When it comes to oral contraceptives, Bayer Healthcare is nothing if not creative. Now the drugmaker is coming out with a pill designed to protect against certain birth defects when the pill doesn't work.
Is the world ready for a vitamin-fortified birth control pill?
Beyaz, as it will be called, just won Food and Drug Administration approval. It's a version of Bayer's Yaz birth control pill with a sprinkle of folic acid, a B-vitamin that's already put in breads, cereal, and other grain products to reduce the risk of neural tube defects such as spina bifida.
"Bayer is once again at the forefront of medical innovation in reproductive health," boasts Phil Smits of Bayer Schering Pharma. It's the latest push by Bayer to make birth control pills that can be marketed with health benefits that aren't limited to preventing pregnancy.
"Beyond birth control" has become Bayer's marketing mantra and strategy. We're curious to see how how Bayer goes about promoting Beyaz. Like other modern birth control pills, Beyaz is 99 percent effective. But now the company can tell women their babies are less likely to have certain kinds of serious birth defects, if the pill fails to work for them.
True enough, as the FDA's approval indicates, but it doesn't strike us as the most confidence-building pitch.
For its part, Bayer says the new formulation is important "because women who discontinue OCs or do not take them correctly may become pregnant before seeking conception counseling from their health care provider."
It's also important – to Bayer Schering Pharma, at least — because sales of Yaz have slipped seriously.
Yaz, introduced in 2006, was the first contraceptive marketed as going "beyond birth control." That advertising tagline was remarkably effective. In just two years Yaz leapfrogged older contraceptives to become the No. 1 pill. It became Bayer's most profitable brand, bringing in more than $600 million in sales.
But last year the FDA and 27 state attorneys general penalized Bayer for going beyond the facts in marketing Yaz for acne, premenstrual syndrome and a smattering of other common complaints, such as anxiety, irritability, headaches and fatigue. (In fact, Yaz is approved for treating only moderate acne and a disabling mood disorder called PMDD or premenstrual dysphoric disorder.) Bayer was forced to run a $20 million corrective ad campaign.
Meanwhile, some European studies raised safety questions about Yaz and its sister contraceptive, Yasmin. Compared to an older Pill, the studies suggested, Yaz and Yasmin raise the risk of serious blood clots in the legs and lungs. Bayer-funded studies found no such risk.
Soon the lawyers were all over Yaz and Yasmin. Nearly 3,000 women have filed suits against Bayer, claiming the contraceptives caused clots and other injuries.
Sales of Yaz have dropped — partly because of the lawsuits, partly because of competition. Teva Pharmaceuticals began marketing a generic version in June. Bayer is suing Teva.
But Bayer seems undaunted. This summer, it launched a brand new pill called Natazia, which contains a novel form of estrogen combined with a progestin that's never been marketed in this country.
And now, there's Bayez — the pill for those times when the pill fails.