After five years on one of Canada’s most popular birth control pills, Adrienne Wolfe was a satisfied customer. Not only did Yasmin keep its central guarantee, but some of the side effects were unexpectedly positive: Her skin was better and she went up a full cup size. While her doctor had warned her that women were more likely to experience blood clots on the pill, she wasn’t considered high-risk. “I’m not a smoker, there’s no family history of clotting, and I have a healthy lifestyle,” says Wolfe, who lives in Montreal. “So I put it out of my mind.”
In December 2010, when she was 26 years old, the headaches started. They were severe, a “tremendous pressure” she’d never felt before. A walk-in clinic diagnosed migraines and prescribed painkillers, but they didn’t help. Soon she began vomiting as the pain peaked, so she went to the ER. A CAT scan returned some alarming results: three large blood clots—the size of grapes—inside the veins of her brain, about to burst and cause a potentially fatal aneurysm. Wolfe was hospitalized and received blood thinners intravenously for 12 days; she ended up missing three months of work due to the exhaustion that followed (a common side effect of the oral blood thinner she downed daily after leaving the hospital). It took two years’ worth of meds before her blood viscosity and her energy level were back to normal. Even today, nearly three years later, she still feels a strange, intense pressure in the areas where the clots developed as soon as she gets a headache.
Her doctors were reluctant to link the clots to Yasmin, but they took her off it immediately and recommended she avoid all hormonal methods of contraception going forward. “My doctor said it could have been a coincidence, but I felt like saying, ‘Well, why don’t you go spend 12 days in the hospital,’ you know?”
Wolfe’s nightmarish experience is, thankfully, extremely rare, especially since she had been on Yasmin for years. Clots are most likely during the first 12 months on a new pill; it’s also worth noting that all oral contraceptives increase their likelihood, and that being pregnant or post- partum carries an even higher risk as blood thickens at these times to help reduce bleeding after birth. And yet, the alarming headlines have been accruing: 23 women in Canada, eight of whom were teens, died suddenly of strokes, heart attacks and blood clots while taking Yasmin or Yaz between late 2007 and early 2013.
The catalyst for the most recent surge in media interest is not a pill recall or a Health Canada alert but a class-action lawsuit certified this past April, now moving through the Ontario judicial system. The suit alleges that Bayer, the manufacturer of Yasmin and Yaz, failed to properly communicate the risks associated with a crucial ingredient of their products—a synthetic progesterone called drospirenone, which promises fewer unpleasant side effects (such as bloating) than the synthetic progesterones used in other pills, and also claims to improve certain conditions (acne, unwanted facial hair, PMS). Included in the suit are families of 13 of the women who died while on Yasmin and Yaz, as well as the hundreds of women who reported non-fatal “adverse reactions,” including venous thromboembolism, which can take the form of deep vein thrombosis (a blood clot in a vein) and/or pulmonary embolism (a clot in your lungs).
But what the headlines don’t say is whether the pills actually caused these side effects or whether they were the result of a pre-existing condition, such as obesity or diabetes, or of being a smoker or having a family history of blood clots—all of which can increase risk. Adverse reactions happen not because the drug is dangerous and should be recalled, says Dr. Ellen Giesbrecht, head of obstetrics and gynecology at BC Women’s Hospital in Vancouver, but because “some doctors prescribe pills to the wrong people” (those with risk factors for clots). Health Canada says it’s impossible to determine what role drospirenone played in these deaths, though it did issue an alert in December 2011, after reviewing adverse reaction reports primarily filed by doctors and multiple international studies of Yasmin and Yaz (some of which may have been funded by Bayer). The risk for blood clots varied from study to study but is generally thought to be one-and-a-half to three times higher for oral contraceptives that contain drospirenone than for those that do not. (Yasmin and Yaz packaging includes a warning label that points out the higher risk.)
No one wants a blood clot, but it’s important to note that they’re highly treatable: The death rate is less than one woman in 100,000, which, according to the Society of Obstetricians and Gynecologists of Canada (SOGC), is similar to the risk of death from falls, drowning, poisoning or domestic violence. Compare this to death rates for other popular drugs, says Dr. Supriya Sharma, a physician and senior medical advisor at Health Canada’s Health Products and Food Branch, and that number is even less daunting: In any given year, for instance, there are about 40 deaths related to Tylenol per 10,000 people.
The risk for any one individual on Yasmin or Yaz is quite small,” concedes Matthew Baer, the London, Ont.–based lead lawyer for the Ontario class-action suit. That said, he stresses that women need to be more aware of the drugs’ potential side effects. “I personally would not choose a [drug] that has increased risk when equally effective alternatives are available.” His case may set a precedent; there are 13 other class actions underway across Canada. (In the U.S., Bayer has already paid over $1 billion to settle thousands of similar lawsuits, without admitting liability.) Despite all of this, Marija Mandic, Bayer’s head of communications, says the company continues to “fully stand behind Yaz and Yasmin.” And for its part, Health Canada says it has no plans to recall either at this time.
Because Yasmin (which contains 21 active pills and seven placebos per pack) and Yaz (which contains 24 active pills and four placebos per pack) are relatively new products—they came on the Canadian market in 2004 and 2008—there are no long-term studies to prove their safety. They’ve also been advertised more heavily than older pills. In 2008, the FDA reprimanded Bayer for over-promising on Yasmin’s skin-and mood-improving side effects in U.S. TV commercials (in them, women kicked balloons labelled with symptoms such as “being anxious” and “bloating,” against a soundtrack that included “Goodbye to You” by The Veronicas). As a result, Bayer was forced to run a follow-up campaign clearly stating that Yasmin is primarily for contraception, and clarifying its risks and benefits.
In the past six years, Health Canada has received more than 500 adverse reaction reports on both pills; in addition to clots there have been accounts of nausea, vomiting and gall bladder disease. But when the class action was certified, the drug regulator hadn’t seen a change in risk. Instead, says Sharma, the suit put the pill in the spotlight again, creating greater fear than what was warranted. And while Sharma believes that a bit of anxiety about any drug is a good thing, she has a line she repeats often: “All drugs have risks. If there’s no risk associated with a medication, it’s probably not working.”
This isn’t to say she doesn’t understand why women are worried. Sharma is still haunted by a young patient she encountered during medical school, who suffered a stroke while on the pill. “When a young, otherwise healthy woman has had a stroke like that … it is devastating. But you do have to put it in the context of an overall population basis.”
The SOGC continues to advise both women and their doctors not to panic, that there is no new data, and that they should stay on their pills. They’re worried that the media frenzy about adverse side effects will cause a repeat of the 1995 pill scare in England—a similar situation, in which two other forms of synthetic progesterone were found to double clot risk. Afterward, the British birth rate and abortion rate both increased. “At the end of the day, I still think Yasmin is a safe and effective pill,” says Dr. Amanda Black, an OB/GYN at The Ottawa Hospital and chair of the SOGC’s Contraception Awareness Program. “If you increase the number of people taking it, there’s a [proportional] increase of adverse events.” Stopping or switching pills comes with its own set of problems. “Every time you stop and restart birth control, your risk goes up,” says Black. (Stopping pills also increases the risk of pregnancy, thus also increasing clot risk.) This new-user effect, says Sharma, applies to more than just birth control—risks of reactions are higher the first time you take any medication.
Even though the SOGC does not advise switching, doctors are allowing it. Anecdotally, many women I know say that over the past two years, their MDs have taken them off Yasmin or Yaz for various reasons though the bad headlines often served as a tipping point. (According to Bayer’s stockholder newsletters, sales of both pills from the most recent quarter are down 15 per cent, compared to the same quarter in 2012.) Yet it proved difficult to get Yasmin-wary MDs to go on the record to explain why they’ve changed their prescribing habits. Finally, I spoke with Dr. Warren Bell, a family doctor in Salmon Arm, B.C., who was refreshingly forthright, telling me he wouldn’t touch Yasmin “with a 10-foot pole.”
Bell, who’s been practising for 37 years, is a vocal advocate for reforming the drug approval process in Canada. He co-authored the only peer-reviewed critique of the Compendium of Pharmaceuticals and Specialties (CPS), a reference volume that’s used by doctors as the ultimate source of information about different drugs. (Most of its listings are written by the manufacturers themselves.) In Bell’s view, the pharmaceutical industry has such a grip on many doctors—especially specialists and those in academic settings—and on Health Canada that both cave to the demands of companies like Bayer and approve drugs before they’ve been thoroughly studied and deemed safe.
Bell is also leery of how fast new drugs become available to patients these days: The human studies Bayer conducts before a drug like Yasmin or Yaz hits the market are usually no longer than a year and can be as short as three months. Instead, Health Canada relies on what’s called post-market surveillance, which involves waiting for adverse reaction reports to roll in once a drug has been prescribed. Effectively, this means that users of any newly approved drug serve as guinea pigs.
He’s also highly skeptical of the SOGC. “I’ve [seen] material from [them] that, without question, contained information straight from the manufacturer. Plus, you throw in a few million dollars of grants … Before doctors even know it, they’re repeating the same information.” This line of thinking is echoed by Baer, the class-action lawyer. “I do not think you would need to do much digging to see Bayer’s influence on SOGC,” he wrote in an email to me. (The SOGC, to whom doctors turn for guidance on clinical practice guidelines, is partially funded by pharmaceutical companies like Bayer; it’s also interesting to note that the SOGC’s wording on the risks associated with Yasmin and Yaz is nearly identical to that on the products’ packaging. However, that may have more to do with Health Canada’s influence—it approves all product monographs, and the SOGC looks to it for direction.)
Doctors should protect their patients from the powers of the pharmaceutical industry, and yet, “the infiltration is so sophisticated,” says Bell. Even as a third-year medical student 40 years ago, he was offered free birth control pills for his wife.
Anne Rochon Ford, executive director of the watchdog group Canadian Women’s Health Network, describes the “tremendous force” of the contraception industry in particular: “Our society has bought a very convenient line that hormonal birth control is safe, that the problems associated with side effects are minimal and the harms of becoming pregnant unexpectedly far exceed any harms from artificial hormones.” This line, she says, “has been nicely spoon-fed to us by those who stand to profit the most from the proliferation of it.”
While her comments are provocative, she isn’t anti-drug. Instead, she says we need “tighter regulation around drug testing, marketing and post-market surveillance than we currently have.”
Four years after her hospitalization, Wolfe has joined the Yasmin class action led by Baer’s firm and is active on its Facebook page, “Take Your Body Back.” The page has more than 7,000 likes (Bayer estimates that about 300,000 women in Ontario have been prescribed Yaz or Yasmin, but it won’t release numbers for the rest of Canada). Wolfe shared her story on the message wall and spent hours scrolling through other posts. “It gives me comfort,” she says, “that this product could be taken off the market.”
Bell says women who are worried about their birth control should ask their doctors where they learned about the medication. Did they get drug information in the mail? Are the pamphlets they hand out provided by drug manufacturers?
In other words, he’s less concerned with what type of pill women choose than he is interested in teaching us to question how the drug industry works. While some may argue the bad press around Yasmin and Yaz was a media pile-on, he sees the controversy as a way in: an opportunity to tell the larger story about how doctors choose which brands to prescribe.
“Drugs like Yasmin come on the market and seem wonderful, until something terrible happens,” Bell says. “I’m hoping that when people see a story like this, they start with the dramatic elements, but then go deeper. It’s not just Yasmin that’s the problem, it’s the system that spits up a new Yasmin every now and then.”
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