Dear Colleague:
The evidence against the safety of RU-486 is mounting, but I wouldn't
strain your ears waiting to hear "women's advocates" call for its
withdrawal from the market.
Steven W. Mosher
President
PRI Weekly Briefing
2 December 2005
Vol. 7 / No. 47
Time for a RU-486 Rollback
By Joseph A. D'Agostino
This week, Australian Prime Minister John Howard agreed to allow a vote in
the Australian parliament to legalize RU-486 in his country. This
unfortunate decision came as a spate of more bad news about the abortion
pill's safety for women reached public notice. In the first trimester,
which is when RU-486 is used, this human pesticide could be ten times more
likely to kill the woman who takes it than surgical abortion. Aren't
pro-abortion agitators happy with surgical abortion's safety (for the
woman), efficacy, availability, and inexpense?
Yet, the FDA under the Clinton Administration officially rushed the
approval of RU-486 under expedited procedures normally reserved for drugs
needed to save people's lives. Women have been paying with their health
and even their lives since.
Political correctness demands the dispensation of RU-486 (brand name
Mifeprex), which is crucial to the abortionists' goal of moving abortion
out of separate surgical clinics and into every medical practice and
pharmacy in America. One of the authors of a Dec. 1, 2005 paper on
RU-486's safety in the New England Journal of Medicine (NEJM), Dr. Marc
Fischer of the Centers for Disease Control and Prevention, downplayed away
his own finding of RU-486's magnitude-greater risk to women. The San Jose
Mercury-News, Nov. 30, 2005, summarized it well:
"He said it appears the risk of maternal death from RU-486 is around one
in 100,000, about the same as for other types of abortion. But he said
risks associated with surgical abortion early in the first trimester of
pregnancy-the period during which RU-486 is prescribed-is about one in a
million. 'On the surface of it, it seems like one risk is 10 times higher
than the other,' he said in an audio interview made available by the
Journal. 'However, when you get numbers that are that small, they are
very difficult to measure with precision, and I don't think I or anyone
else, on the basis of available data, at the moment would be willing to
say this is a necessarily significant difference.'"
So, the experts have evidence indicating the abortion pill, which causes a
medical abortion, is ten times more deadly for the mother than surgical
abortion, but it's no big deal. Shouldn't the experts be saying that
women should avoid RU-486 entirely until more research into its safety has
been completed? After all, the vast majority of abortions are for the
sake of convenience and could easily be avoided in favor of adoption, and
pro-abortion believers can't deny that women who really want an abortion
can get one surgically-even if it means going to an abortion clinic.
Needless to say, the so-called women's advocates aren't making this
recommendation even though, if anything, Fischer's estimate of RU-486's
deadly nature is understated. The reporting of adverse drug reactions to
the FDA is an extremely lax process, and no one believes the FDA has
anything approaching a complete set of data. Most almost certainly go
unreported. There have certainly been many cases of severe bleeding,
pain, and other such effects from the drug, and many women could be
suffering life-long ill effects from using RU-486, whose scientific name
is mifepristone. RU-486 is usually given in combination with another drug
called misoprostol. In addition to the five North American women we know
were killed by the drug, an unknown number of others could have been slain
without the FDA's knowledge. In fact, the death of 18-year-old California
girl Holly Patterson would not have been officially reported as due to
RU-486 if her father had not pursued the issue aggressively.
The NEJM study explained that bacterial infection killed the women who
died from taking RU-486. "Endometritis and toxic shock syndrome
associated with Clostridium sordellii have previously been reported after
childbirth and, in one case, after medical abortion," says the article
summary. "We describe four deaths due to endometritis and toxic shock
syndrome associated with C. sordellii that occurred within one week after
medically induced abortions."
Holly's father Monty has called on the Australian legislature to keep
RU-486 illegal. But after keeping the drug off the market for years,
pro-life Health Minister Tony Abbott must accept Howard's decision. The
parliamentary vote will take place next year, giving our own Family Life
International-Australia affiliate and other pro-life groups Down Under
time to mobilize opposition to legalization.
Fortunately, Australian pro-life efforts have expanded greatly in the past
few years. As FLI-Australia Director Gail Instance points out, "The
Australian Catholic Bishops Conference has established a task force
looking into Australia's high abortion rate and seeking ways to reduce it.
Catholic Respect Life offices have been set up in three dioceses in
recent years-Sydney, Perth and Melbourne-and Centacare in Sydney, a
Catholic family welfare center, is now running a pregnancy support unit at
the request of Cardinal George Pell."
Those three Respect Life offices have issued a joint statement warning MPs
not to approve RU-486. "The U.S. FDA approved RU-486 in 2000 under
pressure from Congress and the Clinton Administration," they say. "This
occurred despite warnings from researchers that adequate clinical trials
had not taken place, that RU-486 did not fit the category of 'accelerated
approval regulations,' which were only meant to be used for
life-threatening diseases like AIDS and cancer."
In the meantime, the trial of Australian abortionist Suman Sood continues.
She allegedly gave the abortion pill to a woman late in pregnancy, and
she gave birth to her baby before the infant died. She is charged with
manslaughter and with using an illegal drug, since RU-486 is illegal in
Australia for the time being.
At least the FDA is looking into RU-486's riskiness. "Officials from the
FDA and the federal Centers for Disease Control and Prevention have
decided to convene a scientific meeting early next year to discuss this
medical mystery, according to two drug agency officials who spoke on the
condition of anonymity because of the sensitivity of the topic," reported
the New York Times on November 23, 2005. "Among other issues, the experts
hope to explore whether the abortion pill, called Mifeprex or RU-486,
somehow makes patients vulnerable to an infection with Clostridium
sordellii, the lethal bacteria. If so, they will explore how such an
infection 'could be more easily diagnosed and even prevented,' one
official said."
Some think that the off-label use of RU-486 and misoprostol is what is
causing the problem. Doctors commonly prescribe drugs to be used in a
manner different from that originally approved by the FDA, but Planned
Parenthood assures American women that off-label use of RU-486 is not the
problem. Scott Spear, chairman of the national medical committee of
Planned Parenthood, informed the Times that there is no evidence Planned
Parenthood's common off-label method "increased the risks of bacterial
infections."
These are the four women who are known to have been killed by RU-486 in
the United States:
* Holly Patterson, died Sept. 17, 2003, age 18
* Vivian Tran, died Dec. 29, 2003, age 22
* Chanelle Bryant, died Jan. 14, 2004, age 22
* Oriane Shevin, died May 24, 2005, age 34
Sen. Jim DeMint (R.-S.C.) has told the Baltimore Sun that the FDA has told
him that RU-486 could be pulled from the market. "Increasingly, they are
aware that it is a dangerous drug," he said. Back on August 10, he, Sen.
Sam Brownback (R.-Kan.), and Sen. Tom Coburn (R.-Okla.) wrote a letter to
their fellow senators pointing out the problems with RU-486 and its
approval process. "A number of patients who use Mifeprex are between the
ages of 12 and 17, and do not need their parents' authorization before
requesting this drug from a provider," they wrote. "The FDA requires
drugs such as these to be tested in a group of patients ranging in age
from 12 to 18 years. We understand the FDA waived this requirement in the
approval process of Mifeprex."
Hopefully, RU-486's poor safety record will prompt a reversal of the FDA's
hasty approval, and prevent the drug's spread to Australia and other
countries, especially after all the controversy surrounding the recent
withdrawals of other drugs from the market due to safety concerns.
Women's groups should be out front in calling for the suspension of RU-486
sales. Killing unborn children is bad enough without killing their
mothers at the same time. I doubt the vast majority of feminists,
pro-abortion activists, and liberal politicians will ever so much as cast
a doubt on RU-486. Anyone who favors partial-birth abortion has gone
beyond the reach of moral thinking.
The promotion of RU-486 is another step toward the easy, casual, and
entirely unfettered use of abortion. How extraordinary to live in times
in which killing nascent human life without any restrictions of any kind
is the paramount concern of so many powerful people. Their mantra is:
Abortion today, abortion tomorrow, abortion forever! And damn the
consequences.
Joseph A. D'Agostino is Vice President for Communications at the
Population Research Institute.
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