New, Improved and Ready for Battle

By Jill Smolowe

Abortion is never easy. There is the anguish of the decision, the invasive nature of the procedure, and sometimes an ugly confrontation with right-to- life forces lying in wait outside the clinic door. But imagine if abortion could be a truly private matter. Say, something as easy as visiting a doctor, getting a few pills, returning home to swallow them, then checking back a few days later to make sure that all went as planned.

Science and politics are now conspiring to make that scenario -- scary to some, a godsend to others -- a reality, one that could allow abortion to be a truly private decision, albeit still not an easy one. Doctors have reported on a pivotal breakthrough in the use of the controversial French abortion drug known as RU 486: a woman who takes the drug will no longer have to go to a clinic for a follow-up injection to induce contractions. Instead, the entire procedure will involve simply taking two sets of pills. Concurrently, President Clinton has firmly signaled a willingness to reconsider the policies of the Reagan and Bush Administrations, which barred RU 486 from the U.S.

The resulting social upheaval could transform one of the nation's most divisive political debates by making abortion far more difficult to regulate. And eventually it could mean abortions will become simpler, safer and more accessible not only throughout the U.S. but also around the world.

Dr. Etienne-Emile Baulieu, the inventor of RU 486, and his French colleagues describe the successful tests of the no-injection method in the New England Journal of Medicine. "This new regimen," they conclude, "is simpler and potentially allows greater privacy than any other abortion method." In a tough accompanying editorial, the Journal brands efforts to block use of the drug in the U.S. a "disgrace."

Those political barriers, however, are quickly crumbling. Two days after his Inauguration, President Clinton ordered his Administration to "promote the testing, licensing and manufacturing" of RU 486. Until then, the French manufacturer of the drug, Roussel Uclaf, and its German parent company, Hoechst AG, had steadfastly shied away from becoming involved in the American market for fear of infuriating antiabortion activists. But in April, at the instigation of the U.S. Food and Drug Administration, Roussel announced a compromise: it agreed to license RU 486 to the U.S. Population Council, a nonprofit organization based in New York City, which in turn would run clinical tests.

As a result, the abortion pill could become available through a testing program later this year. The Oregon and New Hampshire legislatures have already volunteered their states as test sites, and the FDA is enthusiastic. Says commissioner David Kessler: "If there is a safe and effective medical alternative to a surgical procedure, then we believe it should be available in this country." Although testing a new drug generally takes seven to 10 years, RU 486 has been so widely used in France that U.S. approval could come in as little as two to three years. In the meantime, the testing will enable at least 2,000 women to use the pill.

These developments could change the nature of abortion and even of birth control by eventually permitting the widespread distribution of pills. Though the Supreme Court's Roe v. Wade decision of 1973 made abortion legal in the U.S., the ruling was rendered moot in some places by the dearth of doctors willing to perform the procedure and by the fervor of demonstrators who frightened women away from clinics. Now the battleground may shift to the FDA, drug manufacturers and state legislatures.

"We will not allow anti-choice zealots to deny RU 486 to American women," vows Pamela Maraldo, president of the Planned Parenthood Federation of America. The pro-life forces are no less determined. "When they invent new ways to kill children, we will invent new ways to save them," warns the Rev. Keith Tucci of Operation Rescue National. A coalition of antiabortion forces has scheduled a demonstration in front of the French embassy in Washington on June 18, just three days before Roussel Uclaf holds its annual meeting in Paris.

THE ABORTION DRUG HAS BEEN A source of controversy ever since its invention was announced in 1982 by Baulieu, a French physician who worked as a researcher at Roussel Uclaf. The concept was rather simple: RU 486, an antiprogestin, could break a fertilized egg's bond to the uterine wall and thus induce a miscarriage. An injection two days later of prostaglandin, a hormone-like substance, would force uterine contractions and speed the ejection of the embryo. It took six more years and tests on more than 17,000 women before the French government announced that RU 486 would be made available for public use.

The news spawned furious reaction in the press, an outpouring of outraged letters from Roman Catholic doctors, and a church-sponsored protest through the streets of Paris. A month later, a shaken Roussel Uclaf yanked the drug from the market, saying the company did not want to engage in a "moral debate."

Doctors around the world certainly did. Thousands of physicians had convened that month at a medical congress in Rio de Janeiro, and most of them signed a petition demanding that the French government reverse Roussel's decision. Within 48 hours, Health Minister Claude Evin declared that once government approval had been granted, "RU 486 became the moral property of women," and he ordered Roussel to resume distribution. In 1989 RU 486 was made available to all licensed abortion clinics and hospitals in France. The results proved encouraging, save for a freak incident in 1991 when a woman who was an avid smoker suffered a heart attack while trying to use RU 486 to abort her 13th pregnancy. After that mishap, the government banned use of the pill by heavy smokers and women age 35 and older, who have a greater than usual risk of complications.

Using RU 486 was less painful, carried less risk of infection and gave women greater control over the process than a surgical procedure. Over the next 3 1/ 2 years, 100,000 Frenchwomen used it successfully. Of those who made the decision early enough, about 85% chose RU 486 over surgery. (The pill is currently used in France only within seven weeks of the first day of a woman's last menstrual period; there is now talk of extending usage to a 10-week interval.) Almost all judged the method satisfactory.

Such promising results persuaded both Sweden and Britain to license RU 486; India is testing the drug. China is manufacturing clones that as yet are not widely available. Other countries, most notably Canada, are waiting for the U.S. to take the lead. "The U.S. is the leader in advanced research, the main source of development funds and the heart of worldwide networks that can allow RU 486 to help women everywhere," explains Baulieu.

In 1991 the French began testing the new method of using RU 486 that does not require going to a clinic for a follow-up shot. An oral prostaglandin, commercially marketed as Cytotec by the American manufacturer G.D. Searle, enabled women to abort simply by swallowing a combination of pills. The efficiency rate rose from 95.5% to 96.9%, and the speed of the procedure improved. In 61% of the cases, the uterine contents were expelled within four hours after taking Cytotec, in contrast to 47% in the case of prostaglandin injections. Although there were instances of nausea and diarrhea, which are also common side effects with injections, those who took the pills reported considerably less pain. "Women tolerate it much better," says Dr. Elisabeth Aubeny of the Broussais Hospital in Paris, a testing ground for RU 486 in 1984. For French taxpayers, who foot 80% of the bill for each abortion through their national health-care system, there is also an advantage: a dose of Cytotec costs only 72 cents, vs. $22 for the prostaglandin shot.

Once again, controversy erupted. When Baulieu first began experimenting with RU 486 in combination with an oral prostaglandin, Roussel balked. As a result, Baulieu had to persuade French public health officials to defray insurance costs. After preliminary trials, the government compelled Roussel to participate, arguing that the proposed testing of an oral prostaglandin was important for women. Although Searle raised no objections, its executives remain uncomfortable about being linked to the abortion business. "Searle has never willingly made ((Cytotec)) available for use in abortion," a company official wrote in a letter to the Wall Street Journal in February. "It is not Searle's intention or desire to become embroiled in the abortion issue." Searle's reservations echo that of Hoechst president Wolfgang Hilger, who has been open about his ethical objections to RU 486.

The uses of RU 486 could extend well beyond dealing with some of the 37 million abortions carried out around the globe each year. European studies have shown that it is an effective morning-after pill, inducing less nausea or vomiting than other drugs used for the same purpose. There are also indications that RU 486 can combat endometriosis, a leading cause of female infertility, and fibroid tumors, a condition that often necessitates hysterectomy. Thus the same drug that can help some women end unwanted pregnancies may enable others to bear children. Assorted studies have found that RU 486 may also combat breast cancer and Cushing's syndrome, a life- threatening metabolic disorder.

Despite the many potential uses for RU 486 and its effectiveness as an abortion method, efforts to legalize it in the U.S. have met with repeated failure. Last year a pro-choice group called Abortion Rights Mobilization decided to force a court challenge of the import ban imposed on RU 486 by the Bush Administration in 1989. The organization helped Leona Benten, a pregnant 29-year-old California social worker, fly to England, obtain a dose of RU 486, then try to bring it into the U.S. through New York City's Kennedy Airport. Customs officials seized the pills. The ensuing legal battle went up to the Supreme Court, which refused to order the government to return the pills. Benten subsequently had a surgical abortion.

The Clinton Administration has not yet revoked the ban, but its significance is minor. Because distribution of the pills is tightly controlled in Europe and they cannot easily be purchased and imported, the real issue is how quickly the Administration will encourage the manufacture and marketing of the drug in the U.S.

When the pill does become available in America, abortion will not be as easy as going to the doctor and taking some of the tablets home -- at least not right away. In France, for instance, a woman is required to pay four visits over a three-week period to one of the country's 800 licensed clinics or hospitals. The first step is a gynecological exam. Doctors make sure the pregnancy is in its early stages, and a social worker or psychologist discusses with her the decision to abort. Then the woman is sent home for a weeklong "reflection" period.

When she returns, she is required to sign a government form requesting the abortion. She must also sign a Roussel form that confirms her understanding that a malformed fetus might result if she does not see the abortion through to completion. (As yet no defects have been found in the small number of babies born to women known to have taken RU 486.) At that point, the woman is given three aspirin-like RU 486 tablets, each containing 200 mg of the drug. After swallowing the pills, she again goes home.

Except in the rare instance where the RU 486 is enough to induce a quick abortion, the woman must take two 200-mg Cytotec pills within the next 48 hours. Because the timing is critical and doctors want to monitor the effects of this contraction-inducing drug, women are required to return to the clinic. They are encouraged to remain for four hours, even if the expulsion happens earlier. Eight to 10 days later, they must pay a final visit for an exam to make sure no part of the egg remains.

Even with all these steps, the procedure seems blessedly simple to most women. "Taking a pill seems far less murderous and violent to the child than using a vacuum cleaner," says a 31-year-old woman who has had both types of abortion. "You feel so helpless when they put you to sleep and you know they're going to be using their tubes and knives on you." Some women, however, become traumatized by the thought of performing an abortion with their own hand. After her experience with RU 486, Joelle Mevel, 34, vows that if there is a next time, she will choose surgery. "I spent the whole time worrying that I would see the child in the basin, that I would be able to | discern something human in the blood," she says. "I would rather have gone to sleep and awakened later knowing it was all over."

American abortion-rights advocates talk of boiling France's time-consuming RU 486 procedure down to just two visits to the doctor. It would be possible, though controversial, for the government to let RU 486 be administered in any doctor's office or possibly even by trained nurse practitioners. If that happened, many women could avoid running a gauntlet of protesters outside an abortion clinic. Still, it won't take all the anguish out of the procedure. "It's insulting to women to say that abortion now will be as easy as taking aspirins," says Baulieu. "It is always difficult, psychologically and physically, sometimes tragic."

With reporting by J. Madeleine Nash/Chicago, Frederick Painton/Paris, Janice C. Simpson/New York and Tala Skari/Paris