December 7, 2011 — Evidence is growing that Bayer AG minimized the risk factors associated with its popular birth control pills, Yaz and Yasmin, in a way that misled consumers and U.S. regulators.
Bayer is facing an ongoing lawsuit, and two days ago, a document was unsealed in federal court in Illinois that suggests important safety information was withheld from U.S. regulators. The document, a safety report from Bayer’s own researchers, demonstrated an increase in the U.S. reporting rate for blood clots tied to the contraceptives.
Bayer is facing up to 10,000 lawsuits from women who allege that the company went too far in marketing the products for unapproved uses (such as the treatment of PMS and acne) while simultaneously failing to provide safety information, thus misleading them into choosing these medications over other types of oral birth control pills with fewer risk-factors.
A major side effect of using these birth control pills is an increased risk of developing a blood clot, which may travel through the body and cause heart attack, stroke, pulmonary embolism. At least 50 women have died from blood-clot complications after taking the pills.
In October 2011, the FDA announced preliminary results of a massive study that followed more than 800,000 women taking newer types of birth control pills (Yaz, Yasmin, Beyaz, Ocella, Gianvi, Loryna, Syeda, and Safyral) and compared them with older types of oral contraceptives. They found that a woman is 74% more likely to develop a blood clot than women on low-estrogen contraceptives.
Bayer’s marketing team used the largest ad campaign ever to promote the birth control pills over low-estrogen contraceptives — and were wildly successful. After spending nearly $270 million on the campaign between 2004 and 2010, Yaz and Yasmin became the most popular form of oral contraceptives in the U.S. They generated $1.58 billion in sales last year.
However, the success of the advertising campaign may have been partly due to misleading claims. What marketing strategies did Bayer AG use to promote Yaz and Yasmin?
- Bayer hired Judith Reichman, a Los Angeles-based gynecologist who writes a women’s health blog, and paid her $450,000 to “engage in off-label promotion” of Yasmin. In 2005, Reichman wrote a book called Slow Your Clock Down, which promoted Yasmin as a treatment for PMS, bloating, and depression. Bayer planned to purchase 10,000 copies of the book as part of a strategy to make the book a New York Times bestseller.
- A 2006 story appeared in the magazine Allure, which promoted Yaz as a treatment for PMS. Yas is not only approved to treat the symptoms of Premenstrual Dysphoric Disorder (PMDD), not PMS.
- Bayer’s TV advertising campaign had ongoing issues, according to the FDA. You may remember the balloon ads, in which women popped balloons labeled “acne” and “moodiness” while singing “We’re not going to take it.” The FDA sent Bayer warning letters in 2003, 2008, and 2009 regarding the advertisements, which failed to mention any side-effects, promoted the drugs as safer alternatives to other birth control pills, and falsely claimed to treat PMS and serious acne.
Though the difference in blood clot risk is only slightly increased for Yaz and Yasmin (roughly 10 per 10,000 women instead of 6 per 10,000 with low-estrogen contraceptives), because millions of women in the U.S. have taken these pills, there are thousands of women who have experienced a blood clot.