Originally created 05/14/98

RU-486 embarking on new era



Americans began hearing about the "French abortion drug," RU-486, almost a decade ago. Now, after a U.S. study showing the drug is effective and safe, many health experts anticipate a new era in which abortions are completed earlier in pregnancy, with safety, privacy and, possibly, less controversy.

The study, published April 30 in the New England Journal of Medicine, found that 92 percent of women taking RU-486, also called mefipristone, were successful in terminating their pregnancies within 49 days after conception. The women followed the RU-486 four days later with a dose of a prostaglandin (misoprostol), which causes uterine contractions.

The method will become available in the United States, however, only if a manufacturer steps forward to produce the drug.

People with expertise on the medical, consumer and sociopolitical repercussions of the study on RU-486 give their views and discuss what the advance might mean for women's health.

Dr. Daniel Mishell, Professor and chairman of obstetrics and gynecology, University of Southern California School of Medicine

(Mishell has studied mefipristone for 15 years and obtained about 10 percent of the data that made up the recent study.)

Question: The findings of the recent study were similar to what has been seen in Europe. Was that a surprise?

Answer: No. This study was basically a repetition of what has been done in Europe to see if it would be the same in the United States. And it showed that it could be done with equal success here.

Q: Did the study point up any problems with the method?

A: The main point of the study is that it shows there needs to be experience with the drug to improve the success rate. (He notes that his group, with 10 percent of the test subjects, had a 96.7 percent success rate, while other clinics posted success rates in the 80 percent range.)

Q: Why did success rates vary among the clinics conducting the study?

A: The problem is that women bleed with this. And if they don't have access to the original practitioners, they might go somewhere else for the bleeding (where they might be more likely to receive a surgical abortion). To avoid this happening, we did extensive patient counseling.

Q: How important is it for women to receive adequate counseling before undergoing this procedure?

A: It's extremely important because the procedure has side effects. There is a lot of bleeding and passing of clots and tissues that you have to let the patients know about.

Q: Based on the results of this study, are there any reasons that physicians might be reluctant to offer the method?

A: For medical reasons, no. I think there might be reluctance due to religious or moral reasons.

Q: Does this procedure have any effect on a woman's future fertility?

A: It's just my opinion that there is less likely to be problems with a medical abortion compared to a surgical abortion. With a surgical abortion there can be scarring afterward from an infection, and that can lead to infertility.

Q: Why does the method sometimes fail?

A: I wish I knew that. We've looked at the data on failures compared to women who didn't fail. We've looked at all the parameters, and we don't see any difference. But the failure rate is so small. kern,0

***

Nancy L. Sasaki, President and CEO of Planned Parenthood, Los Angeles

(Sasaki oversaw an arm of the U.S. study on RU-486 while serving as director of San Diego Planned Parenthood.)

Question: If RU-486 becomes available in the United States, do you think it will become the preferred method of abortion?

Answer: In Europe, it hasn't surpassed the surgical abortion procedure. Women might not select it because it involves more visits, and it is a lengthy process. Also, (if it fails) you have to have the surgical abortion available as a backup. So some women think, why not just have the surgical abortion? (The medical abortion with RU-486) is not an easy process to go through.

Q: Do Americans have misconceptions about RU-486 and how it works?

A: People still get it confused with the morning-after pill. They are very different treatments, administered at different times. (Morning-after pills are a dose of ordinary birth control pills that can be taken within 72 hours of unprotected intercourse to prevent pregnancy.)

Q: If this method becomes available, how might it alter the experience of abortion in this country?

A: The biggest change is that some physicians who won't provide (surgical) abortions have said they would be willing to provide medical abortions.

Q: Do you think use of RU-486 would make abortion more socially acceptable?

A: I don't think medical abortion will be the panacea everyone thinks it might be. A woman's options with these two choices are not easy. In the majority of counties, women don't have access to abortion. I think RU-486 will increase access. But it will not be the answer to all of the problems surrounding abortion.

***

Marie Bass, Principal, Bass & Howes Inc., Washington, D.C.

(Bass & Howes is a prominent think tankadvocacy firm specializing in women's issues. The firm has worked for a decade to bring medical abortion to the United States.)

Question: How important is the completion of a U.S. study on RU-486?

Answer: It's reassuring. We had hoped the data would be similar to the European experience, and it was. And I think any time a study is written up in the New England Journal of Medicine -- with its imprimatur on it -- that is important.

Q: Do you believe the study results will help attract a U.S. manufacturer?

A: I can only think that it will help. This study legitimizes (the method). It mainstreams it. It says there are no safety and effectiveness question marks in the United States. It's very reassuring.

Q: There has been criticism that the availability of medical abortion will lead to more unintended pregnancies . Is this a valid concern?

A: That hasn't been true in any European countries where it has been used. I don't hear anyone -- who is really watching the situation carefully and who doesn't have some kind of political bias -- saying that.

Q: Will the widespread availability of medical abortion slow down the abortion protest movement in this country?

A: It's unreasonable to expect that to happen. On the other hand, I think the more we can focus on early abortion and all the products to prevent unintended pregnancy, that's a much stronger ground to be arguing on -- from a political standpoint.

Q: So you don't believe the availability of RU-486 would have a major impact here?

A: One thing I've learned over the years is that it's important not to focus totally on this one product. We know there are other potential products for medical abortion being tested. Medical abortion is a reality already in this country even though it still happens in a controlled, clinical trial.