Advocates of abortion and birth control often speak of “empowering women” with unbiased and vital information about reproductive health, but their silence following the most recent warning from the Federal Drug Administration (FDA) calls into question the nature of their concern for women’s health.
On September 26, 2011, the FDA announced that it “remains concerned by the potential increased risk of blood clots” associated with the use of one of the most popular types of birth control pills.
As irony would have it, the date of the FDA announcement was also recognized as “World Contraception Day” (WCD) by organizations dedicated to the promotion of contraception, such as Marie Stopes International, the Population Council, and the International Planned Parenthood Federation.
The stated mission of WCD is to “improve awareness of contraception to enable young people to make informed decisions on sexual and reproductive health.”
Note the emphasis on helping women make “informed decisions.” With such a mission statement, one would expect that the FDA’s concern about the side-effects of certain birth control pills would receive serious attention from the defenders of women’s health in a press release or on the WCD web site. Yet weeks after the FDA’s announcement, nary a mention of the new studies has appeared.
The pills in question contain the progestin drospirenone, and have in recent years been marketed by Bayer Pharmaceuticals to young women under such trade names as Yaz, Beyaz, Yasmin, and Safyral. Following publication in the British Medical Journal of two studies in early 2011 that indicated these birth control pills brought their users a two to three times greater risk for venous thromboembolism (blood clots), the FDA announced on May 31, 2011 that it would undergo an investigation into their safety.
The recent FDA press release reports that the “preliminary results of the FDA-funded study suggest an approximately 1.5 fold increase in the risk of blood clots for women who use drospirenone-containing birth control pills compared to users of other hormonal contraceptives.”
In addressing these “other hormonal contraceptives,” the Physicians Desk Reference (PDR) states that users of birth control are three times more likely to develop superficial venous thrombosis, and have a four to eleven times greater risk for deep vein thrombosis or pulmonary embolism than non-users. The risk goes up by a factor of 1.5 – 6 for those women who are genetically predisposed to clots.
In summary, the PDR notes that, “An increased risk of thromboembolic and thrombotic disease associated with the use of oral contraceptives is well established.”
According to the preliminary conclusions of the FDA’s recent analysis, however, Yaz and other drospirenone containing pills increase these “well established” risks by a factor of 1.5. Awareness of this increased risk is vital for consumers, especially for parents as they make health-care decisions for their teenage daughters, and for college-aged women as they make health care decisions for themselves.
The WCD organizers who claim to provide “accurate and unbiased information” make scant reference to any of the many and scientifically established negative side-effects of combined oral contraceptives. The site brushes aside the increased risk of blood clots, stating that “a few women might suffer from thrombosis, but this is very uncommon.” No mention whatsoever is made about the FDA’s ongoing safety review.
Why is a site dedicated to contraception, and which boasts of its desire to help women make informed choices about their health, either downplaying or ignoring serious threats to the health of women who use the products being promoted? A closer look at the site reveals what may be the answer: the financier of World Contraception Day is Bayer Pharmaceuticals, the very company who manufactures all four of the brand name drugs (Yaz, Yasmin, Beyaz, and Safyral) currently under safety review by the FDA. Yaz and Yasmin alone earned Bayer $505 million in the first half of 2011, which makes it the third highest earning drug for the company.
Is it any wonder that the WCD organizers are silent about the side-effects of the drugs sold by their sponsor?
Bayer has other reasons to downplay the potential negative side-effects of the birth control pills they market and distribute. As they report in their stockholder newsletter, the company is currently facing a “number of lawsuits pending in the United States and served upon Bayer” numbering “about 9,300 as of July 16, 2011.” Bayer notes that, “Plaintiffs allege that they have suffered personal injuries, some of them fatal, from the use of Bayer’s oral contraceptive products Yasmin™ and / or YAZ™.”
Regardless of the outcome of these lawsuits, the findings of ongoing safety studies, and in spite of the virtual silence by organizations that promote birth control to young women, consumers have a right to this information as it is made available.
Thankfully, the FDA, by all appearances, seems to be taking the side-effects somewhat seriously. They note that while the department “has not yet reached a conclusion” regarding the two 2011 studies, they have scheduled a joint meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee for this December to discuss the increasingly worrisome risks associated with drospirenone-containing birth control.
The promoters of World Contraception Day are hocking a product that makes billions annually for companies that know the harm their products cause, but seem to have calculated that the profits outweigh the risks to women’s health. Adding insult to injury, they are doing so with funds provided by those who profit from the sale of these drugs, all in the name of helping women make “informed choices” about their health.
In the face of this conspiracy of silence, where are the real champions of women’s health?