Unlike in the US, where they're on everyone's lips as
George W Bush makes his controversial Supreme Court appointments,
here in Canada abortion rights aren't the hottest of political
topics right now. That could be about to change. Mifepristone,
aka RU-486 or the abortion pill, is causing quite the
uproar as scientists and activists alike are taking sides
on its availability and safety for pregnancy termination.
But for Canadian doctors and their patients, the point
is moot — the drug has yet to be approved here and
many believe you can thank the almighty dollar for the
hold-up.
SLIM
CHOICES
Generally speaking, there are two ways to terminate
a pregnancy: the traditional surgical method commonly
known as vacuum aspiration and the drug-induced, or
medical, abortion. With mifepristone unavailable in
this country, medical abortions are performed using
a combination of methotrexate and misoprostol instead
— if you can find a clinic that offers the procedure.
Dr Ellen Wiebe, a clinical professor at the University
of British Columbia with a full-time family practice
in Vancouver, is one of only two Canadian doctors currently
performing medical abortions on a regular basis. She
estimates that 1-2% of the abortions performed in this
country are drug-induced. Interestingly though, the
percentage in Vancouver, where women actually have access
to the procedure, is closer to 15%. "The reason these
women choose medical abortions is that they don't want
surgery; some because they feel it is more natural,
more private, less invasive, others because they are
frightened of surgery," explains Dr Wiebe.
In her opinion, mifepristone has
not been approved in Canada because no company has ever
submitted an application. It all seems to boil down
to numbers. According to Statistics Canada, about 105,000
abortions are performed annually in this country. Of
these, only about 25% would be eligible for mifepristone-induced
abortion.
RISKS
AND BOONS
But there's much more to this issue than just money.
Important safety concerns have been raised as well,
both here and elsewhere. In 2001, the only Canadian
trial of mifepristone, led by Dr Wiebe, was suspended
after the death of a woman from toxic shock brought
on by a bacterial infection related to her abortion.
Four similar cases have been reported in the US, forcing
Danco Laboratories, the US distributor of mifepristone,
to add a black box warning on the label about the risks
of bacterial infections, sepsis and death. If that weren't
enough to raise a red flag, a citizen petition for the
withdrawal of the drug from the US market has also been
submitted to the FDA.
Danco Laboratories estimates that
over two million women worldwide have safely used mifepristone
to terminate pregnancy. The drug was first approved
over 15 years ago in France, and in 28 other countries
since then including the US, Spain, Britain, Sweden,
Germany, China and Russia. Since then, extensive data
from clinical trials have documented mifepristone's
safety and efficacy for induced abortions, but the study
published in the September issue of Contraception
is the largest and longest to date that examines its
routine clinical use. Over 95,000 mifepristone-induced
abortions were recorded by the PPFA from 2001 through
the first quarter of 2004. Overall, 2.2 per 1,000 women
experienced a complication, most commonly heavy bleeding,
and mortality was estimated to be 1.1 per 100,000 based
on one death.
BAD
BACTERIA
Until now, no formal link had been established between
the reported cases of septic shock and the use of mifepristone.
But in a study appearing in the September issue of the
Annals of Pharmacotherapy, Dr Ralph P Miech,
Professor Emeritus at Brown University, offers evidence
of how this rare but devastating reaction may occur.
Mifepristone's anti-progesterone effects, which cut
off nutrition to the fetus, may also allow the common
vaginal bacteria Clostridium sordellii to enter
the cervical canal and release toxins into the blood.
Meanwhile, the antiglucocorticoid effects of mifepristone
inhibit the innate immune system, impairing the body's
ability to fight off the infection. This combination
sometimes results in widespread septic shock.
C sordellii infections are
rare outside of mifepristone use and have proven particularly
dangerous because they often lack the usual warning
signs, such as fever and abdominal pain. Dr Miech is
concerned by his findings, and warns that additional
research is necessary to evaluate the risk of infection.
"RU-486 has a half-life of about 24 hrs, so it takes
about five days for the body to get rid of it," he explains.
"I think there's a good possibility that association
with infection anywhere in the body during the week
after taking the drug is probably under-reported."
So shouldn't we be thanking our
lucky stars that we can't get our hands on the stuff?
Not so, says the Society of Obstetricians and Gynaecologists
of Canada (SOGC). The SOGC has expressed their support
of RU-486 for the termination of pregnancy. "The drug
is safe and would play an important role in the reproductive
rights of women," they wrote in a statement. Dr Wiebe
is also confident in her support. "The risk of death
from serious infection or other factors is similar with
medical or surgical abortions, at less than one in 100,000,"
she explains. "Mifepristone is much faster than methotrexate
and can be used successfully at higher gestations. Women
and physicians prefer it when given the choice."
|
