FDA Should Take RU 486 Abortion Drug Off the Market for Killing Women

National   |   Steven Ertelt   |   Jan 1, 2009   |   9:00AM   |   WASHINGTON, DC

FDA Should Take RU 486 Abortion Drug Off the Market for Killing Women

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by Joseph A. D’Agostino
December 5, 2005

Joseph A. D’Agostino is Vice President for Communications at the Population Research Institute.

Last 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.