The Pill Arrives

The FDA gives women a new abortion choice. But will they choose it? And will doctors be willing to take the heat?

Did the landscape of abortion in America really change forever last week? Come take a tour. Dr. Stephen Grillot practices family medicine in Colby, Kans. In his town, a woman looking to end a pregnancy would need to drive 300 miles to Wichita to find the nearest abortion clinic. That's if she had the time and means to get away and was willing to pass the protesters to enter a building that has been bombed out and fired upon.

Last Thursday, when the Food and Drug Administration approved the sale of the abortion pill mifepristone--long known as RU 486--it put fewer restrictions on its use than anyone had expected. Virtually any family doctor or ob-gyn can now prescribe the two-drug regimen, provided he or she has some surgical backup arrangement if it fails to end the pregnancy or there are side effects. No more clinics; no more waiting until pregnancy is far enough along for surgical abortion. Just a series of pills taken over a period of days to induce a miscarriage. Advocates hailed it as the greatest breakthrough in women's health since the Pill and vowed to have mifepristone in doctors' hands within a month.

Grillot supports a woman's right to decide whether and how to end a crisis pregnancy. But he will not be offering this drug. Pro-life sentiment runs strong in his town. "My partners would have a fit if I used it in my practice," he says. "It will be used in the bigger cities. But in a small town like this, it would be hard. Everybody would know about it."

If only doctors in the big cities use it, what will really have changed? Last week's much heralded FDA decision--the denouement of years of controversy over a pill developed in France two decades ago--was not hailed as a triumph just for urban women who already have choices. Mifepristone proponents predicted that when it finally reached the market, it would privatize the whole experience of abortion, take it out of the streets and the courts and the Congress and into the privacy of the home and the doctor's office, enabling women to end a pregnancy before the embryo even resembles a fetus, much less a child. It would change medicine by offering a less invasive procedure; change politics by moving abortion earlier in pregnancy, when fewer people have moral qualms; change, above all, the access, since protesters wouldn't know where to set up a picket line if abortion became part of mainstream family practice.

Maybe the doctors who fell so silent last week in the face of such dramatic medical news were just waiting to learn more themselves, study the legal and financial implications, weigh the ethical ones, of offering a new kind of abortion to their patients. But for all the cheering of abortion-rights activists, it could be a long time before we really know what difference the marketing of mifepristone will make. Opponents vow to take to the streets in force, target the doctors who agree to prescribe it, gouge the conscience of anyone willing to wage chemical warfare on women and children. They call the drug baby poison and are enlisting allies in Congress to try to ban it, threatening boycotts of whoever makes it. As for the doctors faced with a decision, the greater the heat, the greater the fear. It's understandable that they could take a while to make up their mind--which means that what really changed last week may be more the promise of abortion in America than the reality of it.

Most people stay in the balcony of the abortion debate, looking down on the drama from the crowded middle seats. Their feelings tip and tilt according to circumstance and conditions: Was there a waiting period, counseling? If it's a teenager, do her parents know? Surveys find that 65% of people accept first-trimester abortion, but 69% oppose anything later than that. The laws reflect the public ambivalence of a country that wants abortion to be available but not easy. And pro-life forces have done everything in their power to make it harder, by focusing on the unimaginably hard cases. How can you abort a fetus developed enough to have fingernails, they ask?

In fact, for all the moral and legal wrangling, science has been the pro-life camp's best ally over the past decade, as doctors steadily moved up the point of viability, saving premature babies as young as 25 weeks, 24, 23. Sonograms as clear as Christmas cards let parents see their babies suck their thumbs in utero. Better prenatal testing has built greater awareness of how, and how quickly, a fetus develops--all of which may have fueled the discomfort with abortions that occur when a pregnancy is well along.

You could argue that the most important thing that happened last week was that science changed sides and put its power to work for the pro-choice team as well. The abortion pill shifts the focus from the latest stage of pregnancy to the earliest, when the entire embryo is the size of a grain of rice. For abortion-rights activists scarred by five years of fighting over "partial birth" abortions, that is where they prefer the public debate to take place.

It was little wonder that Al Gore brought it up every chance he got, wouldn't let it go in his chat with Larry King last week, even as George W. Bush called the FDA ruling "wrong" and promised to build a "culture of life." The next President, Gore warns, could appoint as many as four Supreme Court Justices, enough to bury Roe v. Wade forever. Just in case any swing-voting women out there are taking abortion rights for granted, Gore noted that "I support a woman's right to choose; my opponent does not."

It has been years since a Democrat could promise anything more than to hold his ground on the abortion issue. In the meantime, abortion has become steadily less available in the U.S. There are no providers at all in 86% of U.S. counties; 91% of abortions occur in easily targeted clinics, and 1 in 4 women has to travel at least 50 miles for treatment. Doctors still see women who try to induce miscarriage by taking quinine pills, or provoke their boyfriends to jump on them, or come into emergency rooms with electrical cords hanging out of them.

Since 1988, when mifepristone was first approved in Europe, abortion-rights activists have fought to introduce it to the U.S. as the first alternative to surgical abortion. The FDA under President Bush banned its import in 1989, citing safety concerns. On his third day in office, President Clinton lifted the ban and ordered the FDA to begin safety testing. Developer Roussel Uclaf, meanwhile, sick of getting hammered by both sides, donated U.S. patent rights for mifepristone to the Population Council, a nonprofit reproductive-rights group founded 50 years ago by John D. Rockefeller. The council had to steer the drug through U.S. trials, file the applications for approval, weather the political storms and lawsuits that followed every step of the process. No wonder it took nearly eight years.

Even advocates who had been hoping for this ruling for years were surprised at how few restrictions came with it. Though the agency had ruled mifepristone "safe and effective" back in 1996, it took four more years to find an acceptable manufacturer and figure out distribution. Last summer the FDA hinted that it was thinking of playing very tough: that only doctors who currently do surgical abortions would be allowed to prescribe mifepristone; that there might be some special certification required, or a rule that the doctor have access to an emergency room less than one hour away. All of that would have made the approval of the pill almost meaningless; abortion would still be unavailable in vast swaths of the country.

But last week's ruling said that to prescribe the drug, a doctor must be able only to date the pregnancy conclusively and, if anything goes wrong, provide surgical intervention, either to complete the abortion or to stop heavy bleeding. "All this says is that physicians prescribing this should be good doctors," says Dr. Wendy Chavkin, an ob-gyn at Columbia School of Public Health. In 1998, when the Henry J. Kaiser Family Foundation polled family practitioners about their interest in using mifepristone once it was approved and available, 45% of doctors responding said they were "very" or "somewhat" likely to use it--even though only 3% of them had performed surgical abortions.

But at the time of the survey, the drug was still crawling through the approval process. Now that it has been cleared, the real test begins. A doctor's decision to offer the drug rests on a complex calculation. Many may read the FDA language about the pill's being limited to "physicians who can accurately determine the duration of a patient's pregnancy" to mean that they should do this with ultrasound--and most do not have ultrasound equipment in their office. Likewise, special training and extra malpractice insurance might dampen enthusiasm for offering the drug. Doctors will have the extra burden of locating those women who do not return for the final visit to make sure their pregnancy has been terminated. Were there to be an increase in complications or birth defects associated with mifepristone (none have yet been reported), insurance companies would probably adjust their rates accordingly.

And even though mifepristone has won federal approval, the current patchwork of state laws still applies. Some states require any doctor who performs abortions to register with the state and report every procedure he does. Some have rules about the design of offices where abortions occur or require that the fetal remains be examined by a doctor. In North Dakota, the law requires that remains be buried or cremated.

Apart from the logistical and legal hurdles, there are the moral and psychological ones. Doctors who don't do abortions on principle are not likely to change their mind based on the method. Those who approve of abortion under certain circumstances will still want to see how mifepristone works, how widespread its use becomes and whether a backlash could endanger their entire practice. Dr. Thomas Purdon, president-elect of the American College of Obstetrics and Gynecology, spoke with a lot of his colleagues last week after the news broke and found them both receptive and cautious. "The medical abortion is less traumatic and done so much earlier in a pregnancy that physicians can rationalize the fact that they are not disrupting a more advanced pregnancy," he said. "The emotional and ethical barriers are easier to cross."

But he and others still found that many doctors simply don't want to get involved in a battle that has left the country divided and some of their colleagues dead. They have heard of the doctors and nurses who, when they arrive for work at a clinic, confront protesters who refer to their children by name. "Many doctors feel if someone else provides it, why bother? Somebody else will do it," observes Dr. Lisa Tucker, who works at the Florida clinic where Dr. David Gunn was murdered seven years ago. Experts liken this debate to the one over physician-assisted suicide: "A lot of doctors believe in it but say they won't do it themselves because they don't need the hassle," says George Annas, a medical ethicist at Boston University School of Public Health. "They don't want to get involved in a public debate."

There are already cautionary tales arising from the early clinical trials. A family doctor in a rural, conservative town in the Northeast had a pregnant 18-year-old patient who wanted an abortion. He did not do surgical abortions, but he did offer her a medical alternative, using not mifepristone but the cancer drug methotrexate, which was also being tested in trials as an abortion inducer. The doctor, knowing that his nurses opposed abortion, administered the drug himself. That was in January 1998, and by Easter, the nursing staff had heard what happened and a nurse resigned. The local church got involved; at the Easter service the pastor asked worshippers to "pray for the doctor and the other souls" at the medical center. Soon petitions poured in. The state medical board investigated and found nothing wrong but issued a reprimand anyway. Insurers informed the clinic it was not covered for abortions, although the only classification was for surgical abortions. Some patients dropped the clinic, and some donors stopped providing funds.

Even if more doctors offer mifepristone, there remains the question of how many women will choose it. The women who took part in clinical trials represented a cross section of society, with a range of reasons for opting for the drug. Asian women were twice as likely as others to choose mifepristone because they considered it safer; white women were twice as likely to use it as nonwhites because they considered it more natural. More educated women chose it because they wanted to show support for broader choices and because they wanted to avoid surgery. Nearly all the women in the study found the drug highly acceptable and would recommend it to others.

Yet the women in the trials were a self-selected group. For the general population, the pill is a new option, but not an easy one. It is not likely to be less expensive than surgical abortion, given the number of doctor's visits and the possibility that the pills will sell for $200. And it is not as though you take a pill and the baby disappears. Medical abortion, as opposed to surgical, is a multistep process, requiring three visits to the doctor over a period of two weeks. The first visit is to make sure the pregnancy is still early enough for the pill to be used safely, which will automatically exclude many women who don't realize they are pregnant until more than 49 days after their last period. Two sets of pills are required--first mifepristone, then, two days later, misoprostol, to trigger contractions and expel the fetal tissue--and that can cause nausea, heavy bleeding and painful cramping. After about 12 days, a woman must return to the doctor to confirm that the abortion was successful.

Some doctors see a psychological advantage to the new procedure by giving patients the sense that the process is more natural because their body is doing the work, not a surgeon's vacuum. "My patients are usually under a lot of stress and are trying to find the appropriate action to take," says Dr. Carolyn Westhoff, a professor of obstetrics, gynecology and public health at New York's Columbia University, who has conducted many of the mifepristone trials. "For someone who feels backed in a corner, it is good to feel you have a choice."

That is not to say mifepristone makes abortion morally simple. In fact, some doctors argue the opposite. Carole Joffe, a sociologist of reproductive health and visiting professor at Bryn Mawr College, believes mifepristone could make abortion "more emotionally wrenching because women who take mifepristone experience something like a miscarriage, where they have to confront the product of conception." Women who undergo surgical abortions don't usually see the fetus. With mifepristone, a woman typically passes large blood clots in the toilet within 24 hours after taking the second pill.

"You have to walk around," the nurse had told Chaya, 44, a divorced mother of two teenagers, who took the pills during the clinical trials. "Keep busy so you don't get depressed." Chaya cried when the doctor administered the first dose. She took the second set of pills at home, with her sister, and began to feel cold before the bleeding started.

"I know nothing about these things," she says, recalling the prospect of getting an abortion. The idea of surgery frightened her. "I was so scared. I was afraid of the risks." Her boyfriend had told her about mifepristone; she liked the sound of it. "Without surgery it would be less risky," she thought, "like having a period." But he had also offered to marry her, urged her to keep the baby. Her children said they would baby sit. She didn't think it would work. "I've already had my babies," she said.

The bleeding continued all afternoon, but the pain was not crushing. By evening it was mostly over. Like many women, she compares the experience to a bad period.

After years of steadily declining abortion rates in the U.S., pro-life advocates fear a reversal if the pill encourages women to view abortion more casually. For these activists, the point of the debate about late-term abortion was to draw tight the line between abortion and murder. Mifepristone, argue its supporters, makes abortion look more like birth control, "more like a standard medical treatment than something that has been marginalized and ghetto-ized," notes Boston University ethicist Annas. But even greater availability and a higher comfort level among patients do not mean the total number of abortions will necessarily rise. During the decade that the pill has been available in France, more and more women--now 29%--have chosen medical over surgical abortion, but the availability of the drug did not drive up the total number of abortions. On the other hand, surgical abortion in France does not carry the same stigma, the issue is not as divisive as in the U.S., and so the introduction of a medical alternative may have a greater impact here than abroad.

By focusing debate on the very earliest weeks of pregnancy, mifepristone does force pro-lifers to refine their arguments. "It's a whole new ball game for people in this movement," says Judith Brown, president of the Virginia-based American Life League. She hopes to convince people that even though the fetal material being expelled doesn't look like a baby, it is still an unborn child. "We will have to personalize the egg," she says. By the time a woman misses a period, sees her doctor and confirms the pregnancy, opponents note, there are already distinct signs of life. "Brain waves can be picked up as early as six weeks," says Laura Echevarria, communications director of the National Right to Life Committee. "We will be stepping up our efforts to educate people about the early development of the unborn child."

Abortion foes also plan to drive home the medical risks associated with the drug, especially if it is misused or winds up circulating through an Internet black market. "It can be banned state by state or by Congress," says Michael Schwartz, administrative assistant to Representative Tom Coburn, a doctor from Oklahoma who last year tried to bar the FDA from spending federal funds to develop any kind of abortion drug. Schwartz thinks it is inevitable that the drug will be prescribed for women who are more than seven weeks pregnant, that there will be a lack of patient compliance and that someone will die from it. "These are predictable consequences, even with the guidelines," he says.

But mifepristone's defenders counter that carrying a baby to term is six times as dangerous as ending a pregnancy, whether surgically or medically. There are certainly risks if women were to use the drug without adequate supervision, but the FDA guidelines aim to limit that possibility: a patient will receive written instructions on taking the pills, and must sign a statement swearing that she has read them and that she will agree to a surgical abortion if the medication fails.

Though the abortion debate could now land squarely back in the middle of the presidential campaign, both candidates mainly used last week's announcement to reinforce longstanding positions. While the next President can't reverse the FDA outright, he could pick an FDA commissioner and a Health and Human Services Secretary who would raise safety questions and try to tighten distribution--with the goal of making medical abortion just as hard to get as surgical abortion.

But the real battle is still likely to be waged in the streets, for now. Antiabortion activists may not change anyone's mind about the pill--but they could have an effect if they persuade enough doctors that entering this minefield is dangerous to their health and practice. The tactic has worked well for years now; in much of the country, Roe v. Wade might as well not exist, and the only way the abortion pill changes that is if doctors everywhere decide to offer it. "There are a lot of doctors who feel very strongly that women have a right to make a choice but are unwilling to wear flak jackets to work," says Dr. Diana Dell, an ob-gyn specialist at Duke University Medical Center. "I don't know where it will go." --Reported by Ann Blackman, Polly Forster and Dick Thompson/Washington

For a behind-the-scenes look at how the Clinton Administration insulated itself from the controversial drug-approval process, go to time.com