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.

Amy Rae’s Legacy

FemCare, Law/Legal, Toxic Shock Syndrome

Longtime readers of re:Cycling are probably familiar with the story of Amy Rae Elifritz, who died from tampon-induced Toxic Shock Syndrome (TSS) in 2010, and became the namesake of ARE in You ARE Loved, the educational foundation started by her mother, Lisa Elifritz. This summer marks the second anniversary of Amy’s death, and the Elifritz family is suing the hospital where she was treated for medical malpractice, and the makers of Playtex tampons for negligence and liability.

Details of the suit are not available due to Indiana’s malpractice laws, but the two-part investigative report about TSS conducted last year by Indianapolis television station WISH-TV8 is available here (part 1) and here (part 2). Phillip Tierno, the microbiologist who first identified the connection between synthetic fibres in tampons and TSS more than 30 years ago, is among those interviewed.

The findings of the WISH-TV8 investigative team, led by reporter Karen Hensel, inspired Rep. Carolyn B. Moloney (D-NY) to introduce the Robin Danielson Act to Congress for a fourth time, on June 23, 2011. Moloney first introduced a similar bill, called the Tampon Safety and Research Act, in 1997. The bill would have required independent research on tampon safety, under the auspices of the NIH, to determine whether dioxins, synthetic fibres, and other additives are present in femcare products and to assess their health risks. The bill was introduced in 1997 and in 1999, but never got out of subcommittee. In 2001, it was renamed “The Robin Danielson Act”, after a woman who died of tampon-related TSS in 1998, in hopes that removing the word “tampon” from the title might speed its progress. The bill was introduced again in early 2003 and quickly moved to the House Subcommittee on Health, where it slowly died. The 2011 edition has so far acquired three co-sponsors and been referred to the House Subcommittee on Health, where it currently rests.

The Danielson act would also authorize and compel the Centers for Disease Control (CDC) to develop a “program to collect, analyze, and make available data on toxic shock syndrome, including data on the causes of such syndrome”. Making a compelling case for the bill is complicated by the fact that there are presently no national data on cases of TSS in the U.S. TSS is a nationally notifiable disease that states must report to the CDC, but reporting by the states is voluntary. Amy Rae Elifritz’s home state of Indiana did not begin collecting data on TSS until 2009.

I don’t know the Elifritz family, but my heart hurts for the loss of their daughter. It hurts for them even more when I read the online comments about the lawsuit and the WISH-TV8 investigation that accuse them of “greed” for suing and Amy of “stupidity” for not reading or not following the warnings on the tampon box. Aside from the insensitivity and cruelty of saying such things to a grieving mother, they’re just not true. Amy’s mother is certain that she did read and heed the instructions on the box, but that’s not enough.

It remains controversial whether it is how long one wears a tampon or the fibre content of the tampon itself that is correlated with the growth of bacterial toxins in the bloodstream. The preponderance of evidence would suggest that it’s more likely about the fibres, especially since the manufacturers have the confidence to have withdrawn the warnings not to leave tampons in overnight from the required package inserts several years ago. (Those package inserts were required by court order, by the way, nine years after 38 women died from a tampon-related illness, because the industry refused to implement voluntary standards.)

Accusing the Elifritz family of greed is even worse. Lisa Elifritz started the non-profit foundation, You ARE Loved, for the sole purposes of raising awareness of tampon-related TSS and providing factual information about menstruation. Dedicating your life to preventing the cause of your daughter’s untimely death is just about the least greedy thing a person can do. And I’m pretty sure it’s not very profitable.

The “greedy” remark was about filing medical malpractice and corporate negligence lawsuits, of course, not about starting an educational foundation. But these suits are likely to drag out over a period of years, and require the Elifritz family to relive every agonizing moment of Amy’s last days in painful, public bas-relief. There are easier ways to make money. I have to believe this is about justice — making it impossible for a team of emergency room doctors to be unable to recognize signs and symptoms of TSS. Impossible for FDA regulators and tampon manufacturers to be so cavalier about women’s health. And impossible for girls and women not to know that the femcare industry isn’t looking out for them — they’ve got to look out for themselves.

It’s National Women’s Health Week — Celebrate and Reminisce with the FDA

Activism, Birth Control, Health Care, Law/Legal, politics

I admit, I didn’t know that this is National Women’s Health Week until I received a reminder in my inbox from a U.S. FDA mailing list, letting me know about the Food & Drug Administration’s role in promoting Women’s Health. They’ve published a brochure (available in both HTML and PDF versions) commemorating 100 Years of Protecting and Promoting Women’s Health.

Image Source: Public Domain

Society for Menstrual Cycle Research members and other women’s health advocates and activists will want to look through the list of the accomplishments the FDA claims responsibility for and lists as unequivocal improvements in women’s health.

For instance, we’ve had many discussions at re:Cycling about the FDA approval of the pill in 1960 as one holding mixed benefits for women, and not always the best choice for women’s health. The brochure also asserts that in 1970, “FDA initiated the first package insert written for consumers to explain to women the benefits and potential risks of oral contraceptives.” That happened in 1970, but Barbara Seaman, Alice Wolfson, and the other founding mothers of the National Women’s Health Network had more to do with its initiation than the FDA.

And here’s another inspiring quote from the FDA brochure:

1980: Making Tampon Use Safer

Problem: In 1980, there were 814 confirmed cases of menstrual related Toxic Shock Syndrome (TSS) and 38 deaths from the disease.
Response: FDA began requiring all tampon packages to include package inserts educating women about the risk of TSS and how to prevent it. In 1997, there were only five confirmed menstrually-related TSS cases and no deaths. The tampon package inserts with TSS information continue to be used today.

Sure, the FDA is proud of those safety rules now, but in 1982 the agency asked the industry to come up with their own voluntary standards because they did NOT want to regulate tampon safety. After years of pressure and organizing from Boston Women’s Health Collective members Esther Rome and Judy Norsigian, activist Jill Wolhander, researcher Nancy Reame, and others to standardize tampon absorbency ratings, the FDA finally enacted regulations in 1989, by court order. Nine years after 38 women died from a tampon-related illness.

Just last year, the FDA could have made another decision that would almost certainly save women’s lives, by removing birth control pills containing the synthetic progesterone drospirenone from the market, but instead the advisory panel voted by a four-person margin that the drugs’ benefit outweighed the risks.

You know what else isn’t on the list? Emergency contraception, a.k.a. the Morning After Pill and Plan B. The agency hemmed and hawed and delayed unconscionably for years, until finally approving it for limited over-the-counter availability in 2006 — a year after Susan Wood walked out of the FDA Office of Women’s Health for good over what she believed to be “willful disregard of scientific evidence showing Plan B to be safe.”

Celebrating organizational achievements that advance and protect women’s health is a fine thing. I’m glad Frances Kelsey withheld approval of Thalidomide in 1960, and for the most part, I’m glad the FDA is on the job. But while we’re celebrating women’s health and reminding everyone to be active, eat healthy, and get preventive health care (if they are so fortunate to have access to health care), let’s also celebrate the activists and advocates that keep agencies like the FDA in line.

New Data on Toxic Shock Syndrome

Birth Control, Disposable menstrual products, Health Care, New Research

The first known case of fatal TSS related to an IUD was recently reported recently. Here’s the abstract from the November 2009 Annals of Emergency Medicine (the full article is behind a subscription firewall):

Toxic shock syndrome is a rare toxin-mediated condition that can rapidly produce multiorgan failure and severe shock. Toxic shock syndrome has been previously recognized in various clinical situations relating to surgery, nasal packing, abscesses, burns, and most notably menstrual-related cases. This case report describes a previously healthy 33-year-old woman presenting to the emergency department with complaints of nausea, vomiting, and diarrhea; vital signs at triage were normal. Within hours, she developed shock and cardiopulmonary arrest. The patient met all 6 of the Centers for Disease Control and Prevention diagnostic criteria for toxic shock syndrome, and her intrauterine device grew out Staphylococcus aureus. To our knowledge, this is the first reported case in the medical literature of fatal toxic shock syndrome related to an intrauterine device.

Tampon Coating May Protect from Toxic Shock

FemCare, New Research

tamponsToxic shock syndrome is a potentially deadly complication of bacterial infection, resulting from Staphylococcus aureus (staph) bacteria. It has been associated with the use of super-absorbent tampons (most notably, the infamous Rely brand in 1980), but other risk factors include skin wounds and surgery. Thus it can also affect men, children, and postmenopausal women. Given the history of association of TSS with tampons – 40 women in the US died between March 1980 and March 1981 – research on prevention of TSS in menstruating women is ongoing.

A new finding, published in Clinical Infectious Diseases last week, suggests that using GML as a tampon fiber finish may reduce the risk of TSS in menstruating women. GML (Glycerol monolaurate) is an emulsifier used in ice cream, cosmetics, and chewing gum. (It also occurs naturally in human breast milk.)

The researchers tested the GML coating in a double-blind study in which the women wore the special tampons for 2-6 hours on the second day of menstrual flow. The women’s own tampons were then compared with study tampons with or without GML for S. aureus and the exotoxins associated with TSS. Lower amounts of the exotoxins were present in study tampons with GML than study tampons without GML, leading the researchers to conclude “that GML added to tampons provides additional safety relative to menstrual toxic shock syndrome as well as benefits for vaginal health generally.”