Part two of a two-part series on emergency contraception. Part one dealt with state legislative efforts to mandate that EC be provided to rape victims in emergency rooms.
Condoms break, or slip off, during intercourse. Women forget to take their birth control pills. Couples, caught up in a moment of passion, often addled by intoxication, have unprotected sex. And sexual assaults, ranging from brutal attacks to insidious incidents of date rape, are still all too common.
It all happens. And sometimes --- millions of times every year in the US --- the it becomes a he or a she, an unintended, unexpected, unwanted pregnancy, or worse: an unwanted, or aborted, child.
According to the Alan Guttmacher Institute, a reproductive health research group, about half of the 6.3 million pregnancies each year in the US are unintended, and more than half of those end in abortion.
The social, economic, and emotional tolls associated with unintended pregnancy are immeasurable.
But so, too, are the potential benefits promised by post-coital, or emergency contraception (EC).
Often called "the morning-after pill," EC consists of the same hormones found in birth control pills (estrogen, progestin), but in higher doses. When taken shortly after unprotected sex, the drug works by delaying ovulation, impeding sperm's ability to reach an egg, or altering the lining of the uterus in such a way that a fertilized egg cannot be implanted.
(There are other post-coital emergency contraceptive methods, as well, such as a copper intrauterine device that, if inserted within five days of unprotected intercourse, can be up to 99 percent effective in preventing pregnancy. This method, common in Europe, is used infrequently in the US.)
Doctors have been using high doses of female hormones to prevent pregnancy since the mid-1960s. By the 1970s, EC was widely available in many European countries. And today, over 80 nations have government-approved EC drugs --- from Yemen to the Ukraine, China to Peru.
The US, however, has been relatively slow to embrace this medication. The Federal Drug Administration did not approve an EC product until 1998. And access to EC, much less awareness of it, remains quite limited in this country.
Unlike so many unintended pregnancies, this is no accident. Because EC can prevent the implantation of a fertilized egg --- an effect that, as will be discussed further in this article, may not actually occur --- opponents of abortion rights are against EC, arguing that it can destroy a unique human life.
And, of course, opponents of any method of artificial contraception, such as the Catholic Church, are fundamentally opposed to the use of EC, even for victims of sexual assault. A national survey of all 597 Catholic hospital ERs in the US, conducted last year by Catholics for a Free Choice, found that only 28 percent provide EC to rape victims.
The federal government, particularly the Bush administration and the Republican majority in Congress, has taken a similar approach, promoting abstinence education and ignoring EC, even for rape victims.
Local Rep. Louise Slaughter, a Democrat, introduced a bill last year to provide $10 million for a five-year education campaign about EC. It went nowhere, but will be introduced again this session. Slaughter also co-sponsored a bill last year that would deny federal funds to hospitals that refuse to provide EC to sexual assault survivors. That bill also died.
Critics argue that the availability of EC fosters irresponsible sexual behavior. And they raise concerns that EC medications may increase the risk of breast cancer and heart disease. The FDA recently approved new labels for medications containing estrogen and progestin that are used as hormone replacement therapy for post-menopausal women. The updated labels contain new information reflecting those risks.
Opponents of EC have no research that indicates the drugs pose similar risks to women of childbearing age, but they insist that long-term studies of women who take EC on a regular basis are necessary.
Those fears and moral objections, combined with America's aversion to discussing sex, have helped keep EC, as an op-ed refers to the drug, "the most powerful, and unknown, technology in reproductive health."
A survey conducted in November 2000 by the Kaiser Family Foundation and Lifetime Television found that only 51 percent of US women ages 18 to 44 were aware that a method exists to prevent pregnancy shortly after unprotected sex. And of those who'd heard of such a method, many were unaware that EC drugs are available in the US, that they require a prescription, and that the pills must be taken soon after unprotected intercourse in order to be effective.
In Europe, where EC products have been on the market considerably longer, studies peg awareness of EC at between 75 and 95 percent among women and adolescents of both sexes. Government-sponsored educational campaigns have also had a considerable effect.
Many women in the US confuse EC with RU-486 (now known as mifepristone), the chemical abortion drug. Unlike EC, mifepristone breaks down the lining of the uterus, causing an implanted egg to be expelled, and is effective up to nine weeks after pregnancy.
Those who champion EC charge that this confusion is also no accident.
"Anti-abortion and anti-family planning activists, who believe that life begins after fertilization, have deliberately confused the two drugs by equating the use of emergency contraception with abortion," wrote Heather Boonstra, author of an October 2002 Guttmacher Institute analysis. (The non-profit institute's stated mission is to "protect the reproductive choices of all women and men in the United States and throughout the world.")
Much of the confusion, intentional and otherwise, stems from a confluence of semantics, spirituality, and medicine. Although life technically begins at the moment of conception, a point Catholic theologians and abortion providers can agree on, the point at which pregnancy begins is a murkier matter.
Modern medicine defines pregnancy as occurring when a fertilized egg is implanted in the uterus. Before that happens, and a woman's body begins producing specific hormones in measurable amounts, medical science has no ability to determine whether life exists or not.
But as far as the hierarchy of the Catholic Church and many others are concerned, proof or no proof, the presence of a fertilized egg in a woman's body constitutes pregnancy, and if a fertilized egg is prevented from implanting in the lining of the uterus, that pregnancy has been aborted.
Church officials also say there's much more at stake in the definition of "pregnancy" than the morality of EC. New York State Catholic Conference spokeswoman Kathleen Gallagher expresses the suspicion that efforts to promote EC are a front for "a much broader agenda."
"There's a part of me that thinks this is all about redefining the beginning of human life, to say that human life does not start at conception, it starts at implantation," she says. "And that opens the door for things like stem cell research and cloning and all kinds of bigger and broader agendas. Because if you can say that for that five to seven [day] period where the embryo exists but is not implanted in the uterus yet, if you can say that that being is deserving of no respect whatsoever --- it's not a pregnancy, therefore it's not there, it's not life --- then you can do whatever you want with it."
EC's proponents deny there's a hidden agenda behind their push to make the drug widely available. And they express frustration that anti-abortion groups don't recognize that they share a common agenda: reducing abortions.
The New England Journal of Medicine estimates that EC could reduce the number of unwanted pregnancies in the US by 1.7 million. Similar estimates conclude that wide access to EC could reduce the number of abortions resulting from unintended pregnancies by half --- approximately 850,000 every year. "I say that's disingenuous," says Gallagher, "because if EC acts in a manner to destroy a developing embryo before implantation, it is an abortion, and it's not decreasing abortions, it's increasing abortions."
This particular point, however, may soon be moot.
Sharon Camp is the founder and CEO of the Women's Capital Corporation, a non-profit pharmaceutical company based in Washington, DC, that developed and markets Plan B, one of the two most common EC drugs in the US (Preven, which contains a different hormone mix, is the other). Asked whether EC prevents the implantation of a fertilized egg, Camp says, "We don't think it does."
Though the data hasn't been published yet, Camp says recent findings by Dr. Horacio Croxotto --- an accomplished researcher whose work has helped make EC available even in predominately Catholic Latin American countries --- "indicates that there is, in fact, no post-fertilization effect."
EC's ability to disrupt ovulation and impede sperm seems to be so effective that "it is almost certain that it works all or virtually all of the time before fertilization is complete," Camp says.
If Croxotto's findings are proven, it would make providing EC to rape victims "more palatable," Gallagher says, but given the Church's opposition to all forms of artificial contraception, Catholic opposition to EC would remain.
The anti-choice group Feminists for Life opposes providing EC for rape victims on the grounds it causes abortion, but the group has no position on contraception. All the same, Serrin Foster, the organization's national president, said concerns about possible long-term health risks associated with hormone-based medications would still lead them to oppose it.
EC's effectiveness decreases substantially within a very short time. It can reduce the risk of pregnancy by more than 75 percent if taken within 72 hours of unprotected sex. But Plan B, for example, prevents 95 percent of pregnancies if it's taken within 24 hours.
"For every 12 hours of delay in starting the treatment, the risk of pregnancy goes up 50 percent," says Camp, citing research conducted by the World Health Organization. "So it's really important that women literally be able to use this the morning after."
In nearly 30 countries (including such disparate nations as Albania, Mali, France, and the United Kingdom), and two states (California and Washington), EC is available directly from pharmacists, without a prescription. To get EC, a woman need only answer a short set of simple questions asked to determine whether she's already pregnant. If she is pregnant, taking EC would not harm the woman or her baby --- it would just be unnecessary.
A bill that would make New York the third state to allow EC to be provided without a prescription has been referred to the Assembly's health committee. But the prospects of it passing any time soon are far from certain, considering the fact the bill requiring hospitals to provide EC to rape victims passed the Democrat-controlled Assembly several times in recent years, only to be held up in the Republican-controlled Senate, where it still languishes.
"If the condom breaks on Friday night, that means it has to be available in pharmacies," Camp says. "No women that I know can reach their doctor on a Saturday morning, and get a prescription, and get it filled at a pharmacy."
And that's assuming the woman can find a pharmacy that carries EC. (And a pharmacist willing to fill the prescription. "There is ample anecdotal evidence indicating that individual pharmacists have refused to fill prescriptions for emergency contraceptives, presumably on the grounds that to do so would facilitate abortion," Boonstra wrote in her analysis for the Guttmacher Institute.)
A survey of 170 pharmacies in New York City, conducted last summer by the New York City Council Investigation Division, found that only about half carried EC. Finding EC is easier in Rochester than in the Syracuse area, where access to the drug is "really restricted," says Heather Turner, a nurse at Planned Parenthood of the Rochester/Syracuse Region.
Many pharmacies, including Wal-Mart, cite low demand as the reason they don't carry EC. But unlike other pharmaceutical chains, Wal-Mart's policy is in place at all its stores --- whether demand in a particular region is high or low.
Turner says her office receives between 200 and 300 calls a month from women requesting EC. Women who stop by the clinic can get EC for $25. Going through a pharmacy can cost as much as $40.
Come March, there will be another way for women to access the drug in Rochester. In an attempt to educate women about EC and make it easier for them to obtain it, the University of Rochester's Reproductive Health Program, under the leadership of Dr. Savita Ginde, is initiating a new campaign. Called EC ASAP (After Sex to Avoid Pregnancy), the privately funded project includes an Internet site (www.ecasap.org) and 24-hour hotline --- 866-2ASK4EC (866-227-5432) --- that can provide prescriptions within 12 hours, at no charge, to women of any age, without parental consent.
Later this spring, a nationwide public-education effort spearheaded by the Reproductive Health Technologies Project, called "Back Up Your Birth Control," will be launched. A hotline (888-NOT-2-LATE) and website (www.backupyourbirthcontrol.org) are already established.
And Rochester-area teens who call the newly established, 24-hour Metro Teen Hotline, 888-YOUTH-CALL (968-8422), can get information and referrals for EC. "EC is a resource that teens need to know about," says Sheila Driscoll, director of the Metro Council for Teen Potential.
Women's health groups and medical organizations, such as the American College of Obstetricians and Gynecologists, have been urging women to get advance prescriptions of EC to fill and keep at home in the event of an emergency. And more OB-GYNs are broaching the subject with their patients during regular visits.
"I want to see Plan B in every nightstand in the country," Camp says, "so it's there when the condom breaks."
Toward that end, Camp says her company will submit an appeal to the FDA this year, possibly as soon as March, requesting that Plan B be made available on drugstore shelves as an over-the-counter medication.
The application will be exhaustive, upwards of 15,000 pages, and will detail the results of a host of studies and clinical trials --- including, Camp expects, Dr. Croxotto's findings that EC does not inhibit implantation of a fertilized egg.
Many of the findings included in the Women's Capital Corp. submission run counter to the claims of EC's opponents.
For example, critics say that if EC is made available over-the-counter, women would use the medication incorrectly, failing to understand or ignoring product information provided with the drug. "Who reads all the flyers and inserts?" asks Mary Dwelley, vice president of Feminists for Life of New York. While it's conceivable some women would pop EC pills without so much as glancing at the packaging, Camp says the results of a label-comprehension study conducted in malls across the country show that most who at least read the label on the package, including women of low literacy, understand the instructions.
Camp also notes that the current version of Plan B's packaging won the Health Care Compliance Packaging Council's package of the year award in 2001 --- a citation based on how well a package promotes safe and effective use. "Plan B impressed the judges with its straightforward approach and easy-to-follow instructions," says a news release on the non-profit trade association's website. "As one judge noted, 'A package that says everything it needs to say. Everything the patient needs to know is there...' and several were especially impressed by the clarity of Plan B's instructions."
Another concern critics raise is the possibility women will use EC again and again, as their regular form of birth control, with uncertain effects on their long-term health.
Though that scenario is possible, clinicians at Planned Parenthood who dispense EC, like Turner, say patients rarely come back for a second dose.
For one thing, EC does cause some short-term, but unpleasant, side effects --- basically nausea, and for some women, vomiting or a headache. For another, it's relatively expensive. And once women have had the scare of a near-pregnancy and experienced the side effects of EC, Turner says they're usually quite receptive to exploring other methods of birth control.
But "there's no long-term studies yet that show the effects on, for example, that 15-year-old girl that's going out every week and having sex and then just going to the drugstore to fix it," says Gallagher, of the Catholic Conference. "We don't know what that's doing to her body, much less to the body of a growing embryo inside of her."
"Some of our clinicians are saying that the research isn't in yet, the conclusive evidence is not done," she continues. "Some of it shows [EC] does not have a harmful effect on the unborn, and some of it shows that it does."
Dr. Eric Schaff, a pediatrician and professor of family medicine, pediatrics, and obstetrics and gynecology at the University of Rochester, says he's "surprised" Gallagher and others make those kinds of statements.
"I think you almost have to discount anything they say, because they are biased against all artificial, modern methods of birth control," he says. "The truth of the matter is, emergency contraception's actually been around a long time. It's only been approved by the FDA for several years, but actually, we've been using it in emergency rooms for probably a couple decades now, and the actual medications that are inside them... have been around a long, long time."
Concerns the relatively high doses of hormones in EC pose a health risk are "ridiculous statements to make," Dr. Schaff says, "considering that we're only using very small amounts, compared to [the amounts ingested by] a woman who has to take birth control pills for a whole year."
Camp says that in addition to the studies required by the FDA, her company has compiled post-marketing safety data from around the world that proves Plan B's safety. Those include two studies on adolescents ages 12 to 16, who took EC with no medical oversight, and clinical studies that include over 10 million women who took the same tablets that are in Plan B, either for emergency contraception or as a means of birth control. (The latter group, Camp says, is made up of women who have sex infrequently. Neither the Women's Capital Corp., nor any of the organizations that promote and provide EC, market it as a method of birth control.)
When hearings on Plan B's over-the-counter application take place, perhaps as soon as late 2003, Camp hopes and expects that a wide range of national medical organizations and women's health groups will testify in favor of Plan B being granted over-the-counter status. The American Medical Association and the American College of Obstetricians and Gynecologists are among over 80 medical, public health, and advocacy groups that signed a petition urging the FDA to lift the prescription requirement in February 2001.
Asked whether she thinks the anti-choice, pro-abstinence administration and its allies in Congress and elsewhere will lobby against over-the-counter status for Plan B, Camp says, "I think this might play out in a very interesting way."
Given Plan B's potential to significantly reduce abortions, she says, "it seems to me that the administration might, given its strong opposition to abortion, want to ensure that emergency contraception is, in fact, more accessible."
Well, accidents do happen.