RENEE MONTAGNE, host:
This is MORNING EDITION, from NPR News. I'm Renee Montaigne.
LINDA WERTHEIMER, host:
And I'm Linda Wertheimer.
Today in Your Health, the risks of birth control pills in a period when drug makers are advertising the pill as a drug that delivers more than contraception.
This summer, the leading manufacturer of birth control pills, Bayer Healthcare, came out with a brand-new pill called Natazia. The launch coincides with growing problems for Bayer's last contraceptive, Yaz. Thousands of women are suing the company because they say Yaz caused them serious harm. NPR's Richard Knox has our story.
RICHARD KNOX: When it came out four years ago, Yaz was something entirely new in the history of birth control pills - or at least in the marketing of birth control pills. Bayer sold Yaz as going beyond birth control.
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Unidentified Woman #1: All birth control pills are 99 percent effective and can give you shorter, lighter periods. But there's one pill that goes beyond the rest. It's Yaz, the pill more and more women are turning to.
KNOX: The commercials imply Yaz is good for a slew of common problems. In the ad, bright balloons float away from carefree-looking young women. Each balloon bears the name of a symptom - moodiness, fatigue, headaches, acne.
(Soundbite of advertisement)
Unidentified Woman #1: And it also helps keep skin clear.
KNOX: Those ads caught the attention of a 16-year-old in Maryland named Katie Anderson.
Ms. KATIE ANDERSON: I do remember going to the gynecologist and asking for Yaz, because I had seen the commercials. That's the one that I wanted.
KNOX: She particularly liked the implication that Yaz could treat premenstrual syndrome, and the idea of clear skin appealed to her, too.
Ms. K. ANDERSON: What girl would not fall for something that says, you know, it's going to help with mild or moderate acne? That's great. That's just a perk. That's a plus.
KNOX: So she got her doctor to write a prescription for Yaz. It's a choice she'd live to regret.
We'll come back to Katie Anderson's story in a minute. First, let's hear from Ruth Day of Duke University. She advises the Food and Drug Administration on drug advertising.�Day says she'd never seen a campaign that made such sweeping claims as those Yaz ads. She showed the ad to dozens of young women and asked what they thought.
Professor RUTH DAY (Duke University): Most people thought it was going to prevent all those symptoms, period.
KNOX: For instance, 97 percent thought Yaz can treat ordinary premenstrual syndrome.
Ms. DAY: It does not. And the other question we asked: Does it treat mild acne? And 64 percent said, yes, it does. But the truth is, it does not.
KNOX: In fact, Yaz is approved only to treat a more serious and less common menstrual disorder, and only for more severe acne.
By 2008, the FDA decided the Yaz ads were misleading and ordered Bayer to run a corrective commercial.
(Soundbite of advertisement)
Unidentified Woman #2: You may have seen some Yaz commercials recently that were not clear. The FDA wants us to correct a few points in those ads.
KNOX: But Day found the corrective ad still left a lot of people with the wrong message about what Yaz can and can't do.
There's no question that Bayer's aggressive ad campaign worked. Yaz catapulted past all other birth control pills and became Bayer's top-selling drug. It brought the company $800 million last year.
But one lesson from Yaz is be wary of claims that a potent pill will solve all your problems, something Katie Anderson learned the hard way. She began having persistent leg pains within a month of starting on Yaz.
Ms. K. ANDERSON: I started developing this kind of pinching, twinging, numbing kind of feeling in my left butt cheek.
KNOX: She thought it was a pinched nerve. Then, a couple of weeks later, she was awakened with terrible chest pain.
Ms. BETH ANDERSON: She tells me she woke up at about five o'clock in the morning, and she sat bolt upright in bed, couldn't move, couldn't talk, was trying to cry as silently as possible because it hurt to breathe.
KNOX: That's Beth Anderson, Katie's mom.�
Ms. B. ANDERSON: I went to check on her, and I found her sitting in a puddle of tears saying, mommy, I can't breathe. Mommy I can't breathe.
KNOX: Her doctor diagnosed pleurisy, inflammation of the chest lining, which isn't serious. He prescribed a pain-killer. But over the next few days, it got hard for Katie to breathe, and her left leg went totally numb and cold.
Ms. K. ANDERSON: My left leg was completely purple.
KNOX: It turns out there was an enormous clot in her leg. A piece of it had broken off and lodged in her lung. Doctors call that a pulmonary embolism, and it can be deadly. Beth Anderson took Katie to the emergency room.
Ms. B. ANDERSON: And the doctor came in and he took one look at Katie's cold, blue leg and he said, wow, that's a big blood clot. You're on birth control, aren't you?
KNOX: The link between birth control pills and blood clots isn't new. It's been known for decades. Every year a few thousand women suffer clots because they're on the pill. But it's possible that Yaz and Yasmin, a similar pill, carry a higher risk of clotting.
Danish researchers decided to compare the experience of millions of women taking different contraceptives. They found those taking Yaz and Yasmin had a 64 percent higher risk of blood clots than women taking pills that had been around for decades. That's not a dramatically higher risk, but it's worrisome, given the millions of women taking the pills.
Dr. FRITS ROSENDAAL (Leiden University): Well, the safest is actually still, surprisingly, one of the oldest pills.
KNOX: That's Dr. Frits Rosendaal of Leiden University in Holland, an expert in blood-clotting disorders. He led another study that also found women using Yaz have a higher risk of clotting than those on older pills - about twice as high.
Dr. ROSENDAAL: There are convincing indications this pill is less safe than other pills.
KNOX: Bayer says its research shows Yaz is no riskier than other contraceptives. The FDA found flaws in the Danish and Dutch studies, so it's funding its own research. But on one point, there's no controversy: Some women have a much higher risk of clotting and death when they take birth control pills, and most of them don't know it.
Katie Anderson's mom did know that a super-clotting gene ran in her family, and she pointed that out to Katie's doctor.
Ms. B. ANDERSON: I wanted to make sure that that wasn't going to be an issue, and said she was not aware that there was any specific problem with that.
KNOX: In turned out that Katie had the gene, too. It made her 35 times more likely to have a problem. Yaz might have made that even higher. The labels of all birth control pills warn women not to take them if they have a family history of clotting. But often, that's not mentioned in TV ads. The ones for Yaz simply warned that women over 35 shouldn't smoke, because that increases the risk of blood clots.
Ms. B. ANDERSON: Both Katie and I assumed that since she was well under 35, she wasn't overweight and she had never smoked, that it would be safe, and we assumed wrong.
KNOX: Katie is now one of 2,700 women suing Bayer over Yaz. Three years later, she's left with a massive clot in her leg. She can't hike or be on her feet for long. The clot may never go away. Katie Anderson's experience shows how important it is to pay attention to warnings about bad side effects, and doctors should, too. Birth control pills are a serious business. They carry real risks.
And now Bayer's introducing Natazia, another new birth control pill. This happens over and over again, especially when there's an enormous market like the one for birth control pills. Companies keep coming up with new versions and selling them as different and better. The pressure's even greater when lawsuits or competition from generics have eaten into sales.
Dr. Edio Zampaglione of Bayer is in charge of the new pill. He says the company developed it simply because women need more options.
Dr. EDIO ZAMPAGLIONE (Bayer): Each woman is different, and each woman will, you know, feel differently on these hormones and will react differently to them.
KNOX: To some, those highly individual reactions are an argument for caution. Because when a new birth control pill comes out, no one knows how it will affect millions of different women. And Natazia is really different. Like Yaz, it contains a hormone that's never been used in a birth control pill, and it has a novel dosing regimen, too.
Beth Anderson says Katie's story contains a final lesson for women tempted to take the new pill.
Ms. B. ANDERSON: Really, the moral of the story is that you shouldn't use the latest and greatest drugs unless there's some reason that the ones that have been around don't work for you.
KNOX: Rosendaal, the Dutch clotting expert, agrees.
Dr. ROSENDAAL: Because we know that all drugs have side effects, and we also know that for newer ones which have not yet been used by millions of people, the side effects are generally unknown.
KNOX: Bayer is monitoring how its new pill is doing in 10 of thousands of women. But results of those studies won't be in for at least five years.
Richard Knox, NPR News.
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