An Extract from RU486, by Caroline de Costa

Introduction

On a bright winter’s day at the beginning of July, 2006, I walked from my office in the JCU School of Medicine in Cairns and across the three city blocks to the rooms of my colleague Dr Mike Carrette. Waiting for me with Mike was a woman I will call Joanne. I had met Joanne the previous week when I had shared a three way consultation with herself and Mike.

Joanne was 43 years old and had recently discovered that she was six weeks pregnant. The pregnancy was unplanned. In a previous pregnancy Joanne had suffered an episode of thrombo-embolism – a blood clot had formed in her leg and migrated to her lungs. Fortunately this life-threatening condition had not been fatal for her, although she required anti-coagulant medication for the ensuing six months. The physician caring for her at the time had also given her some strongly worded advice – she should avoid further pregnancy, which posed a serious threat to her life.

In addition to her medical problems Joanne, as a divorced single mother, felt quite unable to proceed with another pregnancy at her age. She had consulted her general practitioner, who talked sympathetically with her about all her options. After thinking long and hard, Joanne decided that she should undergo an abortion. She was also interested in the possibility of a medical abortion, in order to avoid an anaesthetic.

At her first consultation with Mike and myself, the procedure of induced medical abortion using the drugs mifepristone (RU486) and misoprostol was explained. Joanne brought with her a friend, Doreen, to act as support person throughout the process, which would take place in Joanne’s home. Exactly what Joanne could expect to feel, the various risks that were involved, and what she should do in any kind of emergency, were all outlined. She was supplied with written information about the world-wide experience of medical abortion and a detailed consent form to take home and read. The appointment for the following week was pencilled in.

We met again as planned. Joanne was quite sure of her decision and had brought with her the signed consent form. Mike unwrapped the package of mifepristone and as we both watched Joanne took a sip of water and swallowed it down. Would she feel any side effects that afternoon? she asked. Not likely, we replied, RU486 itself has few side effects. But she had contact numbers for both of us in case of any problems.

Two days later we met for the third time. On this occasion Joanne had four tablets of the drug misoprostol inserted vaginally. She had already been given prescriptions for antibiotics and painkillers. She was driven home by Doreen who stayed in close touch with us by phone. Two hours later Doreen reported that Joanne was experiencing some contractions and bleeding; within half an hour the abortion process was complete and bleeding and pain were settling.

Joanne had just become the first woman in twelve years to undergo a legal abortion using RU486 in Australia, and one of the very few ever to use the drug in this country.

Why is this event in any way remarkable? RU486, as mifepristone* continues to be more widely known, has been available in France and Switzerland since 1988, the United Kingdom since 1991, most other European countries since the early-mid 90s, and the United States since 2000. It is used legally in Russia, India, China, Israel, Turkey, Tunisia and New Zealand, amongst many other countries. In almost all these places its use evokes little in the way of controversy. Its actions, side effects and potential risks have been widely studied, and the evidence shows that it is safe, effective, and highly acceptable to women, both for early abortion – usually implying up to nine weeks of pregnancy – and for the much less common procedure of late abortion. However in Australia the drug, after initial (promising) trials directed by Professor David Healy of Monash University, became the focus for political manoeuvring that had nothing to do with the health or human rights of Australian women. Under an extraordinary piece of legislation known as the Harradine Amendment, the use or import of the drug was prohibited without the personal permission of the Federal Minister of Health. This had the effect of discouraging pharmaceutical companies from applying to the Australian Therapeutic Goods Administration (TGA) for approval to import and market the drug – which is the normal pathway by which drugs developed and manufactured overseas enter the country. It also meant that Australian women have been poorly informed about something quite familiar to their sisters in Europe, North America and elsewhere, and denied a choice that is widely available in so many other countries.

This situation was partly remedied by the overturning of the Harradine Amendment by a conscience vote in both Houses of Parliament in February 2006. This unique event occurred because a cross-party group of women senators introduced a Private Members’ Bill in the Senate, which was passed in that House and a week later in the Lower House, the House of Representatives. The bringing of this piece of legislation to the Parliament, and the events that preceded it, demonstrated an extraordinary unity of purpose between women from all shades of the political spectrum and from a huge range of different backgrounds. There was clear recognition from these women- and of course from many men – that access to safe, legal abortion must be a fundamental right of Australian women and that this is the opinion of a majority of the population. Allowing access to RU486 extends that right, increasing the choices available to women having to make the difficult decision about terminating an unwanted pregnancy. Widespread availability of RU486 in this country also offers the possibility of improving access of some Australian women to abortion, particularly rural women and women from certain ethnic groups.

However the overturning of the Harradine legislation did not immediately result in widespread access to the drug for Australian women. All drugs licenced for use in Australia and made available for prescription by doctors must first pass through a rigorous process of approval by the TGA. The TGA acts to ensure that drugs used by the Australian public have been widely and appropriately tested, that they are safe, or at least that any side effects or contra-indications are well known, and that they are effective. The TGA continues to monitor drugs after they have been approved for use in Australia, keeping a register of severe adverse effects, and it has the power to withdraw drugs from the Australian market. It is to the benefit of all of us that the TGA acts in this way.

The TGA can generally only assess a drug when a drug company makes an application to manufacture and/or market that drug in Australia. At the time of writing this book, no such application has been approved by the TGA, and it is believed that no such application has yet been lodged. Drug companies are not usually so reluctant to bring overseas drugs to Australian consumers, and the reasons why this hasn’t yet happened for RU486 are far from clear, although it seems certain that the political controversy surrounding the drug in Australia has played a major role.

However within the extensive legislation governing the role of the TGA there is provision for private doctors to apply to import and use particular drugs for their own patients, in certain serious medical conditions. This is called the Authorised Prescriber legislation. In late 2005 Dr Mike Carrette and I lodged an application under this legislation to be permitted to use mifepristone – RU486 - for the purpose of medical abortion in early pregnancy, in our own practices in Cairns. This was a complex process involving much paperwork but six months later (and two months after the overturning of the Harradine Amendment) this permission was granted to us. We were able to obtain a small supply of RU486 from New Zealand colleagues and we have been using the drug in Cairns under the Authorised Prescriber guidelines for a year now.

In that time several other Australian doctors have made similar applications to the TGA but at the time of writing I am not aware of any others having been granted approval. Dr Carrette and I continue in the bizarre position of being the only medical practitioners in Australia able to use a drug that is widely used and recognised overseas as the most appropriate choice for medical abortion.

I am hopeful that in the near future a drug company will lodge an application with the TGA – given the huge amount of overseas evidence in favour of the drug I believe it is likely that such an application would be granted. I very much look forward to the day when RU486 is simply a non-controversial option for women in this country, one of many choices for reproductive health that currently include most forms of contraception, emergency contraception, surgical abortion and sterilisation. Meanwhile I have written this book to provide accurate information about RU486 and its actions to Australian women (and men), as well as to outline the history of the drug’s development, including its prolonged and unnecessary entanglement in the politics of the Howard government.