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American Morning

Paging Dr. Gupta: New Birth Control Pill

Aired September 05, 2003 - 08:43   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.


SOLEDAD O'BRIEN, CNN ANCHOR: Today, government regulators are expected to decide whether a new birth control pill for women should go on the market. The drug reduces the number of menstrual periods to one every three months.
Dr. Sanjay Gupta is in Los Angeles for us this morning with details.

Hey, Sanjay, good morning.

DR. SANJAY GUPTA, CNN MEDICAL CORRESPONDENT: Good morning, Soledad.

Yes, this is really one of those interesting ones. The FDA is going to decide today -- we don't know what the decision is going to be yet -- on this new birth control pill. It's called Seasonale. Everyone knows the pill. It's a popular oral contraceptive. In fact, statistics show that 80 percent of women born since 1945 have used the pill at one time or another. With the pill, of course, you still get periods. And periods can mean pain, bloating, cramps, all sorts of things like that.

As you correctly mentioned, Soledad, with this new pill, Seasonale, hasn't been approved yet, but maybe today, you could actually possibly greatly reduce the number of periods from about 13 a year, which is 13 four-week periods a year, to about four times a year.

Now the interesting thing about this, most people ask, is it a different medication altogether? Well, it's really not. It's really just different dosing of very common medications that already exist. With the pill, 21 days of medication followed by seven days of a placebo, a sugar pill. With the Seasonale, you can do 84 days of medication, which is about 12 weeks, and then seven days of placebo after that. It uses, in fact, some of the exact same ingredients that exist in some of the pills that are already out there.

Now, as you can imagine, Soledad, it's generating a lot of buzz, generating a lot of controversy. It's in 47 clinical trials now around the country. Here's what one of the trial participants had to say.

(BEGIN VIDEO CLIP)

KELLEY BARCLAY, SEASONALE TRIAL PARTICIPANT: My mood swings were not at all like they had been before, not at all as severe and my pain was not at the level that it had been before I started Seasonale. (END VIDEO CLIP)

GUPTA: So Seasonale is certainly being marketed as an oral contraceptive. But, Soledad, they're also talking about it in terms of greatly reducing periods.

O'BRIEN: And I guess talking about it in terms of convenience, which I think sort of begs the question, is it safe to mess around with Mother Nature? I mean, if we're intended to have a period once a month, I mean, why not just go with that? It just seems like you're potentially adding sex hormones, which are pretty strong, aren't they? Isn't that a risk there, Sanjay?

GUPTA: A huge, huge question, Soledad. A lot of people think it potentially could be a risk.

There are several things to think about here. I think you're asking the right question. First of all, you're going to be giving extra hormones now. And sort of one end of the spectrum possibly could lead to increased depression. We also know that hormones have been associated with breast cancer. We've been talking so much about hormone replacement therapy. Is there a possibility that these extra hormones might also lead to increased risk of cancer? But then as you say, as well, Soledad, is there some function just of having periods that take away from some of that natural period? Here's what one of the doctors we talked to had to say about that, as well.

(BEGIN VIDEO CLIP)

DR. SUSAN RAKO, AUTHOR, "NO MORE PERIODS!": Bleeding is the only way our bodies can rid themselves of excess stored iron, and excess stored iron is another risk factor for heart attacks and strokes.

(END VIDEO CLIP)

GUPTA: So there's a lot of -- certainly a lot of controversy. Long-term studies are probably going to be needed on this. But I wouldn't be surprised still, Soledad, despite not having that long- term data, that this pill may get approved today.

O'BRIEN: It's interesting to see if it does get approved, and also to see if women embrace it and run out and buy it if, and when, it becomes available.

Sanjay, as always, thank you. It's nice to see you.

GUPTA: Good to see you.

TO ORDER A VIDEO OF THIS TRANSCRIPT, PLEASE CALL 800-CNN-NEWS OR USE OUR SECURE ONLINE ORDER FORM LOCATED AT www.fdch.com






Aired September 5, 2003 - 08:43   ET
THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.
SOLEDAD O'BRIEN, CNN ANCHOR: Today, government regulators are expected to decide whether a new birth control pill for women should go on the market. The drug reduces the number of menstrual periods to one every three months.
Dr. Sanjay Gupta is in Los Angeles for us this morning with details.

Hey, Sanjay, good morning.

DR. SANJAY GUPTA, CNN MEDICAL CORRESPONDENT: Good morning, Soledad.

Yes, this is really one of those interesting ones. The FDA is going to decide today -- we don't know what the decision is going to be yet -- on this new birth control pill. It's called Seasonale. Everyone knows the pill. It's a popular oral contraceptive. In fact, statistics show that 80 percent of women born since 1945 have used the pill at one time or another. With the pill, of course, you still get periods. And periods can mean pain, bloating, cramps, all sorts of things like that.

As you correctly mentioned, Soledad, with this new pill, Seasonale, hasn't been approved yet, but maybe today, you could actually possibly greatly reduce the number of periods from about 13 a year, which is 13 four-week periods a year, to about four times a year.

Now the interesting thing about this, most people ask, is it a different medication altogether? Well, it's really not. It's really just different dosing of very common medications that already exist. With the pill, 21 days of medication followed by seven days of a placebo, a sugar pill. With the Seasonale, you can do 84 days of medication, which is about 12 weeks, and then seven days of placebo after that. It uses, in fact, some of the exact same ingredients that exist in some of the pills that are already out there.

Now, as you can imagine, Soledad, it's generating a lot of buzz, generating a lot of controversy. It's in 47 clinical trials now around the country. Here's what one of the trial participants had to say.

(BEGIN VIDEO CLIP)

KELLEY BARCLAY, SEASONALE TRIAL PARTICIPANT: My mood swings were not at all like they had been before, not at all as severe and my pain was not at the level that it had been before I started Seasonale. (END VIDEO CLIP)

GUPTA: So Seasonale is certainly being marketed as an oral contraceptive. But, Soledad, they're also talking about it in terms of greatly reducing periods.

O'BRIEN: And I guess talking about it in terms of convenience, which I think sort of begs the question, is it safe to mess around with Mother Nature? I mean, if we're intended to have a period once a month, I mean, why not just go with that? It just seems like you're potentially adding sex hormones, which are pretty strong, aren't they? Isn't that a risk there, Sanjay?

GUPTA: A huge, huge question, Soledad. A lot of people think it potentially could be a risk.

There are several things to think about here. I think you're asking the right question. First of all, you're going to be giving extra hormones now. And sort of one end of the spectrum possibly could lead to increased depression. We also know that hormones have been associated with breast cancer. We've been talking so much about hormone replacement therapy. Is there a possibility that these extra hormones might also lead to increased risk of cancer? But then as you say, as well, Soledad, is there some function just of having periods that take away from some of that natural period? Here's what one of the doctors we talked to had to say about that, as well.

(BEGIN VIDEO CLIP)

DR. SUSAN RAKO, AUTHOR, "NO MORE PERIODS!": Bleeding is the only way our bodies can rid themselves of excess stored iron, and excess stored iron is another risk factor for heart attacks and strokes.

(END VIDEO CLIP)

GUPTA: So there's a lot of -- certainly a lot of controversy. Long-term studies are probably going to be needed on this. But I wouldn't be surprised still, Soledad, despite not having that long- term data, that this pill may get approved today.

O'BRIEN: It's interesting to see if it does get approved, and also to see if women embrace it and run out and buy it if, and when, it becomes available.

Sanjay, as always, thank you. It's nice to see you.

GUPTA: Good to see you.

TO ORDER A VIDEO OF THIS TRANSCRIPT, PLEASE CALL 800-CNN-NEWS OR USE OUR SECURE ONLINE ORDER FORM LOCATED AT www.fdch.com