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RAY SUAREZ: Yesterday, an FDA advisory panel overwhelmingly voted to recommend that the pill, also known as Plan “B,” be made available over the counter. Meant to be taken within 72 hours of unprotected sex, the pill includes a high dose of the hormone progestin.
It works by either delaying ovulation or blocking fertilization of an egg. And it can also hinder the implantation of a fertilized egg into the uterus. But if the fertilized egg is already implanted into the uterus — in other words, if a woman is already pregnant — the pill has no effects.
The FDA must still decide whether to follow the panel’s recommendation. We get more on how this change may change women’s lives from Gloria Feldt, the president of Planned Parenthood, and Wendy Wright, the policy director of Concerned Women For America.
Gloria Feldt, if the FDA follows the panel’s recommendations, how will this change things, what will be different about the options available to people if this drug is available over the counter?
GLORIA FELDT: Well, it’s interesting, because emergency contraception is, is old technology. It’s basically the same formulation as birth control pills which were very familiar with. But it’s used in a way that enables women to prevent a pregnancy from occurring in emergency situations, such as if the condom breaks, or if contraception is not used, if it’s been forgotten or she just feels like she hasn’t used it correctly or appropriately, or in the tragic circumstances of sexual assault, to prevent a pregnancy from occurring.
So it’s a method of contraception — emergency contraception is contraception — it prevents pregnancy from occurring — your description was absolutely accurate — and it could prevent half of all the unintended pregnancies and therefore half of all the abortions that occur in the United States, and I would think that that would be a very good outcome from most people’s perspective.
RAY SUAREZ: Wendy Wright, Gloria Feldt suggests that this is something that’s already been going on and this just makes it available without a prescription.
WENDY WRIGHT: Well, actually there have been no studies done to find out what kind of medical effects this will have on women in the long term. And there have been no studies done on what kind of effect it has on women who take it multiple times.
In the United Kingdom where it’s been easily available they found of the group of 18 to 19-year-old those took it, a quarter of them used it more than once in a year. In Scotland where it’s also easily available, they found that teen pregnancies went up and abortions went up. So what this seems to imply that is people will engage in risky sexual behavior, including behavior that will end up causing sexually transmitted diseases because they’re expecting that they can rely on the morning after pill to prevent a pregnancy, then they’re not as concerned about protecting themselves against sexually transmitted diseases.
RAY SUAREZ: Gloria Feldt, is that right? Is there as little research into the use of this drug as Wendy Wright suggests?
GLORIA FELDT: Oh, my goodness no, emergency contraception has been very extensively researched. The New England Journal of medicine has published several studies which make very clear that women use emergency contraception responsibly, they don’t use it instead of their regular method of contraception, and in fact there’s something about having access to emergency contraception that seems to actually remind women to use their contraception more effectively themselves, and their rate of unintended pregnancy is lower.
When you compare the rates of unintended pregnancy, teen pregnancy, abortions, and sexually transmitted infections among teens with that of other countries… Let me give you some examples. The rate of teen pregnancy in France, where emergency contraception is widely available by public health policy, unintended pregnancy among teens or pregnancy among teens and abortion rates among teens are approximately one fourth of what they are in the United States.
Similarly, in England, the rate of teen pregnancy is half of that in the United States. So I’m afraid that Wendy just doesn’t have her data correct. There are no studies at all that have found in any way that there is a correlation between increased teen pregnancy or sexually transmitted infections and the use of emergency contraception. It just isn’t true.
WENDY WRIGHT: There also have been no studies done on adolescents, which is now required by law. That was signed into law on December 3 of this year. It’s called the Pediatric Research Equity Act. It requires that if a drug is going to be used by adolescents, it needs to be tested to make sure that it’s safe on adolescents. Adolescent bodies are different from adults. Anyone who has a teenager knows they go through rapid hormonal changes and this is a high dose of a hormone.
And so since this has not been tested on adolescents, we really don’t know what kind of medical effects it could have on them long term. We’re also quite concerned about a problem that we have in the United States with statutory rape, that is older men having sex with minors. Now, if something like the morning after pill is available over the counter, this could exacerbate that problem, because the statutory rapist can simply go to the drug store and pick up a pack to give to the young girl in order to allow the rapes to continue.
In Thailand, where the morning after pill has been easily accessible for 15 years, what they found, through several studies that were done, is that the most frequent buyer of the morning after pill is men. And as one person from the Population Council in Thailand noted, it’s because the men don’t want to wear condoms, and so they will give the morning after pill to the woman, and sometimes they’re not telling the woman what it is, that they’re being told that it’s just a health supplement.
They’ve also found in Thailand, some clinic workers are very concerned because women are using it — up to ten pills in a month on a routine basis.
RAY SUAREZ: But is Thailand a really good parallel for the adolescent, and young adult population in a developed industrialized wealthier country like the United States?
WENDY WRIGHT: Well, we have to look at the experiences in other countries. Right now what we hear from the promoters of Plan B is a lot of hypothesis, a hypothesis that it will lower abortion, that it will not have an effect on sexually transmitted disease rates. That’s why it’s important to look at the experience in other countries that has had it easily available.
We can also look in five states in the United States where it’s available through a pharmacist, that means there’s still counseling involved, there’s still a little bit of intervention to make sure that the person who is buying it understands that there could be risks in taking it. And in Washington State, there has not been a significant decrease in the number of abortions. The only decrease that they’ve had in the number of abortions represents the same decrease we’ve seen nationwide so, that would shows that there no effect in having the morning after pill available.
RAY SUAREZ: Gloria Feldt, why don’t you tie right on to that point, what happens when someone goes to the pharmacist, ideally in your view what would happen when someone tries to acquire this drug? What kind of advice, what kind of counsel would come with it?
GLORIA FELDT: Yes. The information, excuse me, the information about emergency contraception is, should be clear, and the safety and efficacy of emergency contraception has been so well documented by so many studies, and I must tell you, I think it is so disingenuous of Wendy and the organization she represents, because I don’t believe you would find that they would support emergency contraception under any circumstances. Their goals are to take away choices that women have to prevent unintended pregnancies and to be able to make their own decisions about what to do about pregnancies if they have them.
So it’s really disingenuous to be able to claim that they are in a great concern about women’s health right now; that is simply not true. If you’re concerned about women’s health, then one of the things you want to do is ensure that women can have pregnancies when they’re ready to have them because no one knows better than a woman whether she is in fact ready to have a pregnancy.
And it’s about enabling women to plan and space their child bearing responsibly. Emergency contraception is contraception and it is used in an emergency. The information that’s available to women, I believe, should be much more broadly available through public health information, through organizations like Planned Parenthood, through physicians, through pharmacies, there should be a great deal more information out there.
But the fact is that the package labeling of means like emergency contraception will be clear and will explain to women, and they will be able to understand it. I think that Wendy and her group have a very low estimation of women’s ability to make decisions for themselves and to understand what’s going on with their own bodies.
RAY SUAREZ: Wendy Wright?
WENDY WRIGHT: Barr Laboratories, which presented the information yesterday at the FDA hearing, presented a study on how do women, how well do they understand the labeling instructions and they found that a full one-third did not understand that this is not a drug to be used as a regular form of contraceptives.
So it’s important for there to be some form of intervention, that there be a doctor who’s involved, who can explain to the woman what kinds of risks can be associated with taking this drug, what kind of contra-indications, for example, if she has a medical condition, she may not even know about, that’s why it would be necessary for her to have a medical exam first. For example, diabetes, liver problems, heart problems, these are all contraindications for the birth control pill. The morning after pill is a high dose of the birth control pill.
So it’s very important that there be some form of intervention to make sure that the person who is taking the drug understands the risks that are involved. Now the FDA found Women’s Capital Corporation, which is the marker of the drug, guilty of false advertising, for overstating the effectiveness and under stating the risks.
RAY SUAREZ: We’re going to leave it there. Ladies, thank you very much.
WENDY WRIGHT: Thank you.
GLORIA FELDT: Thank you.