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Addyi, a new female libido pill, will hit the market this fall, but the prescription drug was twice rejected by the FDA in the past. For a closer look at the uses and risks, Judy Woodruff speaks to Dr. Adriane Fugh-Berman of the Georgetown University Medical Center and Dr. Mary Jane Minkin of Yale Medical Group.
For a closer look at the new libido pill and at some of the back-and-forth behind its approval, we turn to two physicians who focus on women's health issues.
Dr. Adriane Fugh-Berman, associate professor of pharmacology and physiology at Georgetown University Medical Center, she is also director of PharmedOut, a group that tracks pharmaceutical industry marketing practices. And Dr. Mary Jane Minkin, she's a practicing obstetrician-gynecologist at the Yale Medical Group, and she's also clinical professor at the Yale University School of Medicine.
We welcome you both.
Dr. Minkin, let me start with you.
Explain, first of all, who are the women this drug is designed for?
DR. MARY JANE MINKIN, Yale Medical Group:
This drug is designed for women who have — the fancy term is hypoactive sexual desire disorder.
Women who really don't have an interest in having sex is basically the simple way of thinking about it, and this drug is aimed for women who are premenopausal, not postmenopausal women, younger women.
And what exactly does it do? How is it different? And we just mentioned this, but how is it different from the drugs designed for men like Viagra?
DR. MARY JANE MINKIN:
Well, first of all, Judy, I wish we knew exactly how it works because this brain chemistry stuff, as Adriane will talk about, is very tricky.
But, basically, this drug, flibanserin, works at a central effect in the brain, affecting things like serotonin and dopamine activity. And, again, its focus is to increase sexual desire. It's a very, very different drug than Viagra or any of the drugs in that category for men. Those drugs have a distinct physical effect, basically to increase blood flow to the penis.
That's what it does. So, it's really a performance drug, not so much a desire drug.
And you have told us that you do plan to prescribe this drug for some of your patients.
I do plan on prescribing it under appropriate circumstances with appropriate counseling and ruling out other things going on saying, yes, this is the right thing to try and we will give it a try.
Now, Dr. Fugh-Berman, you have said — you said in an interview I saw — at one point, you said this is a drug that's useless and it's even dangerous. What did you mean?
DR. ADRIANE FUGH-BERMAN, Georgetown University Medical Center:
Well, this drug can cause sudden unconsciousness and also a very dangerously low blood pressure, nausea, sedation.
But the sudden unconsciousness that requires medical intervention is very worrisome. And people in clinical trials are healthier than people in the general population. Once this drug gets out there and is starting to be used by women with medical problems or women who are on multiple medications, I think we're going to see an epidemic of adverse effects.
It's a big interactor. It interacts with alcohol, the birth control pill, and many common medications.
So, you're saying, even though doctors will have looked at who should be taking it, you're saying you still expect there to be problems?
DR. ADRIANE FUGH-BERMAN:
And there already have been doctors quoted in the media as saying they are going to use it in postmenopausal women, which it shouldn't be used in.
Yes. And they will give it to women who are casual drinkers, which — and you are absolutely not supposed to use alcohol with this pill, which is actually pretty unreasonable when you think about it. You're taking this pill every day, and really women are never going to have a drink again if they take this?
What about those issues, Dr. Minkin? I mean, thinking — just thinking about the population of women you said you might be prescribing it to who are premenopausal, what about the issue of alcohol? How do you think about that?
Well, Adriane is correct. It is a concern, and obviously that these are not — certainly a women who is a significant alcohol consumer shouldn't even think about taking this medication.
And as far as it's not supposed to be used in the presence of alcohol and somebody has got to be ready to say I'm not going to drink, and that's a big commitment, understandably.
The drug also is supposed to be taken at night. Supposedly, if there are somnolence issues, this should be seen at night, so it should be less of an issue. But these are concerns that need to be discussed with the patients.
What about Dr. Fugh-Berman's other point, that it can cause unconsciousness?
I must confess that I have not been privy to look at all the clinical trials that have been done.
It's certainly not a common effect that I have been aware of.
How widespread, Dr. Fugh-Berman, do you think — you said you have already seen that some doctors are saying they're going to prescribe it outside the parameters of what's supposed to be prescribed. How widespread do you think the use may end up being?
Yes, great question.
I don't really know, but there has been such — I'm not sure that there's ever been a drug that's come on the market that has such name recognition already, that there is such hype around this drug that was really manufactured by the company, that this is a drug that's been really approved by a public relations campaign.
And in that connection — it sounds like you're saying it was a mistake for the FDA to approve it.
It is definitely a mistake for the FDA to have approved it.
This drug is barely effective, if it's effective at all, because its effect really maybe due to its sedative effect. This drug is as sedating as four drinks.
And, Dr. Minkin, given all that, how much does that give you pause, as someone who may be prescribing it?
Well, it obviously makes you think about doing significant counseling with the patient first as far as its use and talking — and calling if she has any side effects.
I think the most important thing to me in prescribing it to patients is, I don't want women thinking this is a cure-all: Oh, I don't want to have sex, this is going to make me want to have sex.
And this is not a cure for a lousy relationship. If somebody has got a lousy relationship, fix the relationship or get out of it. But this is not the answer for it. This is a very select use in people who are very selective for this particular indication. And it's not a cure-all by any means.
That's a really great point.
And really what we were talking about is an imbalance in libido between two partners. And I think we really need to question why we're saying there is something necessarily wrong with a woman who has a lower libido than her partner. There is not a scientific norm for libido.
And are you getting at this question of why it's taken so much longer to come up with a drug like this for women than it was for men?
And it hasn't been for want of trying. Pharmaceutical companies have really been trying. Viagra didn't work for women and neither have some other drugs.
So, really, women are more complicated than men, which isn't news.
I guess none of us could argue with that, but in a good way.
All right, well, we will leave it there.
Dr. Fugh-Berman, thank you very much.
Dr. Mary Jane Minkin, we thank you both.
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