"I have argued that the morning-after pill is one of the best-kept secrets in America," said David Grimes, professor of obstetrics-gynecology at the University of California at San Francisco.
The morning-after pill - sometimes called emergency contraception or postcoital contraception - is nothing more than a birth control pill named Ovral, made by Wyeth-Ayerst Laboratories in St. Davids.
A woman who takes two Ovral within 72 hours of unprotected sexual intercourse and two more tablets 12 hours later is highly unlikely to get pregnant, researchers have found. By doubling the number of tablets, the same pregnancy prevention can be achieved with lower-dose birth control pill brands Lo/Ovral, Nordette, Levlen, Triphasil and Tri-Levlen.
It's ironic, say morning-after pill proponents, that this last-resort back- up to contraception has remained little known and less used, while a furor has swirled around efforts to distribute the French abortion pill RU-486.
During almost 20 years since the first studies on the morning-after pill were published, the economics of pharmaceutical manufacturing and the politics of abortion have combined to perpetuate its obscurity.
The medical establishment says the morning-after pill is contraception
because it prevents pregnancy, but anti-abortion advocates say it's abortion
because it can block a fertilized egg from implanting in the womb.
The only places the morning-after pill has been routinely prescribed are hospital emergency rooms, where it is standard treatment for rape victims, and
college health centers, according to family planning and reproductive health experts.
But this may be changing, partly because of changing attitudes at the very top, in the White House.
Officials of the Title 10 program, which provides federal funding for family planning clinics serving 4.3 million low-income women, say they've made it clear that they will not question physicians who prescribe the morning- after pill.
Previously, Title 10 adhered to federal regulations that forbid Title 10 agencies from prescribing a drug for an unlabeled use. The birth control pill is not labeled for use in emergency contraception.
Equally significant, Felicia Stewart, an outspoken proponent of the morning-after pill, has been named to a top federal position in which she will oversee Title 10.
"This administration is committed to supporting women's health and reproductive health issues," said Stewart, a California reproductive health expert and author.
On another front, the American College of Obstetricians and Gynecologists held a news conference on the morning-after pill at its annual convention this month. The briefing coincided with the stunning news that the French manufacturer of RU-486 had donated its patent rights to a nonprofit group. The unusual arrangement, encouraged by the Clinton administration, clears the way for testing and licensing RU-486 in the United States, probably within two years.
"There has been a clear lack of information from physicians to patients about the availability of postcoital contraception," said Philip Goldstein, chairman of women's services at Washington Hospital Center in Washington and a speaker at the news conference. "Whose fault is it? At this point, I don't care. We just need to inform women."
Researchers have theories about how Ovral works. They believe that the combination of estrogen and progestin disrupts a woman's hormonal patterns, preventing pregnancy either by blocking fertilization of the egg by the sperm or by keeping a fertilized egg from implanting in the uterus. Implantation doesn't occur until about a week after fertilization, so the pill works during this window of opportunity.
The most common side-effects of the treatment are temporary nausea or vomiting, experienced by about one-third of women. Less common are breast tenderness and headaches.
Like the morning-after pill, RU-486 disrupts normal hormonal patterns. Although RU-486 is best known for its ability to cause nonsurgical abortions in the first seven weeks of pregnancy, studies in the United Kingdom have shown that a lower dose, taken within five days of intercourse, can prevent implantation. Grimes, the San Francisco ob-gyn, is testing RU-486 to determine the precise dosage needed for use as a postcoital contraceptive.
Many women don't realize immediately after intercourse that they've put themselves at risk of pregnancy, but many do. They know their birth control method failed or that they used it incorrectly or that they had unprotected sex at a fertile time of the month.
James Trussell, a population researcher at Princeton University, has worked with Stewart to estimate how many women are potential candidates for the morning-after pill and what would happen if they used it.
They began with data showing the pill is 75 percent effective - that is, it reduces a woman's chances of becoming pregnant at her most fertile time from about 25 percent to about 6 percent. Estimating how many women might use it, they concluded that it could cut in half the 3.5 million unintended pregnancies and the 1.6 million abortions that occur each year in this country.
To try to make the morning-after pill more accessible, these researchers developed what they call an "emergency contraceptive kit" for physicians to give female patients to save for emergencies. The kit includes condoms, instructions for using the morning-after pill, and warnings for diabetics or other women who should not use it. Since the pill is a prescription drug, a physician must add the pills to the kit.
About 10,000 kits have been sold so far, despite some confusion when it was first advertised in March through a mass mailing to 20,000 health professionals.
"From a marketing point of view, we underestimated the lack of awareness," explained John Stanley, vice president of Bridging the Gap Communications Inc. in Decatur, Ga. "After the mailing, we got lots of questions asking: What is it (the morning-after pill)?"
Even on college campuses, the secret of the morning-after pill isn't completely out. Robert Hatcher, a professor of obstetrics-gynecology at Emory University in Atlanta, said he asked 100 medical students what they would do if a patient came to them on Monday, afraid she had accidentally gotten pregnant over the weekend.
Only 15 students suggested the morning-after pill, Hatcher said.
The fundamental reason for this veil of ignorance, everyone agrees, is the fact that drug companies have not sought approval from the federal Food and
Drug Administration to label the birth control pill as a morning-after pill. Without FDA approval, drug companies cannot advertise this use, so awareness among doctors and the public remains limited.
Still, the morning-after pill is described in numerous medical textbooks, so it's not clear how many physicians who are familiar with it simply don't tell their patients about it. Some physicians may fear malpractice suits - even though an estimated 45 percent of all drug prescriptions are for unlabeled purposes, and no studies of the morning-after pill have found serious adverse effects in women or newborns.
An FDA official said the agency has informally encouraged drug companies to seek approval of the morning-after pill.
But drug companies aren't likely to, because of the lack of financial incentive. Seeking approval would cost money, while selling four or eight pills to non-repeat (or rare-repeat) customers probably wouldn't be very profitable.
"It would take a substantial development effort to launch this new purpose," said Wyeth-Ayerst spokeswoman Audrey Ashby. "Like any company, we've set our research priorities."
Besides these economics, the increasingly bitter controversy over abortion has kept the morning-after pill in obscurity.
"When it (the morning-after pill) works to prevent implantation, from the pro-life point of view, that is an abortion," declared George Isajiw, a Lansdowne physician and board member of the Philadelphia Catholic Physicians Guild.
In his opinion, many doctors do not prescribe the morning-after pill
because they oppose abortion.
Maggie Bridwell, student health center director at the University of Maryland in College Park, offered another opinion: "They're worried someone might raise a ruckus."
Such worries influenced Roussel-Uclaf, the French manufacturer of RU-486, to give its valuable patent rights to the Population Council rather than risk boycotts of its other products by anti-abortion advocates.
A few medical objections also have been raised against the morning-after pill: Some women might take risks with contraception if they knew they could just pop a pill to prevent pregnancy. And women who overuse the method might expose themselves to excessive levels of estrogen, which has been linked to breast cancer.
Stewart has ready rebuttals: Women, especially teenagers, are already taking contraceptive risks, she says. When women seek a prescription for the morning-after pill, clinicians can use the opportunity to teach them the importance of conventional contraception. Women aren't likely to casually use the morning-after pill anyway because it can cause nausea. If they do, the health risks of the morning-after pill are outweighed by the health risks of unintended pregnancy.
"The American public wants contraception and prevention (of unintended pregnancy)," Stewart said. "We don't need to be so afraid."