"ABORTION PILL" HERE SOON SEPTEMBER 19, 1996 TRANSCRIPT

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The FDA has tentatively approved U.S. sales of the French abortion drug, RU486, although doctors are still debating the possibility of dangerous side effects. Charlayne Hunter-Gault provides a backgrounder on the pill that has already been used by nearly a quarter of a million women in Europe. She is joined subsequently in a discussion with two physicians who view the drug - and its safety - very differently.

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A RealAudio version of this NewsHour segment is available. April 11, 1996 The aftermath of Clinton's veto of the late term abortion ban. April 10, 1996 President Clinton's comments following his veto of the partial birth abortion bill February 21, 1996 A panel of Republicans discuss the issues that are dividing the party.

CHARLAYNE HUNTER-GAULT: Yesterday, the Food & Drug Administration tentatively approved the so-called "abortion pill," RU-486, the latest development in what has been a highly charged debate. RU-486 was first developed in France by the Russell-Uflad Company in 1980. It was widely hailed by women's groups and abortion rights advocates as revolutionary. Abortions, they said, would be easier, safer, and more private since they could take place at home or in a doctor's office, instead of a hospital or clinic.

The treatment is done in two stages. First, three tablets are taken orally. These pills temporarily block the hormone progesterone in the uterus, which is essential to maintaining the pregnancy. Two days later, another pill form drug is administered which forcefully expels the embryo.

Abortion activists see RU-486, known in this country as Mifepristone, as a promising drug with multiple uses. They say it is a highly effective morning-after pill. They also say it helps induce labor in women who are dangerously overdue and has potential use in treating some diseases and breast cancer.

But opponents revile the process as a mini-birth. They point to its problems. For example, incomplete expulsions, which occur in 4 percent or fewer cases, and requires surgery. They also have pointed to reports of heavy bleeding and cramping and possible cardiovascular and respiratory complications. The pill has been widely available for use in Europe since 1988.

In the United States, anti-abortion activists threatened to boycott all products of the French manufacturer, and the company, as a result, declined to apply for testing and marketing in the U.S.. Eventually, the company gave its American rights to the drug to the Population Council, a New York-based, non-profit, health research organization. The council says it has lined up a manufacturer for the American market but has not disclosed the company's identity. That company will have to satisfy the FDA on its labeling and manufacturing practices before receiving a final go-ahead.

Now to two physicians on RU-486: Dr. Donna Harrison is an obstetrician-gynecologist and private practice in Michigan. She testified against approval of RU-486, and Dr. Beverly Winikoff oversees the reproductive health program for the Population Council. Dr. Winikoff, starting with you, what does the FDA's decision on RU-486 mean?

DR. BEVERLY WINIKOFF, The Population Council: What it means, Charlayne, is that this drug is one step closer to availability for American women. It means that FDA has found the drug's clinical data to show it to be safe and effective and that further information on manufacturing and labeling is going to be inserted in the file before the drug is finally approved.

CHARLAYNE HUNTER-GAULT: And the impact of this decision?

DR. BEVERLY WINIKOFF: The impact is that it's another step in the process of putting it on the market.

CHARLAYNE HUNTER-GAULT: Dr. Harrison, what do you think of the decision and the impact?

DR. DONNA HARRISON, Obstetrician/Gynecologist: Well, I'm very concerned that American women are being misled about the safety of this drug. As you mentioned in your prelude, women have been told that this is a private way to abort, that it is a safer way than surgical abortion. This is not true. You alluded to the hemorrhage rate, the incidence of heavy bleeding. There's also a high incidence of infection. There's a high incidence of incomplete abortion, which may require emergency surgery. I'm very concerned that the women of this country are going to find after approval in five or ten years that we've opened a Pandora's Box as far as complications and damage to women.

CHARLAYNE HUNTER-GAULT: Dr. Winicoff, how do you respond to that, Pandora's Box?

DR. BEVERLY WINIKOFF: No, not at all. I don't understand the allegation. We have one very safe and effective method of abortion now, and it's surgical, and this is another very safe and effective method of abortion.

CHARLAYNE HUNTER-GAULT: What about the concerns that Dr. Harrison just raised, how would you reassure her?

DR. BEVERLY WINIKOFF: Sure. I think the issue that, first of all, there are some things that are patently not the case. There is not a high incidence of infection. Most of the side effects of this drug are involved as a process of it working. In other words, this drug causes what is, in effect, a spontaneous miscarriage, but it turns on a biological process that results in that miscarriage. All of the side effects we see from this drug are the same as those of spontaneous miscarriages, so women, of course, bleed, and, of course, cramp because that is the effect of the drug, and that's the intent of the drug.

Unfortunately, we have to put up with that process in order to end up with a complete abortion. But, by and large, none of these effects are health threatening, and ones that are a problem for women can be handled quite easily in our current medical system and are.

CHARLAYNE HUNTER-GAULT: Dr. Harrison, does that reassure you?

DR. DONNA HARRISON: No, it doesn't, and I would refer Dr. Winikoff back to the World Health Organization's study that showed that 30 percent of women with incomplete abortions had pelvic infections afterward, so I do think that there is a serious concern about infection basically because the way the drug works, progesterone, blocking the progesterone, also can have an effect on the immune system, and that's a very big concern.

CHARLAYNE HUNTER-GAULT: Excuse me. Do you dispute her, umm, her statement that these are the same kinds of after effects that you would get from surgical abortions?

DR. DONNA HARRISON: Yes, I do dispute that statement because surgical abortion or DNC, especially at the stage that the RU-486 is effective has very few complications. Now, RU-486--

CHARLAYNE HUNTER-GAULT: And it's effective only in their early stages, right?

DR. DONNA HARRISON: RU-486 is only effective up to three weeks after you miss your period.

CHARLAYNE HUNTER-GAULT: All right.

DR. DONNA HARRISON: That's not very far.

DR. BEVERLY WINIKOFF: Actually, Charlayne--

CHARLAYNE HUNTER-GAULT: Yes.

DR. BEVERLY WINIKOFF: Actually, that's not completely true. In England, this drug is used 63 days after a missed period, after the last menstrual period, and it can be used further on. It's just that the trials so far have shown effectiveness to 49 days. Some of the issues that are being brought up are misconstrued and out of context. Of course, many women with spontaneous abortions or so-called spontaneous abortions, have infections if those abortions were induced by putting something into the uterus. But, infections, in fact, are quite rare in natural, spontaneous abortions, and in the experience in Europe, infection has not been a problem with this drug.

CHARLAYNE HUNTER-GAULT: Dr. Harrison, if all of these questions that you've just raised could be somehow put to rest, would you still be opposed to this procedure?

DR. DONNA HARRISON: Well, I think I'm talking right now about the short-term effects. I still would be very concerned about the long-term effects of RU-486. The way it works is it works, as you've said, by working with a steroid called progesterone, but there are other progesterone sensitive tissues in the body like the breast, like the endocrine system, like the brain. We have no idea what the effect of RU-486 is going to be on those progesterone sensitive tissues.

CHARLAYNE HUNTER-GAULT: What about that, Dr. Harrison? Because Dr.--I mean, Dr. Winikoff, Dr. Harrison said we don't know say 10 years down the line, do you have any evidence?

DR. BEVERLY WINIKOFF: There is no evidence that there is going to be any problem. This is a drug that stays in the body only a very short time. Within a week or ten days, it's virtually undetectable in the body. Uh, the drug is not meant to be used on a chronic basis. There's no reason to believe that it would have a long-term effect. It's been used in Europe for almost a decade, and we have no evidence of any long-term effects. Very conservatively, once drugs have been on the market for about five years, one begins to see some of the untoward effects, and, in fact, we haven't seen any from European use that totals well over a quarter of a million women by now.

CHARLAYNE HUNTER-GAULT: Is that reassuring to you, Dr. Harrison?

DR. DONNA HARRISON: The question I would have for Dr. Winikoff is what studies are--are looking at these questions. There aren't any studies that exist. So it's very easy to say we have no data that says there are long-term effects as long as you don't look for any long-term effects.

CHARLAYNE HUNTER-GAULT: But does the decade of use in Europe, umm, give you any pause for your concern?

DR. DONNA HARRISON: Not if you don't look for long-term effects. And I, I would contradict Dr. Winikoff in that there is no concern about accumulation in the body. We do know of a--a case of one woman who had a repeat abortion with RU-486 that experienced extreme fatigue. She said she felt like she was dying. She said that she would never undergo another abortion, another repeat abortion with this particular method. So there is a question of what are the effects of repeat abortion. Knowing that 42 percent of abortions in the country are repeat, I think it's a question that needs to be answered before this is unleashed on American women.

CHARLAYNE HUNTER-GAULT: Dr. Winikoff, just what does happen next? I mean, the next step for the FDA is additional labeling and manufacturing information before the final FDA approval. How big of a deal is that, and are these concerns that Dr. Harrison is raising now going to be taken into consideration in the next step?

DR. BEVERLY WINIKOFF: Well, the manufacturing and labeling information should be straightforward to supply to the FDA, and we will do that, and it should not be a problem. The concerns Dr. Harrison raises, some of them are way out of the bounds of any regulatory decision on any drug. If we had to wait for ten or twenty years of information about every new drug, we would have no drug approval. But, of course, umm, as with all responsible scientific institutions, we will be looking at what happens over the long-term, but, again, as with any new technology, it takes a long time and a lot of looking to find things that are rare.

CHARLAYNE HUNTER-GAULT: Dr. Harrison, how do you think doctors in general are going to react to this, if let's say for the sake of argument this next phase of the approval goes through?

DR. DONNA HARRISON: I would hope that most doctors would be cautious about rushing in and performing RU-486 abortions, especially without evidence to document how far along the pregnancy is because despite what Dr. Winikoff had implied, even the researchers say this drug should not be used beyond 49 weeks ges--49 days gestation or three weeks after the last menstrual period. You need an ultrasound to accurately diagnose that, and you also need to be able to handle the hemorrhage and the infection that's going to occur. And I think most prudent physicians should be very cautious about using this drug unless they're prepared to deal with the side effects.

CHARLAYNE HUNTER-GAULT: Dr. Winikoff, how do you think doctors, in general, are going to react?

DR. BEVERLY WINIKOFF: I think doctors will welcome this. Of course, I would agree, and I think everyone would caution every physician to have prudence with patience, but I think doctors will be quite capable of handling this technology and they will be cautious, and women will welcome it.

CHARLAYNE HUNTER-GAULT: All right. Well, thank you both for joining us.

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