One of the older elements in the medicalization of women's sexuality is The Pill. Credited by many as freeing women and kicking off the sexual revolution, birth control pills have definitely changed the sexual landscape for men and women. But at what cost? Hormonal birth control has long been known to contribute to women's risk of blood clots, and resulting effects, including pulmonary embolism, heart attack, stroke, and death.
Most birth control pills in use today are what are known as combined birth control pills, whose active ingredients include both estrogen and a progestin, a synthetic hormone designed to mimic the action of progesterone. In response to the risk of blood clots, and discovering that early combined birth control pills were crude in their dosing, newer formulations were developed using different hormones and generally lower doses of estrogen. As a result, women saw a decreased risk from their birth control pills. Recently, what are known as third-generation birth control pills have taken over much of the birth control pills market. We might expect these newer pills to be safer than ever, but numerous studies are beginning to reveal that these birth controls represent a major step backward in terms of women's safety.
Yaz, Yasmin, and Ocella: A Significant Example
Yaz, Yasmin, and Ocella are sometimes styled as 4th-generation birth control pills to separate them from the negative press surrounding 3rd-generation birth control pills, and to be fair they do use a different hormone than the traditionally-discussed hormone in 3rd generation pills. While 3rd-generation pills generally use desogestrel, Yaz, Yasmin, and Ocella utilize a unique progestin, known as drospirenone. However, the pills do share one common feature, a similar risk profile. Compared to 2nd-generation birth control pills made with estrogen and levonorgestrel, these pills represent a significantly increased risk of blood clots and resulting negative consequences, according to several studies.
However, despite the risk, Yaz is a blockbuster drug, commanding as much as 20% of the entire US birth control pill market, with sales of over $600 million in 2008. How did Yaz manage to grab so much of the market in the short time between its approval in 2002 and 2008? Aggressive marketing.
Marketing Birth Control
How Yaz became a blockbuster drug is very similar to the story behind other recent birth control methods, such as the OrthoEvra birth control patch and the NuvaRing contraceptive vaginal ring . All combined birth control methods are essentially equally effective, so if drug manufacturers hope to market a new method, they need an angle. In the case of OrthoEvra and NuvaRing, the angle was convenience. OrthoEvra patches are worn for a week, so no daily pills. NuvaRing is inserted in the vagina only once a month, worn for three weeks then removed.
Yaz is different, though. In promoting Yaz, marketers at Bayer promoted some side effects of all birth control pills: the reduction of acne, and the reduction of Pre-Menstrual Dysphoric Disorder (PMDD, a rare, severe condition of depression related to a woman's menstrual cycle). All birth control pills reduce acne, and have the ability to reduce hormone-induced mood swings, but only Bayer pursued this angle to get FDA approval for these effects.
Once it had secured approval for treating these conditions, Bayer (over)aggressively marketed them to make sure every woman choosing birth control pills knew about the only one approved to reduce acne. The marketing campaign was so aggressive that in October 2008, the FDA sent Bayer a warning letter, saying that it was over-promoting the benefits of Yaz and downplaying its risks. Among the items Bayer was warned about was implying that Yaz could treat Pre-Menstrual Syndrome (PMS) when it was only approved to treat the much rarer condition of PMDD.
Yaz, Yasmine, and Ocella Lawsuits
As soon as drospirenone-based birth control pills Yaz and Yasmin hit the market, some doctors expressed concern about the unique risk profile of the drugs. Several high-profile instances of women with no risk factors who suffered blood clots, including the death of a 17-year-old woman from massive pulmonary embolism, in the first years since approval raised concern. However, these concerns did not stop Bayer from ramping up marketing of the drospirenone pills, or other pharmaceutical manufacturers from greedily eyeing the market. Barr Pharmaceuticals won the right to launch the generic form of Yaz, Ocella, in March 2008, several years before the drug patent would legally have expired.
As a result of Bayer's aggressive marketing, its high market share, and the number of injuries, hundreds of women have filed product liability lawsuits against the company over Yaz.
