By Tracy Sorensen
The abortion drug RU486, developed in France by Dr Etienne-Emile Beaulieu and manufactured by Roussel-Uclaf, has been successfully used by thousands of French women since 1988. Evaluation of the drug for use in Australia has so far been blocked by the Right to Life lobby.
Right to Life activists hounded Beaulieu when he arrived to promote it here late last year.
Earlier this year, a French woman died of a heart attack after being treated with a synthetic version of the hormone prostaglandin used in association with RU486. Three other French women are known to have suffered non-fatal coronary attacks.
This sobering news prompted ABC radio's Health Report to have a careful look at the issues surrounding the drug on April 15.
As presenter Anne Delaney commented, the controversy created by the Right to Life lobby is unfortunate, because it has "taken the public debate away from asking: is this form of abortion as safe and effective as its advocates claim?"
A discussion of issues surrounding RU486 is now particularly important for women in this country: there is some speculation that the drug is being, or will be, trialled in the coming months by a research unit at Monash University in Melbourne.
Strict controls
In France, where 70,000 women have had non-surgical abortions using this method, RU486 is administered at licensed clinics. The procedure is strictly supervised throughout, and is available only to women up to seven weeks pregnant. Women with histories of asthma, high blood pressure and some other contra-indications, are ineligible.
Before the abortion can go ahead, the woman has to undergo a thorough medical check-up, ultra-sound, a counselling session with a social worker and a day in which to reconsider her decision. She must be judged responsible enough to return for a dose of prostaglandin, which makes the uterus contract and expel the fertilised egg.
The prostaglandin is normally administered three to four days after taking RU486, and some sort of pain-killer is required at this point. Subsequent visits are necessary to check blood levels and to check that the contents of the uterus have been expelled. The French clinics also require that women have counselling about a future contraceptive program.
The procedure is experienced differently by different women. Some have severe pain and/or side effects such as diarrhoea. Some have only light pain and no side effects. A minority — about 15% — abort using RU486 alone, and have no need for a prostaglandin injection.
Because it is still not known whether a pregnancy continued after a duce foetal abnormalities, women are asked to sign a contract promising that they will return to the clinic to continue the abortion treatment. In the 10 cases in France in which women broke their contracts and continued their pregnancies, all the babies have so far been healthy.
While the French health ministry is now conducting an investigation into the recent death, it has already been admitted that there was a direct link between the prostaglandin and subsequent heart failure.
The Health Report's Liz Jensen reported from Paris that one of the questions the inquiry into the death of the 31-year-old woman, in her 13th pregnancy, will examine is whether the guidelines for the use of RU486 with prostaglandin were followed.
"It appears the dead woman was a heavy smoker, which normally disqualifies the use of the injectable prostaglandin, because of the vascular complications which can be involved", said Jensen.
No miracle
At the time of the woman's death, said Jensen, the risks from injected prostaglandin had been known for some time. Beaulieu had begun trials on new forms of prostaglandin which he hoped would be safer.
"Although his initial results are promising, the recent death has sharply reminded doctors working with RU486 and prostaglandin that it's far from being a miracle treatment", said Jensen.
In a telephone interview with Anne Delaney after the French woman's death, Beaulieu confirmed his interest in finding a safer form of prostaglandin.
The injectable form, he said, contained a risk of "response from other arteries, including the coronary artery. So I really prefer something which is distributed into the body more slowly." That is, an oral or pessary form.
Does that mean, asked Delaney, that the prostaglandin in use when the woman died was actually unsafe in association with RU486?
Beaulieu's responses to Delaney's questioning became surprisingly hostile and finally dismissive. He told her that a certain level of risk was normal in medicine. The drug widely in use with RU486 was safe by "general medical criteria". He added that life itself was unsafe: "You might be killed by an automobile accident".
When Delaney asked if women might be being used as guinea pigs in the testing process of these drugs, Beaulieu's temper erupted. "I think we may stop the conversation. You don't what medicine is ... you had better keep that sort of argument for a meeting which is not serious ... Your question is emotional and in fact slightly vicious."
For Dr Lynette Dumble, a senior researcher at the Royal Melbourne Hospital, where she has been doing research on these chemicals, the French woman's death strengthened concerns she had held about the drugs for the past year.
Side effects
"Prostaglandins are very powerful biochemical molecules that have the potential to have serious life-threatening side effects", she told the Health Report. The risks associated with the drug were not eliminated by moving to a pessary, rather than injectable, form.
"Problems remain. Although these drugs may have less opportunity to cause problems within the circulation that are going to be manifest as coronary accidents, they still have the same capacity to have a very high and unacceptable incidence of gastrointestinal side effects, and they have the opportunity to be interfered with by other drugs."
The gastrointestinal and other effects of prostaglandins, she said, were well recognised. These included vomiting, diarrhoea, abdominal cramping, the potential for cardiovascular or cerebro-vascular accidents, interference with protein and carbohydrate metabolism and immunosupression. The pain-killers used in conjunction with them were also cause for concern.
Dumble rejected the suggestion that the only problem revealed by the French woman's death was a failure by her doctor to adhere to guidelines for the drug's use.
"If RU486 was the miracle drug it's supposed to be, it wouldn't require prostaglandin as an adjunct. While we have many reservations about RU486, those reservations are amplified when you put it with a further unacceptable chemical."
The wide range of underlying diseases which would make a woman ineligible for prostaglandin treatment made it less attractive as an abortion method: high blood pressure, kidney disease, epilepsy, cardiac arrhythmia, obesity and heart disorders. Women taking anti-inflammatory drugs are also unsuitable for this kind of treatment.
"I have yet to understand why anyone would contemplate using prostaglandins to terminate a pregnancy, nor why anyone would subject themselves to a termination using prostaglandins", said Dumble. "I think it's one of the most ill-conceived ideas to come out of medical science."