Sunday, January 29, 2006

A brief history on the development of RU486

Have enough precautions for the safety of women’s health been observed in the push to have RU486 placed into the market place? A brief outline of the history of the development of this drug will show the extraordinary speed with which it was developed, tested and then placed into the open market. The speed with which the drug has been marketed is cause for concern. Not enough time has been used in trials, and not enough data has been collected relating to the adverse events associated with RU486/PG.

The speed with which the drug Mifepristone has reached the consumer market for the purpose of chemical abortion has been too rapid. Insufficient data concerning contraindications was collected prior to its introduction in Europe and elsewhere. The lack of data is sufficient reason for proceeding with caution with regards to the uses of Mifepristone. There are some legitimate uses of Mifepristone, just as there are some legitimate uses of the prostaglandin. What is of concern is the use of the combined drugs for the purpose of carrying out a chemical abortion. If the documented contraindications have been ignored, what about the contraindications for its use by poor women in India, Bangladesh and elsewhere? These are drugs that should not be used without proper supervision, yet here in Australia, the people pushing for changes in the legislation to take control of the importation of Mifepristone out of the hands of the Minister for Health, totally ignore the facts surrounding health and safety issues.

THE HISTORY OF RU486

RU486 was discovered in April 1980, by Georges Teutsch and Daniel Philibert of Roussel Uclaf, with French scientist Etienne-Emile Baulieu, a consultant to the company, when they succeeded in synthesizing RU 486, a steroid now with the trade name Mifégyne (mifepristone). The researchers claimed that they were not deliberately setting out to develop an abortifacient, and that RU486 was “a by-product of the company's active search for a molecule which would bind strongly with the glucocorticoid receptor. “ Spinifex Press - RU 486 - Misconceptions, Myths and Morals

After only 17 months of animal testing, the first human tests on this drug were carried out in a trial at Geneva hospital on 11 pregnant women who were prepared to accept a chemical abortion. The women in the trial were given 200 mg of RU486 over 3 consecutive days. Of the women who participated in the trials, nine pregnancies were allegedly successfully terminated. Of these 9, eight of the women took 5 days before the termination was successful, and one woman took eight days. However, of these “successful” terminations, one woman had to undergo an emergency evacuation of her uterus, and another had to receive emergency surgery plus a blood transfusion because of heavy blood loss. It was, as the newspaper Paris Liberation stated “no abortion miracle”.

With such an early history that indicated that there were problems with the use of RU486, why is Senator Allyson so adamant that it is safe and effective? Why is the current head of the AMA prepared to state that RU486 is safe? This is an extremely risky statement for someone in a position of responsibility to make about a drug such as RU486? By endorsing this form of chemical abortion, this doctor has stuck his neck out to the point that he risks a lawsuit when something goes drastically wrong through any unchecked use of Mifepristone. Should Australia follow other countries that have chosen to introduce this procedure for the purpose of inducing abortion? This is an issue that needs careful consideration.

I maintain that Australian women need to be fully informed about the dangers and risks, and the contraindications on the use of RU486. This is not something that should be taken lightly, and it is not something that it is so safe to give to aboriginal women in remote regions of Australia. In fact to give it to an aboriginal woman could be gross negligence on the part of the doctor.

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