Yaz and Yasmin: An Unacceptable Level of Risk?

Activism, Birth Control, History, Toxic Shock Syndrome

Photo by Flickr user Beautiful Lily // Creative Commons 2.0

Don’t feel bad if you missed last week’s headline news about the deaths of 23 young women from their birth control. It was a top story for CBC news and a few other Canadian sources, but it was barely a blip on the radar of most U.S. news outlets. Yaz and Yasmin, two similar new-generation birth control pills from Bayer, are suspected in the recent deaths of these young Canadian women.

These are among the best selling oral contraceptives in the world, but this is not the first time Yaz and Yasmin have been suspected of causing death or adverse effects. Earlier this year, Bayer agreed to pay up to $24 million to settle claims from plaintiffs with gall bladder injuries caused by the drugs, and the company set aside $1 billion to settle claims from approximately 4,800 women who have suffered blood clots due to Yaz or Yasmin. As of February, 2013, approximately 10,000 lawsuits against Bayer are still pending in the U.S., and an additional 1,200 unfiled claims are pending. The company anticipates additional lawsuits—and additional settlements—regarding blood clot injuries, such as pulmonary embolisms or deep-vein thrombosis.

The history of the birth control pill and its social impact is well documented. First approved by the U.S. Food and Drug Administration in 1960, it quickly became the world’s first “lifestyle drug,” and it has become the one of the most studied drugs in history. It is considered to be so safe that the American Congress of Obstetricians and Gynecologists (ACOG) recently recommended that oral contraceptives be sold without a prescription.

But all hormonal contraceptives–the pill, the patch, the shot and the vaginal ring–carry a risk of blood clots. For most users, this is a minor concern, affecting approximately six of every 10,000 pill users. For users of new-generation pills—that is, pills containing drospirenone, the fourth-generation synthetic progesterone found in Yaz, Yasmin, Ocella and several other brands—the risk jumps to ten of every 10,000 users, although Bayer maintains that their own clinical studies find the risk comparable to older pills. Note, however, that the risk in most of these studies is compared either to other hormonal contraceptives or to pregnancy, not to using effective non-hormonal contraception. As if women’s only choices were to be pregnant or be on the pill.

And it is this matter of women’s choices that brings me to my main point: Why we have we seen so little media attention to the safety profile of Yaz/Yasmin (and hormonal contraceptives more generally)? This isn’t about just a few unlucky Canadian women: Four women in Finland have died, more than 50 U.S. users of Yaz and Yasmin died in just a few years and France reports 20 deaths per year due to birth control pills between 2001 and 2011, with 14 attributed to the new-generation contraceptives. This is a major consumer safety concern, and a women’s health issue.

In an earlier time, this might have led to Congressional investigations, such as the Nelson Pill Hearings, which resulted in FDA-mandated Patient Package Inserts (PPIs)—the printed information about risks, ingredients and side effects included in pill packets, first required for oral contraceptives and then for all prescription drugs. It is hard to imagine today’s Congress calling for such an investigation. Among many other social changes since 1970, drug manufacturers in the U.S. hold more influence over both legislators and consumers, now spending nearly twice as much on promotion as they do on research and development.

A parallel can be found in the health crisis triggered by an outbreak of Toxic Shock Syndrome (TSS) linked to tampon use in 1980. TSS is a potentially fatal infection caused by bacterial toxin Staphylococcus Aureus. A new brand of superabsorbent tampon was linked with 813 cases of TSS, including 38 deaths, that year. By 1983, the number of menstrual-related cases reported to the CDC climbed past 2,200, and manufacturer Proctor & Gamble had “voluntarily” pulled the product from the market before the FDA forced them to do so. The intense media coverage, public concern and outcry from feminist activists pushed the FDA to reclassify tampons as a Class II medical device, an upgrade which meant tampons would require more specific regulation and possibly after-market surveillance. They were much slower to mandate absorbency standards, but eventually did so under court order. These actions resulted in a documented decrease in menstrual-related TSS, although it is important to note that it has not disappeared.

Today, more than 30 years later, young women are again dying from something purported to help them, something that affects mostly women. Thousands more are experiencing life-threatening, health-destroying side-effects, such as blindness, depression and pulmonary embolism. Canada’s professional association of OB-GYNs defended the drug, suggesting that perhaps the recent deaths could be attributed to non-contraceptive reasons for which it was prescribed, such as PCOS or diabetes, both of which are associated with higher risks of blood clots. But there is little evidence of public concern, outside of Yaz/Yasmin user message boards. Even feminist outlets aren’t always covering these issues as vigorously as we might hope.

Yet the birth control pill in general has never been more politicized in the U.S.: In the last year or so, we’ve seen headlines and public debates about insurance coverage of the pill, access to emergency contraception and so-called personhood bills which have been introduced in legislatures in at least eight states. Feminist activists and health care advocates have been working tirelessly to protect access to the pill along with other forms of birth control, as well as the right to end an unintended pregnancy—and feminist journalists have been writing about these activities.

In the urgency of responding defensively to these political attacks—and we must respond—feminists cannot ignore corporate threats. Just as preserving contraceptive and abortion access is critical to women’s health and well-being, so is protecting contraceptive safety.

Cross-posted from Ms. magazine blog.

The Disappearing Diaphragm

Birth Control, Health Care, New Research
Photo courtesy of Jenny Lee Silver under Creative Commons 3.0.

Photo courtesy of Jenny Lee Silver under Creative Commons 3.0.

Did you know that last year’s combined sales of Yaz and Yasmin, the most popular oral contraceptives in the U.S., totaled $1.64 billion? Did you know the drugs are also the target of 1,100 lawsuits for potentially fatal blood clots? Did you know that an estimated 50 women have died from taking those contraceptives?

Despite such health risks,  however, oral contraceptives remain an extremely popular method of birth control in the U.S., second only to sterilization. The Guttmacher Institute reports that whether a woman prefers the Pill or sterilization is largely a function of age, with women under 30 choosing the Pill and women over 30 choosing permanent methods. These trends have been fairly stable since 1982.

None of these facts surprised me as much as the news that fewer than one percent of women in North America (and northwestern Europe) use the diaphragm–or any other woman-controlled barrier method. I’m puzzled that a safe, reliable, fairly easy-to-use (with some training and practice), inexpensive method of controlling fertility is not more widely recommended. Used correctly and consistently, the diaphragm has an effectiveness rate of 94 percent. Nevertheless, diaphragm use declined after the Pill was introduced, from 25 percent of married women in 1955 to 10 percent in 1965, and kept dropping thereafter, to just 4.5 percent of all women in 1982 and 0.2 percent today, according to the CDC [pdf].

U S. Medical Eligibility Criteria for Contraceptive Use, 2010, released last month by the Centers for Disease Control, shows that the diaphragm has no medical contraindications for most women. The exceptions are latex allergies, immediate postpartum or post-termination use, uterine prolapse, and women with HIV/AIDS, for whom the risk is not the diaphragm itself but the accompanying spermicide nonoxynol-9, which may increase viral shedding and HIV transmission to uninfected sex partners.

Yet the American College of Obstetricians and Gynecologists (ACOG) Committee on Gynecologic Practice recommends that hormonal methods such as IUDs or injections be offered as “first-line contraceptive methods and encouraged as options for most women.” At this year’s annual ACOG meeting last month in San Francisco, the group issued a press release with eight gushing statements of praise for the Pill on its 50th anniversary. (See re:Cycling‘s response to the ACOG statement here.)

But nearly four of every ten women who use contraceptives are not satisfied with their method, and I hear frequently from young women that they’re pressured at college health centers and physicians’ offices to choose hormonal methods, usually the Pill, over barrier methods such as condoms and diaphragms. Even after negative experiences with the Pill, women are often encouraged to try another brand rather than another method.

I’ve even heard of educators and health care providers actively discouraging use of the diaphragm because “it’s messy”. This complaint baffles me, and I used a diaphragm for 15 years. With or without a diaphragm, sex is messy.

Although diaphragms must be accurately fitted by a health care professional and re-assessed every few years, they remain cheaper than hormonal methods and require less frequent physician visits. A diaphragm can be inserted hours or moments before intercourse, and it is a fully reversible, female-controlled method of birth control. There is some evidence that diaphragm use minimizes women’s exposure to certain STIs , and ongoing research by pharmaceutical companies is aimed at developing a spermicide that is also antimicrobial.

There’s even research on a one-size-fits-all diaphragm in progress: Program for Appropriate Technology in Health (PATH) has developed and patented a single-size diaphragm designed to fit most women comfortably. The modified device has proven effective in initial studies, and the organization plans to apply to the FDA for approval as a contraceptive by the end of next year.

Early last century, Margaret Sanger risked prison to introduce the diaphragm to an American public desperate for effective birth control. We need a contemporary crusader to re-introduce the diaphragm in the 21st century for those seeking safe, effective, hormone-free birth control.

Cross-posted at Ms. magazine blog.