Tuesday, June 06, 2006

Cairns pilot for abortion pill

The controversial RU486 drug will be available in Queensland next month. The tourist town of Cairns in Far North Queensland will be the first place in Australia to trial the drug. RU486 is the so-called “morning after” abortion pill recently made available in Australia after a stormy and emotional parliamentary debate and conscience vote.

Cairns obstetrician Professor Caroline de Costa will be the first Australian doctor to prescribe the drug. She said she was expecting to issue RU486 to patients by July once the initial batch of 40 tablets is cleared by the Therapeutic Goods Administration (TGA).
Professor de Costa said the drug would be administered at a private clinic in Cairns to patients referred by locals GPs. Queensland Attorney-General Linda Lavarch said on Monday state law authorised doctors to prescribe the drug. The cost will be about $60 a tablet.

RU486 is the common name for the drug mifepristone. Mifepristone is a synthetic steroid with anti-progestagenic and anti-glucocorticoid effects. This means it can be used to induce what is known as medical abortion. During early trials, it was known as RU-486 after its designation at Roussel Uclaf, a French pharmaceutical company, which designed the drug. It is an alternative method to abortion.

RU486 is a medical procedure whereas abortion is a surgical procedure. It works by blocking the effects of the hormone progesterone, which is crucial to starting and maintaining pregnancy. Without progesterone, the lining that covers the walls of the uterus breaks down. In the absence of progesterone, the uterus cannot hold onto the fertilised egg, making it impossible for pregnancy to continue. Doctors will prescribe a specified dose of the drug to a pregnant woman. Two days later, the woman returns to the clinic to be administered another drug prostaglandin (usually misoprostol.) Misoprostol causes the uterus to contract, thereby expelling the foetus, usually within a few hours. According to the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG), the experience for the woman ‘may be much like a spontaneous miscarriage, with some pain and bleeding to be expected.’

RU486 is approved for use in the US, the UK, much of Western Europe, Russia, China, Israel, New Zealand, Turkey and Tunisia. Despite the recent conscience vote, it was never actually banned in Australia. According to the Therapeutic Goods Act 1989, RU486 is in the category of ‘restricted goods’ which required the written permission of the Minister for Health to be registered or imported. The act specifies that only abortion drugs are in this restricted category. Medicines used for any other purpose are evaluated and regulated by the Therapeutic Goods Administration (TGA) without any requirement for approval from the Minister.

The restricted goods category was introduced in 1996 as an initiative of the independent Tasmanian Senator Brian Harradine, who had strong anti-abortion views. At the time, the Senator argued RU486 had serious side effects, and the amendment was needed to protect the health of Australian women. Liberal Government support was a trade-off for the Senator's support for a bill to allow the part sale of Telstra. And with Tony Abbott, another strong anti-abortion supporter as Health Minister, drug companies have decided it is not worth the bother of applying for the licence to import the drug.

The legislation was overturned by a private member’s bill in February 2006. The purpose of the bill was to remove the Minister’s override and return the approval to the TGA. The bill was a conscience vote and split the parties almost exactly along gender lines. The bill was passed in the Senate 45-28 and the Lower House passed it on a show of hands to avoid further political controversy.

RU486 is mainly used during the first nine weeks of pregnancy, though is also effective for second trimester termination. How safe is it? Supporters have pointed out its wide availability overseas, evidence of its safety and compared with abortion, and the fact that abortion may not be easily available to rural women and those for whom privacy is an issue for religious, ethnic or other reasons. Detractors have denied it is safe, and counter the rural argument by saying it is a high risk option for women without adequate levels of medical supervision. There have been reports of deaths in the US and Canada due to the drug. Six women in the US and one in Canada have died following medical abortions, causing some medical abortion providers to stop using the method of intra-vaginal placement of the second drug, misoprostol. However these incidents occurred due to the fact that women did not follow the FDA approved instructions for the use of the drug.

Professor of Obstetrics and Gynaecology at Monash University Medical Centre, David Healy, doesn’t share these concerns. He believes that RU486 is safe and psychologically a much better method than surgical abortion. He says that “for most women if taken early, this will be just like having a period, rather than having a miscarriage.” He points out that there are 75,000 abortions each year in Australia and anything that helps alleviate that number has to be supported by the wider community. He concludes “this medicine is safe when used under proper medical care. The rest of the world has really moved on. Surgical abortion is now something that is really becoming increasingly old fashioned and no longer the best treatment available for Australian women.”

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