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 The case, to be heard on March 25, is one of the most closely
watched of the year, partly because it taps into the enduring debate
over abortion and reproductive rights.
The dispute turns on the legal question of whether corporate
employers with religious objections must include contraceptive
coverage in their employee health plans. But it also raises a
scientific dilemma that could influence the court's nine justices.
That scientific question is deceptively simple: whether certain
forms of birth control prevent conception or destroy a fertilized
egg. After decades of research the answer is not absolutely clear.
Two family-owned companies, Oklahoma-based arts-and-crafts retailer
Hobby Lobby, controlled by evangelical Christians, and
Pennsylvania-based cabinet-manufacturer Conestoga Wood Specialties
Corp, owned by Mennonites, object on religious grounds to a
requirement of President Barack Obama's healthcare law: that
employer-sponsored insurance cover contraception.
The companies say they have no objection to covering forms of birth
control that prevent conception, the fertilization of an egg by a
sperm.
What concerns them are after-intercourse products, so-called
emergency contraception such as the "morning-after" pill, which
prevent pregnancy.
Anti-abortion groups contend the products act after fertilization,
destroying embryos.
"For us, the issue is the life-ending mechanisms that some emergency
contraceptives can have," said Anna Franzonello, an attorney at
Americans United for Life, an anti-abortion legal group that has
filed a brief for seven Catholic and other anti-abortion groups
siding with the companies.
Mainstream scientific and medical organizations, as well as
abortion-rights supporters, counter by citing research showing that
the vast majority of emergency contraceptives prevent fertilization.
While the Supreme Court will not be ruling on the science, and has
never defined pregnancy, many groups have filed friend-of-the-court
briefs offering their view of how emergency contraceptives work.
POLITICIZED SCIENCE
The basics of pregnancy are clear, although the language of ending
pregnancy is fraught with politics.
After an egg is released, it has about a day to find a sperm to
fertilize it. Sperm survive several days before losing their ability
to join with an egg. But the union of egg and sperm is merely the
first step: if a fertilized egg does not burrow into the lining of
the uterus, there is no pregnancy. In fact, in an estimated 50
percent to as many as 80 percent of conceptions the fertilized egg
fails to implant.
The Obama healthcare law, known as the Affordable Care Act, requires
coverage of "contraceptive methods," but not drugs which cause an
abortion — that is, end pregnancy.
Medical groups including the American College of Obstetricians and
Gynecologists as well as federal health agencies say pregnancy
begins with implantation. That's what allows James Trussell of
Princeton University, an expert on reproductive health, to say that
emergency contraception "won't cause an abortion in the legal and
medical sense of the word."
That infuriates people who believe life and pregnancy begin with
fertilization. "There is a segment of the medical field that says
there isn't a human life until the baby has implanted," said Dr
Kathleen Raviele, an ob-gyn in Tucker, Georgia, and spokeswoman for
the Catholic Medical Association. The group supports Hobby Lobby and
Conestoga. "You have two groups talking past each other."
COPPER IUDs
The Hobby Lobby and Conestoga families want to protect an egg from
the moment of fertilization, since they believe preventing
implantation ends a life, and they object to the three approved
forms of emergency contraception:
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Copper intrauterine devices (IUDs), a form of contraception that
has only been used as an after-sex emergency contraceptive about
7,000 times since 1976.
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All forms of Teva Pharmaceutical Industries Ltd's Plan B, a
morning-after pill now sold as Plan B One-Step and available
over-the-counter to those 15 and older. It has the vast majority of
the emergency contraception market in the United States.
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Prescription-only ella, from the Watson Pharma unit of Actavis
PLC, which has a tiny share of the U.S. market.
Supporters of Hobby Lobby and Conestoga cite studies that, they
believe, support their position that emergency contraceptives
prevent implantation. Supporters of Obamacare's contraception
mandate point to the larger and growing number of more recent and
more rigorous studies showing that emergency contraception almost
always acts by preventing fertilization.
Complicating the dispute, the positions of drug regulators and
manufacturers have changed over the years.
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The evidence is strongest that copper IUDs can prevent implantation
of a fertilized egg. The T-shaped devices are most likely to work if
inserted well before ovulation, suggesting that their main mechanism
of action is disabling sperm or eggs, preventing fertilization. But
if fertilization already has occurred, an IUD can prevent
implantation, said Kristina Gemzell-Danielsson of the Karolinska
Institute in Sweden, who has reviewed more than 100 studies of
emergency contraception. PLAN B PILLS
The U.S. Food and Drug Administration for years implicitly has
buttressed the idea that Plan B interferes with implantation. In
1999, it approved a label saying the drug can prevent implantation
of a fertilized egg. In a 2009 document on its website, the FDA
still said, "If fertilization does occur, Plan B may prevent a
fertilized egg from attaching to the womb (implantation)".
Since then, however, the International Federation of Gynecology &
Obstetrics, which includes the ob-gyn groups of 125 countries,
reached different conclusions. In a 2012 analysis of 29 rigorous
studies, the organization concluded that the active compound in Plan
B, levonorgestrel, primarily acts by preventing or delaying
ovulation. The drug does that by inhibiting a hormone surge that
allows ovarian follicles to develop and release an egg.
Plan B is most likely to prevent pregnancy in women who take it
before ovulation, said Gemzell-Danielsson.
All told, "there is very, very clear and compelling evidence that
Plan B does not work after fertilization," said Princeton's
Trussell.
Late last year, European drug regulators recognized that scientific
understanding had changed since levonorgestrel came on the market:
they approved changing the label of the version of Plan B One-Step
sold in Europe to say that it "cannot stop a fertilized egg from
attaching to the womb."
It is unclear if the FDA will follow. Spokeswoman Erica Jefferson
said, "The agency is aware of emerging data that suggests that (Plan
B's compound) does not inhibit or prevent implantation of the
fertilized egg and acts only by blocking or delaying ovulation, but
has not had the opportunity to formally evaluate this recent data."
A spokeswoman for the drug's manufacturer, Teva, declined to
comment.
ELLA AND IMPLANTATION
There have been fewer studies of ella. When the FDA approved it, in
2010, the agency said that although ella is thought to work
"primarily by stopping or delaying the release of an egg," it "may
also work by preventing attachment (implantation) to the uterus."
A document from manufacturer Watson says "it is possible that ella
may also work by preventing attachment (implantation) to the
uterus." Watson spokesman David Belian said that language described
the company's current understanding.
Researchers who study contraception say that does not reflect
current science. Studies show that, like Plan B, ella has no effect
on the uterine lining, and mainly works by preventing or postponing
ovulation, said Gemzell-Danielsson. But "mainly" is not good enough
for those who believe life begins at conception. The tiny chance
that ella will prevent implantation of a fertilized egg is, they
say, enough to make it morally objectionable.
IS SCIENCE ENOUGH?
Ultimately the two sides may expect different things from science.
"If you can't be absolutely sure the drugs don't block implantation,
what probability of killing a human being would you accept?" said Dr
Jane Orient, an internist in Tucson, Arizona, and spokeswoman for
the libertarian, anti-abortion Association of American Physicians
and Surgeons, which joined the anti-emergency contraceptive brief.
"In science, you can't prove a 'never happened' or a 'never could
happen,'" responded Dr Timothy Johnson, professor of obstetrics and
gynecology at the University of Michigan.
(Additional reporting by Joan Biskupic;
editing by Howard Goller and
Peter Henderson)
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