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RU-486 is a drug that causes very early abortions. The FDA approved it for use within the first seven weeks of pregnancy.
But then they were subjected to counter-pressures from pro-abortionists, so in 1994 they came up with a "compromise": they donated the U.S. rights to the drug to a pro-abortion advocacy organization, the Population Council. The Population Council is not a drug manufacturer and had no facilities to actually produce or market such a drug, so they created a new company to do this, called Danco Laboritories. FDA approval was delayed until Danco could meet federal manufacturing and labeling requirements.
RU-486 is now available in 14 countries.
In an unusual -- perhaps unprecedented -- move, the FDA has kept secret the names of the officials who were involved in this decision in order to protect them from controversy. "The climate around the reproductive-rights issue and personal safety issues are in our minds," FDA Commissioner Jane Henney explained.
Similarly, Danco Laboritories, the company that will be marketing the drug, has refused to say where it will actually be produced. (Danco has no facilities to actually produce the drug themselves, and no U.S. drug company was willing to risk a boycott from pro-lifers and lawsuits for injuries from complications.) The Wall Street Journal reported (Sept 5) that Danco has contracted with a manufacturing plant in China to produce the drug.
To use this drug, the mother takes three mifepristone pills. This interferes with a hormone called progesterone. Without the action of this hormone the lining of the uterus cannot be maintained, which cuts off the supply of nutrients and oxygen to the developing baby, and sometimes causes him to detach from the uterine lining completely. Two days later, she returns to the doctor to take a second drug, misoprostol, that causes the uterus to contract and expel the dead or dying embryo. Two weeks later she returns for a third visit to make sure the abortion is "complete". If the unborn baby has survived -- as happens in 5 to 8 percent of cases -- then an alternative method of abortion can be performed.
However, these trials specifically excluded women who were considered high-risk, such as women under 18, those with hypertension or anemia, and heavy smokers over 35.
As noted above, the mifepristone must be used with a second drug, misoprostol, to be effective. Misoprostol was developed to treat ulcers, and the company that makes it has objected to its use as an abortion drug because of safety concerns.
A group of doctors and others submitted a petition to the FDA objecting to approval on health grounds. Dr Donna Harrison, an obstetrician and one of the signers, explained, "What we found was a 10 percent hemorrhage rate of which 1 to 2 percent was significant enough to require transfusion. We found a 5 to 15 percent rate of pelvic infection, with 25 percent of those women subsequently sterile."
Early drafts of the FDA approval imposed numerous restrictions on the use of this drug. But most of these restrictions were removed by the final draft. The FDA now requires that women considering RU-486 be given a brochure, called a "MedGuide", that explains the circumstances under which the drug is suitable, and discusses procedures and side effects. To dispense RU-486, an abortionist must certify that he is trained to diagnose factors that would make RU-486 exceptionally dangerous, for example, he must be capable of determining the duration of the pregnancy so women after the seven week limit can be excluded, and he must be able to recognize ectopic (tubal) pregnancies. He must also be able to perform a surgical abortion in cases where the drug fails, or have arrangements for some other abortionist to do this.
"Only four months ago, after years of study, the FDA recognized the substantial risks of this two-drug abortion method, proposing restrictions such as requiring administration within one hour [driving distance] of an emergency room," commented Randall K. O'Bannon, Ph.D., NRLC's Director of Education, who has written extensively on issues surrounding RU-486. "Now, four months later, the FDA has dropped most of these protections for women's health. What has changed, other than a four-month campaign of political pressure by the abortion industry and its allies? The FDA opted for the convenience of abortionists over the safety of women."
The National Abortion Federation, a national affiliation of abortion facilities, said 240 of its member abortion businesses were already prepared to sell Mifeprex, and it is training other abortion practitioners in how to use the pill.
Proponents say that RU-486 will make abortion easier on the mother psychologically than surgical abortion, because it "feels more like a miscarriage", is done earlier in pregnancy, and, they hope, ultimately can be done in the privacy of a woman's own home.
Others worry that this will just make the abortion experience even worse. Women will be having abortions alone, with no one else around for emotional support. And if she later regrets the decision, she will feel the full burden of it herself, with no way to share the responsibility for the decision with others.
Supporters of RU-486 say that it will make abortion "more accessible and more private". They hold it out as a solution for women who live in areas with no convenient abortion clinic, or who are reluctant to pass through protestors to enter an abortion clinic. But when opponents say that it will make abortions even more common, they reply that "health experts" found that it did not increase the number of abortions when it was introduced in Europe. So ... will RU-486 make abortion more accessible for American women, or not?
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Posted 4 Oct 2000.
Copyright 2000 by Pregnant Pause