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19 - 25 October 2000
Issue No. 504
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Tough to swallow

By Nyier Abdou

Many thought the day would never come -- and for some, the timing could not be more divine. On 28 September, the US Food and Drug Administration (FDA) approved the controversial drug mifepristone, commonly known as RU-486, for use as a non-surgical method of abortion. The decision was welcomed by the pro-choice movement and inflamed pro-life organisations; but the biggest headaches to be had are at the Republican and Democratic campaigns, who have sought to keep the volatile topic of abortion off the election agenda.

It's been a long road for RU-486, first discovered by the German company Hoechst AG and developed as an abortifacient in France by the pharmaceutical company Roussel-Uclaf. Mifepristone (the drug's chemical name) was first approved for use in France in September 1988 and its use has been contentious ever since, even as it was approved in the United Kingdom (1991) and Sweden (1992). Since its illustrious introduction, mifepristone has been used in over half a million abortions in Europe.

It was the 1973 landmark case Roe v. Wade that ruled elective abortions (abortions that are not medically required) to be a constitutional right of American women. The staggering ruling changed the political landscape by effectively legalising abortion, but also by putting a large amount of responsibility for further regulation in the hands of state governments. Even though abortion is not technically illegal, state legislatures have enacted regulations that in practice render surgical abortions unavailable in a large part of the US.

In 1989 the Bush administration banned the importation of RU-486, but the ban was lifted in 1993 by the Clinton administration. Roussel-Uclaf clearly felt expanding to the US was a battle not worth fighting; but in a gesture of good will the company donated exclusive US distribution rights to the Population Council, a New York-based non-profit research organisation, in 1994. Mifepristone was essentially approved by the FDA as far back as the summer of 1996, but manufacturers courted by the Population Council were understandably squeamish about signing on. Exasperated, the council finally found a distributor in the New York-based Danco Laboratories. The small pharmaceutical company, set up in the last few years by private investors, will distribute the drug under the brand name "Mifeprex."

In an unprecedented move, the FDA approved the drug for distribution without releasing the name of the manufacturer, stating concerns for the company and its workers. But when the news broke last week that the drug would be manufactured in China by the Hua Lian Pharmaceutical Co, temperatures rose even higher, with anti-abortion groups railing against the China connection as a further outrage. Pro-lifers have cited China's imposition of compulsory abortions, the country's poor human rights record and concerns over the quality of production as strident objections to the choice of manufacturer.

The use of mifepristone is considered a safer and less traumatic way to abort a pregnancy in its early stages, since it avoids complications that can arise from invasive procedures or anaesthesia. But perhaps the most significant facet of non-surgical abortion -- commonly referred to as medical abortion -- is that it takes abortions out of clinics and medical centres and into the privacy of a doctor's office, where anti-abortion protesters cannot make themselves known or felt. Pro-life organisations denounced the FDA ruling, saying that the method is unsafe and will increase abortions in the US. The real fear, however, is that the mifepristone regimen is seen as an easy solution to unwanted pregnancies; the implication being that women who might have thought twice about aborting their baby may be more ready to do so when they realise it only requires swallowing a few pills.


Anti-abortion protesters use theatrics to get their point across. One holds a doll, another is dressed as the Grim Reaper
photo: Ap
Many women have expressed unease about the side effects of the regimen, which include prolonged bleeding, abdominal cramps and nausea, and pro-life campaigns have seized on this fear. Yet evidence shows that women are extremely comfortable with the method. The Population Council found that of the 2,121 women who participated in the study, 96 per cent said they would recommend it to others and 91 said they would choose it again if necessary. "In terms of comparing methods, medical abortion is not meant to replace surgical abortion," Population Council spokeswoman Sandra Waldman told Al-Ahram Weekly. "It is an option. Some women will want it, some will not want it."

One interesting implication of the FDA decision is a nod of credibility toward medical abortions from the hyper-cautious US. The decision could reverberate throughout the Third World, where international women's health organisations struggle with cultural taboos and limited facilities. "Now that FDA approval has been received, countries like Tunisia and Turkey are likely to make the medical abortion option available as an alternative to surgery," regional Population Council director Barbara Ibrahim told the Weekly.

The FDA has approved the use of mifepristone for pregnancies up to 49 days, about halfway into the first trimester. The regimen, which couples mifepristone with the drug misoprostol (which is used in the treatment of ulcers and induces uterine contractions), is administered in three visits to a physician: the first to receive information, sign consent forms, and swallow a dose of mifepristone; the second, a few days later, to receive the misoprostol; and the third, two weeks later, to ensure that the fetus has been expelled.

The FDA decision came only a week before the first presidential debate between Republican hopeful George W Bush and Vice President Al Gore. Bush is pro-life, but supports abortions in cases of rape, incest and when the pregnancy endangers the health of the mother. Gore is pro-choice, but the Clinton administration's veto of the bill banning so-called partial-birth abortion (a largely political term used in reference to later term abortions) is considered risky with the centre vote -- a crucial player in this year's election. Consequently, both candidates have shied away from the issue of RU-486, most notably Bush, who announced early this month that he did not feel he could seek to overturn the FDA's decision and would not take steps to cease the drug's distribution.

Bush's initially weak response to the decision shocked many, but his motivation was perhaps unintentionally clever. Knowing that Gore is equally loath to raise abortion to a campaign issue, Bush is best leaving the beast to be contained by Republicans in Congress. Bush has obviously reasoned that it is too late to stop mifepristone from entering the market; he can only limit how it is used. Bickering about such regulation can in itself be dangerous, as it legitimises abortion by shifting the debate to how and when -- not if at all.

The coming months will tell what kind of social impact the availability of an abortion pill will make on the American public. Gloria Feldt, president of Planned Parenthood Federation of America, couldn't use enough superlatives to describe the moment, calling it historic and likening the advent of chemical abortions to the arrival of the birth control pill in America. But how significant is the FDA's decision in real terms and not ideological ones? Legislation can effectively render the decision a non-event by restricting its use to, say, doctors who are prepared to intervene with the surgical procedure on the premises. This would make Mifeprex's availability equal to surgical abortions and take away the drug's key advantage: privacy.

Essentially, the pro-life movement must accept mifepristone before it can nullify it; a fact that is surely indigestible to hot-headed conservatives and pro-lifers. As Danco readies to launch its imminent campaign to market Mifeprex, one wonders if it will be bang or a whimper.

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