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Yaz Birth Control Controversy: Pharmaceutical Profits, Unnecessary Risks, and the Gendered Distribution of Family Planning

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The current Yaz birth control controversy illustrates the continued tension between what pharmaceutical companies and the doctors that they pay claim is safe for consumption, and contrary scientific evidence. Natasha Singer of the New York Times is reporting that Yaz, a birth control pill manufactured and marketed by Bayer, is under fire as an inappropriately advertised, improperly made, more dangerous pill.  Two new studies out of Denmark and Holland and published in the British Medical Journal indicate that Yaz creates a higher risk of blood clots and strokes than other birth control pills.  A large group (at this time 74) of women in the U.S. are suing for blood clots and resultant health injuries that they have endured as a result of using Yaz.  The U.S. Food and Drug Administration (FDA) has been investigating Bayer and Yaz for some time, and Switzerland’s medicines supervisor is investigating this pill because it contributed to a lung clot that killed a woman earlier this month, and left a 16 year old girl permanently disabled last May.  The evidence has mounted around the globe that Yaz is an unsafe option, that the advertisements used by Bayer to promote Yaz obscured the health risks, and even that the manufacturing plants producing Yaz are not properly producing the drug.

Profit Motive Pushes Companies to Encourage Women to Take Unnecessary Risks

As is often the case in a pharmaceutical controversy, the doctors paid by Bayer are rushing to downplay the risk presented, while independent doctors take the approach you might expect from a health care practitioner: advising that, even if increased risk of blood clots and stroke is low, why not switch to any one of the multiple birth control pills that present a lower risk?  If you find the latter approach more sensible, congratulations; you are thinking like a person who would rather manage health risks than engage in unnecessary ones.  It seems too much of a coincidence that the only people who keep pushing the risk of Yaz are the only ones profiting monetarily from it.

Why Are Less Safe Birth Control Options Still on the Market?

Birth control pills present a unique pharmaceutical situation, for several reasons, one of which is that there are safer pills available and yet the less-safe pills remain on the market.  There are many different formulations of the hormones that go into the myriad birth control pills for sale, and not every combination of hormone is equally safe.  Dutch research shows that, while taking the pill generally increases a woman’s risk of blood clot, the extent of the risk depends on the exact type of hormones in the pill.  This research demonstrates that many women taking the pill are not taking the safest pill available to them.  Drug developers have been recalibrating the combination of hormones in birth control pills since the 1960s with the intent to reduce the risk of blood clots and thus make it safer for the women and girls that take it, which begs the question-why are we still marketed pills that are not at the optimum safety level?  How can companies such as Bayer continue to justify their manufacture of these less safe option?  It also raises the question of whether governments will allow them to advertise as “just as safe” as other oral contraceptive pills now that research shows that they are not “just as safe” as the other oral contraceptive options.

Birth Control: A Gendered Burden

Because only women and girls take birth control pills and other forms of hormonal contraception, this particular pharmaceutical controversy takes on a gendered dimension.  Yaz’s ads attempt a Sex and the City vibe that the New York Times describes as having succeeded in making it and its sister drug “the go-to brands for women under 35.”  The FDA has criticized Yaz’s advertisements-which feature young, attractive women chatting about Yaz at a chic rooftop party; ensconced on a plush sofa, they discuss the pill as servers stroll by with cocktails-for misleading women about the non-pregnancy related uses of this pill.  If ever a TV spot tried to make a pill seem trendy and fashionable, this is it.  It is this marketing of the pill as if it were a handbag or car that raises additional ethical questions.  Of course the pill is not some sort of fashion accessory, and of course the young women that it targets, such as the now permanently disabled 16 year old in Switzerland, should have it presented to them as a contraceptive and not a “lifestyle” drug.  In response to FDA demands, Bayer released a “follow-up” Yaz advertisement to clarify the previous one; and yet here is the same young, beautiful doctor, strolling through a party in a great outfit to tell you about these “clarifications.”  Not much has changed, nor do the ads reveal that this particular type of hormone combination presents a higher risk than others.

Hortense writes on Jezebel.com that flippant and non-medical advertising is a feature of all pharmaceuticals, not just birth control:

This is a problem that extends to all ads for medication; the consumer is told to go to the doctor and demand a certain brand name, without even knowing,  exactly, what the medication really does to the body. Someone always does a voice over about diarrhea and blood clots and death, but all the audience     seems to pick up on are the scenes of horses frolicking or women laughing or couples holding hands in the sun.

And yet contraception is a uniquely female issue; men are less likely to engage in or worry about shopping for or using birth control.  They have fewer options, and a daily pill is not currently available to them, in part because pharmaceutical companies have chosen not to produce one.  Because women and men share unequally in the child bearing process-obviously the burden (or, if you like, the privilege and the joy) of actually bearing the child falls on women, and so, they more readily accept the risks, including stroke and death, associated with pregnancy prevention in order to simply prevent the pregnancy.  Men can don a condom or have a vasectomy, but if a girl or a woman wants to take matters into her own hands, she can take a pill, use a patch, get a shot, etc.  As Lisa Campo-Engelstein writes in Science Progress, this creates an unequal burden that has women and girls using more of their time and money, and encountering more stress and stigma, for finding, using, and dealing with the repercussions-negative health effects; failed contraception-of birth control.

The Yaz controversy highlights the serious health risks associated with female birth control methods.  While these are often presented as minimal, Campo-Engelstein points out that the gravity of these side effects is not only important to consider in its own right,  but becomes more problematic when compared to the side effects of current male options. The comparison reveals the unequal burden: 

The side effects of female hormonal contraceptives can include cardiovascular complications, depression, hepatic adenomas, pathologic weight gain, and possible bone loss. The two available male forms of contraception also carry fewer risks than their corresponding female contraceptives, female barrier methods and tubal ligation, respectively. Some dismiss women’s side effects as “minor”; however, to the women who experience them, they often are far from benign. Women most commonly discontinue contraceptives due to side effects and most forms of contraception have discontinuation rates approaching 50 percent after one year of use.

The fact that women discontinue their use of birth control pills at “rates approaching 50 percent after one year of use” is immensely telling about the health risks these pills present. 

Big Pharmas Shut Down Male Contraception Options

Seeing birth control as a uniquely female issue means that most research dollars are targeted to creating new forms of female birth control vs. new forms of male birth control.  Time Magazine reported in August 2008 that the reason we don’t have male birth control options that mirror female options is that pharmaceutical companies-including Bayer, which led the market in halting the research, inspiring others to abandon it as well-decided in 2006 that there was not a large enough market for male contraception.  This despite the fact that they were reportedly on the verge of successful breakthroughs and that global surveys indicate male interest in birth control pills or injections.  Doctors researching male contraception cite the “knee-jerk” reaction of pharmaceutical companies that men aren’t interested, despite evidence to the contrary.  The Time article notes that “if even a small percentage of sexually active men agreed to try a new method of birth control, that would amount to a colossal number of potential consumers,” meaning, there should be profit incentive for developing the product.  The fact that there is insufficient corporate interest indicates that other barriers, such as gendered and cultural assumptions about male sexuality, are getting in the way of research and development.

To close the gap, the World Health Organization has led the charge in pushing for new male contraception options as part of their family planning programme.  It says something about the stakes involved and the integral role male birth control could play that the WHO has gotten behind it, especially in the face of disinterest by for-profit health related companies.  Until other options are available, however, and even when they are, governments must hold Bayer and other companies accountable for the preventable health risks presented by their products and for the way that these products are marketed.

 

Author

Jessica Corsi

Jessica Corsi has expertise in international law, international politics, and civil society organizing. She will obtain her J.D. from Harvard Law School in May 2010; holds an LL.M. (International Law) from the University of Cambridge; and a B.S. (International Politics) from Georgetown University. She has worked for the United Nations and NGOs in the fields of international human rights law, international public health, women's human rights, transitional justice, international criminal law, and international humanitarian law. She has lived in Mexico, Cambodia, India, Switzerland, England, and Belgium, and is originally from the United States. Jessica contributes to the human rights blog.