Yaz and Yasmin: An Unacceptable Level of Risk?

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.

Yaz and Yasmin Back in the Spotlight

Guest Post by Holly Grigg-Spall, Sweetening the Pill

Last year the FDA made the decision to keep the birth control pills Yaz, Yasmin, and Beyaz on the market despite controversy over corporate corruption of the review process.These drugs are back in the spotlight.

The French health minister has called for doctors to stop writing prescriptions, 2,000 lawsuits against Bayer launched in Canada last month, and Marie Claire Australia dedicated five pages to an in-depth feature about the side effects, instigating an investigation by the country’s top current affairs show Today Tonight.

Bayer has gone about settling the 13,000 lawsuits in the US out of court, likely with the hope of keeping the details of confidential files regarding marketing techniques and research out of the public eye. Unperturbed by mounting reports from women of the myriad health issues caused by their products, the company launched Yaz Flex in Australia at the end of 2012. The first oral contraceptive on the Australian market presented as being for the purpose of preventing periods, Yaz Flex comes in a digital dispenser that records how many pills have been taken and alerts the user when she’s missed a dose. There are enough tablets to allow for just three breaks a year. In the US in April the FDA, equally unperturbed, ruled that pharmaceutical company Activis can start selling generic versions of Yaz, providing a low-cost version of what has been the most expensive oral contraceptive of recent years.

The feature in Marie Claire Australia generated 300+ comments on the magazine and television show’s Facebook pages. Many of the commenters were women who had developed blood clots when taking these brands. Some had made the connection at the time and others made the link only as a result of the coverage after months or years of not knowing why they had endured the injuries. Some of the women were presently experiencing the symptoms of a blood clot mentioned in the show and made the decision to stop taking the pill as they typed.

The piece was written by a long-time member of the Yaz and Yasmin Survivors forum and balances interviews with women who suffered the serious physical side effects with those who have been victim to the serious psychological side effects. I’m among those who experienced a long list of negative physical and psychological effects when taking Yasmin for more than two years and it was this forum that prompted me to stop taking it.

Monash University in Australia is one of the few facilities to have undertaken research into the correlation between birth control pills and depression. Professor Jayashri Kulkarni found that women on the pill were twice as likely to experience depression, anxiety, and mental numbness (known as anhedonia). The Yale Daily News reports that in the wake of her research receiving a little media attention Dr Kulkarni received more than 300 emails from women “clearly describing when they went off the pill that they felt subjectively more happy. The anhedonia, for example, disappeared, the irritability disappeared, the sense of poor self esteem disappeared”.

She is now focusing her attention on researching what she believes to be the particular psychological impact of the Yaz brands, those pills containing the synthetic progesterone drospirenone and low-dose synthetic estrogen.

Although there is no direct-to-consumer advertising in Australia these brands of pill gained popularity there just as they did in Europe and Canada. It is interesting to note that Marie Claire US ran an article in 2011 titled ‘The New Super Pill’ that named Yaz and Yasmin as the latest, greatest “no-acne, no-bloat and pms-be-gone” pills that also allow you to “shorten your period”. The pages of magazines such as Marie Claire in the US are usually scattered with adverts for Yaz and Yasmin, the NuvaRing, Nexplanon impant, and Mirena IUD. The print and television commercials often play on the same insecurities reflected and bolstered by the majority of the women’s magazine articles.

Articles with headlines like that of the Marie Claire Australia piece, “Bitter Pills: The Birth Control With Deadly Side Effects”, are usually accused of scare-mongering women off the pill unnecessarily despite the fact that reactions suggest they might well be saving lives. Generally women who decide they don’t want to take one brand are presented with another — and how many women know Yaz Flex, Yaz, Yasmin and Beyaz are 99% similar in composition and won’t just be shifted among the four? Judging from the comments responding to the piece, women who decide they are done with birth control pills are likely to be offered a Mirena IUD, implant, or Depo shot, all of which hold their own set of deadly and life-shattering side effects.

Women commented on the Facebook pages that they had made an appointment with their doctor only to be told not to worry and keep on taking their pills. Yet more remarked on their anxiety over stopping taking them as the article described the difficulties women experienced after they came off. Among women sharing doubts over whether the implant or shot should be their next choice, one woman asked:

“What other safer alternatives are there to birth control pills then?”

These articles don’t tend to go into the non-hormonal alternatives for contraception and cycle health that could support women in their choice not to take these drugs, and leave those scared of side effects to struggle along feeling trapped between pharmaceuticals and unwanted pregnancy, or on pharmaceuticals and not looking like the models in the magazines. That support needs to be out there and easy to find, or we will continue to see messages like this, sent out into the silence:

“I have been on Yaz for 3 months and just recently got switched to Yaz Flex yesterday so that it’s easier for me to remember takin it on time etc. by my doctor. I told her about what’s been happening in the last month or so, and she just gave me a cream for rashes etc. BUT I am seriously concerned as to if what I am experiencing is normal or not. I may be over reacting, I was put on this pill to regulate and lighten my period and also for my acne, it has helped a lot, but in the last month or so I have been experiencing an extremely itchy face, I have been finding it hard at times to breath and I’m very shortened in breath, it’s starting to scare me a lot. My heartbeat is irregular and I feel extremely light headed. I have been also experiencing horrifying migraines and headaches. I’m only 15 I may just need more understanding to what is happening if it is normal, somehow I feel it’s not please help :,(“

“Lives will be saved” – the FDA decision not to ban Bayer’s birth control pill

Guest Post by Holly Grigg-Spall

 

Photo by Monik Markus // CC 2.0

How many of us read the inserts included in a packet of pills? How many decide not to take the pills on the basis of the information enclosed?  The rapidly reeled-off list of side effects stated at the end of a televised advert for a new drug has more comedic value than serious consequence to most. If we do have doubts, many of us will rely on the reassurance of a doctor, and then take the pill anyway.

I recently wrote a piece for Ms. Magazine Blog outlining the FDA reappraisal of top-selling oral contraceptives Yaz and Yasmin. It was discovered that drugs such as these containing drospirenone held a significantly higher risk of causing blood clots. Research by the FDA and other bodies suggested this conclusion was definite, while research funded by the pharmaceutical company behind these billion-dollar products, Bayer, suggested the opposite conclusion to be true: that there was no increased risk evident. A team of experts, some of which had financial ties to the company, voted against having the pills taken off the market when presented with the question of whether the risks of taking these pills outweighed the benefits.

Bayer is facing 11,300 lawsuits from women who have been seriously injured and family members of women who have died after taking one of the company’s bestselling hormonal contraceptives. They have settled the first 500 addressed with a total of $110 million in payouts. When discussing this process with a lawyer representing many of the women I was told that Bayer would do anything to avoid a trial wherein the full spectrum of their marketing strategies would be revealed.

The FDA came to the decision to add into the insert included with these drugs a statement of the discovery of “conflicting” research that suggested the pills had a higher risk of causing blood clots  (up to three times higher) – acknowledging the discrepancy of the research funded by Bayer and giving it equal standing as that performed by other bodies including the FDA itself.

Prior to this decision being announced a number of women’s health groups got together to write a letter to the FDA asking that they look again at the question put to the board of experts. They argued that the correct comparison for the board to consider would be between drospirenone-containing contraceptives and other oral contraceptives, and not between Bayer’s drugs and unwanted pregnancy. In the final sentence, they remarked that they believed that “lives will be saved” if the pills were no longer on the market. They met with the FDA and one representative asked that the FDA strongly reassess its acceptance of Bayer-funded research. Another asked that the drugs no longer be prescribed and that the FDA “get back to the arc of history and progress that protects women while supporting their contraceptive needs.”

The new labeling will state the “conflicting” findings and advise that women speak to their doctor if concerned. The official statement on this decision, relayed through the media coverage, reminded women that when compared to pregnancy the risk of development of a blood clot was insignificant. They also asked that women currently taking the drugs not stop doing so. Despite the FDA studies suggesting the blood clot risk is particularly high for women under 30, the statement compounded the understanding that the issue is only relevant to those over 35,  those overweight, those that smoke, and those with relevant medical history.

Is this additional text in an insert enough? Cynthia Pearson of the National Women’s Health Network has given an unqualified no as her response to the decision.  If no is the answer, then what needs to happen next? At this time I’ve seen no coverage outside of news reports that has shown the response of the wider feminist, or just female, community.

When I heard that the FDA was asking for a comparison between pregnancy risks and the risks of Yaz and Yasmin, and that the women’s health groups were calling for, in their letter to the FDA, a comparison between these oral contraceptives and other brands not containing drospirenone, I immediately wanted to know why the comparison was not between using these pills and not using them — as in using other forms of non-hormonal contraception with similar effectiveness. This would produce the biggest gap, and put the statistics in starker relief.

There is too much dependent on the FDA not acknowledging the efficacy of non-hormonal contraceptives or admitting that research funded by the pharmaceutical company producing the drug is not reliable. These were for some years the most popular oral contraceptives. It is important that it is believed that there truly is an “arc of history and progress that protects women.”

Even the women’s health group representatives appear to understand this as a blip in an other uninterrupted history of outstanding service. To my mind, such behavior by the FDA should raise some serious suspicions of their motivating force. They advise that women should discuss this with their doctors – doctors who probably know less than I do, due to time constraints, inclination, as well as doctors that could well be directly or indirectly benefitting from backing Bayer.

If it’s taken this long to get a tentative admission of the blood clot risk, what do we not know about the other side effects of these pills? What were the benefits, outside of preventing pregnancy, of Yaz and Yasmin that the FDA saw as so important to women?

The reaction of the women’s health groups suggests an attempt to work within the system, rather than against it.  Does the FDA see itself as protecting the freedom of the millions of women who decided to take Bayer’s oral contraceptives, the millions that made it a bestseller? When a corporation can and will do anything to sell its product in ways that even the most cynical consumer would find shocking can we uphold the notion of informed consent?

We live in a very different time to 1970 when the result of the Nelson Pill Hearings was the inclusion of an insert in birth control pill packets. Then, the other noise of advertising – both overt and hidden – was not loud enough to drown out the message. We are now far happier with corporations telling us what to do than we are with being dictated to by the government. Consumer-driven choice keeps women on the pill – with doctors swapping them between the many brands as side effects appear. Laura Wershler and I put together a guide to a birth control rebellion. We live with a culture that stresses there is no alternative – to the pill or the system that supports it.

To quote a recent New Yorker piece by Margaret Talbot, by the way of Karl Marx, perhaps we must admit that – “Women make their own circumstances but not under circumstances of their own making” – and work from there.

The Next YAZ?

In the flood of media commemorating the 50th anniversary of FDA approval of the birth control pill, this story from the Washington Post about its newest iteration may just slide under your radar: FDA approves new birth control pill from Bayer.

Bayer, as you may recall, is the manufacturer of Yaz and Yasmin, which is currently facing more than 1100 U.S. lawsuits and two Canadian class action suits. The new drug, Natazia, contains various dosing of estrogen and progestin throughout the cycle, making it the first four-phase hormonal contraceptive. The new pill uses dienogest, rather than drospirenone, the synthetic progestin in Yaz that is the apparent source of its dangerous side effects. The most common side effects of Natazia in clinical trials included irregular bleeding, headaches, nausea, and vomiting.

Yaz and Yasmin are Bayer’s best-selling prescriptions, by the way –  combined sales for 2009 were $1.64 billion.

What’s Up with Yaz?

We’ve mentioned Yaz and its sister drug Yasmin before, and our friend Holly Grigg-Spall tracks the progress of complaints against them and other oral contraceptives. Yaz and Yasmin were Bayer’s top-selling drugs in 2008, bringing in about $1.8 billion, a 17 percent increase from 2007. The key element that makes them different from other OCs is drospirenone, a new form of synthetic progestin which has a pharmacological profile that is reported to be closer to the human body’s own progesterone but a safety profile that has come under scrutiny since the FDA approval of Yaz/Yasmin. Last fall, Bayer revealed that they were fighting 129 lawsuits over side effects and marketing of Yaz and Yasmin. More suits have since been filed.

So with this context in mind, it was with great interest that I noticed this study in my periodic searching of menstruation research literature: Bleeding patterns and menstrual-related symptoms with the continuous use of a contraceptive combination of ethinylestradiol and drospirenone: a randomized study, published in last month in Contraception. It’s a small study, only 78 women over six months time, but the researchers conclude: “Continuous use was associated with amenorrhea and fewer menstrual-related symptoms compared to cyclic use.”

It looks like Yaz and/or its analogues are being tested for marketing as menstrual suppression drugs. Time to put in an interlibrary loan request to get my hands on the full study. Anyone want to place bets on how the study was funded?