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AMERICAN MORNING WITH PAULA ZAHN

FDA Holding Hearing Today on Controversial Fertility Treatment

Aired May 9, 2002 - 08:41   ET

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


THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.
PAULA ZAHN, CNN ANCHOR: The Food and Drug Administration is holding a hearing today on a controversial fertility treatment that is supposed to help women when normal in vitro methods have failed, and the feds actually banned it a year ago, and are now deciding whether or not to continue that ban.

Let's turn to Elizabeth Cohen now to explain the treatment it and why it is controversial.

I tell you, I looked at some of your research today, I don't know what half of those words are in these documents.

Good morning.

ELIZABETH COHEN, CNN MEDICAL CORRESPONDENT: You probably hadn't thought about cytoplasm since high school biology, I would imagine.

ZAHN: Yes, exactly.

COHEN: Well, Paula, about 30 children were conceived using this controversial procedure called cytoplasmic transfer. It was invented in 1996, and then the feds said in 2001, you know what, this is experimental, you can't continue doing this without our permission. But 30 children were born using this procedure, and most of them, although not all, turned out just fine. Here you see two children who we caught up with who were born four years ago using the procedure. The mother thinks it's a terrific procedure, and we're going to hear from her later.

But first, let's take a look at what this procedure involves, because that will explain why it's so controversial.

Here you see two eggs, one from a donor, who's a younger woman, and one from the recipient, who was the older woman, who would have failed in vitro fertilization many times over.

What doctors is they take some of the cytoplasm, which is that jelly-like stuff around the nucleus. They take it out, just a small amount, not the whole thing, and then they put it into the recipient egg. Now the cytoplasm in the recipient egg has kind of gotten old and doesn't work real well, and for some reason, when they take it from that younger egg and put it into the older egg, it actually starts to work, and as I said, many people got pregnant using this. Now, fertility doctors and parents who use this procedure are furious that the FDA told these doctors to stop. They say it works. They say, yes, there might be risks, but we were aware of the risks.

Let's hear from the mom of the children that we jaws saw. That mom tried in vitro fertilization eight times and it didn't work, but controversial new procedure did work for her.

(BEGIN VIDEO CLIP)

UNIDENTIFIED FEMALE: So I was willing to give it one more shot, and it was just a miracle that through that, I got pregnant, and I got pregnant with two babies, a boy and a girl, and they turned out in absolute perfect health, and they're just absolutely wonderful, perfect miracles.

I would feel very badly for all of the women who this procedure might help, and I'm relinquishing my privacy on this today because I feel that knowing about this procedure for people who need it is vital, and that it would be helpful to many women out there who have a similar problem that I have.

(END VIDEO CLIP)

COHEN: So you might be asking yourself, gee, why would the FDA want to take away a procedure like this, that helped this woman, that helped many other woman? Well, they say the reason is, when you transfer cytoplasm from one woman's egg to another woman's egg, you're transferring some genetic material. Most genetic material is caught up in nucleus in the middle cell, but there is something called mitochondrial DNA that is in the cytoplasm, They said, look, you didn't do enough experiments to know if this is safe or not. In fact, about two of these 30 pregnancies resulted in fetuses that had a chromosomal abnormality called Turner's Syndrome, which is a very serious abnormality. One of the two women had a miscarriage, the other chose to have an abortion -- Paula.

ZAHN: So if these risks are made well aware to these patients, and they're willing to take the risks, why did the FDA get involved in the first place?

COHEN: Well, the FDA and some bioethicists who we spoke with said, you know what, these women or these couples might have said, yes, going to take the risks, but they're taking the risks really for their unborn child, and they say that's a totally different thing. It's not like a cancer patient saying, you know what, I'm at the end of my life and I'm willing to take a risk on this procedure, and I'm putting myself at risk. If you're assuming the for risk for someone else, and that's one of the reasons why bioethicist have some problems with this procedure.

ZAHN: Are there any other fertility treatments where birth defects are an issue?

COHEN: There are. In fact, there was a study that just came out relatively recently, that said that children who were born using two different kinds of fertility procedures, one of them being in vitro fertilization, do have slightly higher risks of having birth defects.

So this is a relatively new, really in the past 25 years a relatively new field, and they're sort of discovering that there might be some increased risks of birth defects, but in a way, the jury is really still out on that.

ZAHN: Setting aside the controversy about how these two babies were created, those twins were gorgeous.

COHEN: Yes, they were.

ZAHN: Beautiful shots. Thanks, Elizabeth.

We'll look forward to hearing you track what happens at these hearings a little bit later on today.

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