nthe choices available to women having to make the difficult decision \nabout terminating an unwanted pregnancy. Widespread availability \nof RU486 in this country also offers the possibility of improving \n\nRU 486\n4\naccess of some Australian  women to abortion, particularly rural \nwomen and women from certain ethnic groups.\nHowever the overturning of the Harradine legislation did not \nimmediately result in widespread access to the drug for Australian \nwomen. All drugs licenced for use in Australia and made available \nfor prescription by doctors must first pass through a rigorous \nprocess of approval by the TGA. The TGA acts to ensure that drugs \nused by the Australian public have been widely and appropriately \ntested, that they are safe, or at least that any side effects or contra-\nindications are well known, and that they are effective. The TGA \ncontinues to monitor drugs after they have been approved for use in \nAustralia, keeping a register of severe adverse effects, and it has the \npower to withdraw drugs from the Australian market. It is to the \nbenefit of all of us that the TGA acts in this way. \nThe TGA can generally only assess a drug when a drug company \nmakes an application to manufacture and/or market that drug in \nAustralia. At the time of writing this book, no such application  for \nmifepristone has been approved by the TGA, and it is believed that \nno such application has yet been lodged. Drug companies are not \nusually so reluctant to bring overseas drugs to Australian consumers, \nand the reasons why this hasn’t yet happened for RU486 are far \nfrom clear, although it seems certain that the political controversy \nsurrounding the drug in Australia has played a major role.\nHowever within the extensive legislation governing the role of the \nTGA there is provision for private doctors to apply to import and \nuse particular drugs for their own patients, in certain serious medical \nconditions. This is called the Authorised Prescriber legislation. In \nlate 2005 Dr Mike Carrette and I lodged an application under this \nlegislation to be permitted to use mifepristone – RU486 - for the \npurpose of medical abortion in early pregnancy, in our own practices \nin Cairns. This was a complex process involving much paperwork \nbut six months later (and two months after the overturning of the \nHarradine Amendment) this permission was granted to us. We \nwere able to obtain a small supply of RU486 from New Zealand \n\n5\nCAROLINE DE COSTA\ncolleagues and we have been using the drug in Cairns under the \nAuthorised Prescriber guidelines for a year now.\nIn that time several other Australian doctors have made similar \napplications to the TGA but at the time of writing I am not aware of \nany others having been granted approval. Dr Carrette and I continue \nin the bizarre position of being the only medical practitioners in \nAustralia able to use a drug that is widely prescribed and recognised \noverseas as the most appropriate choice for medical abortion.\nI am hopeful that in the near future a drug company will lodge \nan application with the TGA – given the huge amount of overseas \nevidence in favour of the drug I believe it is likely that such an \napplication would be granted. I very much look forward to the day \nwhen RU486 is simply a non-controversial option for women in this \ncountry,  one of many choices for reproductive health that currently \ninclude most forms of contraception, emergency contraception, \nsurgical abortion and sterilisation. Meanwhile I have written this \nbook to provide accurate information about RU486 and its actions \nto Australian women (and men), as well as to outline the history of \nthe drug’s development, including its prolonged and unnecessary \nentanglement in the politics of the Howard government. \n\nSOME BASIC FACTS ABOUT RU 486\nRU 486 was initially RU38486, and was  just one of many sample \ndrugs in the French laboratories of the company  Roussel Uclaf \n-hence “RU”. It was first synthesised in April 1980, then lab-tested \nin France in 1981 before undergoing trials in patients (women \nvolunteers) in France and Switzerland in 1981-82. Although it \nhas since been formally named mifepristone – RU486 being the \nlaboratory name only – and this is the name used by the medical \nprofession, to the public it is still known and quickly recognised as \nRU486.\nThe drug is a synthetic steroid, meaning it has a chemical \nstructure somewhat similar to the naturally-occurring sex hormones \noestrogen and testosterone, but it is made in the laboratory, \nand does not occur in nature.  It acts by opposing the action of \nthe naturally-occurring hormone progesterone. Progesterone is \nnormally produced by one or other of a woman’s ovaries in the \nsecond half of the menstrual cycle. If a woman becomes pregnant \nprogesterone production by the ovary increases and is supplemented \nby progesterone produced by the developing placenta. Progesterone \nis essential to the continuation of the pregnancy. When a pregnant \nwomen takes a single dose of RU486 the drug locks onto the \nchemical receptors in the lining of the uterus that normally bind \nwith progesterone, thereby preventing natural progesterone from \nacting. This effectively ends the pregnancy because the placenta \ncannot develop.\nRU486 has been found to have a number of potential uses in \nmedicine (these are discussed further in Chapter 6). However its \n\n7\nCAROLINE DE COSTA\nbest known and most widespread use at present is for the purpose of \ninduced abortion. For this it is usually used together with another \ndrug, misoprostol. Misoprostol is a synthetic form of prostaglandin. \nLike steroids, prostaglandins are substances some of which occur \nnaturally in the human body, although misoprostol itself is made \nin laboratories. Misoprostol has a number of effects but the most \nimportant is to bring about contractions of the pregnant or recently \npregnant uterus. This property has made it an effective treatment \nfor post-partum haemorrhage – the heavy bleeding that can \nsometimes follow normal childbirth and threaten women’s lives. \nIt also makes misoprostol useful in induced abortion as it brings \nabout the expulsion of the contents of the uterus after mifepristone \nhas ended the pregnancy. Misoprostol acts quickly – usually within \nfour hours of being administered – and it does so generally with \nlittle blood loss. It is also very effective – the abortion process is \nusually complete after a single dose of misoprostol. The action of \nmisoprostol on the uterus is increased by previously administering \nthe mifepristone.\nIt needs to be made clear  that medical abortion using mifepristone/\nmisoprostol is not a ‘magic bullet’ that simply melts the pregnancy \naway. All the products of conception – which in the first trimester \n(the first twelve weeks of pregnancy) are mostly made up of placental \ntissue and membrane – need to be expelled from the woman’s body. \nThis is a process that of necessity involves some bleeding and \nsome pain – both of which are usually manageable by the woman \nconcerned. Bleeding tailing off to a discharge takes a number of \ndays to disappear completely following medical abortion. For most \nwomen this is no problem, women are used to vaginal bleeding, \nit’s scheduled to happen to them every month between the ages of \n12 and 50, and is normal for several weeks following childbirth. \nMedical abortion properly conducted also requires – usually –two \nor three visits to a doctor or clinic, and sometimes more. Surgical \nabortion properly conducted has similar requirements.\nVarious regimens are used in different countries but the principle \nof orally-administered mifepristone followed by orally or vaginally \n\nRU 486\n8\nadministered misoprostol is common to all. When the abortion \nis performed before nine weeks of pregnancy (what is referred to \nmedically as nine weeks’ gestation) this process can occur either \nin a clinic or hospital situation or in the woman’s own home. In \nthe latter case the woman must initially be under medical care and \nmust have access to emergency help in the event of a complication \nof the abortion, although complications are infrequent. Women \nexperience early medical abortion much like a natural miscarriage. \nCrampy pain and vaginal bleeding are an intrinsic part of the \nabortion process as they are with miscarriage. Some tissue, which \nis visibly partly placenta and partly membranes, is passed, together \nwith the fetus which is generally not recognisable as such. At six \nweeks of pregnancy the fetus (technically still called an embryo) is \nabout 2 mm long, at seven weeks  5mm, and at eight weeks about 10 \nmm (one centimetre) long.\nVarious studies have shown that with mifepristone-misoprostol \nregimens in recommended doses 95-99% of women will abort \ncompletely. The remainder will require uterine aspiration (or \ncurettage, ‘D&C’) to complete the abortion, in a clinic or hospital \nsituation. \nMifepristone can also be used for later abortion, again in \nconjunction with misoprostol.  Medical abortions performed later \nthan nine weeks are best performed in a hospital or clinic as there \nmay be a need for strong analgesics (pain relief) and there is a \ngreater risk of heavier bleeding than with early medical abortion. \nNevertheless only a small percentage of late medical abortions \nactually incur these complications.\nIn the United Kingdom, early medical abortion using \nmifepristone/misoprostol has been available since 1991. It is now \nwidely accessed by women – up to a third of early abortions in many \ncentres in the UK are performed this way. Women have found the \nmethod highly acceptable – it is often described as less invasive, \nand allowing women to feel more in control, by those who have \nundergone the procedure. The Royal College of Obstetricians \nand Gynaecologists (RCOG), with headquarters in London, has \n\n9\nCAROLINE DE COSTA\npublished detailed guidelines, based on the evidence of up-to-date \nresearch, about how the drugs should be used. Similar guidelines \nhave been published by the American College of Obstetricians and \nGynecologists (ACOG). In drawing up this information for doctors \nand for the women under their care, these Colleges have made clear \ntheir beliefs that RU486 is a safe, effective option for women who \nhave made this choice of abortion for themselves.\nAll women considering termination of pregnancy should be \nprovided with full information about all their options as well as \navailable procedures and alternatives. Appropriate counselling and \nassessment by a doctor is vital. They should be offered other aspects \nof health care for women including follow-up contraception, Pap \nsmear screening and screening for sexually transmitted infections, \nand they should be fully supported emotionally through the \nabortion process. It is important to make sure that the pregnancy is \nin the uterus and not an ectopic pregnancy e.g. in the fallopian tube, \nand that the abortion has caused all the products of conception to \nbe expelled from the uterus. These considerations are as true of \nmedical abortion as they are of surgical abortion. Surgical abortion \nis legal in all states of Australia under varying circumstances and \nis widely available but there are inequities of access to abortion \nservices, and in some states although a Medicare rebate is payable \nabortions are generally performed in private clinics. Mifepristone \nand misoprostol are cheap to produce; misoprostol is currently \navailable in Australia and is widely used in obstetric practice for \nconditions other than induced medical abortion (for example for \nwomen bleeding after normal vaginal births) although it is not \nlicenced for these purposes. Numerous overseas studies have shown \nthat the majority of women undergoing medical abortion have been \n“satisfied” or “very satisfied” with the procedure.\nThese are the basic facts. Why then if this safe option exists does \nmedical abortion using RU486 continue to be, for all intents and \npurposes, unavailable to Australian women?","source_license":"CC0","license_restricted":false}