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.
It
happens.
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.
This article appears in Feb 26 – Mar 4, 2003.
