The abortion pill: a new battlefield

The abortion pill RU-486, available in Europe for 10 years, is about to be approved in New Zealand. MONIQUE DEVEREUX goes in search of the facts.

More than 16,000 abortions are performed in New Zealand every year. At present they are done surgically, but a new drug being considered by the Ministry of Health may soon give women a choice about how the abortion will be performed.

What is RU-486?

Known as the abortion pill, RU-486 or Mifegyne has been used in Europe for 10 years. It is controversial - international health authorities say it is safe and useful, but right-to-lifers warn it will be more traumatic for women and may mean the number of abortions will increase.

It was invented in 1980 by Dr Etienne-Emile Baulieu for the French firm Roussel-Uclaf. Its name comes from Roussel-Uclaf's initials plus a serial number.

An application to use RU-486 was submitted to the Ministry of Health last year by five specialists who set up a company called Istar, which plans to import the drug.

It is supported by organisations such as Family Planning, which says it is important for women to have a medical and surgical choice about how to have an abortion.

Other groups, including Right to Life, oppose the drug and say it is effectively declaring "chemical warfare" on unborn children.

Who can have it?

The pill is suitable for women up to nine weeks pregnant, but is most effective before seven weeks. It can be prescribed only by a GP and anyone wanting it must go through the same approval procedures as for surgical abortions. That means gaining approval from two consultants.

How does RU-486 work?

It is not a simple process and is not touted by those who favour it as an "easy" option.

The woman must take the drug in the presence of her doctor. About 48 hours later she must return to take a second drug.

The first drug is RU-486. It stops the foetus developing by blocking the hormone progesterone, which is essential to maintain the pregnancy. Without it, the lining of the uterus breaks down and sheds, as it does in a normal menstrual period.

But the RU-486 does not expel the foetus by itself, so 48 hours later the woman must return to the clinic to take prostaglandin, which will complete the abortion by inducing "contractions," forcing the embryo out of the uterus in the manner of a miscarriage.

The woman remains at the clinic for the next four to six hours. Statistics from the United States trial show that most women - up to 90 per cent - abort there, the rest will abort later at home.

The woman must have an ultrasound scan in the next two weeks to make sure the abortion is complete.

The drug is effective only until the pregnancy reaches nine weeks. After that, the body produces higher levels of progesterone and the drug is not powerful enough to stop it.

In a small percentage of cases, the drug does not work and a surgical abortion is needed to complete the procedure.

What are the advantages over surgical abortion?

Surgical abortions are completed at hospitals and special day centres using a vacuum. The woman has either a local or a general anaesthetic and the procedure takes 15 minutes.

Taking RU-486 would greatly reduce the chance of infection or any kind of perforation of the womb or uterus.

Women who have used the drug in Europe and the United States say it gave them a psychological advantage and feeling of control because they took the drug themselves and were not operated on.

It is also seen as a more private experience because, in most cases, the woman is alone when she aborts and the drug is administered by one doctor, as opposed to an operating theatre full of specialists.

It is also popular with women who fear surgery.

Are there any side-effects?

As with all drugs, some women will have side-effects and others will not. Most commonly, women can expect bleeding, similar to a heavy period, which at worst can last for 10 to 12 days. Cramping is also common.

In some women, the prostaglandin causes nausea and diarrhoea.

There are no known effects on long-term fertility, and women surveyed in clinical trials overseas have not reported any problems when trying to get pregnant later.

Where else is it used?

Many European countries offer the medical abortion option. The United States approved the drug for use last September.

France has used it since 1989 for pregnancies up to 7 weeks, and it now accounts for about 30 per cent of all French abortions.

In 1991, RU-486 was approved for use in Britain for pregnancies up to 9 weeks' duration. Sweden was the next country to be licensed to market the drug.

Abortion is an extremely emotive topic, and wherever RU-486 has been considered it has caused controversy.

Hundreds of websites discuss the drug and many carry reports - viewed as propaganda by some favouring the drug - of women's experiences

They talk of women seeing the foetus after it leaves the body, some describing it as partially formed. Some argue that the process takes too long and is traumatic for the women.

In many countries, lobbyists reacted strongly against RU-486, and managed to curtail its availability, even for medical research.

In October 1988, the company that developed it withdrew the drug from the market in France, after some employees had received death threats.

But the French Government promptly forced its return.

In the United States, the Food and Drug Administration banned the import of RU-486 from 1989 until 1993.

It was finally approved last year, but not before presidential candidate - now President - George W. Bush said he thought the decision was wrong.

About 1.3 million surgical abortions are performed in the United States each year.

Opponents of abortion also organised boycotts against Roussel-Uclaf, its German parent company, Hoechst AG, as well as their American affiliates, and have threatened to boycott any other pharmaceutical company making RU-486 available.

The drug may also be effective in developing countries.

The World Health Organisation estimates that about 70,000 to 100,000 women die each year from unsafe, poorly performed or self-induced abortions. Many more women become seriously ill or even permanently impaired.

Even in countries where abortion is legal, safe services are often not available to large portions of the population. Medical abortions may be easier to provide in many developing-country settings than safe surgical abortion services.

What comes next in the approval process in New Zealand?

The head of the drug-control agency Medsafe, Dr Stewart Jessamine, said a committee of clinicians was evaluating the evidence of the efficacy and safety of RU-486.

No decisions had been made yet, but the committee would report to Medsafe, which would then have to decide whether to recommend that the Minister of Health, Annette King, should approve RU-486.

Despite news reports that the committee has approved the drug for limited use, Dr Jessamine said the matter remained with the committee. "We have no timeline as to when it [the approval process] will be finished. It's open-ended."

Mrs King has previously said that there were unlikely to be any safety issues stopping its registration.

She said New Zealand law allowed for medical as well as surgical abortions, so there would be no need for a law change if the abortion pill were approved.

"This drug will give women the choice women in other countries have."