A woman’s choice.
The Ian McDonald Memorial Oration, Auckland 2003.
by
Dr Margaret June Sparrow DCNZM MBE
Medical Training Officer, New Zealand Family Planning Association, Wellington Family Planning Service
Sexual Health Physician, Wellington Sexual Health Service, Wellington Independent Practitioners Association
Senior Lecturer, Department of Obstetrics & Gynaecology, Wellington Clinical School of Medicine
Director, Istar, a not-for-profit company to import mifepristone into New Zealand
[Text of article published in The Australian and New Zealand Journal of Obstetrics and Gynaecology, Vol 44, Number 2, April 2004 and published online at www.blackwell-synergy.com]
Abortion is now the most common gynaecological operation in New Zealand and Australia. Early legal abortion is a safe procedure whether carried out surgically or medically. In contrast, the traditional use of abortifacients has been mostly unscientific, illegal and shrouded in secrecy. Mifepristone as an option for induced abortion has only recently become available in New Zealand and is not yet available in Australia. The reasons for the delay in introducing a significant new abortion technique are political, professional, legal, socio-economic and commercial. Istar a not-for-profit company was formed in New Zealand in 1999 to import mifepristone. The drug was approved for use in New Zealand on August 30 2001. It was first used in October 2001 in Wellington for mid-trimester abortions and in April 2002 for early medical abortions. Legal ambiguities were clarified in a High Court Judgment on 10 April 2003. The experience with mifepristone raises concerns about the introduction of new drugs for reproductive health care, given the commercial risks associated with their development. RANZCOG has a role to play in ensuring that safe abortion services are available for women. Advocates of women’s rights in reproductive health care have made a significant impact in the last three decades and the conclusion that abortion must be the woman’s choice is strongly supported.
Abortion is the most common gynaecological operation in New Zealand and Australia. In New Zealand reliable statistics are available from 1980. The absolute numbers have increased from 5,945 in 1980 to 16,410 in 2001[1]. The increase has been a steady one with only three years (1985, 1992, 1998) recording a small decrease from the previous year. The rates per 1000 women in the different age groups have also increased. The greatest numbers and the greatest increase have occurred in the 20-24 age group followed by the 25-29 age group.
Rather than merely deploring this trend there is a need to understand the reasons behind the increase:
What can be done to reverse the trend? The answer of better education and improved access to contraceptive services can only make an impact if attention is also directed towards the social and economic determinants surrounding sexual behaviour, family formation and parenting. These are wider issues that need input from other sectors of society however the immensity of the task and the limited role of the medical profession, should not stifle initiatives. An important example in New Zealand was to make emergency contraception more readily available through the introduction of over the counter sales of the progestogen-only emergency contraceptive pill by trained pharmacists and nurses in May 2002. Australia is also moving in this direction.
The increase in abortion rates has consequences for gynaecologists. There has not been a parallel increase in the number of doctors willing to provide abortion services and at the present time the burden of providing abortion care rests with a minority of specialists, undertaking specialist care themselves and providing training for a new generation of skilled specialists. Some also provide training and support for non-specialists involved in routine early procedures. More are needed.
Abortion safety
Whereas in the past septic abortion was a major cause of maternal mortality, induced abortion is now one of the safest operations. In New Zealand the total number of abortions from 1980-2001 was 244,149 with no recorded maternal deaths. Although mortality varies with gestational age and maternal age the estimated mortality for induced legal abortions is 1 per 100,00 or 1 per 200,000. New Zealand’s excellent safety record is in part due to the fact that 88% of all abortions carried out in 2001 were within the first trimester and 11% at 13-16 weeks gestation. To promote high standards of care the RCOG guidelines[2] are a source of evidence based best practice.
Traditional abortifacients
Throughout the centuries and in all cultures women have ingested substances believed to bring on a delayed period. The terms ‘emmenology’ and ‘emmenagogues’ were used as early as 1678. Women often used traditional abortifacients before resorting to invasive methods. Many had an effect on the urinary or gastrointestinal tract, the theory being that stimulating other pelvic organs might stimulate the uterus to shed its lining. Many were ineffective. Many were unsafe. The mushroom Amanita muscaria was positively dangerous. Ergot or quinine were commonly used. Herbals included Black Cohosh, Blue Cohosh, Gentian, Pennyroyal, Hellebore (winter rose), Queen Anne’s Lace (wild carrot), Savin-oil of Juniper and Parsley (containing apiol). In New Zealand Supplejack and Flax root, Toetoe and Poroporo leaves were used.
Purported abortifacients were often combined as pills or potions. In the USA Lydia Pinkham first prepared her home remedy in her Massachusetts kitchen and began marketing it in 1875. “A woman best understands a woman’s ills” was one of her slogans. Her vegetable compound was a best seller for several generations of women and used for a variety of menstrual and menopausal disorders. It was a blend of various herbs including Black Cohosh and 20% alcohol.
Beecham’s Pills was another enduring product “for assisting nature in her wondrous functions” and “worth a guinea a box”. Sometimes doctors gave their names to abortifacients to enhance the credibility of the product such as Dr Boswell’s silent pill for females. The well equipped woman in Auckland in the first half of the 20th Century kept a bottle of Dr Bonjean’s female pills. Unlike many, the ingredients were listed on the label – Ergotin, Ferri Sulph Ex, Ext Hellibore, Ext Aloes socatrina, Ol Savin. Christchurch women knew of chemist George Bettle who also advertised his mail order catalogue in the weekly tabloid N. Z. Truth and offered a surgical service if abortifacients were unsuccessful. All of these activities were referred to obliquely and very little is recorded because, until 1977 in New Zealand, self abortion was a criminal offence punishable by 7 years in gaol. Most doctors wanted nothing to do with abortion but illegal abortionists operated in most communities providing a service to meet the needs of desperate women, despite harsh penalties if prosecuted.
Modern methods of medical abortion
None of the above traditional abortifacients have been seriously considered as a modern scientific method. Instead medical research concentrated first on prostaglandins alone, then more recently on methotrexate and mifepristone in conjunction with prostaglandins. Mifepristone emerged in the 1970s through the efforts of the research team at Roussel-Uclaf in France. In October 1986 they presented their findings at the XII World Congress of Fertility and Sterility in Singapore. Mifepristone became better known by its research number RU486 and its complicated history has been summarised elsewhere.[3]
In September 1988 mifepristone was registered for use in France for medical abortion but within a month Roussel-Uclaf announced plans to cancel distribution following boycott threats and pressure from the German parent company Hoechst. Coincidentally on 26 October the principal researcher, Professor Baulieu, was attending an international meeting of O&G specialists in Rio de Janeiro and organised a petition protesting at the proposed withdrawal of a significant new therapeutic agent. On 28 October the French Health Minister Claude Evin ordered that it be made available declaring later in a public interview that it was the “moral property of women”. In November 1990 Baulieu spoke in Melbourne and Auckland. In 1991 mifepristone was approved for use in the UK and in 1992 for use in Sweden.
In June 1995 abortion providers throughout New Zealand met for the first time in Wellington at a national conference where medical abortion was fully discussed. International support has been crucial. In June 1997 Professor David Healy spoke at the 2nd Abortion Providers Conference in Christchurch on his research in Melbourne and that same year the RNZCOG sponsored a tour by Professor David Baird, Edinburgh. More recently Professor Allan Templeton from Aberdeen was invited to visit Wellington following the RANCOG Sydney Scientific Meeting for a full day seminar.
In Australia the early research on mifepristone caused public controversy and in May 1996 the Harradine amendment to the Therapeutic Goods Act was passed requiring approval by the Minister of Health for the importation or use of abortifacients. That restriction has to date prevented further use in Australia.
Istar imports mifepristone
In 1997 there were three sources of mifepristone: (1) China who had manufactured their own (2) the USA where the Population Council since 1994 had inherited the patent rights from Roussel-Uclaf and (3) France where Dr Edouard Sakiz, ex-Chairman of Roussel-Uclaf, formed Exelgyn a small pharmaceutical company with rights to the rest of the world. Initially Exelgyn were not interested in a small market in New Zealand and would only negotiate with a reputable pharmaceutical firm. None were interested in a controversial product so in February 1999 five doctors formed a not-for-profit company called Istar after the Babylonian goddess of love, fertility and war. In May 2000 Istar signed an agreement with Exelgyn to import Mifegyne® the packaging provided for the UK market.
In June 2000 Istar applied to the Ministry of Health for approval of Mifegyne® as a new prescription medicine. On August 30 2001 the approval was gazetted and in September 2001 Istar imported the first consignment. In October 2001 mifepristone plus prostaglandin was first used clinically in Wellington for a 2nd trimeter abortion. It is now used in 5 hospitals and clinicians report favourably on the improved outcomes.
Until April 2003 there were problems with the provision of early medical abortions due to differing legal interpretations of Section 18 of the Contraception, Sterilisation and Abortion Act which states that all abortions must be “performed” in a licensed institution. Did that mean that women must stay in a licensed clinic until the embryo or fetus had been expelled? A High Court Judgment decided that the two sets of pills, the initial oral mifepristone and 48 hours later the vaginal prostaglandin, must be administered in a licensed facility but the woman is not required to stay there between the two doses or until the embryo or fetus is expelled.
Wellington experience
An audit was carried out in April 2003. At this time 147 second trimester abortions had been carried out between October 2001 and April 2003. Between April 2002 and April 2003 64 first trimester abortions had been carried out on pregnancies with a gestational age of <49 days except for one woman who had a failed surgical abortion. Her medical abortion was successful. Selection of cases took regard of the woman’s preference, her social situation and access to emergency care. Fully informed consent was required after an explanation of the options.
The protocol for first trimester abortion was as follows:
The results from application of this protocol are:
As a result of this experience and with a favourable High Court ruling the protocol was changed to include cases up to 63 days from the time of last normal menstrual period. In May 2003 the Abortion Supervisory Committee formed a working party to develop national guidelines for the provision of medical abortion. As with any new technique, professional training will be required as Units develop new protocols. In July-August 2003 Nurse Ann Simmons from Wellington visited clinics in the UK and the USA and is available for professional nurse training. Ultrasonographers also require skills in recognising an early embryo and excluding an ectopic pregnancy.
Future prospects
What are some of the issues that have been raised by the experience with mifepristone and what can be done to ensure that a range of safe medical services is available for women?
The role of RANZCOG
The College has been involved in abortion issues despite the difficulties of balancing widely disparate views within the membership. In May 1995 the RNZCOG made a recommendation to the Minister of Health, the Ministry of Health, PHARMAC (the drug purchasing agency) and the Abortion Supervisory Committee supporting “the introduction and licensing of mifepristone in New Zealand because the medical and scientific data has proven its usefulness for a variety of medical situations.” Dr Lesley McCowan presented a paper supporting this at the college meeting in Nelson in 1996.
At the July 2001 Council meeting RANZCOG adopted the following statement:
“Mifepristone (RU486) has a proven role in fertility control. It is widely available throughout Europe and the USA. It is not yet available to Australian and New Zealand women. As a method of emergency contraception it is more effective that steroid hormones, with fewer side effects. Its use in conjunction with prostaglandins provides the option of medical termination of pregnancy, which is an option preferred by many women.”
RANZCOG has established a Women’s Health Committee Termination of Pregnancy Working Party primarily responsible for professional education on abortion. There is however a need for more academic interest. In ANZJOG there are few articles on abortion. At conferences there are few papers on abortion. There is little research on abortion. The history of abortion is neglected. There is no display on abortion in the College museum. Abortion remains a hidden topic. What message does this give to aspiring specialists?
A woman’s choice
Internationally there has been recognition of women’s rights and equal citizenship with men as exemplified by the United Nations Committee on the Elimination of all forms of Discrimination Against Women (CEDAW).
However feminist attitudes to abortion cover a wide range of views. At the liberal end of the spectrum Australian feminist Leslie Cannold has contributed to the public debate with her view that women can be both pro-choice and pro-family[7]. The desire for responsible motherhood and the safeguarding of a quality of life for the whole family greatly influence women in their choice for or against abortion. However this view diminishes the legitimacy of women making a decision for the enhancement of their own lives.
An Australian study “We women decide”[8] exposed a number of myths – including the myth that abortion is inherently traumatic, an awful choice, the so called “awfulisation” of abortion. The notion that women are capable of deciding for themselves in a responsible, rational and mature way is strongly defended. This view is supported by Janet Hadley9 who looks with a feminist perspective at abortion politics in a number of countries and concludes that access to abortion is pivotal to women’s reproductive freedom and that the final decision about abortion should be the choice of the pregnant woman.
In New Zealand the decision is made by two state funded doctors. While providing support when needed I believe that it is more healthy to respect autonomy and self-determination rather than adopt a “we know best” stance, whoever that “we” is – politicians, lobby groups, religious groups or health professionals.
ACKNOWLEDGEMENTS
I thank RANZCOG for the invitation to give the Ian McDonald Memorial Oration at the 5th Annual Scientific Meeting in Auckland on 18 September 2003. Dr Di Tibbits and Rosalind Winspear provided valuable information during a visit to Melbourne in June 2003. I am indebted to the co-directors of Istar, Dr Diana Edwards, Dr Carol Shand, Professor Peter Stone and Mr John Tait.
REFERENCES