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Saturday Morning News

What Are the Implications of the Approval of RU-486?

Aired September 30, 2000 - 9:06 a.m. ET

THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.

KYRA PHILLIPS, CNN ANCHOR: Now that women in the U.S. can end a pregnancy with a pill, opponents and supporters of abortion are wondering if doctors will offer the drug and if patients will use it. On Thursday, the FDA approved RU-486, has been available for years in Europe.

And now joining us to talk about the medical and political implications of the drug in the U.S. are Dr. Allan Rosenfield, dean of the Columbia University School of Public Health, and Dr. Donna Harrison, an OB/GYN who fought FDA approval of the drug and works with Americans United for Life.

Good morning to both of you.

DR. DONNA HARRISON, OBSTETRICIAN/GYNECOLOGIST: Good morning.

DR. ALLAN ROSENFIELD, COLUMBIA UNIVERSITY.

PHILLIPS: Dr. Harrison, why don't we begin with you? And you say that simply this drug is just not for women. Why?

HARRISON: Well, if you look at both the world's literature, which Americans United for Life had to review when we filed the citizens' petition with the FDA, and you look at the U.S. trials, which were published in "The New England Journal of Medicine," what you find is one out of 10 times, this drug doesn't work. And the women who have it have been to undergo a surgical completion.

In addition, we're looking at a 5 to 10 percent pelvic infection rate, and one to four out of 100 women have to be hospitalized for massive hemorrhaging.

This is a dangerous drug.

PHILLIPS: Dr. Rosenfield, how do you respond to that?

ROSENFIELD: That data simply is not correct. This drug works in -- effectively in about 96 percent of the cases. About 1 percent, one out of 100, not one out of 10, will require a D&C to complete the procedure, a suction curettage. That's one out of -- 1 percent.

I don't know of any data suggesting increase in pelvic inflammatory disease. The side effects are mainly nausea, vomiting, occasionally diarrhea. (inaudible)... PHILLIPS: Dr. Harrison, where have you...

HARRISON: Excuse me...

PHILLIPS: ... where did you receive your information?

HARRISON: My information is from "The New England Journal of Medicine," April 1998, that's the publication of the U.S. trials. My information about pelvic infection is from the World Health Organization as well as a review of 150 papers in the foreign literature. So I have documentation that these are indeed the results, and that's why I'm concerned.

PHILLIPS: Doctor...

HARRISON: And not only myself but many other physicians and scientists around the country are very concerned about the release of this drug without the normal FDA safety requirements because it was a fast-track approval.

PHILLIPS: Now, Dr. Rosenfield, you...

ROSENFIELD: This is not -- this is not a fast-track approval. This drug -- I wrote an editorial in "The New England Journal of Medicine" in 1993 on this drug at the time the FDA began its review. It approved it two years later. It has been under review ever since because of the manufacturing issues. This has been a very carefully reviewed drug. It has not been fast tracked at the present time.

And the FDA, if you read their full report, gives this a high degree of safety. They reviewed it without political implications. They simply reviewed the safety and scientific data. And the data that is being quoted is not correct, in my opinion.

PHILLIPS: And Dr. Rosenfield, why don't you talk about the difference between the pill and the surgical procedure? Is the pill safer than that?

ROSENFIELD: I think they're both safe. The -- one procedure you go to the office, to the clinic, and the procedure's carried out, and it is then done. The small percentage of people who have bleeding following a surgical procedure. The data are not significantly different in terms of safety data, the medical procedure is as safe as the surgical procedure...

PHILLIPS: Now, doctor...

ROSENFIELD: ... according to all of the studies that I've seen.

PHILLIPS: And Dr. Harrison, you felt the FDA, by your term fast- tracking this approval, actually passed up a lot of safety tests that were required, or important?

HARRISON: They are required and important. And one of the reasons that they are important is that we don't have a lot of information about long-term effects of this drug. The way it works is, it blocks a hormone called progesterone, and there are progesterone receptors in the brain, the breast, the adrenal gland, the ovaries, and the immune system. We have very, very little data on the long-term results of blocking this drug -- blocking these receptors with RU-486.

Yet we know these receptors in these areas are blocked. So we need safety data. We need data also looking at what happens to women who are not carefully controlled, like the French studies, but in the U.S. they go home and they abort on their own. (inaudible)...

PHILLIPS: Doctor...

ROSENFIELD: Let me -- let me just say...

PHILLIPS: I'm sorry...

ROSENFIELD: ... that this drug has been in use in France now for about eight years. There's long-term data. You're using a drug one time for one day, one dose. It is beyond my belief that one could expect long-term complications of a pill taken one time. So I don't think these long-term effects are an issue, but there are now long- term data in France where we found none of the problems that are being suggested here.

PHILLIPS: Well, the pill is definitely an issue, and we will continue, I'm sure, the coverage and the debate. Dr. Allan Rosenfield, Dr. Donna Harrison, we are out of time. I apologize. But thank you both for being with us.

HARRISON: You're welcome.

ROSENFIELD: Thank you.

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