2nd February, 2006

ROD BENSON

“There is no quick fix for pregnancy, no magic pill.”
- Father of 18-year-old Californian woman Holly Patterson who died as a result of taking RU486 in 2003.

“These are violently active chemicals and they have violent reactions on the organism...(What is the) situation in which a woman would undergo that kind of assault?”
- Australian feminist Dr Germaine Greer, addressing gynaecologists and obstetricians in 2002.

“A drug which ends a new human life and endangers a woman’s health is never a ‘safe and effective’ solution.”
- Dr Brigid Vout, Life Office, Catholic Diocese of Sydney.

RU486 is not the same as the 'morning after' pill (Postinor-2). RU486 is the generic term for mifepristone, an artificial steroid that blocks progesterone, a vital nutrient hormone. It causes the nutrient lining of the mother’s uterus to disintegrate, and the embryo withers and dies. A second drug, misoprostol, a prostaglandin developed to treat ulcers, is used 48 hours later to induce uterine contractions that detach and expel the embryo and uterine contents.

More than one million women worldwide have used RU486 to end their pregnancy. RU486 is effective from the fifth to the seventh week following the last menstrual period, with decreasing effectiveness up to the ninth week. Used alone, RU486 has an abortion rate of 60 to 80 per cent. Used with misoprostol, this rises to 95 per cent. Mifepristone is also used to treat certain rare forms of cancer, and may have other therapeutic applications. Mifepristone was developed by Roussel-Uclaf, a French pharmaceutical company.

Possible side effects and complications
A common side-effect is severe pain similar to that of miscarriage, with over half of women needing specific pain medication and one-third needing narcotics. Other side-effects may include nausea and dizziness, syncope (brief loss of consciousness), serious bacterial infection, sepsis, prolonged bleeding (averaging from 9 to 30 days) and death. Some women who experienced severe bleeding as a result of taking the drug required blood transfusions. Women lacking ready access to ultrasound and blood transfusion, such as those in remote communities and developing countries, are more likely to die. The drug does not affect ectopic pregnancies, which may go unnoticed and rupture, leading to trauma and death. Some symptoms of a ruptured ectopic pregnancy are the same as those for abortion using RU486 and misoprostol.

Unlike surgical abortion, the process by which RU486 procures abortion normally takes a week to complete, during which time the woman may suffer appalling psychological as well as physical trauma. In cases where the embryo is not killed or expelled, a surgical abortion is required, adding to potential trauma. It appears that women who abort using RU486 are as likely to suffer Post-Abortion Syndrome as those who undergo surgical abortion. It appears that, where abortion has failed and the woman carries the baby to full term, there is a danger of structural and genetic deformities similar to those caused by Thalidomide. RU486 could also affect a woman’s future pregnancies, causing miscarriage and/or foetal deformities in later children. No long-term clinical studies have been carried out.

The US Food and Drug Administration approved the use of RU486 in 2000, despite warnings that procedural and scientific requirements to prove its safety and effectiveness had been bypassed. It is used in some European and other countries. Opponents have called it - some would say crassly - “a human pesticide” and “a chemical coat-hanger".

Why the Health Minister has regulatory control of RU486
The Therapeutic Goods Administration (TGA) regulates therapeutic goods in Australia to ensure the quality, safety and efficacy of medicines and ensure the quality, safety and performance of medical devices. The regulatory framework is based on a risk management approach designed to ensure public health and safety, while at the same time freeing industry from any unnecessary regulatory burden.

Normally the TGA would regulate the use of RU486, but a controversial amendment to the Act was passed in 1996 when former Tasmanian Senator Brian Harradine, a Roman Catholic, argued that the drug should be made illegal. The amendment created new class of drugs known as “restricted goods” which cannot be evaluated, registered, listed or imported without the written approval of the Health Minister. Currently RU486 is the only medicine in this restricted class of goods. All other medications are subject to the TGA’s evidence-based assessment process.

It can be argued that the federal Health Minister merely possesses a requirement, subject to parliamentary scrutiny, to authorise any move by the TGA to consider whether to approve its use - in effect a parliamentary power of veto. If the power to approve were vested in the Minister it may be a good or a bad thing, depending on the attitude of the Minister of the day. As it stands, the worst-case scenario for opponents of RU486 is not that a Minister may approve its use contrary to the advice of the TGA but that he or she may, subject to parliamentary scrutiny, leave it to the TGA to decide.

The move to repeal ministerial responsibility for RU486
In November 2005 a campaign by four senators, representing each of the four main political parties, sought to introduce a private members bill to overturn the effective ban. There was insufficient time for the Senate to discuss this before Parliament concluded for 2005, and the matter was referred to a Senate Community Affairs Committee for consideration. The Committee called for public submissions, with a closing date of 16th January. The Committee’s report is not yet available. Politicians are likely to have a conscience vote on the bill on 9th February.
Lobbying on both sides of the argument is heated. Opponents of abortion declared Sunday 29th January a National Day of Action Against RU486, and a lobby organisation, Australians Against RU486, has been established.

The arguments
Arguments for approving RU486 for use in Australia:
• women who choose to have an abortion should have the option of using RU486;
• it is inappropriate for the Health Minister to intervene in the regulation of a drug in this way;
• other drugs have serious side effects and yet are approved for use under medical supervision;
• many medical agencies support the use of RU486 for abortion under proper medical supervision; and,
• RU486 can be used to treat diseases such as certain kinds of cancer.

Arguments for retaining the Australian ban on RU486:
• RU486 is not a simple and safe alternative to surgical abortion;
• RU486 intentionally kills the embryo and trivialises the taking of human life;
• access to RU486 may be a step toward legislating for abortion on demand;
• access to RU486 may encourage promiscuity among women who view it as a virtual contraceptive;
• women orally self-administer it and the process takes a week to complete, leading to undue trauma;
• women may be unsure of the gestational age of their embryo (without an ultrasound);
• many overseas abortion providers apparently prescribe it beyond the recommended 49 days; and,
• the TGA is not empowered to advise on the moral and social implications of approving a drug.

Conclusion
The current debate on RU486 focuses on two important issues: whether the drug should be permitted in Australia; and who should decide. As to whether RU486 should be permitted in Australia, it is widely acknowledged that RU486 is a dangerous drug. It was specifically developed by the French pharmaceutical company Roussel-Uclaf as a non-surgical abortion option. RU486 intentionally kills the embryo and trivialises the taking of human life. Given the available alternatives, the possible complications seem to constitute an unacceptable burden to women. For those who need an abortion, there are less costly and less traumatic options available. Further, many Christians and persons of other religious faith oppose abortion on moral grounds, and thus oppose the approval of RU486 as an abortifacient.

As to who should decide on the approval of RU486 in Australia, the current regulatory regime, while unusual, ultimately serves Australian women well. There is nothing to lose and everything to gain by leaving the legislation as it stands rather than allowing the TGA to act independently on such matters. The restriction on RU486 should be maintained.

I urge all federal politicians to oppose the Therapeutic Goods Amendment (Repeal of Ministerial Responsibility for Approval of RU486) Bill 2005. Rather than legislating to encourage abortion in Australia, political leaders should encourage development and funding of programs aimed at reducing the need for women to seek abortions.

Rev Rod Benson is the director of the Centre for Christian Ethics, Morling College, in Sydney, Australia. He may be contacted at ethics@morling.edu.au.