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Controversial birth-control pill offers cautionary tale

The topic has been reported on before, but National Public Radio health and science reporter Richard Knox did a terrific job Monday of outlining the lessons women — indeed, all health consumers — can learn from the marketing story behind the controv

The topic has been reported on before, but National Public Radio health and science reporter Richard Knox did a terrific job Monday of outlining the lessons women — indeed, all health consumers — can learn from the marketing story behind the controversial birth-control pill Yaz.

It’s a cautionary tale.

Once America’s No. 1 birth control pill, Yaz dropped 15 percent in sales last year due to concerns over blood clots, reports Knox (although the drug still racked up $800 million in sales in 2009). But that’s not the only financial hit facing Yaz and its manufacturer, Bayer HealthCare. Thousands of women are now suing Bayer. They claim Yaz, which came on the market in 2006, caused them serious harm.

You may remember Yaz from its initial — and highly effective — “floating balloons” TV commercial. Balloons bobbed across the screen as The Veronicas sang “Goodbye to You” in the background. Each balloon had a different word imprinted on it: irritability, feeling anxious, headaches, fatigue, bloating, muscle aches, moodiness, increased appetite. Meanwhile, a woman’s voice declared, “Yaz is the only birth control proven to treat the emotional and physical premenstrual syndromes that are severe enough to impact your life. And it also helps to keep your skin clear.”

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But, as Knox points out, Yaz doesn’t treat acne. Nor does it treat ordinary PMS. It has been approved by the FDA only for the treatment of an uncommon and severe form of PMS known as premenstrual dysphoric disorder (PMDD). (That’s a whole other story. PMDD is considered by some to be disease mongering — the expanding of the definition of illness in order to sell medicine or other treatments.)

The FDA frowned on the Yaz ad, calling it misleading. It ordered Bayer to run a corrective ad. But by then, of course, the promise of clear skin and no more monthly wrangles with PMS had become imprinted on young women’s minds. Yaz had become America’s best-selling birth control pill.

Lesson to learn from this part of the story, says Knox: “Be wary of claims that a potent pill will solve all your problems — it’s probably not true.”

Read the fine print
But this isn’t just a story of a medical product not living up to its marketing hype. Some of the young women who bought the hype, like a Maryland teenager featured in Knox’s story, developed life-threatening blood clots.

All birth-control pills carry some risk of blood clots. But is Yaz particularly risky? Knox describes in detail the studies that do and don’t show Yaz to have a higher risk of blood clots than older birth-control pills. (The “do” studies tended to be conducted by independent researchers; the “don’t” studies tended to be funded by Bayer.) As Knox also reports, some women are at greater risk of clotting when they take birth-control pills because they have a “superclotting” gene called Factor V Leiden. The Maryland teenager had this gene, although she didn’t know it.

Which brings us to Knox’s Lesson No. 2:“Women and girls thinking of taking the pill should pay attention to the fine print. Their parents, too, if they’re in the picture. And especially their doctors.”

Déjà vu
Knox ends his broadcast with Bayer’s latest foray into the birth-control-pill market: Natazia, which contains a type of estrogen never before used in an oral contraceptive. Says Knox:

This happens over and over again. It’s the way the pharmaceutical business works, especially when there’s an enormous market like the one for birth control pills. (About 13 million American women take them, and 100 million around the world.) To garner market share, companies regularly come up with new formulations and market them as new and improved. The pressure’s even greater when lawsuits have dimmed the luster of a previous drug, or when a company faces competition from generic versions, as is now true of Yaz. …
To some, that might be an argument for caution. When a new birth control pill comes out, no one really knows how millions of women will react to it. Pre-market studies of Natazia involved only about 3,000 women. The unknowns are even greater when a contraceptive contains hormones and combinations never used before.

Knox lets the mother of the Maryland teenager deliver his Lesson No. 3: “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,” she said.

A Dutch expert in blood clotting concurs: “Personally,” he told Knox, “I would not start using a new drug unless it’s proven to be better. 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.”

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You can listen to Knox’s broadcast here, where you’ll also find a transcript, if you prefer to read his report.