In 2009, the FDA requested that Bayer distribute a corrective advertisement to counter its aggressively screened commercials that were said to be making misleading assertions about the capabilities of the drug, promoting it for unapproved uses and making light of the more serious health risks (such as blood clots). However, in 2010 the drug remained the second-best-selling Bayer product, bringing in $1.5 billion in sales.
As of January 2012, there are approximately 10,000 lawsuits against Bayer by women who have suffered blood clots and by the families of those women who have died whilst taking Yaz or Yasmin. It is considered the most complained-about drug on the Internet, with thousands of women voicing concerns in online forums and support groups over health issues both physical and emotional. Jane Bennett and Alexandra Pope, authors of The Pill: Are You Sure It’s for You?, characterize many of these problems as “quality-of-life-threatening.” I have written extensively on my own experience with Yasmin in my blog, Sweetening the Pill, and for the UK Independent and have been quoted in Fabulous magazine the Washington Post.
Two studies conducted with funding from Bayer revealed that Yaz and Yasmin held no higher risk of blood clots than other birth control pills. However, last month it was revealed that five other studies undertaken independent of Bayer suggested a 50-to-75 percent increased risk of clots for those taking these birth control pills in comparison to others. A former FDA commissioner, David Kessler, charged that Bayer deliberately withheld data about this early on in order to push through the drugs’ approvals. In response, the FDA called an advisory committee to evaluate the safety of birth control pills containing drospirenone. The decision had the potential to cause the drugs to be pulled off the market, but the panel voted by a four-person margin that the drugs’ benefit outweighed the risks.
Yet a government watchdog group, the Project on Government Oversight (POGO), conducted an independent investigation that revealed three of the advisors on the FDA panel had research or other financial ties to Bayer. A fourth advisor was connected to manufacturing the generic version of these pills. All four voted for Yaz and Yasmin to continue to be prescribed by doctors. POGO asked the FDA that a new advisory committee be brought together to make another assessment.
Should these developments impact women’s perspective on the birth control pill? Should we consider that use of the Pill for pregnancy prevention, let alone acne or PMS, is still today, as women’s health activist Barbara Seaman wrote in her 1969 book The Doctors’ Case Against the Pill, “like tinkering with nuclear bombs to fight off the common cold”?
Says Ms. blogger Elizabeth Kissling, professor of communication and women’s and gender studies at Eastern Washington University and past president of the Society for Menstrual Cycle Research:
I’m surprised there has not been a broader call for more research, or wider public discussions of the risks of this pill. When a drug company is withholding data and 10,000 lawsuits are pending, more than research is needed. I can’t help but wonder why we’re not seeing Congressional hearings–akin to the 1970 Nelson Pill Hearings–again, and more of an outcry from both physicians and patients.Much of the media coverage of these recent developments and research was quick to assert the unimportance of women’s concerns. It was repeatedly reported that, when compared to the risk of blood clot development associated with pregnancy, the risk produced by taking any oral contraceptive–including Yasmin or Yaz–is of little concern. This is misleading in that it suggests there are only two states in which young women can choose to live: on birth control pills or pregnant. The fear has been voiced that any discussion of the negative impact of the Pill will prompt women to come off of it and fall unintentionally pregnant. No coverage that this writer has read discussed a comparison with non-hormonal contraceptive alternatives–which, of course, hold no increased risk of blood clots. Some of these alternatives are just as effective in preventing pregnancy as oral contraceptives, and others are more so.
According to Laura Wershler, veteran pro-choice sexual and reproductive health advocate and board director of the Canadian Federation for Sexual Health,
We need to reframe the idea that hormonal birth control is the gold standard of contraception. If women are quitting the Pill, and they have every right to do so, and they are not using alternative methods of birth control effectively, that’s proof positive that what we are teaching about contraception is incomplete and ineffective. If we make the Pill the ‘right’ choice, then why should we be upset when women stop taking it and get pregnant?It is often claimed within news stories that the Pill “regulates” a woman’s menstrual cycle, when it, in fact, stops and replaces the cycle. All of this propaganda for the Pill is extremely misleading, and it further breeds a lack of confidence to know that Bayer paid women’s magazines to advocate for Yaz. Such actions blind women to their choices and to understanding how their bodies work. There is much research that supports the health benefits of consistent (typically monthly) ovulation, which can be found through the Centre for Menstrual Cycle and Ovulation Research.
The absence of education in body literacy is a major factor in unwanted pregnancies. However, this lack of education is beneficial to some: It helps sustain the billion-dollar profits of pharmaceutical companies.
