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
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
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
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
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
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,"
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