A controversial pill that has been available in parts of Europe for more than a decade may make its US debut if the Food and Drug Administration (FDA) officials decide to approve the use of the so-called abortion pill RU-486 this week.
It is commonly known as RU-486 or mifepristone. Earlier this year, the FDA gave itself a deadline of September 30th to decide whether to approve its use in the US. But it can also set a new deadline. Abortion rights advocates are concerned that further delays may increase the risk of the drug getting approved, especially if the Republicans take control of the White House next year. They are also concerned about restrictions that the FDA may impose on how the drug can be used, how it can be distributed and who can prescribe it.
Mifepristone is the chemical name for the French medication RU-486. It was first used in France twelve years ago in 1988. It is estimated that approximately five hundred thousand women have had medical abortions using the mifepristone regimen.
It is prescribed during the first seven weeks of pregnancy as part of a two-drug regimen. The second drug that is used to trigger the abortion is misoprostol, which is already available for the prevention of ulcers. The side effects of a mifepristone abortion are typically severe cramping, bleeding and nausea. In comparison, surgical abortion is typically performed no earlier than six weeks into pregnancy, requires anesthesia and carries the risk associated with surgery such as infection.
Interview with Gloria Feldt, President of the Planned Parenthood Federation of America
Gloria Feldt says that there is a lot of confusion about whether the RU-486 is an abortion pill or a morning-after pill. The FDA is reviewing it for approval as an abortion pill. She says that there is some evidence that RU-486 has promise as an emergency contraception, but that it's really not being used for that purpose. "It's an early medical abortion pill," says Feldt. "The morning after is emergency contraception, which is really just the birth control pill that we know, taken in higher doses within 72 hours before pregnancy has occurred. That is truly contraception. But, I can't tell you that no doctor in the world is using it for contraception. Once it's approved, I'm sure there will be research to determine if it will be useful as a morning-after pill."
"Mifepristone is an early medical abortion," says Feldt. "It's an abortion that is done very early in pregnancy and without surgery, but after a pregnancy has been diagnosed, up to 49 days after the last menstrual period. It is administered by physicians. That is different from what people know as the morning after pill or as we call it, emergency contraception [which does not require physician administration]."
The FDA's options
The FDA can approve RU-486, not approve it or issue another letter like it did in 1996 and in February of this year, that basically says that it is safe, but that they have more questions, according to Feldt.
Pro-choice advocates are concerned about restrictions that the FDA may impose on RU-486, even if they approve it. For example, one suggestion has been to only allow doctors who give abortions to prescribe it. In response to that idea, Feldt says that there is no medical reason for such a restriction.
"A doctor who administers mifepristone should be able to refer a patient, if necessary, to a doctor who does surgical abortions. But, no doctor provides every medical procedure in the book. Every doctor has referral mechanism to refer to other doctors if they need a procedure done that is not in their area of expertise. Any unneeded restrictions, makes it less likely that proviers will make it available."
Feldt says that Planned Parenthood has been training doctors who provide abortion services for Planned Parenthood on how to use RU-486 when it is approved. Six Planned Parenthood clinics were used in the clinical trials in the US from 1994 through 1996.
Some researches have shown that RU-486 has the potential to be used for other medical purposes such as treating fibroid tumors, ulcers and prostate and brain cancer. If the FDA doesn't approve RU-486, Feldt says that she will be outraged.
"It's so far past time for approval," Feldt says. "Every drug should go through an appropriate medical and scientific process. But, Mifepristone, has had to go through and equally arduous political process and it's time for American women to have access."
Interview with Olivia Gans, a spokesperson for the National Right to Life Committee (NRLC)
Gans is also the Director of American Victims of Abortion, a national group of women who have had abortions and now regret them. "It should be of grave concern to all American women and their families that the FDA may finally release RU-486 to the American public," says Gans. "The circumstances of it are far more complex and worrisome than have been generally understood by the public at large. RU-486 is a very dangerous drug cocktail. It is a compound of two very powerful drugs. It is not a simple one-step procedure. Two or three or more doctor's visits are required. It does not go away with the ingestion of one simple pill. It is a complicated process that not only brings with it the reality of a dead child after the elongated effort, but also the reality that it is difficult anpotentially dangerous if anything should go wrong with these two chemicals in a woman's body."
Gans says that their gravest concern can be sited within the context of what supporters of RU-486 are suggesting. They would like to see approximately 30% of all abortions in the future done by all chemical means. If that happens, and if the current rate of abortion in the US stays at 1.3 million a year, what we know from the trials in the US, is that approximately 2% of the women who used RU-486 in the trials developed hemorrhaging and complications of such a severity that required hospitalization.
Two percent of 30% is a little over 9,000 women a year who will develop complications. That's not something that we should blink at. That's not even looking at the European data that shows that the same phenomenon is as high as 5%."
The concerns of NRLC
The drug will most likely be used by women who are not concerned about the severity of medical requirements attached to using RU-486. For example, younger and poorer women who may not have access to medical care. So the numbers may be higher. If you think about a teenager, do you know one who is prepared to go back for two to three doctor's visits to make sure there are no complications like an incomplete abortion? This has not been addressed by the Clinton and Gore administration. ©MMII CBS Worldwide Inc. All Rights Reserved. This material may not be published, broadcast, rewritten, or redistributed
The only exception was if RU-486 is found to be useful in treating a medical condition like prostate cancer. "What we have a problem with, is that the primary reason for the drug RU-486 is to end the lives of unborn children and it is dangerous to the lives of mothers in a very serious way," says Gans. There is one documented case in Europe in which a woman died after taking RU-486, according to Gans. Although that's a small number, Gans says that she does not discount this one woman's life. She asked wha if it's someone you know.
"As a woman who has had an abortion, I feel very deeply and with great anxiety that the abortion agenda is paramount," says Gans. "Not only in the lives of our children, but now at the risk of our lives and our safety in order to see the agenda for abortion advance further."