Saturday, February 18, 2006

RU486? IM4 Due Process

1996 - Senator Brian Harradine successfully introduces the Therapeutic Goods Amendment Bill 1996 to limit the introduction of pharmacological abortifacients (drugs intended to induce abortion) by taking away the Therapeutic Goods Administration's (TGA's) ability to assess any such drugs unless prior approval is given by the Minister for Health and Ageing. All such drugs are classified under the name of "Restricted Goods".

"restricted goods means medicines (including progesterone antagonists and vaccines against human chorionic gonadotrophin) intended for use in women as abortifacients.
Therapeutic Goods Amendment Bill 1996

The intention was to introduce an added layer of Governmental scrutiny to any attempts to widen the options for women seeking abortion, and presumably to deter any health providers from offering pharmacological abortion (a de facto ban).

Since that time, no pharmaceutical company has made any attempts to apply to import or supply RU486 (Mifepristone) for pharmacological abortion in Australia, most likely on the belief that all presiding Health Ministers would have declined to permit the application from proceeding.

October 2005 - Debate develops over Health Minister Tony Abbott's public anti-abortion stance, and the Democrats state their intention to repeal Tony Abbott's right to veto any application to introduce pharmacological abortifacients (in particular RU486).

November 2005 - Tony Abbott clearly states his opposition to the use of RU486 on the basis of a report from the Chief Medical Officer Professor Andrew Child which is widely criticised.

29 November 2005 - Thoughful Parliamentary Library article on current status of RU486 in Australia.

December 2005 - Professor Caroline de Costa makes the first application to the TGA for a license to prescribe RU486 as a test case.

8 December 2005 - This application prompts Senators Nash, Troeth, Allison and Moore seek to introduce the Therapeutic Goods Amendment (Repeal of Ministerial Responsibility for Approval of RU486) Bill 2005. Background report here.

8 January 2006 - Several more Obstetricians state their intention to apply for a license to prescribe Mifeprostone.

13 February 2006 - The Bill is debated and passed in the Senate.

16 February 2006 - The Bill is debated and passed in the House of Parliament despite attempts to confuse the voting process with multiple amendments.

On Due Process
The TGA has the power as an independent statutory authority to assess all medicines, pharmaceuticals, and therapeutic devices. The items it assesses are not always used only for therapeutic purposes, and often they are used in combination with other procedures or medicines. It has an expert, world-recognised panel to do these assessments, and we entrust them on a day-to-day basis to assess and approve (or decline) all medicines and medical instruments that are in current use.

So why did Senator Harradine wish to remove the authority to review abortifacients from the TGA? This has nothing to do with the TGA's ability or suitability to objectively assess this class of drugs, but merely with his own personal viewpoints that abortion is not acceptable, and any means of preventing access to abortion should be implemented. Therefore a class of "restricted goods" was created which was intended purely to stop one drug entering the country for one specific purpose. This creates an administrative and logical divide - that surgical abortion is allowed but pharmacological abortion is not. This has nothing to do with safety, but was merely Senator Harradine's first step towards banning abortion altogether.

It was about time that commonsense prevailed, and the TGA was allowed to go back to doing its job - assessing the risks and benefits of all therapeutic agents presented to it and making sure that they are used safely and appropriately without the interference of the Parliament.

If the Government wishes to outlaw abortion, then introduce a law to outlaw abortion, do not undermine the currently effective system for assessment and regulation of therapeutic agents by adding beauracratic red tape.

There is a reason why the TGA is empowered to review these agents - because they are experts and they review medical and scientific evidence critically. Based on the tragic misuse of statistics, omission and manipulation of facts, pseudofacts, and illogical arguments during the course of the recent debate in the House of Parliament, it is self-evident why politicians and the Parliament is not entrusted with the critical evaluation of drugs and medicines.

On Abortion
There is no doubt that the whole issue about access to abortion facilities (including counselling services) is one that generates major angst amongst parts of the community. Any event that leads to a perception of loss is traumatic and distressing. As doctors we deal with this every day, patients get upset when their body changes, either because of their own pathology or disease, or because of what is done to them.

The loss of a foetus is even more distressing for any woman because not only is there a perception that their own body is affected, but a potential life. I deliberately use the word "potential" because there is no way to know, either as a layperson, a scientist or any other professional, at what stage a life is involved. What matters most is how the patient or mother regards that potential life, and what attachment she holds to it, and the consequences of allowing that potential life to develop (or not develop, as the case may be). It is her body, and she is the major stakeholder.

Just as the public have no right to tie her down and make her abort or miscarriage, the public have no right to tie her down and stop her from aborting or miscarrying. It is not practicable to deny this choice to women, so the goal of facilitating abortion is one of harm minimisation. Those who reject a woman's right to supervised abortion services must in principle also reject anti-smoking advertisements.

At the Coalface
A purely hypothetical young lady in her early 20s presented to a country hospital with severe right iliac fossa pain (right lower abdomen) for several days. She was also 12 weeks pregnant, which was not wanted. Her obstetrician was a devout Catholic who had declined to perform a suction termination of pregnancy on religious grounds, and no other obstetrician was available to treat her. When it became clear that this young girl had appendicitis she declined surgery, hoping that this would lead to a spontaneous abortion. After 2 days she got what she wanted, at the cost of a perforated appendix and a big scar down the middle of her belly.

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